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

Completed · Phase 1 · Has a placebo group

Conditions studied: Clostridium Difficile

In brief

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.

Key facts

Study ID

NCT02052726

Run by

Pfizer

People needed

184

Starts

2014-01-22

Expected to finish

2015-05-05

Last updated by the study team

2018-12-04

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Vince & Associates Clinical Research, Inc. — Overland Park, Kansas, United States
• Vince & Associates Clinical Research — Overland Park, Kansas, United States
• PMG Research of Raleigh, LLC d/b/a PMG Research of Cary — Cary, North Carolina, United States
• Carolina Phase I Research, LLC — Raleigh, North Carolina, United States
• Texas Center for Drug Development, Inc. — Houston, Texas, United States
• Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID) — Annandale, Virginia, United States
• Manna Research Inc. — Toronto, Ontario, Canada
• Diex Research Montreal Inc — Montreal, Quebec, Canada
• Clinique Medicale St-Louis (recherche) Inc. — Québec, Quebec, Canada
• Diex Research Sherbrooke Inc. — Sherbrooke, Quebec, Canada

Full record on ClinicalTrials.gov

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