Meningococcal VaccinePhase 3NCT04819113

Study to Evaluate the Safety and Immunogenicity of Nimenrix (Registered) in Healthy Infants, Given at 3 and 12 Months of Age

A Phase 3 study testing Nimenrix in people with Meningococcal Vaccine, run by Pfizer at 16 sites in 3 countries.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 76 to 104 daysHealthy volunteers can take part
Conditions the study is for: Meningococcal Vaccine
What is being tested?: Nimenrix
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 149 participants
Where: 16 sitesin 3 countries
Study dates: 9 Apr 2021to 9 Sep 2022
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 76 to 104 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Male or female infants born at >36 weeks of gestation and who are 3 months of age (≥76 to ≤104 days) at the time of consent (the day of birth is considered day of life 1).
Participants whose parent(s)/legal guardian(s) is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
Participants who are available for the duration of the study and whose parent(s)/legal guardian(s) can be contacted by telephone during study participation.
Participants whose parent(s)/legal guardian(s) is capable of giving signed informed consent.

Who cannot join

Previous anaphylactic reaction to any vaccine or vaccine-related component.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
Significant neurological disorder or history of seizure (including simple febrile seizure).
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Family history of congenital or hereditary immunodeficiency.

Show all 9Show fewer

Other medical or psychiatric condition, including recent 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.
Major known congenital malformation or serious chronic disorder.
Previous vaccination with any meningococcal vaccine containing groups A, C, W, or Y.

Trial locations and contacts

16 sites in 3 countries.

Country

City, postcode or hospital

16 sites in 3 countries

Finland8 sites

Espoo Vaccine Research Clinic
Espoo, 02230
FVR, Etelä-Helsingin rokotetutkimusklinikka
Helsinki, 00100
Helsinki South Vaccine Research Clinic
Helsinki, 00100
Helsinki East Vaccine Research Clinic
Helsinki, 00930
Jarvenpaa Vaccine Research Center
Jarvenpaa, Uusimaa, 04400
Jarvenpaa Vaccine Research Center
Jarvenpaa, 04400
Tampere Vaccine Research Clinic
Tampere, Pirkanmaa, 33100
Turku Vaccine Research Clinic
Turku, 20520

Other trials in Finland

Poland5 sites

IN VIVO Bydgoszcz
Bydgoszcz, 85-048
NZOZ Przychodnia Vitamed
Bydgoszcz, 85-079
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
Krakow, 30-348
GRAVITA. Diagnostyka i Leczenie nieplodnosci
Lodz, 91-347
Szpital im. Św. Jadwigi Śląskiej w Trzebnicy
Trzebnica, 55-100

Other trials in Poland

Spain3 sites

Hospital Universitario HM Sanchinarro
Madrid, 28050
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruna, 15706
Instituto Hispalense de Pediatria
Seville, 41012

Other trials in Spain

About this study

Official title: A PHASE 3B, OPEN-LABEL, STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF NIMENRIX(Registered) IN HEALTHY INFANTS, GIVEN AT 3 AND 12 MONTHS OF AGE

This study will evaluate the safety and immunogenicity of a single dose of Nimenrix in infants at 3 months of age, followed by a second dose at 12 months of age. Current posology allows for 2 doses of Nimenrix before 6 months of age, where the first dose is administered from 6 weeks onwards with a second dose at least 2 months later, with a booster at 12 months; and in infants from 6 months of age, a single dose at 6 months, with a booster dose at 12 months. This study will provide valuable immunogenicity and safety data for a single dose in healthy infants <6 months of age, followed by the booster at 12 months

Conditions: Meningococcal Vaccine
Being tested: Nimenrix

What participants receive

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

NimenrixBiological
MenACWY-TT vaccine

Study groups in NCT04819113
Study group	Role	What they receive
Nimenrix	Experimental	Nimenrix Receives: Biological: Nimenrix

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Local reactions included pain at injection site, redness and swelling and were recorded by the participant's parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (>) 0.0 to 2.0 cm; moderate: >2.0 to 7.0 cm; and severe: >7.0 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Exact 2-sided confidence interval (CI) was based on the Clopper and Pearson method.
Measured: Within 7 days after vaccination 2
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Systemic events included fever, decreased appetite, increased sleep and irritability and were recorded by the participant's parents/legal guardians in an e-diary. Fever was defined as temperature greater than or equal to (>=) 38.0 degrees (deg) Celsius (C), categorized as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C,>38.9 to 40.0 deg C and >40.0 deg C; decreased appetite graded as mild: decreased interest in eating, moderate: decreased oral intake and severe: refusal to feed; increased sleep graded as mild: increased or prolonged sleeping bouts, moderate: slightly subdued, interfered with daily activity and severe: disabling, not interested in usual daily activity; irritability graded as mild: easily consolable, moderate: required increased attention and severe: inconsolable, crying could not be comforted. Exact 2-sided CI was based on Clopper and Pearson method.
Measured: Within 7 days after vaccination 2
Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 2
The use of antipyretic medication was recorded by the participant's parents/legal guardians in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 7 days after vaccination 2
Percentage of Participants With Adverse Events (AEs) Within 30 Days After Vaccination 2
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Measured: Within 30 days after vaccination 2
Percentage of Participants With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 2
An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 30 days after vaccination 2
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 30 Days After Vaccination 2
An NDCMC was defined as a significant disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 30 days after vaccination 2
Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 2
Immediate AEs were defined as AEs occurring within the first 30 minutes after administration of the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 30 minutes after vaccination 2
Percentage of Participants Achieving Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 for Each Serogroup, Neisseria Meningitidis Group (Men) A, MenC, MenW-135 and MenY at Baseline: Post Dose 2 Evaluable Immunogenicity Population
Percentage of participants achieving rSBA titer >=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at baseline in participants who received vaccinations 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. Analysis was performed on Post Dose (PD) 2 Evaluable Immunogenicity Population (EIP) (PD2 EIP).
Measured: At baseline (before vaccination 1)
Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 1: Post Dose 2 Evaluable Immunogenicity Population
Percentage of participants achieving rSBA titer >=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at 1 month after vaccination 1 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Measured: 1 month after vaccination 1
Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
Percentage of participants achieving rSBA titer >=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at vaccination 2 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Measured: At vaccination 2
Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
Percentage of participants achieving rSBA titer >=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at 1 month after vaccination 2 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Measured: 1 month after vaccination 2
Geometric Mean Titers (GMTs) of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline: Post Dose 2 Evaluable Immunogenicity Population
GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution).
Measured: At baseline (before vaccination 1)
GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at 1 Month After Vaccination 1: Post Dose 2 Evaluable Immunogenicity Population
GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution).
Measured: 1 month after vaccination 1
GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution).
Measured: At vaccination 2
GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution).
Measured: 1 month after vaccination 2

Secondary outcomes (16)

Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Local reactions included pain at injection site, redness and swelling and were recorded by the participant's parents/legal guardians in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: >0.0 to 2.0 cm; moderate: >2.0 to 7.0 cm; and severe: >7.0 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 7 days after vaccination 1
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Systemic events included fever, decreased appetite, increased sleep and irritability and were recorded in e-diary. Fever was defined as temperature >=38.0 deg C, categorized as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C,>38.9 to 40.0 deg C and >40.0 deg C; decreased appetite graded as mild: decreased interest in eating, moderate: decreased oral intake and severe: refusal to feed; increased sleep graded as mild: increased or prolonged sleeping bouts, moderate: slightly subdued, interfered with daily activity and severe: disabling, not interested in usual daily activity; irritability graded as mild: easily consolable, moderate: required increased attention and severe: inconsolable, crying could not be comforted. Exact 2-sided CI was based on Clopper and Pearson method.
Measured: Within 7 days after vaccination 1
Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 1
The use of antipyretic medication was recorded by the participant's parents/legal guardians in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 7 days after vaccination 1
Percentage of Participants With AEs Within 30 Days After Vaccination 1
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Measured: Within 30 days after vaccination 1
Percentage of Participants With SAEs and NDCMCs: Within 30 Days After Vaccination 1, From 1 Month After Vaccination 1 to 9 Months After Vaccination 1, From Vaccination 1 to 9 Months After Vaccination 1
An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An NDCMC was defined as a significant disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 30 days after vaccination 1, from 1 month after vaccination 1 to 9 months after vaccination 1 and from vaccination 1 to 9 months after vaccination 1
Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 1
Immediate AEs were defined as AEs occurring within the first 30 minutes after administration of the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method.
Measured: Within 30 minutes after vaccination 1
Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
Percentage of participants achieving rSBA titer >=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at baseline and 1 month after Vaccination 1 in participants who received Vaccination 1 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. Analysis was performed on post-dose 1 (PD1) evaluable immunogenicity population (EIP).
Measured: At baseline (before vaccination 1) and 1 month after vaccination 1
Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
Percentage of participants achieving rSBA titer >= 1:128 for each serogroup MenA, MenC, MenW-135 and MenY at baseline and 1 month after vaccination 1 in participants who received vaccination 1 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Measured: At baseline (before vaccination 1) and 1 month after vaccination 1
GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution).
Measured: At baseline (before vaccination 1) and 1 month after vaccination 1
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
Percentage of participants achieving hSBA titers >= 1:4 for each serogroup MenA, MenC, MenW-135 and MenY at baseline and 1 month after vaccination 1 in participants who received Vaccination 1 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Measured: At baseline (before vaccination 1) and 1 month after vaccination 1
Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
Percentage of participants achieving hSBA titers >= 1:8 for each serogroup MenA, MenC, MenW-135 and MenY at baseline and 1 month after vaccination 1 in participants who received Vaccination 1 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Measured: At baseline (before vaccination 1) and 1 month after vaccination 1
GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the hSBA titers (based on the Student t distribution).
Measured: At baseline (before vaccination 1) and 1 month after vaccination 1
Percentage of Participants Achieving hSBA Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
Percentage of participants achieving hSBA titers >= 1:4 for each serogroup MenA, MenC, MenW-135 and MenY at baseline, 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Measured: At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2
Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
Percentage of participants achieving hSBA titers >= 1:8 for each serogroup MenA, MenC, MenW-135 and MenY at baseline, 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Measured: At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2
GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the hSBA titers (based on the Student t distribution).
Measured: At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2
Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
Percentage of participants achieving rSBA Titers >= 1:128 for each serogroup MenA, MenC, MenW-135 and MenY at baseline, 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2 in Participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Measured: At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2

Timeline

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

9 Apr 20219 Sep 2022

First posted26 Mar 2021
Study start9 Apr 2021
Primary completion9 Sep 2022
Study completion9 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Meningococcal VaccineStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 149 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04819113
Sponsor's protocol ID: C0921062
Other IDs: 2020-005059-19
Status last verified: Aug 2023
First submitted: 25 Mar 2021
Last updated: 18 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Koski S, Martinon-Torres F, Ramet M, Zolotas L, Newton R, Maansson R, Cutler M, Peyrani P, Findlow J, Balmer P, Jodar L, Gruber WC, Anderson AS, Beeslaar J. A Phase 3B, Open-Label Study to Evaluate the Immunogenicity and Safety of the Quadrivalent Meningococcal Nimenrix(R) Vaccine When Given to Healthy Infants at 3 and 12 Months of Age. Infect Dis Ther. 2025 Feb;14(2):463-481. doi: 10.1007/s40121-024-01098-8. Epub 2025 Jan 30.
PubMed 39883399

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

Not yet recruitingPhase 4
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 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 3B, OPEN-LABEL, STUDY TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF NIMENRIX(Registered) IN HEALTHY INFANTS, GIVEN AT 3 AND 12 MONTHS OF AGE
ClinicalTrials.gov ID: NCT04819113
Acronym / sponsor ID: C0921062
Conditions: Meningococcal Vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 149 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 9 Apr 2021 (actual)
Primary completion: 9 Sep 2022 (actual)
Study completion: 9 Sep 2022 (actual)
First posted: 26 Mar 2021 (actual)
Results: Posted 18 Mar 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
Nimenrix	Experimental	Biological: NimenrixNimenrix

Who may qualify

Ages: 76 to 104 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Male or female infants born at >36 weeks of gestation and who are 3 months of age (≥76 to ≤104 days) at the time of consent (the day of birth is considered day of life 1).
Participants whose parent(s)/legal guardian(s) is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
Participants who are available for the duration of the study and whose parent(s)/legal guardian(s) can be contacted by telephone during study participation.
Participants whose parent(s)/legal guardian(s) is capable of giving signed informed consent.

Key exclusion criteria (9 listed)

Previous anaphylactic reaction to any vaccine or vaccine-related component.
Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.
Significant neurological disorder or history of seizure (including simple febrile seizure).
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).

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
NimenrixMenACWY-TT vaccine	Biological	Nimenrix

Primary outcome

Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Time frame: Within 7 days after vaccination 2
Local reactions included pain at injection site, redness and swelling and were recorded by the participant's parents/legal guardians in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (>) 0.0 to 2.0 cm; moderate: >2.0 to 7.0 cm; and severe: >7.0 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Exact 2-sided confidence interval (CI) was based on the Clopper and Pearson method.
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Time frame: Within 7 days after vaccination 2
Systemic events included fever, decreased appetite, increased sleep and irritability and were recorded by the participant's parents/legal guardians in an e-diary. Fever was defined as temperature greater than or equal to (>=) 38.0 degrees (deg) Celsius (C), categorized as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C,>38.9 to 40.0 deg C and >40.0 deg C; decreased appetite graded as mild: decreased interest in eating, moderate: decreased oral intake and severe: refusal to feed; increased sleep graded as mild: increased or prolonged sleeping bouts, moderate: slightly subdued, interfered with daily activity and severe: disabling, not interested in usual daily activity; irritability graded as mild: easily consolable, moderate: required increased attention and severe: inconsolable, crying could not be comforted. Exact 2-sided CI was based on Clopper and Pearson method.
Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 2
Time frame: Within 7 days after vaccination 2
The use of antipyretic medication was recorded by the participant's parents/legal guardians in an e-diary for 7 days after vaccination. Exact 2-sided CI was based on the Clopper and Pearson method.
Percentage of Participants With Adverse Events (AEs) Within 30 Days After Vaccination 2
Time frame: Within 30 days after vaccination 2
An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Percentage of Participants With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 2
Time frame: Within 30 days after vaccination 2
An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. Exact 2-sided CI was based on the Clopper and Pearson method.
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 30 Days After Vaccination 2
Time frame: Within 30 days after vaccination 2
An NDCMC was defined as a significant disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects. Exact 2-sided CI was based on the Clopper and Pearson method.
Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 2
Time frame: Within 30 minutes after vaccination 2
Immediate AEs were defined as AEs occurring within the first 30 minutes after administration of the investigational product. Exact 2-sided CI was based on the Clopper and Pearson method.
Percentage of Participants Achieving Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 for Each Serogroup, Neisseria Meningitidis Group (Men) A, MenC, MenW-135 and MenY at Baseline: Post Dose 2 Evaluable Immunogenicity Population
Time frame: At baseline (before vaccination 1)
Percentage of participants achieving rSBA titer >=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at baseline in participants who received vaccinations 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented. Analysis was performed on Post Dose (PD) 2 Evaluable Immunogenicity Population (EIP) (PD2 EIP).
Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 1: Post Dose 2 Evaluable Immunogenicity Population
Time frame: 1 month after vaccination 1
Percentage of participants achieving rSBA titer >=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at 1 month after vaccination 1 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
Time frame: At vaccination 2
Percentage of participants achieving rSBA titer >=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at vaccination 2 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
Time frame: 1 month after vaccination 2
Percentage of participants achieving rSBA titer >=1:8 for each serogroup MenA, MenC, MenW-135 and MenY at 1 month after vaccination 2 in participants who received vaccination 1 and 2 were reported in this outcome measure. Exact 2-sided CI using the Clopper and Pearson method was presented.
Geometric Mean Titers (GMTs) of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline: Post Dose 2 Evaluable Immunogenicity Population
Time frame: At baseline (before vaccination 1)
GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution).
GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at 1 Month After Vaccination 1: Post Dose 2 Evaluable Immunogenicity Population
Time frame: 1 month after vaccination 1
GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution).
GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
Time frame: At vaccination 2
GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution).
GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
Time frame: 1 month after vaccination 2
GMT was derived by calculating the mean on the natural log scale based on the t-distribution, then exponentiating the results. CIs were obtained by exponentiating the limits of CIs for the mean logarithm of the rSBA titers (based on the Student t distribution).

16 secondary outcomes

Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Time frame: Within 7 days after vaccination 1
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Time frame: Within 7 days after vaccination 1
Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 1
Time frame: Within 7 days after vaccination 1
Percentage of Participants With AEs Within 30 Days After Vaccination 1
Time frame: Within 30 days after vaccination 1
Percentage of Participants With SAEs and NDCMCs: Within 30 Days After Vaccination 1, From 1 Month After Vaccination 1 to 9 Months After Vaccination 1, From Vaccination 1 to 9 Months After Vaccination 1
Time frame: Within 30 days after vaccination 1, from 1 month after vaccination 1 to 9 months after vaccination 1 and from vaccination 1 to 9 months after vaccination 1
Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 1
Time frame: Within 30 minutes after vaccination 1
Percentage of Participants Achieving rSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
Time frame: At baseline (before vaccination 1) and 1 month after vaccination 1
Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
Time frame: At baseline (before vaccination 1) and 1 month after vaccination 1
GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
Time frame: At baseline (before vaccination 1) and 1 month after vaccination 1
Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
Time frame: At baseline (before vaccination 1) and 1 month after vaccination 1
Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
Time frame: At baseline (before vaccination 1) and 1 month after vaccination 1
GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline and 1 Month After Vaccination 1: Post Dose 1 Evaluable Immunogenicity Population
Time frame: At baseline (before vaccination 1) and 1 month after vaccination 1
Percentage of Participants Achieving hSBA Titers >= 1:4 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
Time frame: At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2
Percentage of Participants Achieving hSBA Titers >= 1:8 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
Time frame: At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2
GMTs of hSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
Time frame: At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2
Percentage of Participants Achieving rSBA Titers >= 1:128 for Each Serogroup MenA, MenC, MenW-135 and MenY at Baseline, 1 Month After Vaccination 1, at Vaccination 2 and 1 Month After Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population
Time frame: At baseline (before vaccination 1), 1 month after vaccination 1, at vaccination 2 and 1 month after vaccination 2

Results and safety

Results posted to the registry on 18 Mar 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
Nimenrix	149	143

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

Time frame: Within 7 days after vaccination 2. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Nimenrix n = 142
Pain at injection site: Mild	19.7 (13.5)
Pain at injection site: Moderate	7.7 (3.9)
Pain at injection site: Severe	0 (0.0)
Redness: Mild	14.1 (8.8)
Redness: Moderate	2.8 (0.8)
Redness: Severe	0 (0.0)
Swelling: Mild	4.9 (2.0)
Swelling: Moderate	1.4 (0.2)

Population analysed: Dose 2 safety population included participants who received the first and second dose of investigational product at Visit 1 and Visit 3 and for whom safety information was available from Visit 3. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Primary outcome: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2

Time frame: Within 7 days after vaccination 2. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Nimenrix n = 142
Fever: >=38.0 deg C to 38.4 deg C	6.3 (2.9)
Fever: >38.4 deg C to 38.9 deg C	4.9 (2.0)
Fever: >38.9 deg C to 40.0 deg C	3.5 (1.2)
Fever: >40.0 deg C	0 (0.0)
Decreased appetite: Mild	19.7 (13.5)
Decreased appetite: Moderate	11.3 (6.6)
Decreased appetite: Severe	1.4 (0.2)
Increased sleep: Mild	38.0 (30.0)

Primary outcome: Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 2

Time frame: Within 7 days after vaccination 2. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Nimenrix n = 142
Value	55.6 (47.1)

Primary outcome: Percentage of Participants With Adverse Events (AEs) Within 30 Days After Vaccination 2

Time frame: Within 30 days after vaccination 2. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Nimenrix n = 143
Value	19.6 (13.4)

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Local reactions and systemic events were recorded using systematic assessment within 7 days after Vaccination 1 and 2; SAEs and all-cause mortality recorded using non-systematic assessment from Day 1 up to 42 days after Vaccination 2 (approximately 10 months and 12 days); other AEs recorded using non-systematic assessment from Day 1 up to 42 days after Vaccination 1 and from Day of Vaccination 2 up to 42 days after Vaccination 2. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nimenrix	10 of 145 (6.9%)	139 of 145 (95.9%)	0 of 145

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39883399Koski S, Martinon-Torres F, Ramet M, Zolotas L, Newton R, Maansson R, Cutler M, Peyrani P, Findlow J, Balmer P, Jodar L, Gruber WC, Anderson AS, Beeslaar J. A Phase 3B, Open-Label Study to Evaluate the Immunogenicity and Safety of the Quadrivalent Meningococcal Nimenrix(R) Vaccine When Given to Healthy Infants at 3 and 12 Months of Age. Infect Dis Ther. 2025 Feb;14(2):463-481. doi: 10.1007/s40121-024-01098-8. Epub 2025 Jan 30.
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.

Related trials for Meningococcal Vaccine

Not yet recruitingPhase 4
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

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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nimenrix in people with Meningococcal Vaccine, run by Pfizer at 16 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 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Finland, Poland, Spain. 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 18 Mar 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 Local Reactions Within 7 Days After Vaccination 2 (time frame: Within 7 days after vaccination 2). The study lists 15 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 NCT04819113, 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 18 Mar 2024.