CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 350 enrolled
Drug / intervention
Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose +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/NCT00506350
NCT00506350Phase 2Completed
CompareCT.gov

Evaluate the Reactogenicity & Immunogenicity of 1 or 2 Booster Administrations of an Influenza Pandemic Candidate Vaccine (GSK1562902A) in Primed Adults Aged Between 19 & 61 Years

GlaxoSmithKline·interventional·Posted Jul 25, 2007·Updated Oct 4, 2017

In Brief

A Phase 2 clinical trial evaluating Pandemic influenza candidate vaccine (GSK1562902A) - 1 dose and Pandemic influenza candidate vaccine (GSK1562902A) - 2 doses for Influenza. Completed, enrolled 350 participants across 1 site.

Detailed Summary

The present study is designed to evaluate the reactogenicity and immunogenicity of one or two booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in adults aged between 19 and 61 years, previously vaccinated with 2 doses of a pandemic candidate vaccine. Fifty new subjects who did not participate in a primary study (106750, NCT00309634) will be recruited. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00309634)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesBelgium
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 25, 2007
Enrollment StartAug 1, 2007
Primary CompletionOct 12, 2009
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 18.9 years ago

Interventions

Pandemic influenza candidate vaccine (GSK1562902A) - 1 dosebiological

A single dose of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.

Pandemic influenza candidate vaccine (GSK1562902A) - 2 dosesbiological

Two doses of Pandemic influenza candidate vaccine (GSK1562902A) administered intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21.