Dose Escalation Study to Evaluate Oral Rotavirus Vaccine 116E Live Attenuated in Healthy Infants 8 to 20 Weeks Old

This study will be a Phase I, randomized, double blind, safety and immunogenicity trial of the Vero cell based 116E neonatal rotavirus vaccine candidate strain in healthy non-malnourished infants aged 8-20 weeks at three different dosage levels i.e.10\^4.0, 10\^5.0 and 10\^6.0 FFU and for three administrations of each of these dosages given to infants at 4-week intervals. 180 infants (90 vaccinees/90 placebo) will be enrolled for each of the three dosage levels. The progression from the lower to the next higher dosage will be based on approval by the Data Safety Monitoring Board (DSMB) to be constituted by the Department of Biotechnology, New Delhi.