Clinical trial NCT02052726: 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: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Clostridium Difficile
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-02-03
Enrollment: 184
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self reported on e-diaries.
timeFrame: 7 days after vaccination
measure: 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.
timeFrame: 7 days after vaccination
Secondary outcomes:
measure: Proportion of subjects in each vaccine group with neutralizing antibody levels (in Neut units/mL) greater than or equal to specified threshold(s).
timeFrame: Up to 12 months post-dose 3
measure: Proportion of subjects in each vaccine group with neutralizing antibody levels, expressed as geometric mean concentrations (GMCs) (in Neut units/mL).
timeFrame: Up to 12 months post-dose 3
measure: 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).
timeFrame: Up to 12 months post-dose 3
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Vince & Associates Clinical Research, Inc.
state: Kansas
city: Overland Park
country: United States
facility: Vince & Associates Clinical Research
state: Kansas
city: Cary
country: United States
facility: PMG Research of Raleigh, LLC d/b/a PMG Research of Cary
state: North Carolina
city: Raleigh
country: United States
facility: Carolina Phase I Research, LLC
state: North Carolina
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc.
state: Texas
city: Annandale
country: United States
facility: Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)
state: Virginia
city: Toronto
country: Canada
facility: Manna Research Inc.
state: Ontario
city: Montreal
country: Canada
facility: Diex Research Montreal Inc
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
city: Quebec
country: Canada
facility: Clinique Medicale St-Louis (recherche) Inc.
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: