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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 August 9, 2018

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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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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Clostridium Difficile
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
184
May 2015
May 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT02052726
B5091002
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2015

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 thte study website. To get updates and notications about this trail, sign up using the form below.

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