NCT00449670

Assess Consistency of Immunogenicity of GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults

Assess the Consistency of the Immunogenicity of a GlaxoSmithKline Biologicals' Pandemic Influenza Vaccine (GSK1562902A) in Adults Aged Between 18 and 60 Years

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,206 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

The protocol posting has been updated to reflect changes due to an amendment to the protocol (addition of an exclusion criterion). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

• Influenza
• Influenza Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	H5N1 adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain)	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.
BIOLOGICAL	H5N1 non-adjuvanted split virus vaccine (A/Vietnam/1194/2004 strain)	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.
BIOLOGICAL	H5N1 adjuvanted split virus vaccine (A/Indonesia/05/2005 strain)	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.

Timeline

• Start date: 2007-03-24
• Primary completion: 2007-07-12
• Completion: 2008-06-10
• First posted: 2007-03-20
• Last updated: 2020-04-09
• Results posted: 2020-04-09

Locations

6 sites across 4 countries: Hong Kong, Singapore, Taiwan, Thailand