Clinical trial on Liquid Rotavirus vaccine to check consistency of different lots of vaccines manufactured and to compare vaccine non-inferiority with ROTASIIL vaccine in healthy children in India

INTERVENTION: Intervention1: LBRV‐PV (Test Vaccine three lots): Liquid, ready to use formulation of live attenuated human‐bovine reassortant pentavalent rotavirus vaccine (BRV‐PV) based on the UK bovine rotavirus and five human rotavirus strains (G1, G2, G3, G4, and G9), at a dosage of â?¥ Log105.6 fluorescent focus units (FFU) / Serotype / Dose of 2 ml. Manufactured by the Serum Institute of India Pvt. Ltd., India Control Intervention1: ROTASIIL [Lyophilized BRV‐PV (Active Control)]: Lyophilized formulation of live attenuated human‐bovine reassortant pentavalent rotavirus vaccine (BRV‐PV) based on the UK bovine rotavirus and five human rotavirus strains (G1, G2, G3, G4, and G9), at a dosage of â?¥ Log105.6 fluorescent focus units (FFU) / Serotype / Dose. Buffered Diluent: 2.5 ml Citrated Sodium Bicarbonate containing 25.6 g of sodium bicarbonate and 9.6 g citric acid per liter. Manufactured by the Serum Institute of India Pvt. Ltd., India CONDITION: Rotavirus Gastroenteritis PRIMARY OUTCOME: â?¢ To demonstrate non‐inferiority in the immunogenicity of LBRV‐PV as compared with ROTASIIL (lyophilized BRV‐PV) in infants.‐‐‐‐‐‐Timepoint: 28 days post dose 3 SECONDARY OUTCOME: â?¢ To evaluate the safety of LBRV‐PV in terms of immediate post‐vaccination events, solicited reactions, unsolicited adverse events and serious adverse events, including monitoring for intussusception.‐‐‐‐‐‐Timepoint: Throughout the study period INCLUSION CRITERIA: 1. Healthy infants as established by medical history and clinical examination before entering the study. 2. Age: 6‐8 weeks at the time of enrollment. 3. Parental ability and willingness to provide informed consent. 4. Parent who intends to remain in the area with the child during the study period.