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NCT00719043 · ClinicalTrials.gov registry record · Phase 2
Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged ≥18 Years
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 841
- Enrollment target
NCT00719043: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT00719043 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 841 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (532% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00719043, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 841 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether GSK's avian flu vaccine GSK 1557484A is immunogenic and safe when given to adults aged \>=18 years. This Protocol Posting has been updated following Amendments 1-3 of the Protocol, Dec 2009. The impacted sections are study design and outcome measures.
Primary Outcome
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formu
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)
- BIOLOGICAL A/turkey H5N1 vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 841 participants |
| Start Date | 2008-07-11 |
| Est. Completion | 2011-02-18 |
| Phase | Phase 2 |
What the finished NCT00719043 record still lists
NCT00719043 is an interventional study that assigns participants to a tested intervention. The registered 841 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 (532% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00719043 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00719043 about?
NCT00719043 is a clinical study titled "Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged ≥18 Years". The purpose of this study is to determine whether GSK's avian flu vaccine GSK 1557484A is immunogenic and safe when given to adults aged \>=18 years. This Protocol Posting has been updated following Amendments 1-3 of the Protocol, Dec 2009. The impacted sections are study design and outcome measure...
What is the current status of trial NCT00719043?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 841 participants. The study started on 2008-07-11. Estimated completion is 2011-02-18.
What interventions are being tested in trial NCT00719043?
The interventions under investigation include: Placebo (BIOLOGICAL), Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) (BIOLOGICAL), A/turkey H5N1 vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00719043?
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 NCT00719043's enrollment target sits among peer trials
841 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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