Safety and Immunogenicity Study of Live Attenuated Indian Rotavirus Vaccine Candidate Strains 116E and I321 in Infants

PHASE1CompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

January 31, 2005

Primary Completion Date

May 31, 2005

Study Completion Date

May 31, 2005

Conditions
Rotavirus Infections
Interventions
BIOLOGICAL

116E AGMK

Single dose of 116E 10\^5 FFu

DRUG

I321

Single dose of I321 10\^5 FFu

DRUG

Placebo

1 crystal of potassium permanganate dissolved in the bicarbonate buffer to colour match the vaccine

Trial Locations (1)

110016

Society for Applied Studies, New Delhi

All Listed Sponsors
collaborator

All India Institute of Medical Sciences

OTHER

collaborator

National Institutes of Health (NIH)

NIH

collaborator

Centers for Disease Control and Prevention

FED

collaborator

Stanford University

OTHER

collaborator

Indian Institute of Science

OTHER_GOV

collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

collaborator

Ministry of Science and Technology, India

OTHER_GOV

collaborator

PATH

OTHER

lead

Society for Applied Studies

OTHER

NCT00280111 - Safety and Immunogenicity Study of Live Attenuated Indian Rotavirus Vaccine Candidate Strains 116E and I321 in Infants | Biotech Hunter | Biotech Hunter