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NCT01310413 · ClinicalTrials.gov registry record · Phase 3
Monovalent H5N1 Vaccine GSK1557484A in Children 6 Months to < 18 Years of Age
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 842
- Enrollment target
NCT01310413: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01310413 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 842 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01310413, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 842 participants
- Enrollment target
Study Summary
This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate vaccine GSK1557484A in children 6 months to \< 18 years of age.
Primary Outcome
A seroprotected subject against the a/Indonesia/5/2005 (A/INDO) virus strain was defined as a subject with H5N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (\>=) the seroprotection cut-off of 1:40.
Interventions
- BIOLOGICAL Saline placebo
- BIOLOGICAL Influenza A (H5N1) Virus monovalent vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 842 participants |
| Start Date | 2011-03-07 |
| Est. Completion | 2014-01-26 |
| Phase | Phase 3 |
What the finished NCT01310413 record still lists
NCT01310413 is an interventional study that assigns participants to a tested intervention. The registered 842 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Saline placebo is the first listed.
NCT01310413 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01310413 about?
NCT01310413 is a clinical study titled "Monovalent H5N1 Vaccine GSK1557484A in Children 6 Months to < 18 Years of Age". This study will assess safety and immunogenicity of GSK Biologicals' H5N1 flu candidate vaccine GSK1557484A in children 6 months to \< 18 years of age.
What is the current status of trial NCT01310413?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 842 participants. The study started on 2011-03-07. Estimated completion is 2014-01-26.
What interventions are being tested in trial NCT01310413?
The interventions under investigation include: Saline placebo (BIOLOGICAL), Influenza A (H5N1) Virus monovalent vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01310413?
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 NCT01310413's enrollment target sits among peer trials
842 392nd of 2000 higher than 1,609 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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