Sanofi Pasteur, TIV + H1N1, Pediatric Population

Summary

The purpose of this study is to assess the safety and immune response (body's defense against disease) to an experimental H1N1 influenza vaccine against the 2009 H1N1 virus. This study will help determine how and when the H1N1 flu shot should be given with the seasonal flu shot to make it most effective. The 650 participants will be divided into the following age groups: infants from 6 months-36 months old, children 36 months-9 years old, and adolescents 10-17 years old. Each age group will have 200 children. There are 4 treatment groups in each age level. Study procedures include: medical history, targeted physical exam based on history, maintaining a memory aid, and blood sample collection. Participants will be involved in the study for about 8 months.

Timeline

Start

2009-08

Primary completion

2010-05

Completion

2010-05

Publications

• Results Frey SE, Bernstein DI, Gerber MA, Keyserling HL, Munoz FM, Winokur PL, Turley CB, Rupp RE, Hill H, Wolff M, Noah DL, Ross AC, Cress G, Belshe RB. Safety and immune responses in children after concurrent or sequential 2009 H1N1 and 2009-2010 seasonal trivalent influenza vaccinations. J Infect Dis. 2012 Sep 15;206(6):828-37. doi: 10.1093/infdis/jis445. Epub 2012 Jul 16.
• Kotloff KL, Halasa NB, Harrison CJ, Englund JA, Walter EB, King JC, Creech CB, Healy SA, Dolor RJ, Stephens I, Edwards KM, Noah DL, Hill H, Wolff M. Clinical and immune responses to inactivated influenza A(H1N1)pdm09 vaccine in children. Pediatr Infect Dis J. 2014 Aug;33(8):865-71. doi: 10.1097/INF.0000000000000329.

Drugs

Indications