Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South Africa

Summary

The purpose of this study is to determine the appropriate regimen of GSK HRV vaccine for concomitant administration with EPI vaccines to infants in South Africa.

Timeline

Start

2003-09

Primary completion

2004-09

Completion

2004-09

Publications

• Background Steele AD et al. Comparison of 2 different regimens (two doses versus three doses) in terms of reactogenicity and immunogenicity of the live attenuated human rotavirus vaccine Rotarix™ (RIX4414) in South African infants. Abstract presented at the 9th dsRNA Virus Meeting. Cape Town, South Africa, 21-26 Oct 2006.
• Background Steele AD et al. Comparison of 2 different regimens (two doses versus three doses) in terms of reactogenicity and immunogenicity of the live attenuated human rotavirus vaccine Rotarix™ (RIX4414) in South African infants. Abstract presented at ASCOOD. Bangkok, Thailand, 8-10 March 2006.
• Background Steele AD et al. Difference in immune responses between 2 different regimens of RIX4414 ( 106.5 CCID50 viral concentration) in South Africa. Abstract presented at the 4th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Warsaw, Poland, 01-04 Sept 2005.

Drugs

Indications