CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 185 enrolled
Drug / intervention
Clostridium difficile vaccine +2 morebiological
Likely dose
Clostridium difficile vaccine 0.5 mLfrom 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/NCT02117570
NCT02117570Phase 2Completed
CompareCT.gov

A Phase 2, Placebo-controlled, Randomised, Observer-blinded Trial To Evaluate The Safety, Tolerability And Immunogenicity Of A Clostridium Difficile Vaccine Administered As A 3-dose Regimen In Healthy Adults Aged 50 To 85 Years

Pfizer·interventional·Posted Apr 21, 2014·Updated Jan 30, 2017

In Brief

A Phase 2 clinical trial evaluating Clostridium difficile vaccine and Placebo for Clostridium Difficile Associated Disease. Completed, enrolled 185 participants across 12 sites.

Detailed Summary

This study will investigate a Clostridium difficile vaccine in healthy adults aged 50 to 85 years, who will each receive 3 doses of vaccine. The study will assess the safety and tolerability of the vaccine, and also look at the subjects' immune response to the vaccine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClostridium Difficile Associated Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 21, 2014
Enrollment StartJul 1, 2014
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.2 years ago

Interventions

Clostridium difficile vaccinebiological

0.5 mL intramuscular injection on day 1, day 8, and day 30.

Clostridium difficile vaccinebiological

0.5 mL intramuscular injection on day 1, day 8, and day 30.

Placebobiological

Placebo (0.9 percent saline) given as a 0.5 mL intramuscular injection on day 1, day 8, and day 30.