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

Clostridium Difficile Associated Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02117570
• Other study ID #: B5091003
• Secondary ID: 2013-004764-58
• Status: Active, not recruiting
• Phase: Phase 2
• First received: April 16, 2014
• Last updated: December 14, 2015
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 749
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Clostridium Difficile Associated Disease

Intervention

Biological:
• Clostridium difficile vaccine
0.5 mL intramuscular injection on day 1, day 8, and day 30.
• Clostridium difficile vaccine
0.5 mL intramuscular injection on day 1, day 8, and day 30.
• Placebo
Placebo (0.9 percent saline) given as a 0.5 mL intramuscular injection on day 1, day 8, and day 30.

Locations

Country	Name	City	State
United States	Benchmark Research	Austin	Texas
United States	PMG Research of Charlotte	Charlotte	North Carolina
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	Clinical Research Center of Nevada, LLC	Las Vegas	Nevada
United States	Meridian Clinical Research	Norfolk	Nebraska
United States	Meridian Clinical Research, LLC	Omaha	Nebraska
United States	West Texas Medical Associates	San Angelo	Texas
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Meridian Clinical Research	Savannah	Georgia
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina
United States	PMG Research of Winston-Salem	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numbers and proportions of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self-reported on e-diaries		For 7 days after the first vaccination and for 14 days after the second and third vaccinations	Yes
Primary	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.		For 7 days after the first vaccination and for 14 days after the second and third vaccinations	Yes
Primary	Number of subjects reporting adverse events (AEs) and serious adverse events (SAEs)		2 months (AEs); 13 months (SAEs)	Yes

External Links

•   To obtain contact information for a study center near you, click here.