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 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052726
• Other study ID #: B5091002
• Status: Completed
• Phase: Phase 1
• Start date: January 22, 2014
• Est. completion date: May 5, 2015

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: May 5, 2015
• Est. primary completion date: May 2, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile

Intervention

Biological:
• C. difficile vaccine with adjuvant
C. difficile vaccine with adjuvant administered at Month 0, 1, and 3.
• Placebo
Placebo administered at Month 0, 1, and 3.
• C. difficile vaccine with adjuvant
C. difficile vaccine with adjuvant administered at day 1, 8, 30.
• placebo
Placebo administered at Day 1, 8, and 30.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self reported on e-diaries.		7 days after vaccination
Primary	Proportion 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.		7 days after vaccination
Secondary	Proportion of subjects in each vaccine group with neutralizing antibody levels (in Neut units/mL) greater than or equal to specified threshold(s).		Up to 12 months post-dose 3
Secondary	Proportion of subjects in each vaccine group with neutralizing antibody levels, expressed as geometric mean concentrations (GMCs) (in Neut units/mL).		Up to 12 months post-dose 3
Secondary	Proportion of subjects in each vaccine group with a greater than or equal to 4 and higher fold-rises in neutralizing antibody levels (in Neut units/mL).		Up to 12 months post-dose 3