Complete the 4-Dose Series of PREVENAR® at the 12-Month Visit* - *The 4th dose of Prevnar® is recommended at 12 to 15 months of age. - This Site is Intended for U.S. Health Care Professionals Only. - Please scroll down to see Important Safety Information. Important Safety Information

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References

  1. Prescribing Information for Prevnar®, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein). Wyeth Pharmaceuticals Inc.
  2. Centers for Disease Control and Prevention. Recommended childhood and adolescent immunization schedule-United States, 2005. MMWR. 2005;53:Q1-Q3.
  3. Black S, Shinefield H, Fireman B, et al. Efficacy, safety, and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Pediatr Infect Dis J. 2000;19:187-195.
  4. Data on file, Wyeth Pharmaceuticals Inc.
  5. Eskola J, Kilpi T, Palma A, et al. Efficacy of a pneumococcal conjugate vaccine against acute otitis media. N Engl J Med. 2001;344:403-409.
  6. Fireman B, Black S, Shinefield H, et al. The impact of the pneumococcal conjugate vaccine on otitis media. Pediatr Infect Dis J. 2003;22:10-16.
  7. Shinefield HR, Black S, Ray P. Safety and immunogenicity of heptavalent pneumococcal CRM197 conjugate vaccine in infants and toddlers. Pediatr Infect Dis J. 1999;18:757-763.
  8. Rennels MB, Edwards KM, Keyserling HL, et al. Safety and immunogenicity of heptavalent pneumococcal vaccine conjugated to CRM197 in United States infants. Pediatrics. 1998;101:604-611.
  9. Centers for Disease Control and Prevention. Active Bacterial Core Surveillance (ABCs) Report: Streptococcus pneumoniae, 2002. http://www.cdc.gov/ncidod
    /dbmd/abcs/survreports/spneu02.pdf. Accessed April 18, 2005.
  10. Overturf GD, and the Committee on Infectious Diseases. American Academy of Pediatrics. Technical report: prevention of pneumococcal infections, including the use of pneumococcal conjugate and polysaccharide vaccines and antibiotic prophylaxis. Pediatrics. 2000;106:367-376.
  11. IMS HEALTH, Wellness visits for ages 0-10 years, April 3, 2003.
  12. Whitney CG, Farley MM, Hadler J, et al. Decline in invasive pneumococcal disease after the introduction of protein-polysaccharide conjugate vaccine. N Engl J Med. 2003;348:1737-1746.
  13. Flannery B, Schrag S, Bennett NM, et al. Impact of childhood vaccination on racial disparities in invasive Streptococcus pneumoniae infections. JAMA. 2004;291:2197-2203.
  14. Black S, Shinefield H, Baxter R, et al. Postlicensure surveillance for pneumococcal invasive disease after use of heptavalent pneumococcal conjugate vaccine in Northern California Kaiser Permanente. Pediatr Infect Dis J. 2004;23:485-489.
  15. Centers for Disease Control and Prevention. Direct and indirect effects of routine vaccination of children with 7-valent pneumococcal conjugate vaccine on incidence of invasive pneumococcal disease − United States, 1998-2003. MMWR. 2005;54:893-897.
  16. Levine OS, Farley M, Harrison LH, et al. Risk factors for invasive pneumococcal disease in children: a population-based case-control study in North America. Pediatrics. 1999;103:1-5.
  17. Whitney CG, Farley MM, Hadler J, et al. Increasing prevalence of multidrug-resistant Streptococcus pneumoniae in the United States. N Engl J Med. 2000;343:1917-1924.
  18. Centers for Disease Control and Prevention. 2009 Child & Adolescent Immunization Schedule for persons aged 0 through 6 years. http://www.cdc.gov/vaccines/recs
    /schedules/child-schedule.htm. Accessed January 19, 2009.
  19. Black SB, Shinefeld HR, Ling S, et al. Effectiveness of heptavalent pneumococcal conjugate vaccine in children younger than five years of age for prevention of pneumonia. Pediatr Infect Dis J. 2002;21:810-815.
  20. Eskola J, Anttila M. Pneumococcal conjugate vaccines. Pediatr Infect Dis J. 1999;18:543-551.
  21. Eskola J. Immunogenicity of pneumococcal conjugate vaccines. Pediatr Infect Dis J. 2000;19:388-393.
  22. Centers for Disease Control and Prevention. Preventing pneumococcal disease among infants and young children: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR [serial online]. 2000;49(RR-9):1-38. http://www.cdc.gov/mmwr/PDF/RR/RR4909.pdf. Accessed June 25, 2003.
  23. Dagan R. Antibiotic resistance and the potential impact of pneumococcal conjugate vaccines. Commun Dis Intell. 2003;27(suppl):S135-S143.
  24. Schrag SJ, Beall B, Dowell S. Resistant pneumococcal infections: the burden of disease and challenges in monitoring and controlling antimicrobial resistance. http://www.who.int/csr/resources/publications/drugresist
    /WHO_CDS_CSR_DRS_2001_6/en/print.html. Accessed March 6, 2007.
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  27. Syrogiannopoulos GA, Grivea IN, Katopodis GD, et al. Carriage of antibiotic-resistant Streptococcus pneumoniae in Greek infants and toddlers. Eur J Clin Microbiol Infect Dis. 2000;19:288-293.
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  31. Butler JC, Breiman RF, Lipman HB, et al. Serotype distribution of Streptococcus pneumoniae infections among preschool children in the United States, 1978-1994: implications for development of a conjugate vaccine. J Infect Dis. 1995;171:885-889.
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  33. Herz AM, Greenhow T, Alcantara J et al. Changing epidemiology of outpatient bacteremia in 3- to 36-month-old children after the introduction of the heptavalent-conjugated pneumococcal vaccine. Pediatr Infect Dis J. 2006;25:293-300.
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  35. Choo S, Seymour L, Morris R, et al. Immunogenicity and reactogenicity of a pneumococcal conjugate vaccine administered combined with a Haemophilus influenzae type b conjugate vaccine in United Kingdom infants. Pediatr Inf Dis J. 2000;19:854-862.
  36. Schmitt HJ, Faber J, Lorenz I, et al. The safety, reactogenicity and immunogenicity of a 7-valent pneumococcal conjugate vaccine (7VPnC) concurrently administered with a combination DTaP-IPV-Hib vaccine. Vaccine. 2003;21:3653-3662.
  37. Tichmann-Schumann I, Soemantri P, Ulrich B, et al. Immunogenicity and reactogenicity of four doses of diphtheria-tetanus-three-component acellular pertussis-hepatitis B-inactivated polio virus-Haemophilus influenzae type b vaccine coadministered with 7-valent pneumococcal conjugate vaccine. Pediatr Inf Dis J. 2005;24:70-77.
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  43. Hicks LA, Harrison LH, Flannery B, et al; for Active Bacterial Core Surveillance Program of the Emerging Infections Program Network. Incidence of pneumococcal disease due to non–pneumococcal conjugate vaccine (PCV7) serotypes in the United States during the era of widespread PCV7 vaccination, 1998–2004. J Infect Dis. 2007;196:1346-1354.

Important Safety Information

In clinical trials (n=18,168), the most frequently reported adverse events included injection site reactions, fever (38ºC/100.4ºF), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea, and rash.

Risks are associated with all vaccines, including Prevnar®. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. Prevnar® does not provide 100% protection against vaccine serotypes or protect against nonvaccine serotypes.

Please see Prescribing Information.

Indication

Prevnar® is indicated for active immunization of infants and toddlers against invasive disease caused by S. pneumoniae due to capsular serotypes included in the vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F). The routine schedule is 2, 4, 6, and 12 to 15 months of age.

The decision to administer Prevnar® should be based primarily on its efficacy in preventing invasive pneumococcal disease. As with any vaccine, Prevnar® may not protect all individuals receiving the vaccine from invasive pneumococcal disease.

Prevnar® is also indicated for active immunization of infants and toddlers against otitis media caused by serotypes included in the vaccine. However, for vaccine serotypes, protection against otitis media is expected to be substantially lower than protection against invasive disease. Additionally, because otitis media is caused by many organisms other than serotypes of S. pneumoniae represented in the vaccine, protection against all causes of otitis media is expected to be low.

This vaccine is not intended to be used for treatment of active infection.