Meningococcal VaccinePhase 2NCT04440176
A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules
A Phase 2 study testing MenABCWY and Saline in people with Meningococcal Vaccine, run by Pfizer at 20 sites in United States.
Trial summary
This study is designed to describe the short-term immunogenicity and safety of 2 doses of Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) separated by either 12 or 36 months during adolescence, and immunopersistence up to 24 months after completing 2 doses separated by a 12-month interval. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Vaccine
- What is being tested?
- MenABCWY and Saline
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 20 sitesUnited States
- Study dates
- 17 Jun 2020to 5 Jan 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female participants 11 through <15 years of age at the time of randomization.
- Participants who have never received a prior dose of any meningococcal vaccine. Written confirmation of vaccination history must be obtained prior to randomization.
- Available for the entire study period and can be reached by telephone.
- Healthy participant as determined by medical history, physical examination, and judgement of the investigator.
- Negative urine pregnancy test for all female participants; pregnancy test is not applicable to male participants.
Who cannot join
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as participants with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy.
- History of microbiologically proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae.
- Significant neurological disorder or history of seizure (excluding simple febrile seizure).
- Any neuroinflammatory or autoimmune condition, including, but no limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
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- Participants receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
- Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination.
- Current use of systemic antibiotics with no foreseeable date of discontinuation prior to anticipated date of enrollment (first vaccination).
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, 22902
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45206
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Ohio Pediatric Research Association Inc.
Dayton, Ohio, 45414
Benchmark Research
Fort Worth, Texas, 76135
Texas Health Resources
Fort Worth, Texas, 76135
Wee Care Pediatrics
Kaysville, Utah, 84037
AMR Clinical
Mobile, Alabama, 36608
Wasatch Pediatrics, Cottonwood Office
Murray, Utah, 84107
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, 68701
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Utah Valley Pediatrics - Timpanogos Office
Orem, Utah, 84057
Nona Pediatric Center
Orlando, Florida, 32829
AMR Clinical
Roy, Utah, 84067
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121
Diagnostics Research Group
San Antonio, Texas, 78229
California Research Foundation
San Diego, California, 92123
AMR Clinical
South Jordan, Utah, 84095
Wee Care Pediatrics
Syracuse, Utah, 84075
About this study
Official title: A PHASE 2b, RANDOMIZED, OBSERVER-BLINDED TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY ADMINISTERED ON 2 DIFFERENT DOSING SCHEDULES IN HEALTHY PARTICIPANTS ≥11 TO <15 YEARS OF AGE
This study is designed to describe the short-term immunogenicity and safety of 2 doses of Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) separated by either 12 or 36 months during adolescence, and immunopersistence up to 24 months after completing 2 doses separated by a 12-month interval.
- Conditions
- Meningococcal Vaccine
- Being tested
- MenABCWY, Saline
- Keywords
- pentavalent meningococcal vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenABCWYBiological
Also called pentavalent meningococcal vaccine
Neisseria meningitidis group A, B, C, W, and Y vaccine
SalineBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (MenABCWY 0-, 12-months) | Experimental | MenABCWY administered at Month 0 and Month 12 Receives: Biological: MenABCWY |
| Group 2 (MenABCWY 0-, 36-months) | Experimental | MenABCWY administered at Month 0 and Month 36 Receives: Biological: MenABCWY; Biological: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MenB) Test Strains at Baseline: 0 and 12 Month Schedule
Percentage of participants achieving hSBA titer >=LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for each of the 4 primary MenB test strains at baseline were reported in this outcome measure. Here, 'Post Vaccination 2 Evaluable Population'=PV2 EP and "Number analyzed" = number of participants evaluable at specific rows.
Measured: Baseline (before vaccination 1)
Percentage of Participants With hSBA Titer >=LLOQ for Each of the 4 Primary MenB Test Strains at 1 Month After Vaccination 2: 0 and 12 Month Schedule
Percentage of participants achieving hSBA titer >=LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for each of the 4 primary MenB test strains at 1 month after vaccination 2 in participants who received MenABCWY at Month 0 and Month 12 were reported in this outcome measure. "Number analyzed" = number of participants evaluable at specific rows.
Measured: 1 month after vaccination 2 (second dose of MenABCWY)
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MenB Test Strains at Baseline: 0 and 36 Month Schedule
Percentage of participants achieving hSBA titer >=LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for each of the 4 primary MenB test strains at baseline were reported in this outcome measure. "Number of Participants Analyzed"= number of participants evaluable for this outcome measure and "Number analyzed" = number of participants evaluable at specific rows.
Measured: Baseline (before vaccination 1)
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MenB Test Strains at 1 Month After Vaccination 3: 0 and 36 Month Schedule
Percentage of participants achieving hSBA titer >=LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for each of the 4 primary MenB test strains at 1 month after vaccination 3 (second dose of MenABCWY) in participants who received MenABCWY at Month 0 and Month 36. "Number of Participants Analyzed"= number of participants evaluable for this outcome measure and "Number analyzed" = number of participants evaluable at specific rows.
Measured: 1 Month After Vaccination 3 (second dose of MenABCWY)
Percentage of Participants Reporting Adverse Events (AEs) Within 30 Days After Vaccination 1: 0 and 12 Month Schedule
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Measured: Within 30 days after vaccination 1 (first dose of MenABCWY)
Percentage of Participants Reporting AEs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Measured: Within 30 days after vaccination 2 (second dose of MenABCWY)
Percentage of Participants Reporting AEs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Measured: Within 30 days after vaccination 1 (first dose of MenABCWY)
Percentage of Participants Reporting AEs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Measured: Within 30 days after vaccination 2 (saline)
Percentage of Participants Reporting AEs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Measured: Within 30 days after vaccination 3 (second dose of MenABCWY)
Percentage of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Newly Diagnosed Chronic Medical Condition (NDCMCs) Within 30 Days After Vaccination 1: 0 and 12 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a non-serious AE (other than serious AE) that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: Within 30 days after vaccination 1 (First dose of MenABCWY)
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: Within 30 days after vaccination 2 (Second dose of MenABCWY)
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: Within 30 days after vaccination 1 (First dose of MenABCWY)
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: Within 30 days after vaccination 2 (Saline)
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: Within 30 days after vaccination 3 (Second dose of MenABCWY)
Percentage of Participants Reporting AEs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Measured: Within 30 Days after any MenABCWY vaccination
Percentage of Participants Reporting AEs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Measured: Within 30 days after any MenABCWY vaccination
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: Within 30 days after any MenABCWY vaccination
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: Within 30 days after any MenABCWY vaccination
Percentage of Participants Reporting AEs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Measured: From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)
Percentage of Participants Reporting AEs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Measured: Vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)
Percentage of Participants Reporting AEs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Measured: From vaccination 2 through 1 month after vaccination 2 (Second dose of MenABCWY)
Percentage of Participants Reporting AEs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Measured: From vaccination 2 through 1 month after vaccination 2 (Saline)
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: From vaccination 2 through 1 month after vaccination 2 (Second dose of MenABCWY)
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: From vaccination 2 through 1 month after vaccination 2 (Saline)
Percentage of Participants Reporting AEs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Measured: From vaccination 3 through 1 month after vaccination 3 (Second dose of MenABCWY)
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: From vaccination 3 through 1 month after vaccination 3 (Second dose of MenABCWY)
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: From 1 month after vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: From 1 month after vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: From 1 month after vaccination 2 through 6 months after vaccination 2 (Second dose of MenABCWY)
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: From 1 month after vaccination 2 through 6 months after vaccination 2 (Saline)
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: From vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: From vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: From vaccination 2 through 6 months after vaccination 2 (Second dose of MenABCWY)
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Measured: From vaccination 2 through 6 months after vaccination 2 (Saline)
Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 1: 0 and 12 Month Schedule
Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.
Measured: 30 minutes after vaccination 1 (First dose of MenABCWY)
Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 2: 0 and 12 Month Schedule
Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.
Measured: 30 minutes after vaccination 2 (Second dose of MenABCWY)
Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 1: 0 and 36 Month Schedule
Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.
Measured: 30 minutes after vaccination 1 (First dose of MenABCWY)
Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 2: 0 and 36 Month Schedule
Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.
Measured: 30 minutes after vaccination 2 (Saline)
Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 3: 0 and 36 Month Schedule
Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.
Measured: 30 minutes after vaccination 3 (Second dose of MenABCWY)
Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 1: 0 and 12 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Measured: Within 6 months after vaccination 1 (First dose of MenABCWY)
Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 1: 0 and 36 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Measured: Within 6 months after vaccination 1 (First dose of MenABCWY)
Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 2: 0 and 12 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Measured: Within 6 months after vaccination 2 (Second dose of MenABCWY)
Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 2: 0 and 36 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Measured: Within 6 months after vaccination 2 (Saline)
Percentage of Participants Who Missed School or Work Because of AEs Within 1 Month After Vaccination 3: 0 and 36 Month Schedule
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Measured: Within 1 month after vaccination 3 (Second dose of MenABCWY)
Secondary outcomes (6)
Percentage of Participants With hSBA Titer >= LLOQ for Each of the Meningococcal Group A, C, W, and Y (MenACWY) Test Strains at Baseline and 1 Month After the First Dose of MenABCWY: 0 and 12 Month Schedule-Post-Vaccination 1 Evaluable Population
Percentage of participants achieving hSBA titer >=LLOQ (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY serogroups) for each of the MenACWY test strains at baseline and one month after first dose of MenABCWY in participants who received the first dose of MenABCWY were reported in this outcome measure. "Number analyzed" = number of participants evaluable at specific rows.
Measured: Baseline (before vaccination 1) and 1 month after the first dose of MenABCWY
Percentage of Participants With hSBA Titer >= LLOQ for Each of the MenACWY Test Strains at Baseline and 1 Month After the Second Dose of MenABCWY: 0 and 12 Month Schedule-Post-Vaccination 2 Evaluable Population
Percentage of participants achieving hSBA titer >=LLOQ (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY serogroups) for each of the MenACWY test strains at baseline and one month after second dose of MenABCWY in participants who received the first and second dose of MenABCWY were reported in this outcome measure. "Number analyzed" = number of participants evaluable at specific rows.
Measured: Baseline (before vaccination 1) and 1 month after the second dose of MenABCWY
Percentage of Participants With hSBA Titer >=LLOQ for Each of the MenACWY Test Strains at Baseline and 1 Month After First Dose of MenABCWY: 0 and 36 Month Schedule-Post-Vaccination 1 Evaluable Population
Percentage of participants achieving hSBA titer >=LLOQ (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY serogroups) for each of the MenACWY test strains at baseline and one month after first dose of MenABCWY in participants who received who received the first dose of MenABCWY were reported in this outcome measure. "Number analyzed" = number of participants evaluable at specific rows.
Measured: Baseline (before vaccination 1) and 1 month after first dose of MenABCWY
Percentage of Participants With hSBA Titer >=LLOQ for Each of the MenACWY Test Strains at Baseline and 1 Month After Second Dose of MenABCWY: 0 and 36 Month Schedule-Post-Vaccination 2 Evaluable Population
Percentage of participants achieving hSBA titer >=LLOQ (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY serogroups) for each of the meningococcal group A, C, W, and Y (MenACWY) test strains at baseline and one month after second dose of MenABCWY in participants who received the first and second dose of MenABCWY were reported in this outcome measure. "Number of Participants Analyzed"= number of participants evaluable for this outcome measure and "Number analyzed" = number of participants evaluable at specific rows.
Measured: Baseline (before vaccination 1) and 1 month after second dose of MenABCWY
Percentage of Participants With hSBA Titer >=LLOQ for Each of the 4 Primary MenB Test Strains at 12 Months and 24 Months After Vaccination 2: 0 and 12 Month Schedule
Percentage of participants achieving hSBA titer >=LLOQ for each of the 4 primary MenB test strains (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) at 12 and 24 months after the second dose of MenABCWY were reported in this outcome measure. "Number of Participants Analyzed"= number of participants evaluable for this outcome measure and "Number analyzed" = number of participants evaluable at specific rows.
Measured: At 12 months and 24 months after vaccination 2 (Second dose of MenABCWY)
Percentage of Participants With hSBA Titer >=LLOQ for Each ACWY Test Strains at 12 Months and 24 Months After Vaccination 2: 0 and 12 Month Schedule
Percentage of participants achieving hSBA titer >=LLOQ (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY serogroups) for each of the ACWY test (MenA, MenC, MenW, MenY) at 12 and 24 months after the second dose of MenABCWY2 were reported in this outcome measure. "Number of Participants Analyzed"= number of participants evaluable for this outcome measure and "Number analyzed" = number of participants evaluable at specific rows.
Measured: At 12 months and 24 months after vaccination 2 (Second dose of MenABCWY)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start17 Jun 2020
- Primary completion5 Jan 2024
- Study completion5 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meningococcal VaccineStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440176
- Sponsor's protocol ID
- C3511004
- Other IDs
- 2019-004923-19, 2019
- Status last verified
- Apr 2026
- First submitted
- 15 Jun 2020
- Last updated
- 27 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Publications
Jones JC, Tipton MD, Zolotas L, Maguire JD, Belanger K, Liu Y, Maansson R, O'Neill RE, Balmer P, Peyrani P, Beeslaar J. Immunogenicity and Safety of Extended Dosing Intervals for Pfizer Pentavalent MenABCWY Meningococcal Vaccination in Healthy Adolescents: Results from a Randomized, Phase 2b Study. Vaccines (Basel). 2026 Apr 15;14(4):352. doi: 10.3390/vaccines14040352.
PubMed 42042828
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 2b, RANDOMIZED, OBSERVER-BLINDED TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY ADMINISTERED ON 2 DIFFERENT DOSING SCHEDULES IN HEALTHY PARTICIPANTS ≥11 TO <15 YEARS OF AGE
- ClinicalTrials.gov ID
- NCT04440176
- Acronym / sponsor ID
- C3511004
- Conditions
- Meningococcal Vaccine
- Keywords
- pentavalent meningococcal vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 19 Jun 2020 (actual)
- Results
- Posted 8 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to describe the short-term immunogenicity and safety of 2 doses of Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) separated by either 12 or 36 months during adolescence, and immunopersistence up to 24 months after completing 2 doses separated by a 12-month interval.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (MenABCWY 0-, 12-months) | Experimental | Biological: MenABCWYMenABCWY administered at Month 0 and Month 12 |
| Group 2 (MenABCWY 0-, 36-months) | Experimental | Biological: MenABCWY, Biological: SalineMenABCWY administered at Month 0 and Month 36 |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or female participants 11 through <15 years of age at the time of randomization.
- Participants who have never received a prior dose of any meningococcal vaccine. Written confirmation of vaccination history must be obtained prior to randomization.
- Available for the entire study period and can be reached by telephone.
- Healthy participant as determined by medical history, physical examination, and judgement of the investigator.
- Negative urine pregnancy test for all female participants; pregnancy test is not applicable to male participants.
Key exclusion criteria (9 listed)
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as participants with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy.
- History of microbiologically proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae.
- Significant neurological disorder or history of seizure (excluding simple febrile seizure).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MenABCWYAlso: pentavalent meningococcal vaccineNeisseria meningitidis group A, B, C, W, and Y vaccine | Biological | Group 1 (MenABCWY 0-, 12-months), Group 2 (MenABCWY 0-, 36-months) |
| SalinePlacebo | Biological | Group 2 (MenABCWY 0-, 36-months) |
Primary outcome
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MenB) Test Strains at Baseline: 0 and 12 Month Schedule
Time frame: Baseline (before vaccination 1)
Percentage of participants achieving hSBA titer >=LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for each of the 4 primary MenB test strains at baseline were reported in this outcome measure. Here, 'Post Vaccination 2 Evaluable Population'=PV2 EP and "Number analyzed" = number of participants evaluable at specific rows.
Percentage of Participants With hSBA Titer >=LLOQ for Each of the 4 Primary MenB Test Strains at 1 Month After Vaccination 2: 0 and 12 Month Schedule
Time frame: 1 month after vaccination 2 (second dose of MenABCWY)
Percentage of participants achieving hSBA titer >=LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for each of the 4 primary MenB test strains at 1 month after vaccination 2 in participants who received MenABCWY at Month 0 and Month 12 were reported in this outcome measure. "Number analyzed" = number of participants evaluable at specific rows.
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MenB Test Strains at Baseline: 0 and 36 Month Schedule
Time frame: Baseline (before vaccination 1)
Percentage of participants achieving hSBA titer >=LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for each of the 4 primary MenB test strains at baseline were reported in this outcome measure. "Number of Participants Analyzed"= number of participants evaluable for this outcome measure and "Number analyzed" = number of participants evaluable at specific rows.
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MenB Test Strains at 1 Month After Vaccination 3: 0 and 36 Month Schedule
Time frame: 1 Month After Vaccination 3 (second dose of MenABCWY)
Percentage of participants achieving hSBA titer >=LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for each of the 4 primary MenB test strains at 1 month after vaccination 3 (second dose of MenABCWY) in participants who received MenABCWY at Month 0 and Month 36. "Number of Participants Analyzed"= number of participants evaluable for this outcome measure and "Number analyzed" = number of participants evaluable at specific rows.
Percentage of Participants Reporting Adverse Events (AEs) Within 30 Days After Vaccination 1: 0 and 12 Month Schedule
Time frame: Within 30 days after vaccination 1 (first dose of MenABCWY)
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting AEs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule
Time frame: Within 30 days after vaccination 2 (second dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting AEs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule
Time frame: Within 30 days after vaccination 1 (first dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting AEs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule
Time frame: Within 30 days after vaccination 2 (saline)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting AEs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule
Time frame: Within 30 days after vaccination 3 (second dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Newly Diagnosed Chronic Medical Condition (NDCMCs) Within 30 Days After Vaccination 1: 0 and 12 Month Schedule
Time frame: Within 30 days after vaccination 1 (First dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a non-serious AE (other than serious AE) that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule
Time frame: Within 30 days after vaccination 2 (Second dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule
Time frame: Within 30 days after vaccination 1 (First dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule
Time frame: Within 30 days after vaccination 2 (Saline)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule
Time frame: Within 30 days after vaccination 3 (Second dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting AEs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule
Time frame: Within 30 Days after any MenABCWY vaccination
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting AEs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule
Time frame: Within 30 days after any MenABCWY vaccination
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule
Time frame: Within 30 days after any MenABCWY vaccination
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule
Time frame: Within 30 days after any MenABCWY vaccination
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting AEs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule
Time frame: From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting AEs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule
Time frame: Vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule
Time frame: From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule
Time frame: From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting AEs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule
Time frame: From vaccination 2 through 1 month after vaccination 2 (Second dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting AEs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule
Time frame: From vaccination 2 through 1 month after vaccination 2 (Saline)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule
Time frame: From vaccination 2 through 1 month after vaccination 2 (Second dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule
Time frame: From vaccination 2 through 1 month after vaccination 2 (Saline)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting AEs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule
Time frame: From vaccination 3 through 1 month after vaccination 3 (Second dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule
Time frame: From vaccination 3 through 1 month after vaccination 3 (Second dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule
Time frame: From 1 month after vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule
Time frame: From 1 month after vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule
Time frame: From 1 month after vaccination 2 through 6 months after vaccination 2 (Second dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule
Time frame: From 1 month after vaccination 2 through 6 months after vaccination 2 (Saline)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule
Time frame: From vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule
Time frame: From vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule
Time frame: From vaccination 2 through 6 months after vaccination 2 (Second dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule
Time frame: From vaccination 2 through 6 months after vaccination 2 (Saline)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 1: 0 and 12 Month Schedule
Time frame: 30 minutes after vaccination 1 (First dose of MenABCWY)
Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.
Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 2: 0 and 12 Month Schedule
Time frame: 30 minutes after vaccination 2 (Second dose of MenABCWY)
Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.
Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 1: 0 and 36 Month Schedule
Time frame: 30 minutes after vaccination 1 (First dose of MenABCWY)
Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.
Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 2: 0 and 36 Month Schedule
Time frame: 30 minutes after vaccination 2 (Saline)
Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.
Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 3: 0 and 36 Month Schedule
Time frame: 30 minutes after vaccination 3 (Second dose of MenABCWY)
Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.
Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 1: 0 and 12 Month Schedule
Time frame: Within 6 months after vaccination 1 (First dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 1: 0 and 36 Month Schedule
Time frame: Within 6 months after vaccination 1 (First dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 2: 0 and 12 Month Schedule
Time frame: Within 6 months after vaccination 2 (Second dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 2: 0 and 36 Month Schedule
Time frame: Within 6 months after vaccination 2 (Saline)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Percentage of Participants Who Missed School or Work Because of AEs Within 1 Month After Vaccination 3: 0 and 36 Month Schedule
Time frame: Within 1 month after vaccination 3 (Second dose of MenABCWY)
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product.
6 secondary outcomes
Percentage of Participants With hSBA Titer >= LLOQ for Each of the Meningococcal Group A, C, W, and Y (MenACWY) Test Strains at Baseline and 1 Month After the First Dose of MenABCWY: 0 and 12 Month Schedule-Post-Vaccination 1 Evaluable Population
Time frame: Baseline (before vaccination 1) and 1 month after the first dose of MenABCWY
Percentage of Participants With hSBA Titer >= LLOQ for Each of the MenACWY Test Strains at Baseline and 1 Month After the Second Dose of MenABCWY: 0 and 12 Month Schedule-Post-Vaccination 2 Evaluable Population
Time frame: Baseline (before vaccination 1) and 1 month after the second dose of MenABCWY
Percentage of Participants With hSBA Titer >=LLOQ for Each of the MenACWY Test Strains at Baseline and 1 Month After First Dose of MenABCWY: 0 and 36 Month Schedule-Post-Vaccination 1 Evaluable Population
Time frame: Baseline (before vaccination 1) and 1 month after first dose of MenABCWY
Percentage of Participants With hSBA Titer >=LLOQ for Each of the MenACWY Test Strains at Baseline and 1 Month After Second Dose of MenABCWY: 0 and 36 Month Schedule-Post-Vaccination 2 Evaluable Population
Time frame: Baseline (before vaccination 1) and 1 month after second dose of MenABCWY
Percentage of Participants With hSBA Titer >=LLOQ for Each of the 4 Primary MenB Test Strains at 12 Months and 24 Months After Vaccination 2: 0 and 12 Month Schedule
Time frame: At 12 months and 24 months after vaccination 2 (Second dose of MenABCWY)
Percentage of Participants With hSBA Titer >=LLOQ for Each ACWY Test Strains at 12 Months and 24 Months After Vaccination 2: 0 and 12 Month Schedule
Time frame: At 12 months and 24 months after vaccination 2 (Second dose of MenABCWY)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42042828Jones JC, Tipton MD, Zolotas L, Maguire JD, Belanger K, Liu Y, Maansson R, O'Neill RE, Balmer P, Peyrani P, Beeslaar J. Immunogenicity and Safety of Extended Dosing Intervals for Pfizer Pentavalent MenABCWY Meningococcal Vaccination in Healthy Adolescents: Results from a Randomized, Phase 2b Study. Vaccines (Basel). 2026 Apr 15;14(4):352. doi: 10.3390/vaccines14040352.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MenABCWY and Saline in people with Meningococcal Vaccine, run by Pfizer at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MenB) Test Strains at Baseline: 0 and 12 Month Schedule (time frame: Baseline (before vaccination 1)). The study lists 46 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04440176, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.