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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-22

Study Completion Date

2015-05-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Clostridium Difficile

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm Label: Month 0, 1 and 3 Schedule

Group Type EXPERIMENTAL

C. difficile vaccine with adjuvant

Intervention Type BIOLOGICAL

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

Placebo

Intervention Type BIOLOGICAL

Placebo administered at Month 0, 1, and 3.

Day 1, 8, and 30 Schedule

Group Type EXPERIMENTAL

C. difficile vaccine with adjuvant

Intervention Type BIOLOGICAL

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

placebo

Intervention Type BIOLOGICAL

Placebo administered at Day 1, 8, and 30.

Interventions

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C. difficile vaccine with adjuvant

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

Intervention Type BIOLOGICAL

Placebo

Placebo administered at Month 0, 1, and 3.

Intervention Type BIOLOGICAL

C. difficile vaccine with adjuvant

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

Intervention Type BIOLOGICAL

placebo

Placebo administered at Day 1, 8, and 30.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female adults aged 50 to 85 years at enrollment

Exclusion Criteria

* Proven or suspected prior episode of Clostridium difficile associated diarrhea.
* Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine.
* Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes