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NCT04789577 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine GSK3206641A Administered in Adults 18 to 64 Years of Age and 65 Years of Age and Older
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 833
- Enrollment target
NCT04789577: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT04789577 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 833 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (526% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04789577, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 833 participants
- Enrollment target
Study Summary
Study to evaluate the safety and immunogenicity of H7N9 antigen in combination with full or half doses of AS03 adjuvant system in healthy adults.
Primary Outcome
Center for Biologics Evaluation and Research (CBER) criteria for seroprotection rate (SPR) for 18 to 64 years of age is shown if the Lower Limit (LL) of the 99.17% confidence interval (CI) for the SPR meets or exceeds 70%, and for greater than or equal to (≥) 65 years of age if the LL of the 99.17% CI for the SPR meets or exceeds 60%. SPR is defined as the percentage of participants with an HI antibody titer ≥40 1/dilution (DIL). The percentage of participants was calculated along with Clopper-P
Interventions
- BIOLOGICAL FLU-Q-PAN H7N9 Formulation 1
- BIOLOGICAL FLU-Q-PAN H7N9 Formulation 2
- BIOLOGICAL FLU-Q-PAN H7N9 Formulation 3
- BIOLOGICAL AS03B
- BIOLOGICAL AS03A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 833 participants |
| Start Date | 2021-03-16 |
| Est. Completion | 2022-09-12 |
| Phase | Phase 2 |
What the finished NCT04789577 record still lists
NCT04789577 is an interventional study that assigns participants to a tested intervention. The registered 833 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (526% higher).
The record links to 0 conditions, and to 5 interventions - of which FLU-Q-PAN H7N9 Formulation 1 is the first listed.
NCT04789577 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04789577 about?
NCT04789577 is a clinical study titled "A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine GSK3206641A Administered in Adults 18 to 64 Years of Age and 65 Years of Age and Older". Study to evaluate the safety and immunogenicity of H7N9 antigen in combination with full or half doses of AS03 adjuvant system in healthy adults.
What is the current status of trial NCT04789577?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 833 participants. The study started on 2021-03-16. Estimated completion is 2022-09-12.
What interventions are being tested in trial NCT04789577?
The interventions under investigation include: FLU-Q-PAN H7N9 Formulation 1 (BIOLOGICAL), FLU-Q-PAN H7N9 Formulation 2 (BIOLOGICAL), FLU-Q-PAN H7N9 Formulation 3 (BIOLOGICAL), AS03B (BIOLOGICAL), AS03A (BIOLOGICAL).
Who is sponsoring clinical trial NCT04789577?
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 NCT04789577's enrollment target sits among peer trials
833 36th of 2000 higher than 1,965 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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