Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations

Summary

The purpose of this study is to assess the safety and the body's immune response (body's defense against disease) to an experimental H1N1 influenza vaccine in healthy adult and elderly populations. The study will enroll up to 450 healthy adults ages 18 and older with no history of H1N1 infection or vaccination. Two hundred individuals will be 18-64 years old, and the other 200 will be greater than or equal to 65 years of age. Participants will be randomly assigned to 1 of 2 possible vaccine groups: group 1 will receive 15 mcg of H1N1 vaccine; group 2 will receive 30 mcg of H1N1 vaccine. Both groups will receive vaccine injections on days 0 and 21 in the arm muscle. Study procedures include: medical history, physical exam, maintaining a memory aid, and blood sample collection. Participants will be involved in study related procedures for approximately 7 months.

Timeline

Start

2009-08

Primary completion

2010-03

Completion

2010-03

Publications

• Results Chen WH, Winokur PL, Edwards KM, Jackson LA, Wald A, Walter EB, Noah DL, Wolff M, Kotloff KL; Pandemic H1N1 Vaccine Adult Study Group. Phase 2 assessment of the safety and immunogenicity of two inactivated pandemic monovalent H1N1 vaccines in adults as a component of the U.S. pandemic preparedness plan in 2009. Vaccine. 2012 Jun 13;30(28):4240-8. doi: 10.1016/j.vaccine.2012.04.044. Epub 2012 Apr 23.

Drugs

Indications