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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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Immunogenicity Information

GMC of antibody levels in recipients of the 7-valent pneumococcal conjugate vaccine

Chart - GMC of antibody levels in recipients of the 7-valent pneumococcal conjugate vaccine

  • GMC=geometric mean concentration.

Immunogenicity was assessed in 212 healthy 2-month-old infants from four communities across the United States. Antibody concentrations to each of the seven pneumococcal serotypes were measured by enzyme-linked immunosorbent assay at five time points: prevaccination, post-2nd dose, post-3rd dose, pre-4th dose, and post-4th dose.8

  • After 3 doses of vaccine, geometric mean concentrations (GMCs) in the 7-valent pneumococcal conjugate vaccine group were significantly higher (P>0.001) for each serotype than those in the meningococcal group C conjugate vaccine group.8
  • One month after the 4th dose, a rapid rise in antibody levels was noted, demonstrating a brisk anamnestic response to each of the 7 serotypes contained in the vaccine.8
  • Administration of the 4th dose increased GMC of antibody levels in each of the vaccine serotypes to greater than those achieved after the primary 3-dose series.8

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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.