Meningococcal VaccinePhase 4NCT04893811

Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immunocompromised Participants ≥10 Years of Age

A Phase 4 study testing Trumenba in people with Meningococcal Vaccine, run by Pfizer at 14 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of this study is to evaluate the safety, tolerability, and immunogenicity of 2 doses of Trumenba® (on a 0- and 6-month schedule) in immunocompromised participants by functionally assessing antibody production in asplenic and complement-deficient individuals ≥10 years of age. Read more about this study

Who is it for?: Ages 10 years and olderHealthy volunteers can take part
Conditions the study is for: Meningococcal Vaccine
What is being tested?: Trumenba
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 14 sitesin 3 countries
Study dates: 18 Aug 2021to 6 Sep 2023
Phase: Phase 4
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 10 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Male or female participants ≥10 years of age at the time of consent.
Participants with an increased risk for meningococcal disease due to anatomic asplenia or functional asplenia (eg, sickle cell anemia) or complement deficiencies.
Negative urine pregnancy test for all female participants.

Who cannot join

Previous vaccination with any meningococcal serogroup B vaccine.
Participants who are receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
Significant neurological disorder or history of seizure (excluding simple febrile seizure).
Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Any confirmed or suspected human immunodeficiency virus infection.

Show all 11Show fewer

Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Receipt of immunoglobulin infusion or injection during the 42 days preceding enrollment.
Current chronic use of systemic antibiotics.
Previous receipt or current use of complement inhibitors (eg, eculizumab, ravulizumab).
Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation.

Trial locations and contacts

14 sites in 3 countries.

Country

City, postcode or hospital

14 sites in 3 countries

Turkey (Türkiye)7 sites

Baskent Universitesi Dr. Turgut Noyan Adana Uygulama ve Arastirma Merkezi
Adana, Yüreği̇r, 01120
Baskent Universitesi Dr. Turgut Noyan Adana Uygulama ve Arastirma Merkezi
Adana, Yüreği̇r
Baskent Universitesi Dr. Turgut Noyan Adana Uygulama ve Arastirma Merkezi
Adana, 01120
Acibadem Adana Hastanesi
Adana, 01130
Baskent Universitesi Dr. Turgut Noyan Adana Uygulama ve Arastirma Merkezi
Adana, 01240
Hacettepe Universitesi Tip Fakultesi
Ankara, 06230
Mersin Universitesi Tip Fakultesi Hastanesi
Mersin, 33343

Other trials in Turkey (Türkiye)

Poland4 sites

IN-VIVO Sp. z o.o.
Bydgoszcz, 85-048
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
Krakow, 30-348
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728
Szpital Bielański im. Ks. Jerzego Popiełuszki SPZOZ
Warsaw, 01-809

Other trials in Poland

Czechia3 sites

Fakultni Nemocnice Brno - Detska Nemocnice - Klinika Detskych Infekcnich Nemoci Center 3
Brno, 613 00
Fakultni Nemocnice Brno - Detska Nemocnice - Klinika Detskych Infekcnich Nemoci Center 3
Brno, 61300
Fakultni nemocnice v Motole
Prague, 150 06

Other trials in Czechia

About this study

Official title: A PHASE 4, OPEN-LABEL, SINGLE-ARM TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF TRUMENBA(REGISTERED) WHEN ADMINISTERED TO IMMUNOCOMPROMISED PARTICIPANTS ≥10 YEARS OF AGE

Conditions: Meningococcal Vaccine
Being tested: Trumenba
Keywords: Meningococcal Vaccine, Meningitis Vaccine, Asplenia, Sickle cell anemia, Complement deficiencies
Medical subject headings: Anemia, Sickle Cell, Hereditary Complement Deficiency Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TrumenbaBiological
Bivalent recombinant lipoprotein 2086 vaccine

Study groups in NCT04893811
Study group	Role	What they receive
Single Arm	Experimental	Bivalent recombinant lipoprotein 2086 vaccine Receives: Biological: Trumenba

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 (MnB) Test Strains at Baseline
Four primary MnB strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). The percentage of participants who achieved an hSBA titer PMB80 (A22) more than or equal to (=>)1:16, and hSBA titer PMB2001 (A56), PMB2001 (B24), and PMB2707 (B44) =>1:8 are reported. Evaluable immunogenicity population (EIP) included all participants who were eligible through 1 month after Vaccination 2, received the study vaccination at Visit 1 and Visit 3 as planned, had blood drawn for assay testing within the required time frames at Visit 1 (before Vaccination 1) and 1 month after Vaccination 2 (28-42 days after Visit 3), had at least 1 valid and determinate assay result 1 month after Vaccination 2, received no prohibited vaccines or medications through Visit 4, and had no major protocol deviations through Visit 4.
Measured: Baseline (Before Vaccination 1 on Day 1/Month 0)
Percentage of Participants With hSBA Titer => LLOQ for Each of the 4 Primary MnB Test Strains at 1 Month After Vaccination 2
Four primary MnB strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). The percentage of participants who achieved an hSBA titer PMB80 (A22) =>1:16, and hSBA titer PMB2001 (A56), PMB2001 (B24), and PMB2707 (B44) =>1:8 were reported.
Measured: 1 Month after Vaccination 2 (Vaccination 2 at Month 6)
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1
Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. Each caliper unit = 0.5 centimeter (cm). Redness and swelling were graded as mild (more than [>]2.0 to 5.0cm), moderate (>5.0 to 10.0cm) and severe (>10.0cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Measured: Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2
Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. Each caliper unit = 0.5 cm. Redness and swelling were graded as mild (>2.0 to 5.0cm), moderate (>5.0 to 10.0cm) and severe (>10.0cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Measured: Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1
Systemic events included: fever, fatigue, headache, chills, muscle pain, joint pain, vomiting, and diarrhea. Fever classified as =>38.0 degree Celsius (C), 38.0-38.4, >38.4-38.9, >38.9 40.0 and >40.0-degree C. Fatigue, headache, chills, muscle pain and joint pain graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting graded as mild (1-2 times in 24 hours [hrs]), moderate (>2 times in 24 hrs) and severe (required intravenous [IV] hydration). Diarrhea graded as mild (2-3 loose stools in 24 hrs), moderate (4-5 loose stools in 24 hrs) and severe (=>6 in 24 hrs).
Measured: Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2
Systemic events included: fever, fatigue, headache, chills, muscle pain, joint pain, vomiting, and diarrhea. Fever classified as =>38.0 degree C, 38.0-38.4, >38.4-38.9, >38.9 40.0 and >40.0-degree C. Fatigue, headache, chills, muscle pain and joint pain graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting graded as mild (1-2 times in 24 hrs), moderate (>2 times in 24 hrs) and severe (required IV hydration). Diarrhea graded as mild (2-3 loose stools in 24 hrs), moderate (4-5 loose stools in 24 hrs) and severe (=>6 in 24 hrs).
Measured: Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)
Percentage of Participants Reporting Use of Antipyretic Medication Within 7 Days After Vaccination 1
Measured: Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
Percentage of Participants Reporting Use of Antipyretic Medication Within 7 Days After Vaccination 2
Measured: Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)
Percentage of Participants Reporting Adverse Events (AEs) During 30 Days After Vaccination 1
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events.
Measured: 30 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
Percentage of Participants Reporting AEs During 30 Days After Vaccination 2
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events.
Measured: 30 Days after Vaccination 2 (Vaccination 2 at Month 6)
Percentage of Participants Reporting AEs During 30 Days After Any Vaccination
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events.
Measured: 30 Days after any Vaccination
Percentage of Participants Reporting AEs During the Vaccination Phase
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events.
Measured: Vaccination Phase: From Vaccination 1 through one Month after Vaccination 2 (approximately 7 Months)
Percentage of Participants Reporting Serious Adverse Events (SAEs) During 30 Days After Vaccination 1
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event.
Measured: 30 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
Percentage of Participants Reporting SAEs During 30 Days After Vaccination 2
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event.
Measured: 30 Days after Vaccination 2 (Vaccination 2 at Month 6)
Percentage of Participants Reporting SAEs During 30 Days After Any Vaccination
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event.
Measured: 30 Days after any Vaccination
Percentage of Participants Reporting SAEs During the Vaccination Phase
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event.
Measured: Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)
Percentage of Participants Reporting SAEs During the Follow-up Phase
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event.
Measured: Follow-up Phase: From 1 Month after Vaccination 2 through 6 Months after Vaccination 2 (approximately 5 Months)
Percentage of Participants Reporting SAEs During the Entire Study
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.
Measured: Entire Study: From Vaccination 1 through 6 Months after Vaccination 2 (approximately 12 Months)
Percentage of Participants Reporting Medically Attended Adverse Event (MAEs) During 30 Days After Vaccination 1
MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.
Measured: 30 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
Percentage of Participants Reporting MAEs During 30 Days After Vaccination 2
MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.
Measured: 30 Days after Vaccination 2 (Vaccination 2 at Month 6)
Percentage of Participants Reporting MAEs During 30 Days After Any Vaccination
MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.
Measured: 30 Days after any Vaccination
Percentage of Participants Reporting MAEs During the Vaccination Phase
MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.
Measured: Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)
Percentage of Participants Reporting MAEs During the Follow-up Phase
MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.
Measured: Follow-up Phase: From 1 Month after Vaccination 2 through 6 Months after Vaccination 2 (approximately 5 Months)
Percentage of Participants Reporting MAEs During the Entire Study
MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.
Measured: Entire Study: From Vaccination 1 through 6 Months after Vaccination 2 (approximately 12 Months)
Percentage of Participants Reporting Immediate AEs After Vaccination 1
Immediate AE was defined as AE occurring within the first 30 minutes after study intervention administration.
Measured: 30 Minutes post Vaccination 1 (Vaccination 1 on Day 1/Month 0)
Percentage of Participants Reporting Immediate AEs After Vaccination 2
Immediate AE was defined as AE occurring within the first 30 minutes after study intervention administration.
Measured: 30 Minutes post Vaccination 2 (Vaccination 2 at Month 6)
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase
A 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: Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)
Percentage of Participants With NDCMC During the Follow-up Phase
A 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: Follow-up Phase: From 1 Month after Vaccination 2 through 6 Months after Vaccination 2 (approximately 5 Months)
Percentage of Participants With NDCMC During the Entire Study
A 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: Entire Study: From Vaccination 1 through 6 Months after Vaccination 2 (approximately 12 Months)
Mean Number of Days Participants Missed School or Work Because of AEs During the Vaccination Phase
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Aug 20216 Sep 2023

First posted20 May 2021
Study start18 Aug 2021
Primary completion6 Sep 2023
Study completion6 Sep 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.
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 4
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04893811
Sponsor's protocol ID: B1971060
Other IDs: 2018-002588-24, 2018
Status last verified: Oct 2024
First submitted: 14 May 2021
Last updated: 16 Oct 2024
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
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 3
Study on an Investigational Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Administered as a 5- and/or 10-year Booster Doses in Children and Adolescents Vaccinated 5 or 10 Years Earlier as Toddlers
Meningococcal Immunisation, Healthy Volunteers
RecruitingObservational study
A Study to Learn About the Safety of PENBRAYA During Pregnancy
Meningococcal Disease
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Epidemic Meningitis, Meningococcal Vaccines

All Meningococcal Vaccine trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 4, OPEN-LABEL, SINGLE-ARM TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF TRUMENBA(REGISTERED) WHEN ADMINISTERED TO IMMUNOCOMPROMISED PARTICIPANTS ≥10 YEARS OF AGE
ClinicalTrials.gov ID: NCT04893811
Acronym / sponsor ID: B1971060
Conditions: Meningococcal Vaccine
Keywords: Meningococcal Vaccine, Meningitis Vaccine, Asplenia, Sickle cell anemia, Complement deficiencies
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 18 Aug 2021 (actual)
Primary completion: 6 Sep 2023 (actual)
Study completion: 6 Sep 2023 (actual)
First posted: 20 May 2021 (actual)
Results: Posted 16 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single Arm	Experimental	Biological: TrumenbaBivalent recombinant lipoprotein 2086 vaccine

Who may qualify

Ages: 10 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Male or female participants ≥10 years of age at the time of consent.
Participants with an increased risk for meningococcal disease due to anatomic asplenia or functional asplenia (eg, sickle cell anemia) or complement deficiencies.
Negative urine pregnancy test for all female participants.

Key exclusion criteria (11 listed)

Previous vaccination with any meningococcal serogroup B vaccine.
Participants who are receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
Significant neurological disorder or history of seizure (excluding simple febrile seizure).
Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

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
TrumenbaBivalent recombinant lipoprotein 2086 vaccine	Biological	Single Arm

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 (MnB) Test Strains at Baseline
Time frame: Baseline (Before Vaccination 1 on Day 1/Month 0)
Four primary MnB strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). The percentage of participants who achieved an hSBA titer PMB80 (A22) more than or equal to (=>)1:16, and hSBA titer PMB2001 (A56), PMB2001 (B24), and PMB2707 (B44) =>1:8 are reported. Evaluable immunogenicity population (EIP) included all participants who were eligible through 1 month after Vaccination 2, received the study vaccination at Visit 1 and Visit 3 as planned, had blood drawn for assay testing within the required time frames at Visit 1 (before Vaccination 1) and 1 month after Vaccination 2 (28-42 days after Visit 3), had at least 1 valid and determinate assay result 1 month after Vaccination 2, received no prohibited vaccines or medications through Visit 4, and had no major protocol deviations through Visit 4.
Percentage of Participants With hSBA Titer => LLOQ for Each of the 4 Primary MnB Test Strains at 1 Month After Vaccination 2
Time frame: 1 Month after Vaccination 2 (Vaccination 2 at Month 6)
Four primary MnB strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). The percentage of participants who achieved an hSBA titer PMB80 (A22) =>1:16, and hSBA titer PMB2001 (A56), PMB2001 (B24), and PMB2707 (B44) =>1:8 were reported.
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1
Time frame: Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. Each caliper unit = 0.5 centimeter (cm). Redness and swelling were graded as mild (more than [>]2.0 to 5.0cm), moderate (>5.0 to 10.0cm) and severe (>10.0cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2
Time frame: Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)
Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units. Each caliper unit = 0.5 cm. Redness and swelling were graded as mild (>2.0 to 5.0cm), moderate (>5.0 to 10.0cm) and severe (>10.0cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1
Time frame: Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
Systemic events included: fever, fatigue, headache, chills, muscle pain, joint pain, vomiting, and diarrhea. Fever classified as =>38.0 degree Celsius (C), 38.0-38.4, >38.4-38.9, >38.9 40.0 and >40.0-degree C. Fatigue, headache, chills, muscle pain and joint pain graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting graded as mild (1-2 times in 24 hours [hrs]), moderate (>2 times in 24 hrs) and severe (required intravenous [IV] hydration). Diarrhea graded as mild (2-3 loose stools in 24 hrs), moderate (4-5 loose stools in 24 hrs) and severe (=>6 in 24 hrs).
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2
Time frame: Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)
Systemic events included: fever, fatigue, headache, chills, muscle pain, joint pain, vomiting, and diarrhea. Fever classified as =>38.0 degree C, 38.0-38.4, >38.4-38.9, >38.9 40.0 and >40.0-degree C. Fatigue, headache, chills, muscle pain and joint pain graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting graded as mild (1-2 times in 24 hrs), moderate (>2 times in 24 hrs) and severe (required IV hydration). Diarrhea graded as mild (2-3 loose stools in 24 hrs), moderate (4-5 loose stools in 24 hrs) and severe (=>6 in 24 hrs).
Percentage of Participants Reporting Use of Antipyretic Medication Within 7 Days After Vaccination 1
Time frame: Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
Percentage of Participants Reporting Use of Antipyretic Medication Within 7 Days After Vaccination 2
Time frame: Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)
Percentage of Participants Reporting Adverse Events (AEs) During 30 Days After Vaccination 1
Time frame: 30 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events.
Percentage of Participants Reporting AEs During 30 Days After Vaccination 2
Time frame: 30 Days after Vaccination 2 (Vaccination 2 at Month 6)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events.
Percentage of Participants Reporting AEs During 30 Days After Any Vaccination
Time frame: 30 Days after any Vaccination
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events.
Percentage of Participants Reporting AEs During the Vaccination Phase
Time frame: Vaccination Phase: From Vaccination 1 through one Month after Vaccination 2 (approximately 7 Months)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events.
Percentage of Participants Reporting Serious Adverse Events (SAEs) During 30 Days After Vaccination 1
Time frame: 30 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event.
Percentage of Participants Reporting SAEs During 30 Days After Vaccination 2
Time frame: 30 Days after Vaccination 2 (Vaccination 2 at Month 6)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event.
Percentage of Participants Reporting SAEs During 30 Days After Any Vaccination
Time frame: 30 Days after any Vaccination
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event.
Percentage of Participants Reporting SAEs During the Vaccination Phase
Time frame: Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event.
Percentage of Participants Reporting SAEs During the Follow-up Phase
Time frame: Follow-up Phase: From 1 Month after Vaccination 2 through 6 Months after Vaccination 2 (approximately 5 Months)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or that was considered to be an important medical event.
Percentage of Participants Reporting SAEs During the Entire Study
Time frame: Entire Study: From Vaccination 1 through 6 Months after Vaccination 2 (approximately 12 Months)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.
Percentage of Participants Reporting Medically Attended Adverse Event (MAEs) During 30 Days After Vaccination 1
Time frame: 30 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)
MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.
Percentage of Participants Reporting MAEs During 30 Days After Vaccination 2
Time frame: 30 Days after Vaccination 2 (Vaccination 2 at Month 6)
MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.
Percentage of Participants Reporting MAEs During 30 Days After Any Vaccination
Time frame: 30 Days after any Vaccination
MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.
Percentage of Participants Reporting MAEs During the Vaccination Phase
Time frame: Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)
MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.
Percentage of Participants Reporting MAEs During the Follow-up Phase
Time frame: Follow-up Phase: From 1 Month after Vaccination 2 through 6 Months after Vaccination 2 (approximately 5 Months)
MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.
Percentage of Participants Reporting MAEs During the Entire Study
Time frame: Entire Study: From Vaccination 1 through 6 Months after Vaccination 2 (approximately 12 Months)
MAEs was defined as a nonserious AE that resulted in an evaluation at a medical facility.
Percentage of Participants Reporting Immediate AEs After Vaccination 1
Time frame: 30 Minutes post Vaccination 1 (Vaccination 1 on Day 1/Month 0)
Immediate AE was defined as AE occurring within the first 30 minutes after study intervention administration.
Percentage of Participants Reporting Immediate AEs After Vaccination 2
Time frame: 30 Minutes post Vaccination 2 (Vaccination 2 at Month 6)
Immediate AE was defined as AE occurring within the first 30 minutes after study intervention administration.
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase
Time frame: Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)
A 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 With NDCMC During the Follow-up Phase
Time frame: Follow-up Phase: From 1 Month after Vaccination 2 through 6 Months after Vaccination 2 (approximately 5 Months)
A 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 With NDCMC During the Entire Study
Time frame: Entire Study: From Vaccination 1 through 6 Months after Vaccination 2 (approximately 12 Months)
A 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.
Mean Number of Days Participants Missed School or Work Because of AEs During the Vaccination Phase
Time frame: Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)
An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Results and safety

Results posted to the registry on 16 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Trumenba (B1971060)	53	47
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	51	47

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 (MnB) Test Strains at Baseline

Time frame: Baseline (Before Vaccination 1 on Day 1/Month 0). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Trumenba (B1971060) n = 43	Trumenba (B1971057, Historical Age- and Sex-Matched Control) n = 44
PMB80 (A22)	32.6 (19.1 to 48.5)	31.0 (17.6 to 47.1)
PMB2001 (A56)	25.6 (13.5 to 41.2)	23.3 (11.8 to 38.6)
PMB2948 (B24)	2.4 (0.1 to 12.6)	23.3 (11.8 to 38.6)
PMB2707 (B44)	9.3 (2.6 to 22.1)	11.4 (3.8 to 24.6)

Population analysed: B1971060: EIP was analyzed. B1971057: Historical data of the age- and sex-matched healthy participants (selected randomly) as reference for current study, relevant for this outcome measure. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. "Number Analyzed" signifies number of participants evaluable for specified rows.

Primary outcome: Percentage of Participants With hSBA Titer => LLOQ for Each of the 4 Primary MnB Test Strains at 1 Month After Vaccination 2

Time frame: 1 Month after Vaccination 2 (Vaccination 2 at Month 6). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Trumenba (B1971060) n = 44	Trumenba (B1971057, Historical Age- and Sex-Matched Control) n = 44
PMB80 (A22)	75.0 (59.7 to 86.8)	95.3 (84.2 to 99.4)
PMB2001 (A56)	90.9 (78.3 to 97.5)	100.0 (92.0 to 100.0)
PMB2948 (B24)	70.5 (54.8 to 83.2)	81.8 (67.3 to 91.8)
PMB2707 (B44)	79.1 (64.0 to 90.0)	92.9 (80.5 to 98.5)

Population analysed: B1971060: EIP was analyzed. B1971057: Historical data of the age- and sex-matched healthy participants (selected randomly) as reference for current study, relevant for this outcome measure. Here, "Number Analyzed" signifies number of participants evaluable for specified rows.

Primary outcome: Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1

Time frame: Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Trumenba (B1971060) n = 53	Trumenba (B1971057, Historical Age- and Sex-Matched Control) n = 51
Redness: Any	18.9 (9.4 to 32.0)	11.8 (4.4 to 23.9)
Redness: Mild	5.7 (1.2 to 15.7)	5.9 (1.2 to 16.2)
Redness: Moderate	9.4 (3.1 to 20.7)	3.9 (0.5 to 13.5)
Redness: Severe	3.8 (0.5 to 13.0)	2.0 (0.0 to 10.4)
Swelling: Any	22.6 (12.3 to 36.2)	11.8 (4.4 to 23.9)
Swelling: Mild	7.5 (2.1 to 18.2)	7.8 (2.2 to 18.9)
Swelling: Moderate	15.1 (6.7 to 27.6)	3.9 (0.5 to 13.5)
Swelling: Severe	0 (0.0 to 6.7)	0 (0.0 to 7.0)

Population analysed: B1971060: Vaccination 1 safety set included all participants who received the first dose of study intervention at Visit 1 and for whom safety information was available from Visit 1 to prior to Visit 3. B1971057: Historical data of the age- and sex-matched healthy participants (selected randomly) as reference for current study, relevant for this outcome measure.

Primary outcome: Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2

Time frame: Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Trumenba (B1971060) n = 45	Trumenba (B1971057, Historical Age- and Sex-Matched Control) n = 43
Redness: Any	20.0 (9.6 to 34.6)	7.0 (1.5 to 19.1)
Redness: Mild	6.7 (1.4 to 18.3)	2.3 (0.1 to 12.3)
Redness: Moderate	11.1 (3.7 to 24.1)	4.7 (0.6 to 15.8)
Redness: Severe	2.2 (0.1 to 11.8)	0 (0.0 to 8.2)
Swelling: Any	26.7 (14.6 to 41.9)	4.7 (0.6 to 15.8)
Swelling: Mild	13.3 (5.1 to 26.8)	0 (0.0 to 8.2)
Swelling: Moderate	13.3 (5.1 to 26.8)	4.7 (0.6 to 15.8)
Swelling: Severe	0 (0.0 to 7.9)	0 (0.0 to 8.2)

Population analysed: B1971060: Vaccination 2 safety set included all participants who received the second dose of study intervention at Visit 3 and for whom safety information was available from Visit 3 up to and including Visit 4. B1971057: Historical data of the age- and sex-matched healthy participants (selected randomly) as reference for current study, relevant for this outcome measure. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Adverse events

Time frame: Local reactions, systemic events within 7 days of each vaccination; SAEs and Non-SAEs: From Day 1 of vaccination up to 6 months after last study vaccination (approximately 12 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Trumenba (B1971060)	10 of 53 (18.9%)	51 of 53 (96.2%)	1 of 53
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	1 of 51 (2%)	49 of 51 (96.1%)	0 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

14 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Trumenba in people with Meningococcal Vaccine, run by Pfizer at 14 sites in 3 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 3 inclusion and 11 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 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Turkey (Türkiye), Poland, Czechia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 16 Oct 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?

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 (MnB) Test Strains at Baseline (time frame: Baseline (Before Vaccination 1 on Day 1/Month 0)). The study lists 30 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 NCT04893811.

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 16 Oct 2024.