drugset / Trial / NCT02556996
Efficacy of an Oral, Killed Enterotoxigenic Escherichia Coli Vaccine in Prevention of Diarrhea in Egyptian Infants and Young Children
Phase 3
Completed
356 enrolled
U.S. Army Medical Research and Development Command
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabGöteborg University · collabInternational Vaccine Institute · collabMinistry of Health and Population, Egypt · collabU.S. Naval Medical Research Unit No. 3 · collab
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 1998-10
- Primary completion
- 2001-03
- Completion
- 2002-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ETEC/rCTB vaccine | Vaccine | 1 mg | Oral |
| Subject | ETEC/rCTB vaccine | Vaccine | 1e+11 cells | Oral |