Overview

This trial is active, not recruiting.

Condition clostridium difficile associated disease
Treatments clostridium difficile vaccine, placebo
Phase phase 2
Sponsor Pfizer
Start date July 2014
End date December 2015
Trial size 749 participants
Trial identifier NCT02117570, 2013-004764-58, B5091003

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. The study will assess the safety and tolerability of the vaccine, and also look at the subjects' immune response to the vaccine.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
clostridium difficile vaccine
0.5 mL intramuscular injection on day 1, day 8, and day 30.
(Experimental)
clostridium difficile vaccine
0.5 mL intramuscular injection on day 1, day 8, and day 30.
(Placebo Comparator)
placebo
Placebo (0.9 percent saline) given as a 0.5 mL intramuscular injection on day 1, day 8, and day 30.

Primary Outcomes

Measure
Numbers and proportions of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self-reported on e-diaries
time frame: For 7 days after the first vaccination and for 14 days after the second and third vaccinations
Numbers and proportions of subjects reporting systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and their severity, as self-reported on e-diaries.
time frame: For 7 days after the first vaccination and for 14 days after the second and third vaccinations
Number of subjects reporting adverse events (AEs) and serious adverse events (SAEs)
time frame: 2 months (AEs); 13 months (SAEs)

Eligibility Criteria

Male or female participants from 65 years up to 85 years old.

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.

Additional Information

Official title A Phase 2, Placebo-controlled, Randomised, Observer-blinded Trial To Evaluate The Safety, Tolerability And Immunogenicity Of A Clostridium Difficile Vaccine Administered As A 3-dose Regimen In Healthy Adults Aged 50 To 85 Years
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Pfizer.