Phase 3
N=149
Study to Evaluate the Safety and Immunogenicity of Nimenrix (Registered) in Healthy Infants, Given at 3 and 12 Months of Age
Meningococcal Vaccine
Bottom Line
View on ClinicalTrials.gov: NCT04819113 ↗Enrolled (actual)
149
Serious AEs
6.9%
Results posted
Mar 2024
Primary outcome: Primary: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 — 19.7; 7.7; 0; 14.1 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nimenrix (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 |
19.7; 7.7; 0; 14.1; 2.8; 0 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 |
6.3; 4.9; 3.5; 0; 19.7; 11.3 | — |
| PRIMARY Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 2 |
55.6 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) Within 30 Days After Vaccination 2 |
19.6 | — |
| PRIMARY Percentage of Participants With Serious Adverse Events (SAEs) Within 30 Days After Vaccination 2 |
1.4 | — |
| PRIMARY Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 30 Days After Vaccination 2 |
0.0 | — |
| PRIMARY Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 2 |
0.0 | — |
| PRIMARY 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 |
0.0; 4.7; 0.8; 7.8 | — |
| PRIMARY 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 |
82.3; 91.1; 89.5; 90.3 | — |
| PRIMARY 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 |
33.6; 64.8; 67.2; 66.4 | — |
| PRIMARY 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 |
100.0; 100.0; 100.0; 100.0 | — |
| PRIMARY 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 |
4.0; 4.4; 4.1; 5.0 | — |
| PRIMARY 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 |
54.7; 107.6; 202.4; 187.2 | — |
| PRIMARY GMTs of rSBA Titer for Each of MenA, MenC, MenW-135 and MenY Serogroups at Vaccination 2: Post Dose 2 Evaluable Immunogenicity Population |
9.9; 21.8; 21.7; 24.5 | — |
| PRIMARY 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 |
1818.0; 1299.5; 2714.1; 1667.1 | — |
| SECONDARY Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 |
13.8; 2.8; 0; 6.2; 1.4; 0 | — |
| SECONDARY Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 |
7.6; 2.1; 0; 0; 15.2; 8.3 | — |
| SECONDARY Percentage of Participants With Use of Antipyretic Medication Within 7 Days After Vaccination 1 |
39.3 | — |
| SECONDARY Percentage of Participants With AEs Within 30 Days After Vaccination 1 |
6.9 | — |
| SECONDARY 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 |
1.4; 4.1; 5.5; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Immediate AE Within 30 Minutes After Vaccination 1 |
0.0 | — |
| SECONDARY 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 |
0.0; 81.0; 5.2; 89.7; 0.9; 88.8 | — |
| SECONDARY 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 |
0.0; 35.3; 0.0; 65.5; 0.9; 79.3 | — |
| SECONDARY 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 |
4.0; 50.1; 4.3; 96.7; 4.1; 193.3 | — |
| SECONDARY 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 |
7.6; 94.3; 13.0; 91.6; 13.8; 33.9 | — |
| SECONDARY 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 |
6.5; 94.3; 13.0; 91.6; 13.8; 33.9 | — |
| SECONDARY 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 |
2.4; 82.0; 2.9; 128.4; 2.9; 6.9 | — |
| SECONDARY 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 |
8.0; 95.5; 49.1; 100.0; 11.7; 93.1 | — |
| SECONDARY 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 |
7.0; 95.5; 46.3; 100.0; 11.7; 93.1 | — |
| SECONDARY 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 |
2.4; 86.9; 9.5; 1208.4; 2.9; 149.8 | — |
| SECONDARY 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 |
0; 40.3; 15.2; 100.0; 0.8; 67.7 | — |
Summary
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
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT04819113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.