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NCT01196988 · ClinicalTrials.gov registry record · Phase 3
Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine When Administered in Children
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,027
- Enrollment target
NCT01196988: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01196988 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 3,027 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (292% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01196988, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,027 participants
- Enrollment target
Study Summary
This study is designed to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational vaccine GSK2321138A in children aged 3 to 17 years, and to describe safety and immunogenicity of the GSK Biologicals' investigational vaccine GSK2321138A in children aged 6 to 35 months.
Primary Outcome
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).
Interventions
- BIOLOGICAL Influenza vaccine GSK2321138A
- BIOLOGICAL FluarixTM
- BIOLOGICAL Influenza vaccine GSK2604409A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,027 participants |
| Start Date | 2010-10-04 |
| Est. Completion | 2011-06-15 |
| Phase | Phase 3 |
What the finished NCT01196988 record still lists
NCT01196988 is an interventional study that assigns participants to a tested intervention. Its 3,027 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 (292% higher).
The record links to 0 conditions, and to 3 interventions - of which Influenza vaccine GSK2321138A is the first listed.
NCT01196988 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01196988 about?
NCT01196988 is a clinical study titled "Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine When Administered in Children". This study is designed to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational vaccine GSK2321138A in children aged 3 to 17 years, and to describe safety and immunogenicity of the GSK Biologicals' investigational vaccine GSK2321138A in children aged 6 to 35 mont...
What is the current status of trial NCT01196988?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,027 participants. The study started on 2010-10-04. Estimated completion is 2011-06-15.
What interventions are being tested in trial NCT01196988?
The interventions under investigation include: Influenza vaccine GSK2321138A (BIOLOGICAL), FluarixTM (BIOLOGICAL), Influenza vaccine GSK2604409A (BIOLOGICAL).
Who is sponsoring clinical trial NCT01196988?
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 NCT01196988's enrollment target sits among peer trials
3,027 79th of 2000 higher than 1,922 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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