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NCT04707391 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,250
- Enrollment target
NCT04707391: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT04707391 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,250 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04707391, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,250 participants
- Enrollment target
Study Summary
The purpose of this study was to assess immunogenicity and safety of MenABCWY vaccine in healthy adolescents and adults aged 15 to 25 years previously vaccinated with MenACWY vaccine.
Primary Outcome
Four-fold rise is defined as: - a post-vaccination hSBA titer equal to or higher than (\>=) 16 for participants with a pre-vaccination hSBA titer \<4; - a post-vaccination hSBA titer \>= 4 times the LLOQ for participants with a pre vaccination hSBA titer \>= limit of detection (LOD) but \< LLOQ; and - a post-vaccination hSBA titer \>= 4 times the pre-vaccination titer for participants with a pre-vaccination hSBA titer \>= LLOQ.
Interventions
- COMBINATION_PRODUCT Placebo
- COMBINATION_PRODUCT MenABCWY vaccine
- BIOLOGICAL MenACWY vaccine
- COMBINATION_PRODUCT MenB vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,250 participants |
| Start Date | 2021-01-25 |
| Est. Completion | 2023-09-29 |
| Phase | Phase 3 |
What the finished NCT04707391 record still lists
NCT04707391 is an interventional study that assigns participants to a tested intervention. Its 1,250 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 (62% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04707391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04707391 about?
NCT04707391 is a clinical study titled "Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine". The purpose of this study was to assess immunogenicity and safety of MenABCWY vaccine in healthy adolescents and adults aged 15 to 25 years previously vaccinated with MenACWY vaccine.
What is the current status of trial NCT04707391?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,250 participants. The study started on 2021-01-25. Estimated completion is 2023-09-29.
What interventions are being tested in trial NCT04707391?
The interventions under investigation include: Placebo (COMBINATION_PRODUCT), MenABCWY vaccine (COMBINATION_PRODUCT), MenACWY vaccine (BIOLOGICAL), MenB vaccine (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04707391?
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 NCT04707391's enrollment target sits among peer trials
1,250 207th of 2000 higher than 1,791 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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