NCT02052726

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2014

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

January 22, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2015

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2015

Completed
Last Updated

December 4, 2018

Status Verified

November 1, 2018

Enrollment Period

1.3 years

First QC Date

December 17, 2013

Last Update Submit

November 30, 2018

Conditions

Clostridium Difficile

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (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

  • 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

Study Arms (2)

Arm Label: Month 0, 1 and 3 Schedule

EXPERIMENTAL
Biological: C. difficile vaccine with adjuvantBiological: Placebo

Day 1, 8, and 30 Schedule

EXPERIMENTAL
Biological: C. difficile vaccine with adjuvantBiological: placebo

Interventions

C. difficile vaccine with adjuvantBIOLOGICAL

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

Arm Label: Month 0, 1 and 3 Schedule
placeboBIOLOGICAL

Placebo administered at Month 0, 1, and 3.

Arm Label: Month 0, 1 and 3 Schedule

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male and female adults aged 50 to 85 years at enrollment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Vince & Associates Clinical Research, Inc.

Overland Park, Kansas, 66212, United States

Location

Vince & Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

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

Cary, North Carolina, 27518, United States

Location

Carolina Phase I Research, LLC

Raleigh, North Carolina, 27612, United States

Location

Texas Center for Drug Development, Inc.

Houston, Texas, 77081, United States

Location

Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)

Annandale, Virginia, 22003, United States

Location

Manna Research Inc.

Toronto, Ontario, M9W 4L6, Canada

Location

Diex Research Montreal Inc

Montreal, Quebec, H4N 3C5, Canada

Location

Clinique Medicale St-Louis (recherche) Inc.

Québec, Quebec, G1W4R4, Canada

Location

Diex Research Sherbrooke Inc.

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

MeSH Terms

Interventions

Adjuvants, Pharmaceutic

Intervention Hierarchy (Ancestors)

Pharmaceutic AidsPharmaceutical PreparationsSpecialty Uses of ChemicalsChemical Actions and Uses

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2013

First Posted

February 3, 2014

Study Start

January 22, 2014

Primary Completion

May 2, 2015

Study Completion

May 5, 2015

Last Updated

December 4, 2018

Record last verified: 2018-11

Locations

CA(4)US(6)