Immunogenicity 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]): Studied head-to-head versus Pneumovax® 23 in 2 comparative trials of immune response2

Primary end points

In both studies, Prevnar 13® demonstrated a noninferior immune response versus Pneumovax® 23 for the 12 shared serotypes
​​​​​​​
In a separate primary end point for serotype 6A, titer levels were statistically significantly greater after receiving Prevnar 13® than Pneumovax® 23

Secondary end points

Prevnar 13® demonstrated a statistically significantly greater immune response versus Pneumovax® 23 for 8 of 12 shared serotypes for vaccine-naive adults and 9 of 12 shared serotypes for previously vaccinated adults

  • The comparative efficacy of Prevnar 13® and Pneumovax® 23 has not been evaluated in randomized controlled studies

In vaccine-naive adults (aged 50-64 years)

  • Never been vaccinated with Pneumovax® 23
  • Study subjects were given either Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) or Pneumovax® 23
    • Immune response compared between Prevnar 13® and Pneumovax® 23 in patients aged 60-64 years
  • ​​​​​​​This study recruited immunocompetent adults, including those with stable underlying conditions, such as:
    • ​​​​​​​Chronic cardiovascular disease     
    • Renal disorders     
    • ​​​​​​​Chronic liver disease   
    • ​​​​​​​Smoking
    • Chronic pulmonary disease   
    • Diabetes mellitus   
    • Alcoholism​​​​​​​

​​​​​​​Study description

Clinical trials were conducted in adults not previously vaccinated with pneumococcal polysaccharide vaccine, Pneumovax® 23. In an active-controlled, modified double-blind* clinical trial (noninferiority study in Pneumovax® 23–unvaccinated adults) of Prevnar 13® in the United States:

  • Pneumovax® 23–unvaccinated adults aged 60 through 64 years received either Pneumovax® 23 (n=367-402) or Prevnar 13® (n=359-404), and adults aged 50 through 59 years received 1 dose of Prevnar 13® (open label, n=350-384)
  • Immune responses elicited by Prevnar 13® and Pneumovax® 23 were measured by an opsonophagocytic assay (OPA) for the 13 pneumococcal serotypes contained in Prevnar 13®. OPA quantifies the ability of immune sera to mediate the killing of Streptococcus pneumoniae by phagocytic cells
  • Serotype-specific OPA geometric mean titers (GMTs), measured 1 month after each vaccination, were used to calculate the geometric mean ratios (GMRs) comparing Prevnar 13® and Pneumovax® 23 (Prevnar 13®/Pneumovax® 23)
  • Study end points used GMRs to compare serotype-specific OPA responses of Prevnar 13® relative to those of Pneumovax® 23 for shared serotypes
  • ​​​​​​​Response to serotype 6A, which is contained in Prevnar 13® but not in Pneumovax® 23, was assessed by the proportion of subjects in each group who demonstrated a 4-fold increase in the specific OPA titer above preimmunization levels

   *Modified double-blind means that the site staff dispensing and administering the vaccine were unblinded, but all other study personnel and subjects were blinded.

  • Previously vaccinated with Pneumovax® 23 at least 5 years prior
  • Study subjects were given either Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) or Pneumovax® 23
  • This study recruited immunocompetent adults, including those with stable underlying conditions, such as:
    • Chronic cardiovascular disease
    • Renal disorders     
    • Chronic liver disease     
    • Smoking
    • Chronic pulmonary disease     
    • Diabetes mellitus     
    • Alcoholism

​​​​​​​Study description

​Clinical trials were conducted in adults not previously vaccinated with pneumococcal polysaccharide vaccine, Pneumovax® 23. In an active-controlled, modified double-blind* clinical trial (noninferiority study in Pneumovax® 23–unvaccinated adults) of Prevnar 13® in the United States and Sweden:

   
  • Pneumovax® 23–prevaccinated adults aged 70 years and older who had received 1 dose of Pneumovax® 23 at least 5 years prior received either Pneumovax® 23 (n=395-445) or Prevnar 13® (n=400-426)

  • Subjects were previously vaccinated with Pneumovax® 23 at least 5 years prior per CDC recommendations for adults aged 65 years and older

  • Immune responses elicited by Prevnar 13® and Pneumovax® 23 were measured by an opsonophagocytic assay (OPA) for the 13 pneumococcal serotypes contained in Prevnar 13®. OPA quantifies the ability of immune sera to mediate the killing of S. pneumoniae by phagocytic cells   
  • Serotype-specific OPA geometric mean titers (GMTs), measured 1 month after each vaccination, were used to calculate the geometric mean ratios (GMRs) comparing Prevnar 13® and Pneumovax® 23 (Prevnar 13®/Pneumovax® 23)   
  • Study end points used GMRs to compare serotype-specific OPA responses of Prevnar 13® relative to those of Pneumovax® 23 for shared serotypes   
  • Response to serotype 6A, which is contained in Prevnar 13® but not in Pneumovax® 23, was assessed by the proportion of subjects in each group who demonstrated a 4-fold increase in the specific OPA titer above preimmunization levels

In previously vaccinated adults (aged ≥70 years)

   *Modified double-blind means that the site staff dispensing and administering the vaccine were unblinded, but all other study personnel and subjects were blinded.

In vaccine-naive adults (aged 18-49 years) 

  • Never been vaccinated with Pneumovax® 23   
  • Study subjects were given Prevnar 13®
  • ​​​​​​​Immune response to Prevnar 13® was compared to that elicited by Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in vaccine-naive adults aged 60-64 years, for all 13 serotypes
  • This study recruited immunocompetent adults, including those with stable underlying conditions, such as:3​​​​​​​
    • Chronic cardiovascular disease     
    • Renal disorders     
    • Chronic liver disease     
    • Smoking
    • Chronic pulmonary disease     
    • Diabetes mellitus     
    • Alcoholism      

 Study description3

This was a cohort analysis from a larger randomized, double-blind clinical trial that compared the immunogenicity, tolerability, and safety of Prevnar 13® and Pneumovax® 23 in Pneumovax® 23-naive adults. In this analysis, the immunogenicity, tolerability, and safety of Prevnar 13® in adult subjects 18-49 years of age was compared with adults 60-64 years of age.

   
  • Pneumovax® 23-naive adults were grouped by age into 2 cohorts: 18-49 years (n=899) and 60-64 years (n=417). All subjects received 1 dose of Prevnar 13®   
  • Immunogenicity was assessed by an opsonophagocytic assay (OPA) for the 13 pneumococcal serotypes contained in Prevnar 13®. OPA quantifies the ability of immune sera to mediate the killing of S. pneumoniae by phagocytic cells   
  • Serotype-specific OPA geometric mean titers (GMTs), measured 1 month after each vaccination, were used to calculate the GMT ratio comparing the 2 age cohorts   
  • The primary immunogenicity objective of the study was to demonstrate the noninferiority of the immune response in the 18- to 49-year-old cohort to that of the 60- to 64-year-old cohort

   *Modified double-blind means that the site staff dispensing and administering the vaccine were unblinded, but all other study personnel and subjects were blinded.

​​​​​​​In the 6 immunogenicity and safety studies (N=7097), in both pneumococcal vaccine–naive and previously vaccinated adults aged 18 years and older, the following adverse events were reported2:

Local adverse events

​​​​​​​The most commonly reported local adverse events (>20%) in adults were:

  • pain at the injection site (>50%)
  • redness (>10%)
  • swelling (>10%)
  • limitation of arm movement (>10%)

Systemic adverse events


The most commonly reported systemic adverse events (>20%) in adults were:

  • ​​​​​​​fatigue (>30%)
  • headache (>20%)
  • muscle pain (>20%)
  • joint pain (>10%)
  • decreased appetite (>10%)
  • vomiting (>5%)
  • fever (>5%)
  • chills (>5%)
  • rash (>5%)

Incidence of fever

In clinical trials of Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), incidence of fever (defined as temperatures ≥100.4°F) was:

  • 1.5% to ~4.2% in vaccine-naive adults   
  • ​​​​​​​1.0% to ~1.1% in previously vaccinated adults

Solicited adverse reactions for Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in the safety and immunogenicity studies were monitored by subjects recording local adverse reactions and systemic reactions daily using an electronic diary for 14 consecutive days following vaccination. Unsolicited serious and nonserious adverse events were collected for 1 month after each vaccination.

Local adverse events

Vaccine-naive adults aged 60-64 years

Prevnar 13® local adverse events compared with Pneumovax® 23 within 14 days after vaccination in clinical trials

   *Number of subjects with known values.

Previously vaccinated adults aged ≥70 years

Prevnar 13® local adverse events compared with Pneumovax® 23 within 14 days after vaccination in clinical trials 

   *Number of subjects with known values.

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

Vaccine-naive adults aged 18-49 years

Prevnar 13® local adverse events reported within 14 days after vaccination in clinical trials

   *Number of subjects with known values.

    ‡Local adverse events within 14 days after vaccination in an open-label, noncomparator cohort of a randomized, double-blind comparator clinical trial.

Systemic adverse events

Vaccine-naive adults aged 60-64 years

Prevnar 13® systemic adverse events compared with Pneumovax® 23 within 14 days after vaccination in clinical trials

   *Number of subjects with known values.

    †Generalized pain.

Previously vaccinated adults aged ≥70 years

Prevnar 13® systemic adverse events compared with Pneumovax® 23 within 14 days after vaccination in clinical trials

   *Number of subjects with known values.

    †Generalized pain.

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

Vaccine-naive adults aged 18-49 years

Prevnar 13® systemic adverse events reported within 14 days after vaccination in clinical trials

   *Number of subjects with known values.

    †Generalized pain.

    ‡Systemic adverse events within 14 days after vaccination in an open-label, noncomparator cohort of a randomized, double-blind comparator clinical trial.

Incidence of fever

Percentage of subjects with fever within 14 days after vaccination with Prevnar 13® or Pneumovax® 23 in clinical trials

Vaccine-naive adults study

  *Open-label administration of Prevnar 13®

   †Number of subjects with known values.

   ‡Fevers >104.0°F were confirmed to be data entry errors

Previously vaccinated adults study

   †Number of subjects with known values.

    Pneumovax is a registered trademark of Merck & Co., Inc.

    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 study2

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 and 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. Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information, Wyeth Pharmaceuticals LLC, 2019.
  3. Bryant KA, Frenck R, Gurtman A, et al. lmmunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults 18-49 years of age, naive to 23-valent pneumococcal polysaccharide vaccine. Vaccine. 2015;33(43):5854-5860. doi:10.1016/j.vaccine.2015.08.080.

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