CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 248 enrolled
Drug / intervention
PATH-wSP +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02543892
NCT02543892Phase 2Completed
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Phase 1-2 Safety and Immunogenicity Study of PATH-wSP in Kenyan Adults and Toddlers

PATH·interventional·Posted Sep 7, 2015·Updated Nov 28, 2018

In Brief

A Phase 2 clinical trial evaluating PATH-wSP and Placebo for Pneumonia. Completed, enrolled 248 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumonia
CountriesKenya
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 7, 2015
Enrollment StartAug 10, 2016
Primary CompletionJan 4, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.8 years ago

Interventions

PATH-wSPbiological

Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide

Placebobiological

Normal Saline