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Clinical studiesClinical studies

CAPiTA: Community-Acquired Pneumonia Immunization Trial in Adults

Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) was evaluated in a landmark trial of nearly 85,000 participants1-3

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Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) study description Study end points
Adults age 65 or older Primary
  • A double-blind, randomized, parallel-group, placebo-controlled vaccine efficacy trial 
 
  • 84,496 immunocompetent adults age 65 or older
 
  • 59 sites throughout the Netherlands conducted surveillance 
 
  • 3.93 years—median duration of follow-up
  • Prevention of a first episode of confirmed vaccine-type CAP, and a positive vaccine-type specific urinary antigen test or isolation of vaccine-type Streptococcus pneumoniae from blood or another sterile site
Adults were excluded if they: Secondary
  • Had immunocompromising conditions
 
  • Received immunosuppressive therapy
 
  • Resided in a long-term care facility
 
  • Required semi-skilled nursing care
  • 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
 
  • Prevention of a first episode of vaccine-type IPD in which the presence of S. pneumoniae was detected in a sterile site
CAP=community-acquired pneumonia; IPD=invasive pneumococcal disease.Prevnar 13 was evaluated in CAPiTA, a landmark clinical trial1,4

~85,000 adults age 65 or older participated in CAPiTA1,2


Primary end point2:

(95.2% CI, 21.8-62.5) 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 points2:

(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)
 

Prevnar 13 will only help protect against Streptococcus pneumoniae serotypes in the vaccine.1SAFETY PROFILE FOR ADULTS IN THE CAPiTA STUDY1,2
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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
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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
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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 3.3† 0.8
Vomiting 0.3 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
Prevnar 20 real-world effectiveness study Learn moreLoadingPrevnar 13 will only help protect against Streptococcus pneumoniae serotypes in the vaccine.1PCV13=Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]).Number of patients with known values.Statistically significant difference P<0.05. No adjustments for multiplicity.Generalized pain.References:Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals LLC, 2019.Bonten MJ, Huijts SM, Bolkenbaas M, et al. Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults. N Engl J Med. 2015;372(12):1114-1125.Bonten MJ, Huijts SM, Bolkenbaas M, et al. Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults: Supplementary appendix. N Engl J Med. 2015;372(11):1-74.Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) Prescribing Information, Wyeth Pharmaceuticals LLC, 2022.
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January 2023
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INDICATIONS AND SELECT SAFETY INFORMATION
  • Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) is indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older
  • The indication of Prevnar 20® for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial
  • Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) is indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in adults 18 years of age and older
Prevnar 13® Limitations of Use: Prevnar 13® will only help protect against S. pneumoniae serotypes in the vaccine

SELECT SAFETY INFORMATION
 
  • Severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 20®, Prevnar 13®, or to diphtheria toxoid is a contraindication
  • Safety and immunogenicity data on Prevnar 20® are not available for individuals in immunocompromised groups and vaccination should be considered on an individual basis. Based on experience with pneumococcal vaccines, individuals with altered immunocompetence may have reduced immune responses to Prevnar 20® 
Important Safety Information
  • Severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 20®, Prevnar 13®, or to diphtheria toxoid is a contraindication
  • Safety and immunogenicity data on Prevnar 20® are not available for individuals in immunocompromised groups and vaccination should be considered on an individual basis. Based on experience with pneumococcal vaccines, individuals with altered immunocompetence may have reduced immune responses to Prevnar 20®
  • Immunocompromised individuals or individuals with impaired immune responsiveness due to the use of immunosuppressive therapy may have reduced antibody response to Prevnar 13®
  • For Prevnar 20®, in adults 18 years of age and older, the most commonly reported solicited adverse reactions (>10%) were pain at the injection site, muscle pain, fatigue, headache, and arthralgia. Additionally, injection site swelling was also reported (>10%) in adults 18 through 59 years of age  
  • For Prevnar 13®, in adults 18 years of age and older, the most commonly reported solicited adverse reactions (>5%) were pain, redness, and swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, vomiting, fever, chills, and rash
Patients should always ask their healthcare providers for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1-800-822-7967.

Please click for Prevnar 20® Full Prescribing Information.

Please click for Prevnar 13® Full Prescribing Information.Indications
  • Prevnar 20® (Pneumococcal 20-valent Conjugate Vaccine) is indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older
  • The indication of Prevnar 20® for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial
  • Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diptheria CRM197 Protein]) is indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in adults 18 years of age and older
Prevnar 13® Limitations of Use: Prevnar 13® will only help protect against S. pneumoniae serotypes in the vaccine