Healthy Volunteers (Meningococcal Infection)Phase 3NCT03691610
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
A Phase 3 study testing Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine, Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine and Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine in people with Healthy Volunteers (Meningococcal Infection), run by Sanofi Pasteur, a Sanofi Company at 47 sites in 2 countries.
Trial summary
The primary objective of this study is to demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with routine pediatric vaccines to infants and… Read more about this study
- Who is it for?
- Ages 6 to 19 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers (Meningococcal Infection)
- What is being tested?
- Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine, Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine and Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 950 participants
- Where
- 47 sitesin 2 countries
- Study dates
- 4 Oct 2018to 20 Oct 2023
- Phase
- Phase 3
- 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 6 to 19 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 6 to 7 months (168 to 224 days) or 17 to 19 months on the day of the first visit
- Informed consent form has been signed and dated by the parent(s) or other guardian and by an independent witness if required by local regulations
- Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
- For subjects 6 to 7 months of age at enrollment (Group 1 and Group 2), documented history of having received 2 doses of diphtheria, tetanus and acellular pertussis (DTaP), Haemophilus influenza type B (Hib), inactivated poliovirus (IPV), pneumococcal, hepatitis B (for children who received hepatitis B at 2 and 4 months of age, prior receipt of 3 doses of hepatitis B), and rotavirus vaccines
- For subjects to be enrolled at 17 to 19 months of age (Group 3 and Group 4), documented history of having received all routine pediatric vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) up to the age of enrollment
Who cannot join
- Participation at the time of study enrollment or in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks before and / or following any trial vaccination except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
- Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine)
- For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), prior receipt of more than 2 doses of rotavirus vaccine (Rotateq), DTaP, Hib, IPV, pneumococcal, hepatitis B (for children who received hepatitis B at 2 and 4 months of age, prior receipt of more than 3 doses of hepatitis B vaccine)
- For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), receipt of the 2 doses of rotavirus vaccine at 2 and 4 months of age
- Receipt of immune globulins, blood, or blood-derived products in the past 3 months
Show all 26Show fewer
- Known or suspected congenital or acquired immunodeficiency or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) within the past 3 months
- Family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated
- Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
- Individuals with active tuberculosis
- History of any Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically
- History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, hepatitis A, measles, mumps, rubella, varicella; and of Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection or disease
- At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease)
- History of intussusception
- History of any neurologic disorders, including any seizures and progressive neurologic disorders
- History of Arthus-type hypersensitivity reaction after a previous dose of tetanus toxoid-containing vaccine
- History of Guillain-Barré syndrome
- Known systemic hypersensitivity to any of the vaccine components or to latex, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances, including neomycin, gelatin, and yeast
- Verbal report of thrombocytopenia contraindicating intramuscular vaccination in the investigator's opinion
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the investigator's opinion
- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
- Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0 C [≥ 100.4 F]). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
- Identified as a natural or adopted child of the investigator or employee with direct involvement in the proposed study
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
47 sites in 2 countries.
47 sites in 2 countries
United States45 sites
MedPharmics Inc Site Number : 8400006
Albuquerque, New Mexico, 87102
Emmaus Research Center, Inc Site Number : 8400019
Anaheim, California, 92804
Victory Clinical Research Site Number : 8400026
Baltimore, Maryland, 21209
Meridian Clinical Research, LLC Site Number : 8400035
Baton Rouge, Louisiana, 70806
Tekton Research Site Number : 8400047
Beaumont, Texas, 77706
Coast Clinical Trials, LLC Site Number : 8400073
Bellflower, California, 90706
Alabama Clinical Therapeutics Site Number : 8400036
Birmingham, Alabama, 35205
Craig Spiegel, MD Site Number : 8400023
Bridgeton, Missouri, 63044
Coastal Pediatric Research Charleston Site Number : 8400002
Charleston, South Carolina, 29414
Coastal Pediatric Research Charleston Site Number : 8400011
Charleston, South Carolina, 29414
Eagle Clinical Research Site Number : 8400094
Chicago, Illinois, 60621
Ohio Pediatric Research Site Number : 8400022
Dayton, Ohio, 45414
PriMed Clinical Research Site Number : 8400008
Dayton, Ohio, 45419
Mercury Clinical Research, Inc. Site Number : 8400088
Dickinson, Texas, 77539
Southeastern Pediatric Associates Site Number : 8400009
Dothan, Alabama, 36305
Allegheny Health and Wellness Pavilion Site Number : 8400025
Erie, Pennsylvania, 16505
Pediatric Associates of Fall River Site Number : 8400112
Fall River, Massachusetts, 02721
Matrix Clinical Research Site Number : 8400082
Gardena, California, 90247
Tribe Clinical Research Site Number : 8400118
Greenville, South Carolina, 29607
Cyn3rgy Research Site Number : 8400010
Gresham, Oregon, 97030
Meridian Clinical Research Site Number : 8400097
Hastings, Nebraska, 68901
Kid's Way Pediatrics Site Number : 8400015
Hermitage, Pennsylvania, 16148
Next Phase Research Alliance Site Number : 8400044
Homestead, Florida, 33030
Clinical Trial Network - 7080 Southwest Fwy Site Number : 8400037
Houston, Texas, 77074-2085
Snake River Research, PLLC Site Number : 8400058
Idaho Falls, Idaho, 83404
PAS Research Site Number : 8400101
Land O' Lakes, Florida, 34639
Midwest Childrens Health Research Institute Site Number : 8400111
Lincoln, Nebraska, 68504
Midwest Childrens Health Research Institute Site Number : 8400117
Lincoln, Nebraska, 68505
Brownsboro Park Pediatrics Site Number : 8400039
Louisville, Kentucky, 40207
All Children Pediatrics Site Number : 8400024
Louisville, Kentucky, 40243
Axcess Medical Research Site Number : 8400021
Loxahatchee Groves, Florida, 33470
Madera Family Med Group Site Number : 8400065
Madera, California, 93637
Velocity Clinical Research Site Number : 8400016
Metairie, Louisiana, 70006
Y and L Advance Health Care, Inc D/B/A Elite Clinical Res Site Number : 8400046
Miami, Florida, 33144
Biomedical Research LLC Site Number : 8400041
Miami, Florida, 33186
Crystal Biomedical Research Site Number : 8400034
Miami Lakes, Florida, 33014
Advantage Clinical Trials Site Number : 8400069
New York, New York, 10468
MedPharmics, LLC - Phoenix Site Number : 8400013
Phoenix, Arizona, 85015
Omega Pediatrics Site Number : 8400093
Roswell, Georgia, 30076
Tekton Research, Inc. Site Number : 8400040
San Antonio, Texas, 78240
Willis-Knighton Physician Network Site Number : 8400075
Shreveport, Louisiana, 71105
PAS Research Site Number : 8400059
Tampa, Florida, 33613
Pediatric Clinical Trials Tullahoma Site Number : 8400106
Tullahoma, Tennessee, 37388
Oklahoma State University - Center for Health Sciences Site Number : 8400110
Tulsa, Oklahoma, 74127
Wilmington Health Site Number : 8400054
Wilmington, North Carolina, 28405
Puerto Rico2 sites
Investigational Site Number : 6300102
Guayama, 007874
Investigational Site Number : 6300014
San Juan, 00918
About this study
Official title: Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
The primary objective of this study is to demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with routine pediatric vaccines to infants and toddlers 6 to 7 months of age and 12 to 13 months of age.
The secondary objectives of the study are:
- To demonstrate the non-inferiority of the percentage of participants with antibody titers to meningococcal serogroups A, C, Y, and W ≥ 1:8 following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with pediatric routine vaccines to infants and toddlers at 6 to 7 months of age and 12 to 13 months of age.
- To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 12 to 13 months of age with MenACYW conjugate vaccine or MENVEO®.
- To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days and 6 months after the first vaccination at 6 to 7 months of age with MenACYW conjugate vaccine or MENVEO®.
- To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 20 to 23 months of age with MenACYW conjugate vaccine or Menactra®.
Read the detailed description
Study duration per participant is approximately 1 year in Group 1 and Group 2, and 10 months in Group 3 and Group 4. This duration includes a safety follow-up contact at 6 months after the last vaccination.
- Being tested
- Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine, Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine, Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine, Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccineBiological
Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate VaccineBiological
Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate VaccineBiological
Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate VaccineBiological
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus VaccineBiological
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
Haemophilus b Conjugate VaccineBiological
Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
Pneumococcal 13-valent Conjugate VaccineBiological
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
Rotavirus Vaccine, Live, Oral, PentavalentBiological
Pharmaceutical form:Oral solution Route of administration: Oral, 2 mL
Hepatitis B VaccineBiological
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
Measles, Mumps, and Rubella Virus Vaccine LiveBiological
Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL
Varicella Virus Vaccine LiveBiological
Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | MenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age Receives: Biological: Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine; Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine; Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine; Biological: Haemophilus b Conjugate Vaccine; Biological: Pneumococcal 13-valent Conjugate Vaccine; Biological: Rotavirus Vaccine, Live, Oral, Pentavalent; Biological: Hepatitis B Vaccine; Biological: Measles, Mumps, and Rubella Virus Vaccine Live; Biological: Varicella Virus Vaccine Live |
| Group 2 | Active comparator | MENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age Receives: Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine; Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine; Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine; Biological: Haemophilus b Conjugate Vaccine; Biological: Pneumococcal 13-valent Conjugate Vaccine; Biological: Rotavirus Vaccine, Live, Oral, Pentavalent; Biological: Hepatitis B Vaccine; Biological: Measles, Mumps, and Rubella Virus Vaccine Live; Biological: Varicella Virus Vaccine Live |
| Group 3 | Experimental | MenACYW conjugate vaccine at 17 to 19 months of age and 20 to 23 months of age Receives: Biological: Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine |
| Group 4 | Active comparator | Menactra® at 17 to 19 months of age and 20 to 23 months of age Receives: Biological: Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination titer >= 1:16 for participants with pre-vaccination hSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase from baseline for participant with pre-vaccination hSBA titer >= 1:8.
Measured: Baseline (Day 0) and 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO, maximum of 14 months
Secondary outcomes (11)
Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Seroprotection rate was defined as percentage of participants with hSBA titers >= 1:8.
Measured: At 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 1:4 and >= 1:8 were analyzed. PPAS1= Per-Protocol Analysis Set 1; FAS1= Full analysis set 1; PPAS3= Per-Protocol Analysis Set 3; and FAS3= Full analysis set 3.
Measured: PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO
Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers.
Measured: PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 1:4 to >= 1:128 were analyzed.
Measured: PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 4-fold increase from baseline (pre-vaccination) were analyzed.
Measured: PPAS1: At 30 days post first dose (6 to 7 MoA); and PPAS2: At 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO
Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post First Dose of MenACYW Conjugate Vaccine or MENVEO
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA vaccine seroresponse which was defined as >= 4-fold increase from baseline (pre-vaccination) were analyzed.
Measured: At 30 days post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 1:4 and >= 1:8 were analyzed.
Measured: Baseline (Day 0) and 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers.
Measured: Baseline (Day 0) and 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 1:4 to >= 1:128 were analyzed.
Measured: Baseline (Day 0) and at 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers >= 4-fold increase from baseline (pre-vaccination) were analyzed.
Measured: At 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
Toddlers Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or Menactra
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA vaccine seroresponse which was defined as >= 4-fold increase from baseline (pre-vaccination) were analyzed.
Measured: At 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start4 Oct 2018
- Primary completion20 Oct 2023
- Study completion20 Oct 2023
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 Healthy Volunteers (Meningococcal Infection)Studies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 950 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691610
- Sponsor's protocol ID
- MET61
- Other IDs
- U1111-1205-2836, MET61, 2019-004460-22, 2019
- Status last verified
- Jun 2024
- First submitted
- 28 Sep 2018
- Last updated
- 25 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
Duffy C, Lyabis O, Dhingra MS, Zambrano B, Chaix J, Syrkina O, B'Chir S, Gupta S, Rehm C. Meningococcal quadrivalent ACYW-TT conjugated vaccine at 6-23 months: phase III study (US/Puerto Rico). Pediatr Res. 2026 Mar 6. doi: 10.1038/s41390-026-04833-8. Online ahead of print.
PubMed 41792337
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
- ClinicalTrials.gov ID
- NCT03691610
- Acronym / sponsor ID
- MET61
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 950 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 2 Oct 2018 (actual)
- Results
- Posted 25 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with routine pediatric vaccines to infants and toddlers 6 to 7 months of age and 12 to 13 months of age.
The secondary objectives of the study are:
- To demonstrate the non-inferiority of the percentage of participants with antibody titers to meningococcal serogroups A, C, Y, and W ≥ 1:8 following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with pediatric routine vaccines to infants and toddlers at 6 to 7 months of age and 12 to 13 months of age.
- To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 12 to 13 months of age with MenACYW conjugate vaccine or MENVEO®.
- To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days and 6 months after the first vaccination at 6 to 7 months of age with MenACYW conjugate vaccine or MENVEO®.
- To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 20 to 23 months of age with MenACYW conjugate vaccine or Menactra®.
Detailed description
Study duration per participant is approximately 1 year in Group 1 and Group 2, and 10 months in Group 3 and Group 4. This duration includes a safety follow-up contact at 6 months after the last vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine, Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine, Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine, Biological: Haemophilus b Conjugate Vaccine, Biological: Pneumococcal 13-valent Conjugate Vaccine, Biological: Rotavirus Vaccine, Live, Oral, Pentavalent, Biological: Hepatitis B Vaccine, Biological: Measles, Mumps, and Rubella Virus Vaccine Live, Biological: Varicella Virus Vaccine LiveMenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age |
| Group 2 | Active comparator | Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine, Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine, Biological: Haemophilus b Conjugate Vaccine, Biological: Pneumococcal 13-valent Conjugate Vaccine, Biological: Rotavirus Vaccine, Live, Oral, Pentavalent, Biological: Hepatitis B Vaccine, Biological: Measles, Mumps, and Rubella Virus Vaccine Live, Biological: Varicella Virus Vaccine LiveMENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age |
| Group 3 | Experimental | Biological: Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccineMenACYW conjugate vaccine at 17 to 19 months of age and 20 to 23 months of age |
| Group 4 | Active comparator | Biological: Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate VaccineMenactra® at 17 to 19 months of age and 20 to 23 months of age |
Who may qualify
- Ages
- 6 to 19 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 6 to 7 months (168 to 224 days) or 17 to 19 months on the day of the first visit
- Informed consent form has been signed and dated by the parent(s) or other guardian and by an independent witness if required by local regulations
- Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
- For subjects 6 to 7 months of age at enrollment (Group 1 and Group 2), documented history of having received 2 doses of diphtheria, tetanus and acellular pertussis (DTaP), Haemophilus influenza type B (Hib), inactivated poliovirus (IPV), pneumococcal, hepatitis B (for children who received hepatitis B at 2 and 4 months of age, prior receipt of 3 doses of hepatitis B), and rotavirus vaccines
- For subjects to be enrolled at 17 to 19 months of age (Group 3 and Group 4), documented history of having received all routine pediatric vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) up to the age of enrollment
Key exclusion criteria (26 listed)
- Participation at the time of study enrollment or in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks before and / or following any trial vaccination except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
- Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine)
- For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), prior receipt of more than 2 doses of rotavirus vaccine (Rotateq), DTaP, Hib, IPV, pneumococcal, hepatitis B (for children who received hepatitis B at 2 and 4 months of age, prior receipt of more than 3 doses of hepatitis B vaccine)
- For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), receipt of the 2 doses of rotavirus vaccine at 2 and 4 months of age
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 |
|---|---|---|
| Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccinePharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL | Biological | Group 1, Group 3 |
| Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate VaccinePharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL | Biological | Group 2 |
| Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate VaccinePharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL | Biological | Group 4 |
| Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate VaccinePharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL | Biological | Group 1, Group 2 |
| Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus VaccinePharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL | Biological | Group 1, Group 2 |
| Haemophilus b Conjugate VaccinePharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL | Biological | Group 1, Group 2 |
| Pneumococcal 13-valent Conjugate VaccinePharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL | Biological | Group 1, Group 2 |
| Rotavirus Vaccine, Live, Oral, PentavalentPharmaceutical form:Oral solution Route of administration: Oral, 2 mL | Biological | Group 1, Group 2 |
| Hepatitis B VaccinePharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL | Biological | Group 1, Group 2 |
| Measles, Mumps, and Rubella Virus Vaccine LivePharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL | Biological | Group 1, Group 2 |
| Varicella Virus Vaccine LivePharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL | Biological | Group 1, Group 2 |
Primary outcome
Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO
Time frame: Baseline (Day 0) and 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO, maximum of 14 months
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination titer >= 1:16 for participants with pre-vaccination hSBA titer < 1:8, or a post-vaccination titer >= 4-fold increase from baseline for participant with pre-vaccination hSBA titer >= 1:8.
11 secondary outcomes
Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO
Time frame: At 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8
Time frame: PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO
Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Time frame: PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128
Time frame: PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO
Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination
Time frame: PPAS1: At 30 days post first dose (6 to 7 MoA); and PPAS2: At 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO
Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post First Dose of MenACYW Conjugate Vaccine or MENVEO
Time frame: At 30 days post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8
Time frame: Baseline (Day 0) and 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
Time frame: Baseline (Day 0) and 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128
Time frame: Baseline (Day 0) and at 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination
Time frame: At 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
Toddlers Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or Menactra
Time frame: At 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41792337Duffy C, Lyabis O, Dhingra MS, Zambrano B, Chaix J, Syrkina O, B'Chir S, Gupta S, Rehm C. Meningococcal quadrivalent ACYW-TT conjugated vaccine at 6-23 months: phase III study (US/Puerto Rico). Pediatr Res. 2026 Mar 6. doi: 10.1038/s41390-026-04833-8. Online ahead of print.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Related trials for Healthy Volunteers (Meningococcal Infection)
RecruitingPhase 3
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
Meningococcal Infection, Healthy Volunteers
Active, not recruitingPhase 1/2
Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants
Meningococcal Immunization, Healthy Volunteers
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.
Clinical Sciences & Operations study director
Sanofi Pasteur, a Sanofi Company
47 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine, Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine and Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine in people with Healthy Volunteers (Meningococcal Infection), run by Sanofi Pasteur, a Sanofi Company at 47 sites in 2 countries.
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 26 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 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 25 Jun 2024). 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?
Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO (time frame: Baseline (Day 0) and 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO, maximum of 14 months). 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 NCT03691610, 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 25 Jun 2024.