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NCT01974895 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age
A Phase 2 study of Influenza, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 316
- Enrollment target
- 12
- Study locations
NCT01974895: Completed Phase 2 study of Influenza, sponsored by GlaxoSmithKline.
NCT01974895 is a Phase 2 study of Influenza that has completed, run by GlaxoSmithKline. The registered enrollment target is 316 participants, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 12 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01974895, a Phase 2 study of Influenza, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 316 participants
- Enrollment target
- 12
- Study locations
Study Summary
The purpose of this study is to evaluate the immunogenicity and safety of the new influenza vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's Fluzone® (TIV) in children 6 to 35 months of age.
Primary Outcome
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/2/2012 (Yamagata), Flu B/Brisbane/60/2008 (Victoria). This outcome concerns solely subjects in the FluLaval Quadr
Conditions Studied
Interventions
- BIOLOGICAL FluLaval® Quadrivalent
- BIOLOGICAL Fluzone®
Study Locations (12)
California
- GSK Investigational Site - Sacramento
- GSK Investigational Site - West Covina
Massachusetts
- GSK Investigational Site - Fall River
- GSK Investigational Site - Woburn
South Carolina
- GSK Investigational Site - Barnwell
- GSK Investigational Site - Cheraw
Florida
- GSK Investigational Site - Altamonte Springs
Michigan
- GSK Investigational Site - Stevensville
New York
- GSK Investigational Site - Syracuse
Ohio
- GSK Investigational Site - Cleveland
Pennsylvania
- GSK Investigational Site - Hermitage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 316 participants |
| Start Date | 2013-10-23 |
| Est. Completion | 2014-07-03 |
| Phase | Phase 2 |
What the finished NCT01974895 record still lists
NCT01974895 is an interventional study that assigns participants to a tested intervention. The registered 316 participants enrollment target is mid-sized for trials with a published cap, below the 36,802-participant average among 156 other Influenza trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which FluLaval® Quadrivalent is the first listed.
NCT01974895 lists 12 locations in 9 states (California, Massachusetts, South Carolina).
Frequently Asked Questions
What is clinical trial NCT01974895 about?
NCT01974895 is a clinical study titled "Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age". The purpose of this study is to evaluate the immunogenicity and safety of the new influenza vaccine GSK2282512A (FLU Q-QIV) and compare its activity to Sanofi Pasteur's Fluzone® (TIV) in children 6 to 35 months of age.
What is the current status of trial NCT01974895?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 316 participants. The study started on 2013-10-23. Estimated completion is 2014-07-03.
What conditions does trial NCT01974895 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT01974895?
The interventions under investigation include: FluLaval® Quadrivalent (BIOLOGICAL), Fluzone® (BIOLOGICAL).
Who is sponsoring clinical trial NCT01974895?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01974895 being conducted?
This trial has 12 study locations across California, Florida, Massachusetts, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01974895's enrollment target sits among peer trials
316 62nd of 156 higher than 95 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza 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.
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