Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects
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.
Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|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|
- Percentage of Participants With Pre-specified Local Reactions [ Time Frame: Days 1 through 14 ] [ Designated as safety issue: Yes ]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 [ Time Frame: Days 1 through 14 ] [ Designated as safety issue: Yes ]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 [ Time Frame: Days 1 through 14 ] [ Designated as safety issue: Yes ]Use of pain or antipyretic medication was collected by the participants using an electronic diary.
|Study Start Date:||May 2008|
|Study Completion Date:||May 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
13-valent Pneumococcal Conjugate Vaccine
|Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)|
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|Study Director:||Medical Monitor||Wyeth is now a wholly owned subsidiary of Pfizer|