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A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years

NCT02561195 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2021-03-08

Study results available
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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.

Conditions

  • Clostridium Difficile Associated Disease

Interventions

BIOLOGICAL

Clostridium difficile Vaccine

0.5 mL intramuscular injection.

BIOLOGICAL

Placebo

0.5 mL intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-16
Primary Completion
2017-03-07
Completion
2020-02-13
FDA Drug
Yes

Countries

  • United States

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 NCT02561195 on ClinicalTrials.gov