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NCT04318548 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine When Administered Concomitantly With GSK Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 945
- Enrollment target
NCT04318548: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT04318548 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 945 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04318548, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 945 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age.
Primary Outcome
Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.
Interventions
- COMBINATION_PRODUCT Placebo
- COMBINATION_PRODUCT Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ)
- BIOLOGICAL Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 945 participants |
| Start Date | 2020-08-25 |
| Est. Completion | 2023-11-21 |
| Phase | Phase 3 |
What the finished NCT04318548 record still lists
NCT04318548 is an interventional study that assigns participants to a tested intervention. The registered 945 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04318548 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04318548 about?
NCT04318548 is a clinical study titled "Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine When Administered Concomitantly With GSK Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age". The purpose of this study is to evaluate the immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age.
What is the current status of trial NCT04318548?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 945 participants. The study started on 2020-08-25. Estimated completion is 2023-11-21.
What interventions are being tested in trial NCT04318548?
The interventions under investigation include: Placebo (COMBINATION_PRODUCT), Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ) (COMBINATION_PRODUCT), Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04318548?
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 NCT04318548's enrollment target sits among peer trials
945 334th of 2000 higher than 1,667 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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