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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,500

Participants

Timeline

Start Date

November 30, 2015

Primary Completion Date

April 30, 2017

Study Completion Date

June 30, 2017

Conditions
Rotavirus Gastroenteritis
Interventions
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)

Trial Locations (10)

400008

T. N. Medical College and B. Y. L. Nair Charitable, Mumbai

400012

Seth G S Medical College & KEM Hospital, Mumbai

411043

Bharati Vidyapeeth Medical College and Hospital, Pune

412216

KEM Hospital and Research Centre, Vadu, Pune

500020

Gandhi Medical College and Gandhi Hospital, Hyderabad

530002

King George Hospital, Visakhapatnam

570004

JSS Medical College and Hospital, Mysore

600116

Sri Ramachandra Medical Centre, Chennai

700017

Institute of Child Health, Kolkata

Unknown

Maulana Azad Medical College, New Delhi

All Listed Sponsors
collaborator

PATH

OTHER

lead

Serum Institute of India Pvt. Ltd.

INDUSTRY

NCT02584816 - Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization | Biotech Hunter | Biotech Hunter