Assessment of Clinical Consistency of Three Production Lots of GSK Biologicals' HRV Vaccine

Summary

The purpose of this study is to evaluate the lot-to-lot consistency of three production lots of GSK Biologicals' HRV vaccine in terms of immunogenicity and safety in healthy infants aged 2 months at the time of first vaccination.

Timeline

Start

2003-08

Primary completion

2004-01

Completion

2004-01

Publications

• Results Lopez P, Herrera JFG, Cervantes Y, et al. Three consecutive production lots of the human monovalent RIX4414 G1P(8) rotavirus vaccine, Rotarix™ induce a consistent immune response in Latin American infants. Proc 4th World Congress Pediatr Infect Dis, Warsaw, Poland, 2005.

Drugs

Indications