Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Children

Summary

The present study is designed to evaluate in children (aged between 3 and 9 years) the immunogenicity and safety of different antigen doses of the candidate vaccine (GSK1562902A) administered following a two-administration schedule (21 days apart). Subjects in the control group will receive Fluarix. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Timeline

Start

2007-07-23

Primary completion

2009-12-04

Completion

2009-12-04

Outcome

Met primary endpoint

paper achieved humoral antibody titers against the vaccine-homologous strain, which fulfilled the United States influenza vaccines licensure criteria for immunogenicity. PMID 20375709 ↗

paper the H5N1 vaccine had a clinically acceptable reactogenicity and safety profile. PMID 20375709 ↗

Publications

• Diez-Domingo J, Baldo JM, Planelles-Catarino MV, Garces-Sanchez M, Ubeda I, Jubert-Rosich A, Mares J, Garcia-Corbeira P, Moris P, Teko M, Vanden Abeele C, Gillard P. Phase II, randomized, open, controlled study of AS03-adjuvanted H5N1 pre-pandemic influenza vaccine in children aged 3 to 9 years: follow-up of safety and immunogenicity persistence at 24 months post-vaccination. Influenza Other Respir Viruses. 2015 Mar;9(2):68-77. doi: 10.1111/irv.12295. Epub 2015 Feb 5.
• Diez-Domingo J, Garces-Sanchez M, Baldo JM, Planelles MV, Ubeda I, JuBert A, Mares J, Moris P, Garcia-Corbeira P, Drame M, Gillard P. Immunogenicity and Safety of H5N1 A/Vietnam/1194/2004 (Clade 1) AS03-adjuvanted prepandemic candidate influenza vaccines in children aged 3 to 9 years: a phase ii, randomized, open, controlled study. Pediatr Infect Dis J. 2010 Jun;29(6):e35-46. doi: 10.1097/INF.0b013e3181daf921.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Fluarix	Vaccine	—	Intramuscular
Subject	GSK1562902A	Vaccine	1.9 ug	Intramuscular
Subject	GSK1562902A	Vaccine	3.75 ug	Intramuscular

Indications