A Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine in Children

Summary

This study is designed to test the efficacy of an investigational influenza vaccine, in children compared to Havrix®, a licensed Hepatitis A virus vaccine. This study will also evaluate the immunogenicity and safety of the investigational vaccine.

Timeline

Start

2010-12-09

Primary completion

2012-01-09

Completion

2012-01-09

Outcome

Met primary endpoint

paper 62 children in the QIV group (2.40%) and 148 in the control group (5.73%) had rt-PCR-confirmed influenza PMID 24328444 ↗

paper representing a QIV efficacy of 59.3% (95% confidence interval [CI], 45.2 to 69.7) PMID 24328444 ↗

Publications

• Jain VK, Rivera L, Zaman K, Espos RA Jr, Sirivichayakul C, Quiambao BP, Rivera-Medina DM, Kerdpanich P, Ceyhan M, Dinleyici EC, Cravioto A, Yunus M, Chanthavanich P, Limkittikul K, Kurugol Z, Alhan E, Caplanusi A, Durviaux S, Boutet P, Ofori-Anyinam O, Chandrasekaran V, Dbaibo G, Innis BL. Vaccine for prevention of mild and moderate-to-severe influenza in children. N Engl J Med. 2013 Dec 26;369(26):2481-91. doi: 10.1056/NEJMoa1215817. Epub 2013 Dec 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	FluLaval® Quadrivalent	Vaccine	—	Intramuscular
Comparator	Havrix	Vaccine	—	Intramuscular

Indications