Clinical trial NCT00500266: Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects
Official title: A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, & Reactogenicity of a 13vPnC Vaccine in Ambulatory Elderly Adults Aged 68 Years & Older Who Received 1 or More Doses of 23vPS Vaccine at Least 3 Years Before Study Enrollment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infections
Keywords: pneumococcal conjugate vaccine
vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-07-11
Enrollment: 1053
Sex: ALL
Minimum age (years): 68
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in elderly subjects who were vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine (23vPS) at least 3 years before study enrollment.


Eligibility criteria: MAIN INCLUSION CRITERIA:

* Male or female aged 68 years or older
* Determined by medical history, physical examination, and clinical judgment to be eligible for the study
* Documented vaccination with 1 or more doses of pneumococcal vaccine at least 3 years before study enrollment

MAIN EXCLUSION CRITERIA:

* Known history of severe reaction to a vaccine
* Documented S pneumoniae infection within the past 5 years.
* Known or suspected immunodeficiency or receiving treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids
* Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the investigator's opinion precludes the subject from participating in the study.

Primary outcomes:
measure: Percentage of Participants With Pre-specified Local Reactions
timeFrame: Days 1 through 14
measure: Percentage of Participants With Pre-specified Systemic Events
timeFrame: Days 1 through 14
measure: Percentage of Participants Taking Pain or Antipyretic Medication
timeFrame: Days 1 through 14
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
state: Arizona
city: Glendale
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Rolling Hills Estates
country: United States
state: California
city: Apopka
country: United States
state: Florida
city: Boynton Beach
country: United States
state: Florida
city: Chiefland
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Arkansas City
country: United States
state: Kansas
city: Newton
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Crescent Springs
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Nitchitoches
country: United States
state: Louisiana
city: Camillus
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Canal Fulton
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Franklin
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Pittsburgh
country: United States
state: Pennsylvania
city: Goose Creek
country: United States
state: South Carolina
city: Mt Pleasant
country: United States
state: South Carolina
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Bellingham
country: United States
state: Virginia
city: Walla Walla
country: United States
state: Washington
city: Wenatchee
country: United States
state: Washington
city: Berlin-Charlottenburg
country: Germany
city: Berlin-Wilmersdorf
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Deggingen
country: Germany
city: Frankfurt-am-Main
country: Germany
city: Hannover
country: Germany
city: Kassel
country: Germany
city: Leipzig
country: Germany
city: Offenbach
country: Germany
city: Wangen
country: Germany
city: Wuerzburg
country: Germany
city: Arlov
country: Sweden
city: Gothenburg
country: Sweden
city: Skene
country: Sweden
city: Skivarp
country: Sweden
city: Stockholm
country: Sweden
city: Umea
country: Sweden
city: Uppsala
country: Sweden
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: