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

Phase 1CompletedNCT02052726

Pfizer184 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

184

Conditions

Clostridium Difficile

Interventions

C. difficile vaccine with adjuvantBIOLOGICAL

C. difficile vaccine with adjuvant administered at Month 0, 1, and 3.

PlaceboBIOLOGICAL

Placebo administered at Month 0, 1, and 3.

C. difficile vaccine with adjuvantBIOLOGICAL

C. difficile vaccine with adjuvant administered at day 1, 8, 30.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (10)

Vince & Associates Clinical Research, Inc.

Overland Park, Kansas, United States

Vince & Associates Clinical Research

Overland Park, Kansas, United States

PMG Research of Raleigh, LLC d/b/a PMG Research of Cary

Cary, North Carolina, United States

Outcomes

Primary Outcomes

Proportion of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self reported on e-diaries.

Time frame: 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.

Time frame: 7 days after vaccination

Secondary Outcomes

Proportion of subjects in each vaccine group with neutralizing antibody levels (in Neut units/mL) greater than or equal to specified threshold(s).

Time frame: 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).

Time frame: Up to 12 months post-dose 3

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).

Time frame: Up to 12 months post-dose 3

Data from ClinicalTrials.gov

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