A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 To 85 Years, Who Will Each Receive 3 Doses Of Vaccine.
- Conditions
- Clostridium Difficile
- Interventions
- Biological: C. difficile vaccine with adjuvantBiological: placebo
- Registration Number
- NCT02052726
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 184
- Healthy male and female adults aged 50 to 85 years at enrollment
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Day 1, 8, and 30 Schedule C. difficile vaccine with adjuvant - Day 1, 8, and 30 Schedule placebo - Arm Label: Month 0, 1 and 3 Schedule C. difficile vaccine with adjuvant - Arm Label: Month 0, 1 and 3 Schedule placebo -
- Primary Outcome Measures
Name Time Method Proportion of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self reported on e-diaries. 7 days after vaccination 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 Outcome Measures
Name Time Method 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 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 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
Trial Locations
- Locations (10)
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, 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
Manna Research Inc.
🇨🇦Toronto, Ontario, Canada
Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)
🇺🇸Annandale, Virginia, United States
Clinique Medicale St-Louis (recherche) Inc.
🇨🇦Quebec, Canada
Diex Research Sherbrooke Inc.
🇨🇦Sherbrooke, Quebec, Canada
Diex Research Montreal Inc
🇨🇦Montreal, Quebec, Canada