CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,206 enrolled
Drug / intervention
H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain) +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.

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Search/NCT00449670
NCT00449670Phase 3Completed
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Assess the Consistency of the Immunogenicity of a GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults Aged Between 18 and 60 Years

GlaxoSmithKline·interventional·Posted Mar 20, 2007·Updated Apr 9, 2020

In Brief

A Phase 3 clinical trial evaluating H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain), H5N1 non-adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain), and 1 other intervention for Influenza and Influenza Vaccines. Completed, enrolled 1,206 participants across 6 sites in 4 countries.

Detailed Summary

The present study is designed to assess the lot-to-lot consistency of the immunogenicity of a GlaxoSmithKline Biologicals' pandemic influenza candidate vaccine (GSK1562902A) in adults aged between 18 and 60 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Influenza Vaccines
CountriesHong Kong, Singapore, Taiwan, Thailand
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 20, 2007
Enrollment StartMar 24, 2007
Primary CompletionJul 12, 2007
Study CompletionJun 10, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 19.3 years ago

Interventions

H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain)biological

Two doses of the GSK1562902A adjuvanted split virus vaccine, administered intramuscularly into the deltoid region of the non-dominant arm at Day 0 and Day 21.

H5N1 non-adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain)biological

Two doses of the GSK1562902A non-adjuvanted split virus vaccine, administered intramuscularly into the deltoid region of the non-dominant arm at Day 0 and Day 21.

H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain)biological

Booster administration at Month 6 (and a second booster dose 21 days later for the un-adjuvanted group only) with an adjuvanted split virus pandemic influenza candidate vaccine containing the strain A/Indonesia/5/2005.