NCT02133690 - A Clinical Trial to Study the Effect and Safety of Rotavirus Vaccine Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants | Biotech Hunter

Enrollment

7,500

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

March 31, 2016

Study Completion Date

March 31, 2017

Conditions

Rotavirus Gastroenteritis

Interventions

BIOLOGICAL

Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV)

Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV), at a dosage of ≥ Log10\^5.6 fluorescent focus units (FFU)/Serotype/Dose in 2.5 ml of buffered diluent

OTHER

Placebo

Lyophilized minimal essential medium (MEM) + excipients reconstituted in 2.5 ml of buffered diluents

Trial Locations (6)

Unknown

Dr Dinesh Kumar Government Medical College, Jammu Department of Community Medicine, Government Medical College, Jammu

Kasturba Medical College, Manipal, Manipal

KEM Hospital and Research Centre, Pune

Dr. Sushila Nayar School of Public Health ,Mahatma Ghandi School of Medicine, Sewāgrām

Center for Health Research and Development (CHRD) -Society for applied studies (SAS), New Delhi

National Institute of Cholera & Enteric Diseases, Kolkata

All Listed Sponsors

collaborator

PATH

OTHER

lead

Serum Institute of India Pvt. Ltd.

INDUSTRY