NCT02584816

Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,500 (actual)
• Sponsor: Serum Institute of India Pvt. Ltd. · Industry
• Sex: All
• Age: 6 Weeks – 8 Weeks
• Healthy volunteers: Accepted

Summary

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).

Detailed description

The study is designed to evaluate lot-to-lot consistency in the manufacturing of Rotavirus vaccine by testing the vaccine in infants in order to demonstrate equivalence in the induction of specific anti-rotavirus IgA antibodies across three production lots. The study will also examine the potential interference of vaccine with UIP vaccines that will be administered concurrently by assessing non-inferiority in the immune responses to those vaccines when administered with / without the study vaccine.

Conditions

• Rotavirus Gastroenteritis

Interventions

Type	Name	Description
BIOLOGICAL	BRV-PV Lot A + DPT-HepB-Hib + OPV	Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
BIOLOGICAL	BRV-PV Lot B + DPT-HepB-Hib + OPV	Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
BIOLOGICAL	BRV-PV Lot C + DPT-HepB-Hib + OPV	Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
BIOLOGICAL	ROTARIX + DPT-HepB-Hib + OPV	Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week (Third dose-Placebo)

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-04-01
• Completion: 2017-06-01
• First posted: 2015-10-23
• Last updated: 2018-09-11

Locations

10 sites across 1 country: India