CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 300 enrolled
Drug / intervention
Clostridium difficile Vaccine +1 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/NCT02561195
NCT02561195Phase 2Completed
CompareCT.gov

A PHASE 2, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF TWO 3-DOSE REGIMENS OF A CLOSTRIDIUM DIFFICILE VACCINE IN HEALTHY ADULTS AGED 65 TO 85 YEARS

Pfizer·interventional·Posted Sep 25, 2015·Updated Mar 8, 2021

In Brief

A Phase 2 clinical trial evaluating Clostridium difficile Vaccine and Placebo for Clostridium Difficile Associated Disease. Completed, enrolled 300 participants across 17 sites.

Detailed Summary

This study will investigate a Clostridium difficile vaccine in healthy adults aged 65-85 years. Each subject will initially receive 3 doses of vaccine on 1 of 2 vaccination schedules. The study will assess the safety and tolerability of the vaccine as well as the subjects' immune response to the vaccine. One year after the third dose subjects that did not receive placebo will be randomized to receive a fourth dose. Subjects will be followed for up to 4 years after their third vaccination.

Study Details

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

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 25, 2015
Enrollment StartJul 16, 2015
Primary CompletionMar 7, 2017
Study CompletionFeb 13, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 10.8 years ago

Interventions

Clostridium difficile Vaccinebiological

0.5 mL intramuscular injection.

Placebobiological

0.5 mL intramuscular injection