NCT02556996

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 356 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 6 Months – 18 Months
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled clinical trial performed in Egyptian children 6-18 months of age. The primary aim of the study is to determine the protective efficacy of an oral, inactivated whole-cell enterotoxigenic Escherichia coli (ETEC) vaccine against diarrhea associated with excretion of ETEC that express a vaccine-shared antigen over a one year period of follow-up by active surveillance. The vaccine consists of a mixture of five formalin-killed ETEC bacteria expressing prevalent ETEC colonization factors and recombinant cholera toxin B-subunit (killed ETEC/rCTB vaccine). The placebo preparation is heat-killed Escherichia coli K-12 bacteria.

Conditions

• Diarrhea

Interventions

Type	Name	Description
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)

Timeline

• Start date: 1998-10-01
• Primary completion: 2001-03-01
• Completion: 2002-04-01
• First posted: 2015-09-22
• Last updated: 2015-10-12