Safety and Immunogenicity of 2 Formulations of an Intramuscular A/H5N1 Pandemic Influenza Vaccine in Children

NCT00491985 ↗

Phase 2 Completed 240 enrolled Sanofi Pasteur, a Sanofi Company

RandomizedParallel-groupOpen-labelPrevention

Summary

This is an open, randomized, multicenter clinical trial. Objectives: * To describe the safety profiles during the 21 days following each primary and booster injection. * To describe the immune response 21 days after each primary and booster injection of each formulation. * To describe the antibody persistence after the first vaccination

Timeline

Start: 2007-06
Primary completion: 2009-12
Completion: 2010-06

Publications

Chotpitayasunondh T, Thisyakorn U, Pancharoen C, Pepin S, Nougarede N. Safety, humoral and cell mediated immune responses to two formulations of an inactivated, split-virion influenza A/H5N1 vaccine in children. PLoS One. 2008;3(12):e4028. doi: 10.1371/journal.pone.0004028. Epub 2008 Dec 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	A/H5N1 Inactivated, split-virion pandemic influenza vaccine	Vaccine	0.25 ml	Intramuscular
Subject	A/H5N1 Inactivated, split-virion pandemic influenza vaccine	Vaccine	0.5 ml	Intramuscular

Safety and Immunogenicity of 2 Formulations of an Intramuscular A/H5N1 Pandemic Influenza Vaccine in Children

Summary

Timeline

Publications

Drugs

Indications