CompletedPhase 2

A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years

United States300 participantsStarted 2015-07-16

Plain-language summary

This study will investigate a Clostridium difficile vaccine in healthy adults aged 65-85 years. Each subject will initially receive 3 doses of vaccine on 1 of 2 vaccination schedules. The study will assess the safety and tolerability of the vaccine as well as the subjects' immune response to the vaccine. One year after the third dose subjects that did not receive placebo will be randomized to receive a fourth dose. Subjects will be followed for up to 4 years after their third vaccination.

Who can participate

Age range65 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy male and female subjects * Aged 65 to 85 years Additional Inclusion Criteria for the extension Stage: * Receipt of all 3 doses of C difficile vaccine (100 µg or 200 µg antigen dose level) in the original portion of the study. Exclusion Criteria: * Proven or suspected prior episode of Clostridium difficile associated diarrhea * Unstable chronic medical condition * Disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine * Serious chronic disorders * Congenital or acquired immunodeficiency disorders * Rheumatologic disorders or other illnesses requiring chronic treatment with known immunosuppressant medications. * Active or treated leukemia or lymphoma or bone marrow disorder * Any contraindication to vaccination or vaccine components including previous anaphylactic reaction to any vaccine or vaccine-related components Additional Exclusion Criteria for the Extension Stage: * Subjects originally randomized to placebo during the original portion of the study. * Subjects who have already completed Visit 9 prior to study unblinding.

What they're measuring

Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 37

Timeframe: Day 37 (7 days after Vaccination 3 of Day 1, 8 and 30 regimen)

Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Month 7

Timeframe: Month 7 (1 month after Vaccination 3 of Month 0, 1 and 6 regimen)

Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 37

Timeframe: Day 37 (7 days after Vaccination 3 of Day 1, 8 and 30 regimen)

Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Month 7

Timeframe: Month 7 (1 month after Vaccination 3 of Month 0, 1 and 6 regimen)

Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 37

Timeframe: Day 37 (7 days after Vaccination 3 of Day 1, 8 and 30 regimen)

Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Month 7

Timeframe: Month 7 (1 month after Vaccination 3 of Month 0, 1 and 6 regimen)

Trial details

NCT IDNCT02561195

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-03-07

Results submitted2018-03-05

View on ClinicalTrials.gov More Clostridium Difficile Associated Disease trials