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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Clostridium Difficile Associated Disease

Treatments: Biological: Clostridium difficile vaccine; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02117570

B5091003

2013-004764-58 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 185 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Healthy male and female subjects aged 50 to 85 years

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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185 participants in 3 patient groups, including a placebo group

High dose of C. difficile vaccine

Experimental group

Treatment:

Biological: Clostridium difficile vaccine

Biological: Clostridium difficile vaccine

Low dose of C. difficile vaccine

Experimental group

Treatment:

Biological: Clostridium difficile vaccine

Biological: Clostridium difficile vaccine

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo