Trial | NCT02556996  Report issue

Official Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    356
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.
Study Started
Oct 31
1998
Primary Completion
Mar 31
2001
Study Completion
Apr 30
2002
Last Update
Oct 12
2015
Estimate

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)

Killed ETEC/rCTB vaccine Experimental

Three doses administered orally at 2-week intervals

Placebo Placebo Comparator

Three doses administered orally at 2-week intervals

Criteria 

Inclusion Criteria:

Willingness of parent to have the child participate;
Plans to reside in catchment area continuously for at least one year

Exclusion Criteria:

Global developmental delay
Severe malnutrition
Chronic bedridden status
Serious chronic disorder requiring chronic medication
No Results Posted