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NCT03537508 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US
A Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,627
- Enrollment target
NCT03537508: Completed Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT03537508 is a Phase 3 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 2,627 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (240% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03537508, a Phase 3 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,627 participants
- Enrollment target
Study Summary
The purpose of this study was to compare the immunogenicity and describe the safety of MenACYW conjugate vaccine and MENVEO® when both are administered concomitantly with routine pediatric vaccines to healthy infants and toddlers in the US.
Primary Outcome
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Vaccine seroresponse was defined as a post 4th dose (Day 30 after 12-month) hSBA titer \>=1:16 for participants with pre 1st dose (Day 0 before 2-month) hSBA titer less than (\<) 1:8, or at least a 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8. Percentages are rounded off to th
Interventions
- BIOLOGICAL MenACYW conjugate vaccine
- BIOLOGICAL MenACYW-135 conjugate vaccine
- BIOLOGICAL DTaP-IPV//Hib vaccine
- BIOLOGICAL Pneumococcal 13-valent conjugate vaccine
- BIOLOGICAL Pentavalent rotavirus vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,627 participants |
| Start Date | 2018-04-25 |
| Est. Completion | 2023-09-22 |
| Phase | Phase 3 |
What the finished NCT03537508 record still lists
NCT03537508 is an interventional study that assigns participants to a tested intervention. Its 2,627 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (240% higher).
The record links to 0 conditions, and to 5 interventions - of which MenACYW conjugate vaccine is the first listed.
NCT03537508 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03537508 about?
NCT03537508 is a clinical study titled "Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US". The purpose of this study was to compare the immunogenicity and describe the safety of MenACYW conjugate vaccine and MENVEO® when both are administered concomitantly with routine pediatric vaccines to healthy infants and toddlers in the US.
What is the current status of trial NCT03537508?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,627 participants. The study started on 2018-04-25. Estimated completion is 2023-09-22.
What interventions are being tested in trial NCT03537508?
The interventions under investigation include: MenACYW conjugate vaccine (BIOLOGICAL), MenACYW-135 conjugate vaccine (BIOLOGICAL), DTaP-IPV//Hib vaccine (BIOLOGICAL), Pneumococcal 13-valent conjugate vaccine (BIOLOGICAL), Pentavalent rotavirus vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03537508?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03537508's enrollment target sits among peer trials
2,627 84th of 2000 higher than 1,917 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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