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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.

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ClinicalTrials.gov Identifier: NCT02052726
Recruitment Status : Completed
First Posted : February 3, 2014
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 17, 2013
First Posted Date  ICMJE February 3, 2014
Last Update Posted Date December 4, 2018
Actual Study Start Date  ICMJE January 22, 2014
Actual Primary Completion Date May 2, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2014)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2014)
  • Proportion of subjects in each vaccine group with: •Toxin A-specific; •Toxin B-specific; •Both toxin A- and toxin B-specific 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: •Toxin A- and toxin B-specific 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-fold, 8-fold, 16-fold, and 32-fold rise in: •Toxin A-specific; •Toxin B-specific; •Both toxin A- and toxin B-specific neutralizing antibody levels (in Neut units/mL). [ Time Frame: Up to 12 months post-dose 3 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 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.
Detailed Description Not 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 Date May 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 Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP