Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

January 22, 2019

Primary Completion Date

October 4, 2019

Study Completion Date

October 4, 2019

Conditions
DiarrheaDiarrhea Rotavirus
Interventions
BIOLOGICAL

ROTAVAC®

0.5 ml of the vaccine will be administered orally thrice at 6, 10 and 14 weeks of age.

BIOLOGICAL

ROTAVAC 5D

0.5 ml of the vaccine will be administered orally thrice at 6, 10 and 14 weeks of age.

BIOLOGICAL

Rotarix®

1.5 ml of the liquid vaccine will be administered orally twice at 6 and 10 weeks of age.

Trial Locations (1)

10101

George Research Centre, Lusaka

All Listed Sponsors
collaborator

PATH

OTHER

collaborator

Christian Medical College, Vellore, India

OTHER

collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

collaborator

Bharat Biotech International Limited

INDUSTRY

lead

Centre for Infectious Disease Research in Zambia

OTHER

NCT03602053 - Study of BBIL's ROTAVAC® and ROTAVAC 5CM Vaccines in Zambia | Biotech Hunter | Biotech Hunter