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Evaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT03579459
Collaborator
(none)
1,317
Enrollment
24
Locations
4
Arms
12.2
Actual Duration (Months)
54.9
Patients Per Site
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will investigate a Clostridium difficile vaccine in healthy adults 65 to 85 years of age, who will each receive 3 doses of vaccine. The study will assess the lot consistency, safety, and tolerability of the vaccine, and also look at the subjects' immune response to the vaccine.

Condition or Disease Intervention/Treatment Phase
  • Biological: Clostridium difficile vaccine
  • Biological: placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1317 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A PHASE 3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE LOT CONSISTENCY, SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A CLOSTRIDIUM DIFFICILE VACCINE IN HEALTHY ADULTS 65 TO 85 YEARS OF AGE
Actual Study Start Date :
Jul 31, 2018
Actual Primary Completion Date :
Aug 6, 2019
Actual Study Completion Date :
Aug 6, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Clostridium difficile vaccine Lot 1

Biological: Clostridium difficile vaccine
Toxoid based Clostridium difficile vaccine
Active Comparator: Clostridium difficile vaccine Lot 2

Biological: Clostridium difficile vaccine
Toxoid based Clostridium difficile vaccine
Active Comparator: Clostridium difficile vaccine Lot 3

Biological: Clostridium difficile vaccine
Toxoid based Clostridium difficile vaccine
Placebo Comparator: Placebo

Normal saline solution (0.9% sodium chloride)

Biological: placebo
Normal saline solution
Other Names:
  • 0.9% sodium chloride

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Toxin A- and toxin B-specific neutralizing antibody levels for each lot, expressed as geometric mean concentrations [1 month after the third vaccination]

      As measured by the central laboratory

    2. Percentage of subjects reporting local reactions [Up to 7 days following each vaccination]

      Pain, erythema, and induration, as self-reported in electronic diaries

    3. Percentage of subjects reporting systemic events [Up to 7 days following each vaccination]

      Fever, vomiting, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain, as self-reported in electronic diaries

    4. Percentage of subjects reporting nonserious adverse events [Up to 1 month after the last dose of vaccine]

      As elicited by investigational site staff

    5. Percentage of subjects reporting serious adverse events [Up to 1 month after the last dose of vaccine]

      As elicited by investigational site staff

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Evidence of a personally signed and dated informed consent document.

    • Willing and able to comply with study procedures.

    • Healthy adults 65 to 85 years of age.

    • Male subjects or female subjects who are not of childbearing potential.

    • Ability to be contacted by telephone during study participation.

    Exclusion Criteria:

    • Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.

    • Participation in other studies involving investigational drug(s)/vaccine(s) within 28 days prior to study entry through conclusion of the study.

    • Previous administration of an investigational C difficile vaccine or C difficile monoclonal antibody therapy.

    • Proven or suspected prior episode of C difficile infection.

    • Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of investigational product.

    • Serious chronic medical disorders, including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease.

    • Any bleeding disorder or anticoagulant therapy that would contraindicate intramuscular injection.

    • Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.

    • Subjects who may be unable to respond to vaccination due to:

    • Congenital or acquired immunodeficiency.

    • Receipt of systemic corticosteroids (greater than or equal to 20 mg/day of prednisone or equivalent) for greater than or equal to 14 days within 28 days of enrollment.

    • Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months of enrollment.

    • Underlying bone marrow disorder treated within the past year, such as myelodysplasia, myeloma, or myeloproliferative disorder, treated within the past year, or any history of bone marrow transplant.

    • Malignancy that required treatment with chemotherapy (including the use of adjunctive and hormonal therapy), immunotherapy, radiation therapy, or antineoplastic target therapies within the past 24 months.

    • Receipt of blood products or immunoglobulins within 6 months before enrollment through conclusion of the study.

    • Residence in a nursing home or other long-term care facility, or requirement for semiskilled nursing care or assisted living. An ambulatory subject who lives in an autonomous manner in a retirement home or village is eligible for the trial.

    • A known infection with human immunodeficiency virus (HIV).

    • Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavioral or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.

    • Female subjects of childbearing potential; pregnant female subjects; breastfeeding female subjects; fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Coastal Clinical Research, Inc. Mobile Alabama United States 36608
    2 Paradigm Clinical Research Centers, Inc. Redding California United States 96001
    3 Clinical Research of South Florida Coral Gables Florida United States 33134
    4 Avail Clinical Research, LLC DeLand Florida United States 32720
    5 Research Centers of America, LLC Hollywood Florida United States 33024
    6 Atlanta Center for Medical Research Atlanta Georgia United States 30331
    7 Clinical Research Atlanta Stockbridge Georgia United States 30281
    8 East-West Medical Research Institute Honolulu Hawaii United States 96814
    9 Advanced Clinical Research Meridian Idaho United States 83642
    10 Heartland Research Associates, LLC Wichita Kansas United States 67207
    11 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
    12 Meridian Clinical Research, LLC Norfolk Nebraska United States 68701
    13 Meridian Clinical Research, LLC Omaha Nebraska United States 68134
    14 Amici Clinical Research Raritan New Jersey United States 08869
    15 PMG Research of Charlotte, LLC Charlotte North Carolina United States 28209
    16 PMG Research of Wilmington, LLC Wilmington North Carolina United States 28401
    17 Lynn Health Science Institute Oklahoma City Oklahoma United States 73112
    18 Medical Research South, LLC Goose Creek South Carolina United States 29445
    19 Benchmark Research Austin Texas United States 78705
    20 Diagnostics Research Group San Antonio Texas United States 78229
    21 J. Lewis Research Inc. / Foothill Family Clinic Draper Draper Utah United States 84020
    22 J. Lewis Research, Inc./ Foothill Family Clinic South Salt Lake City Utah United States 84109
    23 J. Lewis Research, Incorporated/Foothill Family Clinic South Salt Lake City Utah United States 84121
    24 J. Lewis Research, Inc. / Jordan River Family Medicine South Jordan Utah United States 84095

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT03579459
    Other Study ID Numbers:
    • B5091008
    First Posted:
    Jul 6, 2018
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pfizer
    Clostridium Difficile
    vaccine
    Additional relevant MeSH terms:
    Clostridium Infections

    Study Results

    No Results Posted as of Jun 30, 2022