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NCT03621670 · ClinicalTrials.gov registry record · Phase 3
Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,196
- Enrollment target
NCT03621670: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT03621670 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,196 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03621670, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,196 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with Pneumococcal conjugate vaccine (PCV 13) and other recommended routine infant vaccinesv(RIV).
Primary Outcome
Assessed solicited administration site events include injection site tenderness (administration site pain), erythema (redness), swelling and induration. Any solicited administration site events = occurrence of the event regardless of intensity grade. Rotarix was administered orally; therefore, no administration site events were analyzed.
Interventions
- BIOLOGICAL Rotarix
- BIOLOGICAL Pediarix
- BIOLOGICAL Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ)
- BIOLOGICAL Prevnar13
- BIOLOGICAL Hiberix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,196 participants |
| Start Date | 2018-07-27 |
| Est. Completion | 2024-12-27 |
| Phase | Phase 3 |
What the finished NCT03621670 record still lists
NCT03621670 is an interventional study that assigns participants to a tested intervention. Its 1,196 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 (55% higher).
The record links to 0 conditions, and to 5 interventions - of which Rotarix is the first listed.
NCT03621670 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03621670 about?
NCT03621670 is a clinical study titled "Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants". The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with Pneumococcal conjugate vaccine (PCV 13) and other recommended routine infant ...
What is the current status of trial NCT03621670?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,196 participants. The study started on 2018-07-27. Estimated completion is 2024-12-27.
What interventions are being tested in trial NCT03621670?
The interventions under investigation include: Rotarix (BIOLOGICAL), Pediarix (BIOLOGICAL), Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ) (BIOLOGICAL), Prevnar13 (BIOLOGICAL), Hiberix (BIOLOGICAL).
Who is sponsoring clinical trial NCT03621670?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03621670's enrollment target sits among peer trials
1,196 228th of 2000 higher than 1,772 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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