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A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 to 85 Years, Who Will Each Receive 3 Doses Of Vaccine.

NCT02117570 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2017-01-30

Study results available
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Summary

This study will investigate a Clostridium difficile vaccine in healthy adults aged 50 to 85 years, who will each receive 3 doses of vaccine. The study will assess the safety and tolerability of the vaccine, and also look at the subjects' immune response to the vaccine.

Conditions

  • Clostridium Difficile Associated Disease

Interventions

BIOLOGICAL

Clostridium difficile vaccine

0.5 mL intramuscular injection on day 1, day 8, and day 30.

BIOLOGICAL

Clostridium difficile vaccine

0.5 mL intramuscular injection on day 1, day 8, and day 30.

BIOLOGICAL

Placebo

Placebo (0.9 percent saline) given as a 0.5 mL intramuscular injection on day 1, day 8, and day 30.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-12-31
Completion
2015-12-31

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 NCT02117570 on ClinicalTrials.gov