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Evaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT03579459•Pfizer

View on ClinicalTrials.gov

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

Serology for B5091008 was delayed due to discussions with the FDA on statistical analysis as well as delays attributed to the COVID pandemic.

Eligibility

Age

65 - 85 years

Sex

ALL

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.
+9 more criteria

Locations (24)

Coastal Clinical Research, Inc.

Mobile, Alabama, United States

Paradigm Clinical Research Centers, Inc.

Redding, California, United States

Clinical Research of South Florida

Coral Gables, Florida, United States

Avail Clinical Research, LLC

DeLand, Florida, United States

Research Centers of America, LLC

Hollywood, Florida, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Clinical Research Atlanta

Stockbridge, Georgia, United States

East-West Medical Research Institute

Honolulu, Hawaii, United States

Advanced Clinical Research

Meridian, Idaho, United States

Heartland Research Associates, LLC

Wichita, Kansas, United States

Key Dates

Start Date

July 31, 2018

Primary Completion Date

August 6, 2019

Completion Date

August 6, 2019

Last Updated

January 19, 2023

Enrollment

1,317

ACTUAL participants

Conditions

Clostridium Difficile Associated Disease

Interventions

Clostridium difficile vaccine

BIOLOGICAL

placebo

BIOLOGICAL