NCT02052726

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

A Phase 1, Placebo-controlled, Randomized, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of An Adjuvanted Clostridium Difficile Vaccine Administered As A 3-dose Regimen In Healthy Adults Aged 50 To 85 Years

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2014-01-22
• Primary completion: 2015-05-02
• Completion: 2015-05-05
• First posted: 2014-02-03
• Last updated: 2018-12-04

Locations

10 sites across 2 countries: United States, Canada