CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 310 enrolled
Drug / intervention
GSK Biologicals' Influenza investigational vaccine GSK2340274A +2 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/NCT01035749
NCT01035749Phase 2Completed
CompareCT.gov

Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine (GSK2340274A) in Children Aged 10 to Less Than 18 Years

GlaxoSmithKline·interventional·Posted Dec 21, 2009·Updated Aug 17, 2018

In Brief

A Phase 2 clinical trial evaluating GSK Biologicals' Influenza investigational vaccine GSK2340274A, GSK Biologicals' Influenza investigational vaccine GSK2340273A, and 1 other intervention for Influenza. Completed, enrolled 310 participants across 9 sites in 2 countries.

Detailed Summary

The purpose of this study is to show that vaccination with a single dose of GSK Biologicals' pandemic H1N1 vaccine results in an immune response that meets or exceeds European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) guidance criteria for a pandemic influenza vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesEstonia, Slovakia
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 21, 2009
Enrollment StartFeb 1, 2010
Primary CompletionSep 27, 2010
Study CompletionMay 10, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 16.5 years ago

Interventions

GSK Biologicals' Influenza investigational vaccine GSK2340274Abiological

One or two doses administered intramuscularly

GSK Biologicals' Influenza investigational vaccine GSK2340273Abiological

Two doses intramuscularly

Placebo (saline)biological

One dose intramuscularly