ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03579459
Recruitment Status : Not yet recruiting
First Posted : July 6, 2018
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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
Clostridium Difficile Associated Disease Biological: Clostridium difficile vaccine Biological: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1316 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
Estimated Study Start Date : August 3, 2018
Estimated Primary Completion Date : October 25, 2019
Estimated Study Completion Date : October 25, 2019

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 Name: 0.9% sodium chloride




Primary Outcome Measures :
  1. Toxin A- and toxin B-specific neutralizing antibody levels for each lot, expressed as geometric mean concentrations [ Time Frame: 1 month after the third vaccination ]
    As measured by the central laboratory

  2. Percentage of subjects reporting local reactions [ Time Frame: Up to 7 days following each vaccination ]
    Pain, erythema, and induration, as self-reported in electronic diaries

  3. Percentage of subjects reporting systemic events [ Time Frame: 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 [ Time Frame: Up to 1 month after the last dose of vaccine ]
    As elicited by investigational site staff

  5. Percentage of subjects reporting serious adverse events [ Time Frame: Up to 1 month after the last dose of vaccine ]
    As elicited by investigational site staff


Secondary Outcome Measures :
  1. Toxin A- and toxin B-specific neutralizing antibody levels(combined active arms), expressed as geometric mean concentrations [ Time Frame: Baseline and Month 7 ]
    As measured by the central laboratory

  2. Geometric mean fold rise in toxin A-specific neutralizing antibody levels [ Time Frame: Baseline and Month 7 ]
    As measured by the central laboratory

  3. Geometric mean fold rise in toxin B-specific neutralizing antibody levels [ Time Frame: Baseline and Month 7 ]
    As measured by the central laboratory



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579459


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Show 23 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03579459     History of Changes
Other Study ID Numbers: B5091008
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
URL: http://

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:
Vaccines
Immunologic Factors
Physiological Effects of Drugs