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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.

NCT02052726 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2018-12-04

No results posted yet for this study

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. Subjects will receive their vaccine doses at either months 0, 1, and 3 or days 1, 8, and 30. Subjects will be divided into 2 age groups (50-64 and 65-85 years of age). The study will assess how safe and tolerable the vaccine is, and also look at subjects' immune response to the vaccine.

Conditions

  • Clostridium Difficile

Interventions

BIOLOGICAL

C. difficile vaccine with adjuvant

C. difficile vaccine with adjuvant administered at Month 0, 1, and 3.

BIOLOGICAL

Placebo

Placebo administered at Month 0, 1, and 3.

BIOLOGICAL

C. difficile vaccine with adjuvant

C. difficile vaccine with adjuvant administered at day 1, 8, 30.

BIOLOGICAL

placebo

Placebo administered at Day 1, 8, and 30.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE

Eligibility

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

Timeline & Regulatory

Start
2014-01-22
Primary Completion
2015-05-02
Completion
2015-05-05

Countries

  • United States
  • Canada

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 NCT02052726 on ClinicalTrials.gov