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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
1,053
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.
Time frame: Days 1 through 14
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.
Time frame: Days 1 through 14
Percentage of Participants Taking Pain or Antipyretic Medication
Use of pain or antipyretic medication was collected by the participants using an electronic diary.
Time frame: Days 1 through 14
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Unnamed facility
Chandler, Arizona, United States
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Glendale, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Rolling Hills Estates, California, United States
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Apopka, Florida, United States
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Boynton Beach, Florida, United States
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Chiefland, Florida, United States
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Gainesville, Florida, United States
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Largo, Florida, United States
...and 49 more locations