H5N1 Mix and Match With AS03

Summary

Approximately 216, and up to 240, healthy males and non-pregnant females, 18 to 49 years old, inclusive, will be enrolled over a 5-month period into this multicenter, randomized, double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study and provide informed consent will be randomized 2:1 between adjuvanted and unadjuvanted vaccine and placed into one of 6 groups (see table) to receive two doses of an intramuscular subvirion inactivated monovalent influenza A/H5N1 virus vaccine at 3.75, 7.5, or 15 mcg given with the adjuvant AS03 or diluent (N=216, up to 240). All eligible subjects will receive 2 doses separated by approximately 21 days.

Timeline

Start

2011-05

Primary completion

2012-09

Completion

2012-09

Publications

• Chen WH, Jackson LA, Edwards KM, Keitel WA, Hill H, Noah DL, Creech CB, Patel SM, Mangal B, Kotloff KL. Safety, Reactogenicity, and Immunogenicity of Inactivated Monovalent Influenza A(H5N1) Virus Vaccine Administered With or Without AS03 Adjuvant. Open Forum Infect Dis. 2014 Oct 8;1(3):ofu091. doi: 10.1093/ofid/ofu091. eCollection 2014 Dec.

Drugs

Indications