Back to resultsStudy Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects
Primary Purpose
Pneumococcal Infections
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
13-valent Pneumococcal Conjugate Vaccine (13vPnC)
Sponsored by
About this trial
This is an interventional prevention trial for Pneumococcal Infections focused on measuring pneumococcal conjugate vaccine, vaccine
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
13-valent Pneumococcal Conjugate Vaccine
Outcomes
Primary Outcome Measures
Percentage of Participants With Pre-specified Local Reactions
Local reactions were collected by the participant using an electronic diary. Redness and swelling scaled as any(present); mild(2.5-5.0 centimeters[cm]); moderate(5.1-10.0 cm); severe(>10.0cm). Pain as any(present); mild(present, no interference with activity); moderate(present, some interference with activity); severe(present, prevents daily activity). Limitation of arm movement as any(present); mild(present, could move arm above head); moderate(could move arm above shoulder but not above head); severe(could not move arm above shoulder). Participants may be represented in more than 1 category.
Percentage of Participants With Pre-specified Systemic Events
Systemic events were collected by participant using electronic diary. Fatigue,headache,new/aggravated generalized muscle pain,new/aggravated generalized joint pain: any, mild(no interference with activity), moderate(some interference with activity), severe(prevents routine daily activity). Fever(>=38 degrees Celsius[C]), chills, rash, vomiting(mild:1-2 times daily; moderate:>2 times daily; severe:prevents daily activity) decreased appetite & diarrhea(mild:2-3 loose stools/day; moderate:4-5 loose stools/day; severe:>=6 loose stools/day) reported. Participants may be represented in >1 category.
Percentage of Participants Taking Pain or Antipyretic Medication
Use of pain or antipyretic medication was collected by the participants using an electronic diary.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00500266
Brief Title
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
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infections
Keywords
pneumococcal conjugate vaccine, vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1053 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
13-valent Pneumococcal Conjugate Vaccine
Intervention Type
Biological
Intervention Name(s)
13-valent Pneumococcal Conjugate Vaccine (13vPnC)
Primary Outcome Measure Information:
Title
Percentage of Participants With Pre-specified Local Reactions
Description
Local reactions were collected by the participant using an electronic diary. Redness and swelling scaled as any(present); mild(2.5-5.0 centimeters[cm]); moderate(5.1-10.0 cm); severe(>10.0cm). Pain as any(present); mild(present, no interference with activity); moderate(present, some interference with activity); severe(present, prevents daily activity). Limitation of arm movement as any(present); mild(present, could move arm above head); moderate(could move arm above shoulder but not above head); severe(could not move arm above shoulder). Participants may be represented in more than 1 category.
Time Frame
Days 1 through 14
Title
Percentage of Participants With Pre-specified Systemic Events
Description
Systemic events were collected by participant using electronic diary. Fatigue,headache,new/aggravated generalized muscle pain,new/aggravated generalized joint pain: any, mild(no interference with activity), moderate(some interference with activity), severe(prevents routine daily activity). Fever(>=38 degrees Celsius[C]), chills, rash, vomiting(mild:1-2 times daily; moderate:>2 times daily; severe:prevents daily activity) decreased appetite & diarrhea(mild:2-3 loose stools/day; moderate:4-5 loose stools/day; severe:>=6 loose stools/day) reported. Participants may be represented in >1 category.
Time Frame
Days 1 through 14
Title
Percentage of Participants Taking Pain or Antipyretic Medication
Description
Use of pain or antipyretic medication was collected by the participants using an electronic diary.
Time Frame
Days 1 through 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85028
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85104
Country
United States
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
City
Apopka
State/Province
Florida
ZIP/Postal Code
32703
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
City
Chiefland
State/Province
Florida
ZIP/Postal Code
32626
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Arkansas City
State/Province
Kansas
ZIP/Postal Code
67005
Country
United States
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
City
Crescent Springs
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
City
Nitchitoches
State/Province
Louisiana
ZIP/Postal Code
71547
Country
United States
City
Camillus
State/Province
New York
ZIP/Postal Code
13031
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
City
Canal Fulton
State/Province
Ohio
ZIP/Postal Code
44614
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97205
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15216
Country
United States
City
Goose Creek
State/Province
South Carolina
ZIP/Postal Code
29445
Country
United States
City
Mt Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
City
Bellingham
State/Province
Virginia
ZIP/Postal Code
98226
Country
United States
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
City
Berlin-Charlottenburg
ZIP/Postal Code
14059
Country
Germany
City
Berlin-Wilmersdorf
ZIP/Postal Code
10717
Country
Germany
City
Berlin
ZIP/Postal Code
10717
Country
Germany
City
Berlin
ZIP/Postal Code
10969
Country
Germany
City
Deggingen
ZIP/Postal Code
73326
Country
Germany
City
Frankfurt-am-Main
ZIP/Postal Code
60322
Country
Germany
City
Hannover
ZIP/Postal Code
30625
Country
Germany
City
Kassel
ZIP/Postal Code
34121
Country
Germany
City
Leipzig
ZIP/Postal Code
04357
Country
Germany
City
Offenbach
ZIP/Postal Code
63071
Country
Germany
City
Wangen
ZIP/Postal Code
88239
Country
Germany
City
Wuerzburg
ZIP/Postal Code
97070
Country
Germany
City
Arlov
ZIP/Postal Code
23234
Country
Sweden
City
Gothenburg
ZIP/Postal Code
41136
Country
Sweden
City
Skene
ZIP/Postal Code
51162
Country
Sweden
City
Skivarp
ZIP/Postal Code
27402
Country
Sweden
City
Stockholm
ZIP/Postal Code
11136
Country
Sweden
City
Umea
ZIP/Postal Code
90736
Country
Sweden
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects
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