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NCT01198756 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,109
- Enrollment target
NCT01198756: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01198756 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 3,109 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (303% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01198756, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,109 participants
- Enrollment target
Study Summary
This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in children compared to two other influenza vaccines.
Primary Outcome
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Florida/4/2006 (Yamagata) flu strains.
Interventions
- BIOLOGICAL Quadrivalent seasonal influenza vaccine GSK2282512A
- BIOLOGICAL Fluarix™ VB
- BIOLOGICAL Fluarix™ YB
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,109 participants |
| Start Date | 2010-10-01 |
| Est. Completion | 2011-07-01 |
| Phase | Phase 3 |
What the finished NCT01198756 record still lists
NCT01198756 is an interventional study that assigns participants to a tested intervention. Its 3,109 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 (303% higher).
The record links to 0 conditions, and to 3 interventions - of which Quadrivalent seasonal influenza vaccine GSK2282512A is the first listed.
NCT01198756 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01198756 about?
NCT01198756 is a clinical study titled "A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Children". This study is designed to test the immunogenicity and safety of an investigational influenza vaccine, in children compared to two other influenza vaccines.
What is the current status of trial NCT01198756?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,109 participants. The study started on 2010-10-01. Estimated completion is 2011-07-01.
What interventions are being tested in trial NCT01198756?
The interventions under investigation include: Quadrivalent seasonal influenza vaccine GSK2282512A (BIOLOGICAL), Fluarix™ VB (BIOLOGICAL), Fluarix™ YB (BIOLOGICAL).
Who is sponsoring clinical trial NCT01198756?
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 NCT01198756's enrollment target sits among peer trials
3,109 76th of 2000 higher than 1,925 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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