Proven efficacy and safety

Prevnar 13®PROVEN  in CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults)—one of the largest randomized prospective adult vaccine trials ever conducted2,3
84,496 immunocompetent adults aged 65 and older2
  • Double-blind, randomized, parallel-group, placebo-controlled vaccine efficacy trial comparing Prevnar 13® (n=42,240) vs placebo (n=42,256)2,4
    Median duration of follow-up for both groups was 3.93 years4
    42.3% of subjects had pre-existing medical conditions, including heart disease (25.4%), lung disease or asthma (15.1%), and type 1 and type 2 diabetes mellitus (12.5%). 12.3% of subjects reported smoking at baseline4
    Surveillance conducted at 59 sites throughout the Netherlands2
    Adults with immunocompromising conditions or receiving immunosuppressive therapy and adults residing in a long-term care facility or requiring semiskilled nursing care were excluded4
Primary objective2
Demonstrate the efficacy of Prevnar 13® in the prevention of a first episode of confirmed vaccine-type pneumococcal community-acquired pneumonia (CAP)
Secondary objectives2
Demonstrate the efficacy of Prevnar 13® in the prevention of a first episode of confirmed nonbacteremic/noninvasive vaccine-type pneumococcal CAP

Demonstrate the efficacy of Prevnar 13® in the prevention of a first episode of vaccine-type invasive pneumococcal disease (IPD)
CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults) Description2,4
A double-blind, randomized, parallel-group, controlled efficacy trial comparing Prevnar 13® vs placebo was conducted in 84,496 community-dwelling adults aged 65 and older (mean age 72.8 ± 5.7 years) across 59 sites in the Netherlands. 42,240 subjects were vaccinated with Prevnar 13® and 42,256 subjects were vaccinated with placebo. Median duration of follow-up for both groups was 3.93 years. Surveillance for suspected pneumonia and IPD began immediately after vaccination and continued through identification of a prespecified number of cases.2,4
42.3% of subjects had pre-existing medical conditions, including heart disease (25.4%), lung disease or asthma (15.1%), and type 1 and type 2 diabetes mellitus (12.5%). 12.3% of subjects reported smoking at baseline.4
Inclusion/Exclusion Criteria2
  • Subjects aged 65 years or older who were registered with a general practitioner referring patients to the trial were eligible for inclusion
  • Subjects were excluded from the trial if they had previously received a pneumococcal vaccine, used an investigational vaccine or medication within 30 days prior to vaccination, resided in a nursing home or other institution, required semiskilled nursing care, were contraindicated for vaccination with Prevnar 13® or influenza vaccine, had a history of severe adverse reaction to a vaccine or vaccine component, or had an immune deficiency or suppression. Subjects who had a CAP or IPD episode with symptom onset less than 14 days after vaccination were excluded from all analyses
Trial End Points2
  • The primary end point was prevention of a first episode of confirmed vaccine-type CAP, defined as the presence of ≥2 prespecified clinical criteria, findings on chest radiography consistent with CAP, and a positive vaccine-type–specific urinary antigen test or isolation of vaccine-type Streptococcus pneumoniae from blood or another sterile site
  • The secondary end point of nonbacteremic/noninvasive vaccine-type CAP was defined as prevention of a first episode of vaccine-type CAP for which the result of a blood culture and results of cultures of any other sterile site were negative for S. pneumoniae
  • The secondary end point of vaccine-type IPD was defined as prevention of a first episode of vaccine-type IPD in which the presence of S. pneumoniae is detected in a sterile site

Prevnar 13®PROVEN  to help protect against pneumococcal pneumonia and IPD in adults aged 65 and older2
  • Prevnar 13® provided a statistically significant reduction in 3 end points
Primary end point:
46%
(95.2% confidence interval [CI], 21.8-62.5)
STATISTICALLY SIGNIFICANT RISK REDUCTION
of a first episode of either vaccine-type nonbacteremic/noninvasive or vaccine-type bacteremic/invasive pneumococcal CAP


(Number of episodes: Prevnar 13® n=49; placebo n=90)
Secondary end points
45%
(95.2% CI, 14.2-65.3)
STATISTICALLY SIGNIFICANT RISK REDUCTION
of a first episode of vaccine-type nonbacteremic/noninvasive pneumococcal CAP


(Number of episodes: Prevnar 13® n=33; placebo n=60)
75%
(95% CI, 41.4-90.8)
STATISTICALLY SIGNIFICANT RISK REDUCTION
of a first episode of vaccine-type IPD


(Number of episodes: Prevnar 13® n=7; placebo n=28)
  • The median duration of follow-up was 3.93 years4

From the CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults) study, for a subset of 2011 subjects (1006 Prevnar 13® 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.4
Prevnar 13® incidence of local adverse events compared with placebo4
 
Prevnar 13®
(n=886-914*)
Placebo
(n=859-865*)
Local events % %
Redness (any) 4.9 1.2
Swelling (any) 6.8 1.2
Pain (any) 36.1 6.1
Limitation of arm movement (any)
14.1 3.2
*Number of subjects with known values.
Statistically significant difference, P<0.05. No adjustments for multiplicity.
Prevnar 13® incidence of systemic adverse events compared with placebo4
 
Prevnar 13®
(n=881-896*)
Placebo
(n=859-878*)
Systemic events % %
Fatigue 18.8 14.8
Headache 15.9 14.8
Chills 9.4 8.4
Rash
3.3 0.8
Vomiting
0.3 0.9
Decreased appetite
5.3 3.7
New muscle pain
18.4 8.4
Aggravated muscle pain
9.1 4.4
New joint pain
7.4 5.4
Aggravated joint pain
5.2 4.2
*Number of subjects with known values.
Statistically significant difference, P<0.05. No adjustments for multiplicity.
Prevnar 13® incidence of fever compared with placebo4
 
Prevnar 13®
(n=881-896*)
Placebo
(n=859-878*)
Fever % %
≥ 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
*Number of subjects with known values.
Statistically significant difference, P<0.05. No adjustments for multiplicity.
ACIP=Advisory Committee on Immunization Practices; CDC=Centers for Disease Control and Prevention.
The safety of Prevnar 13® was evaluated in 6 safety and immunogenicity studies and 1 efficacy study4