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NCT03673462 · ClinicalTrials.gov registry record · Phase 3
Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
A Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,797
- Enrollment target
NCT03673462: Completed Phase 3 study, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT03673462 is a Phase 3 study that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 2,797 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (262% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03673462, a Phase 3 study, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,797 participants
- Enrollment target
Study Summary
The primary objective of this study was to describe the safety profile of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate Vaccine and Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®) Conjugate Vaccine when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers.
Primary Outcome
An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not have any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Immediate adverse events are unsolicited systemic adverse events occurring in the 30 minutes after injection. Reported AEs for each arm were pres
Interventions
- BIOLOGICAL Pneumococcal 13-valent Conjugate Vaccine
- BIOLOGICAL Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine)
- BIOLOGICAL Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®)
- BIOLOGICAL Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine
- BIOLOGICAL Rotavirus Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,797 participants |
| Start Date | 2018-09-17 |
| Est. Completion | 2023-03-16 |
| Phase | Phase 3 |
What the finished NCT03673462 record still lists
NCT03673462 is an interventional study that assigns participants to a tested intervention. Its 2,797 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 (262% higher).
The record links to 0 conditions, and to 5 interventions - of which Pneumococcal 13-valent Conjugate Vaccine is the first listed.
NCT03673462 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03673462 about?
NCT03673462 is a clinical study titled "Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers". The primary objective of this study was to describe the safety profile of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate Vaccine and Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®) Conjugate Vaccine when administered c...
What is the current status of trial NCT03673462?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,797 participants. The study started on 2018-09-17. Estimated completion is 2023-03-16.
What interventions are being tested in trial NCT03673462?
The interventions under investigation include: Pneumococcal 13-valent Conjugate Vaccine (BIOLOGICAL), Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine) (BIOLOGICAL), Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®) (BIOLOGICAL), Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine (BIOLOGICAL), Rotavirus Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03673462?
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 NCT03673462's enrollment target sits among peer trials
2,797 82nd of 2000 higher than 1,919 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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