Phase III Study of Liquid Formulation of ROTAVIN

PHASE3CompletedINTERVENTIONAL
Enrollment

825

Participants

Timeline

Start Date

March 16, 2019

Primary Completion Date

January 8, 2020

Study Completion Date

January 8, 2020

Conditions
DiarrheaDiarrhea Rotavirus
Interventions
BIOLOGICAL

ROTAVIN (liquid formulation)

Live attenuated human rotavirus vaccine containing ≥ 2x10\^6 plaque forming units (PFU) of strain G1P\[8\] per dose of 2 mL.

BIOLOGICAL

ROTAVIN-M1 (frozen formulation)

Live attenuated human rotavirus vaccine containing ≥ 2x10\^6 PFU of strain G1P\[8\] per dose of 2 mL.

Trial Locations (2)

10000

CDC Nam Dinh, Nam Định

CDC Quang Ninh, Quang Ninh

All Listed Sponsors
collaborator

PATH

OTHER

collaborator

National Institute of Hygiene and Epidemiology, Vietnam

OTHER

collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

lead

Center for Research and Production of Vaccines and Biologicals, Vietnam

OTHER_GOV

NCT03703336 - Phase III Study of Liquid Formulation of ROTAVIN | Biotech Hunter | Biotech Hunter