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

Last updated on December 2, 2019

FOR MORE INFORMATION
Study Location
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, 66212 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Clostridium Difficile
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT02052726
Pfizer
Completed
A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 To 85 Years, Who Will Each Receive 3 Doses Of Vaccine.

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Clostridium Difficile Associated Disease
NCT03918629
All Genders
50+
Years
Multiple Sites
Descriptive Information
Brief Title  ICMJE A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 To 85 Years, Who Will Each Receive 3 Doses Of Vaccine.
Official Title  ICMJE 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
Brief SummaryThis 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 DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Clostridium Difficile
Intervention  ICMJE
  • Biological: C. difficile vaccine with adjuvant
    C. difficile vaccine with adjuvant administered at Month 0, 1, and 3.
  • Biological: Placebo
    Placebo administered at Month 0, 1, and 3.
  • Biological: C. difficile vaccine with adjuvant
    C. difficile vaccine with adjuvant administered at day 1, 8, 30.
  • Biological: placebo
    Placebo administered at Day 1, 8, and 30.
Study Arms  ICMJE
  • Experimental: Arm Label: Month 0, 1 and 3 Schedule
    Interventions:
    • Biological: C. difficile vaccine with adjuvant
    • Biological: Placebo
  • Experimental: Day 1, 8, and 30 Schedule
    Interventions:
    • Biological: C. difficile vaccine with adjuvant
    • Biological: placebo
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2015)
184
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2014)
344
Actual Study Completion Date  ICMJE May 5, 2015
Actual Primary Completion DateMay 2, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02052726
Other Study ID Numbers  ICMJE B5091002
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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