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CAPiTA | Study end points |
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Adults age 65 or older | Primary |
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Adults were excluded if they | Secondary |
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(95.2% CI, 14.2-65.3) of a first episode of vaccine-type nonbacteremic/noninvasive pneumococcal CAP (Number of episodes: Prevnar 13 n=33; placebo n=60)
(95% CI, 41.4-90.8) of a first episode of vaccine-type IPD (Number of episodes: Prevnar 13 n=7; placebo n=28)
Local adverse events (%) | PCV13 (n=886-914*) |
Placebo (n=859-865*) |
---|---|---|
Pain (any) | 36.1† | 6.1 |
Limitation of arm movement (any) | 14.1† | 3.2 |
Swelling (any) | 6.8† | 1.2 |
Redness (any) | 4.9† | 1.2 |
Incidence of fever (%) | PCV13 (n=881-896*) |
Placebo (n=860-878*) |
---|---|---|
≥100.4 °F | 2.9† | 1.3 |
100.4-101.1 °F | 1.1 | 0.6 |
101.2-102.0 °F | 0.6 | 0.2 |
102.1-104.0 °F | 0.7 | 0.2 |
>104.0 °F | 0.8 | 0.3 |
Systemic adverse events (%) | PCV13 (n=881-896*) |
Placebo (n=860-878*) |
---|---|---|
Fatigue | 18.8† | 14.8 |
New muscle pain‡ | 18.4† | 8.4 |
Headache | 15.9 | 14.8 |
Chills | 9.4 | 8.4 |
Aggravated muscle pain‡ | 9.1† | 4.4 |
New joint pain‡ | 7.4 | 5.4 |
Decreased appetite | 5.3 | 3.7 |
Aggravated joint pain‡ | 5.2 | 4.2 |
Rash | 5.2 | 0.8 |
Vomiting | 5.2 | 0.9 |
From the CAPiTA study, for a subset of 2011 subjects (1006 PCV13 and 1005 placebo recipients), solicited adverse reactions were monitored by recording local and systemic events using electronic diaries for 7 days after vaccination. Unsolicited adverse events were collected for 28 days after vaccination.1
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