CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,994 enrolled
Drug / intervention
Clostridium difficile +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/NCT03918629
NCT03918629Phase 3Completed
CompareCT.gov

A PHASE 3, RANDOMIZED OBSERVER-BLINDED STUDY TO EVALUATE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF 2 DOSES COMPARED TO 3 DOSES OF CLOSTRIDIUM DIFFICILE VACCINE IN ADULTS 50 YEARS OF AGE AND OLDER

Pfizer·interventional·Posted Apr 17, 2019·Updated Jan 10, 2024

In Brief

A Phase 3 clinical trial evaluating Clostridium difficile and Placebo for Clostridium Difficile Associated Disease. Completed, enrolled 1,994 participants across 52 sites.

Detailed Summary

This study will investigate a Clostridium difficile vaccine in adults 50 years of age and older. In half the adults, all 3 doses given are the Clostridium difficile vaccine, and in half the adults, 2 of the 3 doses are the Clostridium difficile vaccine with the other dose containing no active ingredients. The study will look at the subjects' immune response to the vaccine and assess the safety and tolerability of a 2-dose regimen of Clostridium difficile vaccine compared to a 3-dose regimen of Clostridium difficile vaccine.

Study Details

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

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedApr 17, 2019
Enrollment StartApr 1, 2019
Primary CompletionDec 22, 2020
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.2 years ago

Interventions

Clostridium difficilebiological

Toxoid-based Clostridium difficile vaccine

Placebobiological

Normal saline solution (0.9% sodium chloride)