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NCT04502693 · ClinicalTrials.gov registry record · Phase 3
Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,657
- Enrollment target
NCT04502693: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT04502693 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 3,657 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (374% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04502693, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,657 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the effectiveness of 2 doses or 3 doses of GSK's licenced meningococcal group B Bexsero (rMenB+OMV NZ) vaccine and of 2 doses of GSK's investigational combined meningococcal (MenABCWY) vaccine (GSK3536819A) in healthy adolescents and young adults. The immunogenicity and safety were evaluated in the study.
Primary Outcome
The effectiveness (test-based) of rMenB+OMV vaccine at 1 month after the 3 doses in MenB\_0\_2\_6 group and 1 month after the 2 dose schedule in MenB\_0\_6 group when compared to one dose of MenACWY vaccination in ACWY group, against a panel of N. meningitidis serogroup B strains was measured in terms of percentage of samples without bactericidal activity using endogenous complement human Serum Bactericidal Assay (enc-hSBA), which provides a qualitative assessment (yes/no) of the presence of suf
Interventions
- COMBINATION_PRODUCT Placebo
- COMBINATION_PRODUCT rMenB+OMV NZ vaccine
- BIOLOGICAL Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
- COMBINATION_PRODUCT MenABCWY-1
- COMBINATION_PRODUCT MenABCWY-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,657 participants |
| Start Date | 2020-08-14 |
| Est. Completion | 2022-09-13 |
| Phase | Phase 3 |
What the finished NCT04502693 record still lists
NCT04502693 is an interventional study that assigns participants to a tested intervention. Its 3,657 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 (374% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT04502693 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04502693 about?
NCT04502693 is a clinical study titled "Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults". The purpose of this study was to evaluate the effectiveness of 2 doses or 3 doses of GSK's licenced meningococcal group B Bexsero (rMenB+OMV NZ) vaccine and of 2 doses of GSK's investigational combined meningococcal (MenABCWY) vaccine (GSK3536819A) in healthy adolescents and young adults. The immuno...
What is the current status of trial NCT04502693?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,657 participants. The study started on 2020-08-14. Estimated completion is 2022-09-13.
What interventions are being tested in trial NCT04502693?
The interventions under investigation include: Placebo (COMBINATION_PRODUCT), rMenB+OMV NZ vaccine (COMBINATION_PRODUCT), Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY) (BIOLOGICAL), MenABCWY-1 (COMBINATION_PRODUCT), MenABCWY-2 (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04502693?
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 NCT04502693's enrollment target sits among peer trials
3,657 67th of 2000 higher than 1,934 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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