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NCT02242643 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,432
- Enrollment target
NCT02242643: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT02242643 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 2,432 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (215% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02242643, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,432 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' quadrivalent influenza vaccine (GSK2282512A) compared to Sanofi Pasteur's Fluzone® Quadrivalent in children 6 to 35 months of age.
Primary Outcome
Antibody titers were expressed as Seroconversion rate (SCR) and SCR difference. SCR was defined as the proportion of vaccinees who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria).
Interventions
- BIOLOGICAL Fluzone® Quadrivalent
- BIOLOGICAL FluLaval™ Quadrivalent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,432 participants |
| Start Date | 2014-10-01 |
| Est. Completion | 2015-06-23 |
| Phase | Phase 3 |
What the finished NCT02242643 record still lists
NCT02242643 is an interventional study that assigns participants to a tested intervention. Its 2,432 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 (215% higher).
The record links to 0 conditions, and to 2 interventions - of which Fluzone® Quadrivalent is the first listed.
NCT02242643 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02242643 about?
NCT02242643 is a clinical study titled "Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age". The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' quadrivalent influenza vaccine (GSK2282512A) compared to Sanofi Pasteur's Fluzone® Quadrivalent in children 6 to 35 months of age.
What is the current status of trial NCT02242643?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,432 participants. The study started on 2014-10-01. Estimated completion is 2015-06-23.
What interventions are being tested in trial NCT02242643?
The interventions under investigation include: Fluzone® Quadrivalent (BIOLOGICAL), FluLaval™ Quadrivalent (BIOLOGICAL).
Who is sponsoring clinical trial NCT02242643?
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 NCT02242643's enrollment target sits among peer trials
2,432 88th of 2000 higher than 1,913 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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