CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,116 enrolled
Drug / intervention
GSK investigational vaccine GSK1557482A +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00980005
NCT00980005Phase 3Completed
CompareCT.gov

Immunogenicity & Safety Study of GSK Biologicals' Thimerosal-free Trivalent Influenza Vaccine (TIV) Versus a Licensed Comparator in Children

GlaxoSmithKline·interventional·Posted Sep 18, 2009·Updated Sep 21, 2018

In Brief

A Phase 3 clinical trial evaluating GSK investigational vaccine GSK1557482A and Fluzone® for Influenza. Completed, enrolled 2,116 participants across 28 sites.

Detailed Summary

The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK1557482A.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 18, 2009
Enrollment StartOct 13, 2009
Primary CompletionMar 2, 2010
Study CompletionJun 17, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.8 years ago

Interventions

GSK investigational vaccine GSK1557482Abiological

One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects

Fluzone®biological

One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects