A Phase III, Multicenter, Open Label, Randomized Study of Bovine Rotavirus Pentavalent Vaccine (BRV-PV) to Evaluate Lot-To-Lot Consistency and to Investigate Potential Interference With Routine UIP Vaccinations in Healthy Infants in India.

NCT02584816 Phase 3 COMPLETED

This is a Phase 3, open-label, randomized study to evaluate lot-to-lot consistency in the manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV).

Details

Lead sponsor	Serum Institute of India Pvt. Ltd.
Phase	Phase 3
Status	COMPLETED
Enrolment	1500
Start date	2015-11
Completion	2017-06

Conditions

• Rotavirus Gastroenteritis

Interventions

• BRV-PV Lot A + DPT-HepB-Hib + OPV
• BRV-PV Lot B + DPT-HepB-Hib + OPV
• BRV-PV Lot C + DPT-HepB-Hib + OPV
• ROTARIX + DPT-HepB-Hib + OPV

Primary outcomes

• Rotavirus vaccine lots Immunogenicity — Four weeks after the third dose of vaccination
  Serum anti- rotavirus IgA antibody concentrations expressed as GMCs for the BRV-PV to demonstrate equivalence in lot consistency among three lots.
• Immunogenicity of UIP vaccines — Four weeks after the third dose of vaccination

Countries

India