Pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]

(Prevnar 13®)

Pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]

Drug updated on 7/25/2024

Dosage FormInjection (intramuscular; 0.5 mL)
Drug ClassVaccines
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in children 6 weeks through 5 years of age (prior to the 6th birthday).
  • Indicated for active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in children 6 weeks through 5 years of age (prior to the 6th birthday). No otitis media efficacy data are available for serotypes 1, 3, 5, 6A, 7F, and 19A.
  • Indicated for active immunization for the prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in children 6 years through 17 years of age (prior to the 18th birthday),.
  • Indicated for active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in adults 18 years of age and older.

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Summary
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  • Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) [Prevnar 13] is indicated for active immunization to prevent invasive disease and otitis media caused by Streptococcus pneumoniae in various age groups.
  • The information was derived from a systematic review of 16 studies.
  • Prevnar 13 shows higher efficacy and effectiveness compared to PPSV23, with PCV13 demonstrating consistent results across different studies for both IPD (Invasive Pneumococcal Disease) and PP (Pneumococcal Pneumonia).
  • In infants under two years old, Prevnar 13 generally has higher IgG responses for certain serotypes compared to PCV10, indicating better immunogenicity.
  • For children under five years old, the effectiveness of Prevnar 13 against otitis media ranges between approximately 2.2% to 68%, showing variability based on age and setting but still providing significant protection.
  • Vaccine failures in using Prevnar 13 are mainly associated with serotypes such as 19A, 3, and 19F; however, it remains highly effective overall despite these specific challenges.
  • Co-administration studies indicate that co-administering Prevnar with other vaccines does not significantly increase adverse events, suggesting it is safe when used alongside other vaccinations.
  • Compared to other pneumococcal vaccines like PCV10 or PHiD-CV, mixed schedules involving Prevnar are safe, effective, and show high levels of immunogenicity against IPD.

Product Monograph / Prescribing Information

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Systematic review and meta-analysis of the efficacy and effectiveness of pneumococcal vaccines in adults.2023Pathogens
Immunogenicity and seroefficacy of 10-valent and 13-valent pneumococcal conjugate vaccines: a systematic review and network meta-analysis of individual participant data.2023EclinicalMedicine
Systematic review of the efficacy, effectiveness and impact of high-valency pneumococcal conjugate vaccines on otitis media.2023Human Vaccines and Immunotherapeutics
Effectiveness of pneumococcal vaccines on otitis media in children: a systematic review.2023Value in Health
A systematic review of invasive pneumococcal disease vaccine failures and breakthrough with higher-valency pneumococcal conjugate vaccines in children.2022Expert Review of Vaccines
Current situation and need for prevention of invasive pneumococcal disease and pneumococcal pneumonia in 6- to 64-year-olds in Japan.2021Journal of Infection and Chemotherapy
Efficacy and effectiveness of the PCV-10 and PCV-13 vaccines against invasive pneumococcal disease.2020Pediatrics
Interchangeability between pneumococcal conjugate vaccines for pediatric use: a systematic literature review.2020Expert Review of Vaccines
Safety of co-administration versus separate administration of the same vaccines in children: a systematic literature review.2019Vaccines
Outbreaks of severe pneumococcal disease in closed settings in the conjugate vaccines era, 2010-2018: a systematic review to inform national guidance in the UK.2019Journal of Infection
The impact of routine childhood immunization with higher-valent pneumococcal conjugate vaccines on antimicrobial-resistant pneumococcal diseases and carriage: a systematic literature review.2019Expert Review of Vaccines
Pneumococcal conjugate vaccine against serotype 3 pneumococcal pneumonia in adults: a systematic review and pooled analysis.2019Vaccine
A systematic literature review and network meta-analysis feasibility study to assess the comparative efficacy and comparative effectiveness of pneumococcal conjugate vaccines.2019Human Vaccines & Immunotherapeutics
Impact of the 13-Valent pneumococcal conjugate vaccine among adults: a systematic review and meta-analysis.2019Clinical Infectious Diseases
Serotype distribution of disease-causing Streptococcus pneumoniae in Thailand: a systematic review.2019Vaccine
Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine compared to 23-valent pneumococcal polysaccharide in immunocompetent adults: a systematic review and meta-analysis.2019Vaccine

Clinical Practice Guidelines