Proven efficacy and safety

THE CDC'S ACIP RECOMMENDS PREVNAR 13® (PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE [DIPHTHERIA CRM197 PROTEIN]) FOR IMMUNOCOMPROMISED ADULTS AGED ≥19 AND FOR IMMUNOCOMPETENT ADULTS AGED ≥65 BASED ON SHARED CLINICAL DECISION-MAKING1

Prevnar 13® is a vaccine approved for adults 18 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Prevnar 13® will only help protect against S. pneumoniae serotypes in the vaccine. Severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 13® or any diphtheria toxoid–containing vaccine is a contraindication.

Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]): 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® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) (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)

Trial description

CAPiTA (Community-Acquired Pneumonia Immunization Trial in Adults) Description2,4

A double-blind, randomized, parallel-group, controlled efficacy trial comparing Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) 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® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) provided a statistically significant reduction in 3 end points

Primary end point:

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:

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)

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​​​​​​​

Local adverse events

Prevnar 13® incidence of local adverse events compared with placebo4
​​​​​​​

** This is an optional area where footnotes can live.

   ​​​​​​​*Number of subjects with known values

   †Statistically significant difference, P<0.05. No adjustments for multiplicity.

Systemic adverse events

Prevnar 13® incidence of systemic adverse events compared with placebo4

** This is an optional area where footnotes can live.

   ​​​​​​​*Number of subjects with known values

   †Statistically significant difference, P<0.05. No adjustments for multiplicity.

Incidence of fever

Prevnar 13® incidence of fever compared with placebo4​​​​​​​

** This is an optional area where footnotes can live.

   *Number of subjects with known values

   †Statistically significant difference, P<0.05. No adjustments for multiplicity.

Real-world effectiveness

​​​​​​Studied in a real-world patient population

Test-negative design (TND): a well-established measure of vaccine effectiveness5

  • Minimizes bias caused by differences among cases and controls

  • Helps to ensure a representative patient population

  • Commonly used to assess vaccine effectiveness

Study limitations​​​​​​​5

  • ​​​​​​​Observational in nature

  • Low Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) uptake in study population (~14%)

  • Serotype-specific vaccine effectiveness and stratified analyses not possible

  • May be susceptible to selection bias or confounding factors

  • ​​​​​​​Overall number of CAP cases was relatively small (n=68)​​​​​​​




CAP surveillance study population5

Adults 18+ admitted for CAP at 1 of 9 hospitals in Louisville, Kentucky


Real-world effectiveness study population5

  • Immunocompromised patients were included in the RWE study population, but were not studied in CAPiTA
  • ​​​​​​​Adults 65+ with CAP and pneumococcal vaccination history confirmed by EHR enrolled between April 2015 and April 2016 (N=2034)​​​​​​​

** This is an optional area where footnotes can live.

Efficacy results from the CAPiTA RCT were confirmed by a RWE study2,5

The RWE study was conducted as a nested case-control study in US patients using a test-negative design (TND) (N=2034)5

CAPiTA PRIMARY END POINT2​​​​​​​

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)​​​​​​​

​​​​​​​

(95.2% CI, 21.8-62.5)

RWE PRIMARY END POINT5

of vaccine-type CAP hospitalization5​​​

​​​​​​


​​​​​​​​​​

(95% CI, 12.8-91.5)

COMORBID CONDITIONS5

88% of patients had ≥1 comorbid condition that increased their risk5

Study limitations5

  • ​​​​​Observational in nature
  • Low Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) uptake in study
  • Serotype-specific vaccine effectiveness and stratified analyses not possible
  • May be susceptible to selection bias or confounding factors
  • ​​​​​​​Overall number of CAP cases was relatively small (n=68)
  • Prevnar 13® will only help protect against S. pneumoniae serotypes in the vaccine

CAP=community-acquired pneumonia; CI=confidence interval; RCT=randomized controlled trial; RWE=real-world effectiveness.

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

Patient profiles

Learn more about adult patients who may be appropriate candidates for vaccination with Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein])

View patient profiles

Efficacy & Safety 

  • Risk factors
  • Proven efficacy & safety
  • Immunogenicity & safety

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References:
  1. Matanock A, Lee G, Gierke R, Kobayashi M, Leidner A, Pilishvili T. Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged ≥65 years: updated recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2019;68:1069-1075. doi: http://dx.doi.org/10.15585/mmwr.mm6846a5.   
  2. Bonten MJM, Huijts SM, Bolkenbaas M, et al. Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults. N Engl J Med. 2015;372(12):1114-1125.
  3. Hak E, Grobbee DE, Sanders EAM, et al. Rationale and design of CAPITA: a RCT of 13-valent conjugated pneumococcal vaccine efficacy among older adults. Neth J Med. 2008;66(9):378-383.
  4. Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals LLC, 2019.
  5. McLaughlin JM, Jiang Q, Isturiz RE, et al. Effectiveness of 13-valent pneumococcal conjugate vaccine against hospitalization for community-acquired pneumonia in older US adults: a test-negative design. Clin Infect Dis. In press. doi:10.1093/cid/ciy312.

Indication

  • In adults 18 years of age and older, Prevnar 13® 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

Limitations of Use and Effectiveness

  • Prevnar 13® will only help protect against S. pneumoniae serotypes in the vaccine
  • Severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 13® or any diphtheria toxoid–containing vaccine is a contraindication
  • Immunocompromised individuals or individuals with impaired immune responsiveness due to the use of immunosuppressive therapy may have reduced antibody response
  • In adults, the most commonly reported solicited adverse reactions 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 doctors 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 www.vaers.hhs.gov or call 1-800-822-7967. This website is neither owned nor controlled by Pfizer. Pfizer does not endorse and is not responsible for the content or services of this site.

Please see full Prescribing Information for Prevnar 13®.

  • In adults 18 years of age and older, Prevnar 13® 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

Limitations of Use and Effectiveness

  • Prevnar 13® will only help protect against S. pneumoniae serotypes in the vaccine