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

NCT03579459

Last updated date
Study Location
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Clostridium Difficile Associated Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Clostridium Difficile Associated Disease
Intervention  ICMJE
  • Biological: Clostridium difficile vaccine
    Toxoid based Clostridium difficile vaccine
  • Biological: placebo
    Normal saline solution
    Other Name: 0.9% sodium chloride
Study Arms  ICMJE
  • Active Comparator: Clostridium difficile vaccine Lot 1
    Intervention: Biological: Clostridium difficile vaccine
  • Active Comparator: Clostridium difficile vaccine Lot 2
    Intervention: Biological: Clostridium difficile vaccine
  • Active Comparator: Clostridium difficile vaccine Lot 3
    Intervention: Biological: Clostridium difficile vaccine
  • Placebo Comparator: Placebo
    Normal saline solution (0.9% sodium chloride)
    Intervention: 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: August 20, 2019)
1317
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2018)
1316
Actual Study Completion Date  ICMJE August 6, 2019
Actual Primary Completion Date August 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03579459
Other Study ID Numbers  ICMJE B5091008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2020

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