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 1

Conditions

Clostridium Difficile

Treatments

Biological: placebo

Biological: Placebo

Biological: C. difficile vaccine with adjuvant

Study type

Interventional

Funder types

Industry

Identifiers

NCT02052726

B5091002

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. 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.

Enrollment

184 patients

Sex

All

Ages

50 to 85 years old

Volunteers

Accepts Healthy Volunteers

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