A/H1N1 Immunogenicity and Safety in Infants, Children and Adolescents

Phase 1/2 Completed 400 enrolled Alachua Government Services, Inc.

RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to determine the preferred dose of H1N1 pandemic influenza vaccine in a pediatric population, aged 6 months to 17 years, based upon assessments of immunogenicity and safety.

Timeline

Start: 2009-09
Primary completion: 2010-04
Completion: 2011-03

Publications

Loew-Baselli A, Pavlova BG, Fritsch S, Poellabauer EM, Draxler W, Kistner O, Behre U, Angermayr R, Neugebauer J, Kirsten K, Forster-Waldl E, Koellges R, Ehrlich HJ, Barrett PN. A non-adjuvanted whole-virus H1N1 pandemic vaccine is well tolerated and highly immunogenic in children and adolescents and induces substantial immunological memory. Vaccine. 2012 Sep 7;30(41):5956-66. doi: 10.1016/j.vaccine.2012.07.039. Epub 2012 Jul 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	H1N1 pandemic influenza vaccine	Vaccine	3.75 ug	Intramuscular
Subject	H1N1 pandemic influenza vaccine	Vaccine	7.5 ug	Intramuscular
Subject	Seasonal Trivalent Influenza Vaccine	Vaccine	—	—

A/H1N1 Immunogenicity and Safety in Infants, Children and Adolescents

Summary

Timeline

Publications

Drugs

Indications