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Efficacy of an Oral, Killed Enterotoxigenic Escherichia Coli Vaccine in Prevention of Diarrhea in Egyptian Infants and Young Children
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.
Details
| Lead sponsor | U.S. Army Medical Research and Development Command |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 356 |
| Start date | 1998-10 |
| Completion | 2002-04 |
Conditions
- Diarrhea
Interventions
- ETEC/rCTB vaccine
- Placebo
Primary outcomes
- Time to first event of diarrhea due to vaccine-preventable ETEC (VP-ETEC) as defined below, and no other copathogen. — 365-day period starting 14 days after the third vaccination
Time to first event of diarrhea associated with excretion of VP-ETEC (defined as ETEC expressing heat-labile \[LT\] and heat-stable enterotoxin \[ST\], or ST and a vaccine-shared colonization factor \[i.e., CFA/I, CS1, CS2, CS3, CS4, and/or CS5\]) and no other copathogen.