NCT02556996View on ClinicalTrials.gov

Efficacy of an Oral, Killed Enterotoxigenic Escherichia Coli Vaccine in Prevention of Diarrhea in Egyptian Infants and Young Children

PHASE3CompletedINTERVENTIONAL
Enrollment

356

Participants

Timeline

Start Date

October 31, 1998

Primary Completion Date

March 31, 2001

Study Completion Date

April 30, 2002

Conditions
Diarrhea
Interventions
BIOLOGICAL

ETEC/rCTB vaccine

Cocktail of five whole-cell, formalin-inactivated ETEC strains (total of 10\^11 formalin-killed bacteria per dose) plus recombinant cholera toxin B-subunit (rCTB) (1 mg)

OTHER

Placebo

Heat-killed, nonpathogenic E. coli K-12 bacteria (total of 10\^11 heat-killed bacteria per dose)

All Listed Sponsors
collaborator

U.S. Naval Medical Research Unit No. 3

UNKNOWN

collaborator

Ministry of Health and Population, Egypt

OTHER_GOV

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

International Vaccine Institute

OTHER

collaborator

Göteborg University

OTHER

lead

U.S. Army Medical Research and Development Command

FED

NCT02556996 - Efficacy of an Oral, Killed Enterotoxigenic Escherichia Coli Vaccine in Prevention of Diarrhea in Egyptian Infants and Young Children | Biotech Hunter | Biotech Hunter