CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 17,535 enrolled
Drug / intervention
Clostridium difficile vaccine +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/NCT03090191
NCT03090191Phase 3Completed
CompareCT.gov

A PHASE 3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF A CLOSTRIDIUM DIFFICILE VACCINE IN ADULTS 50 YEARS OF AGE AND OLDER

Pfizer·interventional·Posted Mar 24, 2017·Updated Feb 13, 2023

In Brief

A Phase 3 clinical trial evaluating Clostridium difficile vaccine and Placebo for Clostridium Difficile Infection. Completed, enrolled 17,535 participants across 426 sites in 23 countries.

Detailed Summary

The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated. Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClostridium Difficile Infection
CountriesArgentina, Australia, Belgium, Bulgaria, Canada, Chile, Colombia, Czechia, Finland, France, Germany, Hungary, Japan, Peru, Poland, Portugal, Slovakia, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 24, 2017
Enrollment StartMar 29, 2017
Primary CompletionDec 21, 2021
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 9.3 years ago

Interventions

Clostridium difficile vaccinebiological

Toxoid-based Clostridium difficile vaccine

Placebobiological

Normal saline solution (0.9% sodium chloride)