Assess the Immunogenicity & Safety of 2 Doses of Oral Live Attenuated Human Rota(HRV)Vaccine in Healthy Infants in India

Summary

Rotavirus disease is the most common cause of gastroenteritis and dehydration in young children worldwide. The global public health burden has prompted the development of a human rotavirus vaccine against rotavirus disease by GlaxoSmithKline Biologicals. This pre-registration study is undertaken to provide immunogenicity, reactogenicity and safety data for the vaccine when used in Indian infants aged approximately 8 weeks at the time of the first dose.

Timeline

Start

2006-02-10

Primary completion

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Completion

2006-09-08

Publications

• Background Bhattacharya SK et al. Immune response in infants sero-positive at pre-vaccination human rotavirus vaccine Rotarix™. Poster presented at WSPID, Bangkok, Thailand,15-18 November 2007
• Background Bose et al. Safety and immunogenicity of RIX4414 (Rotarix TM) live-attenuated human rotavirus vaccine in Indian infants. Poster presented at WSPID, Bangkok, Thailand, 15-18 November 2007.
• Background Narang A, Bose A, Pandit AN, Dutta P, Kang G, Bhattacharya SK, Datta SK, Suryakiran PV, Delem A, Han HH, Bock HL. Immunogenicity, reactogenicity and safety of human rotavirus vaccine (RIX4414) in Indian infants. Hum Vaccin. 2009 Jun;5(6):414-9. doi: 10.4161/hv.5.6.8176. Epub 2009 Jun 15.

Drugs

Indications