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NCT00976820 · ClinicalTrials.gov registry record · Phase 2
Safety and Immunogenicity of H1N1 Vaccines in Children Aged 6 Months to Less Than 9 Years of Age
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 323
- Enrollment target
NCT00976820: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT00976820 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 323 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (143% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00976820, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 323 participants
- Enrollment target
Study Summary
The purpose of this study is to characterize the safety and immune response of the H1N1 (swine) flu vaccines GSK2340274A and GSK2340273A in children 6 months to less than 9 years of age. This Protocol Posting has been updated following the Protocol amendment 1 \& 2, September and October 2009. The sections impacted are study design, objectives and analysis methods.
Primary Outcome
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (\<) 10 and a post-vaccination reciprocal HI titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Interventions
- BIOLOGICAL GSK2340274A
- BIOLOGICAL GSK2340273A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 323 participants |
| Start Date | 2009-10-20 |
| Est. Completion | 2011-03-21 |
| Phase | Phase 2 |
What the finished NCT00976820 record still lists
NCT00976820 is an interventional study that assigns participants to a tested intervention. The registered 323 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 (143% higher).
The record links to 0 conditions, and to 2 interventions - of which GSK2340274A is the first listed.
NCT00976820 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00976820 about?
NCT00976820 is a clinical study titled "Safety and Immunogenicity of H1N1 Vaccines in Children Aged 6 Months to Less Than 9 Years of Age". The purpose of this study is to characterize the safety and immune response of the H1N1 (swine) flu vaccines GSK2340274A and GSK2340273A in children 6 months to less than 9 years of age. This Protocol Posting has been updated following the Protocol amendment 1 \& 2, September and October 2009. The ...
What is the current status of trial NCT00976820?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 323 participants. The study started on 2009-10-20. Estimated completion is 2011-03-21.
What interventions are being tested in trial NCT00976820?
The interventions under investigation include: GSK2340274A (BIOLOGICAL), GSK2340273A (BIOLOGICAL).
Who is sponsoring clinical trial NCT00976820?
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 NCT00976820's enrollment target sits among peer trials
323 150th of 2000 higher than 1,851 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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