Clinical Trial Info

Developing World Study for RotaTeq™

Authored by
Staff

The purpose of this Phase 3 study is to evaluate whether the vaccine is effective, well-tolerated, and immunogenic among infants in developing countries. The study began in March 2007 and completed in March 2009.

The study was conducted at 5 international sites - Ghana, Kenya, Mali, Bangladesh, and Vietnam from 29 March 2007 (first patient in) to 13 October 2008 (last dose given).

Approximately 5468 children up to 12 weeks of age were participants in this Phase 3 trial.

Results

According to articles published in The Lancet, the Pentavalent rotavirus vaccine is effective against severe rotavirus gastroenteritis in the first 2 years of life in African countries with high mortality in infants younger than 5 years. Additionally, The Lancet reported, in infants in developing countries in Asia, pentavalent rotavirus vaccine is safe and efficacious against severe rotavirus gastroenteritis.

Based upon the results, we support WHO's recommendation for the adoption of the rotavirus vaccine into national expanded programs on immunization in Africa.