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Clostridium Difficile Vaccine Efficacy Trial

NCT03090191 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 17535

Last updated 2023-02-13

Study results available
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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.

Conditions

  • Clostridium Difficile Infection

Interventions

BIOLOGICAL

Clostridium difficile vaccine

Toxoid-based Clostridium difficile vaccine

BIOLOGICAL

Placebo

Normal saline solution (0.9% sodium chloride)

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-29
Primary Completion
2021-12-21
Completion
2021-12-21
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Bulgaria
  • Canada
  • Chile
  • Colombia
  • Czechia
  • Finland
  • France
  • Germany
  • Hungary
  • Japan
  • Peru
  • Poland
  • Portugal
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03090191 on ClinicalTrials.gov