drugset / Trial / NCT02543892

A Study of a Vaccine for Pneumonia in Adults and Toddlers in Kenya

NCT02543892

Phase 1/2 Completed 248 enrolled PATH
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This study aimed to determine whether PATH-wSP, a vaccine against a germ that causes pneumonia, is safe and induces immune responses in adults and toddlers. The study vaccine was compared to placebo. First adults received 2 injections of a lower dose of the vaccine or placebo, 28 days apart. Since the lower dose was considered safe, a higher dose was tested. Once the safety was established in adults the lower and higher dose was tested in toddlers, starting with the lower dose and then the higher dose.

Timeline

Start
2016-08-10
Primary completion
2018-01-04
Completion
2018-01-04

Drugs

EvaluationDrugModalityDoseRoute
Subject PATH-wSP Vaccine 0.6 mg
Subject PATH-wSP Vaccine 1 mg

Indications