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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02052726

Enrollment

184

Registered

2014-02-03

Start date

2014-01-22

Completion date

2015-05-05

Last updated

2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Difficile

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.

Interventions

BIOLOGICALC. difficile vaccine with adjuvant

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

BIOLOGICALPlacebo

Placebo administered at Month 0, 1, and 3.

BIOLOGICALplacebo

Placebo administered at Day 1, 8, and 30.

Study design

Allocation

RANDOMIZED

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
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 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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026