A Study to Evaluate the Safety and Immunogenicity of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine in Children

Phase 3 Completed 520 enrolled GlaxoSmithKline

RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' influenza vaccine in children aged 3 to 17 years.

Timeline

Start: 2011-07-28
Primary completion: 2012-08-02
Completion: 2012-10-05

Publications

Izurieta P, Uy-Aragon MJ, Drame M, Vaughn DW. Assessment of Prime-boost Vaccination Using an AS03B-adjuvanted Influenza A (H5N1) Vaccine: A Randomized Trial in Children of Three to Less Than Eighteen Years of Age. Pediatr Infect Dis J. 2016 Feb;35(2):e35-47. doi: 10.1097/INF.0000000000000968.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Havrix	Vaccine	—	Intramuscular
Subject	Havrix Junior	Vaccine	—	Intramuscular
Subject	Influenza vaccine GSK1562902A Formulation 1	Vaccine	—	Intramuscular
Subject	Influenza vaccine GSK1562902A Formulation 2	Vaccine	—	Intramuscular

A Study to Evaluate the Safety and Immunogenicity of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine in Children

Summary

Timeline

Publications

Drugs

Indications