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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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Efficacy Information

Efficacy of Prevnar® against Invasive Pneumococcal Disease in a Large-scale Multicenter Trial
(through April 20, 1999)3

Chart - Efficacy of Prevnar® against Invasive Pneumococcal Disease in a Large-scale Multicenter Trial (through April 20, 1999)


Cases of Invasive Pneumococcal Disease
(through April 20, 1999)3

Chart - Cases of Invasive Pneumococcal Disease (through April 20, 1999)

  • †Includes one case in an immunocompromised subject.

A multicenter clinical trial (N=37,816) was conducted at NCKP. Infants were immunized with Prevnar® (4, 6B, 9V, 14, 18C, 19F, and 23F) or an investigational meningococcal group C conjugate vaccine at 2, 4, 6, and 12 to 15 months of age.

The per-protocol analysis of the primary end point included cases which occurred 14 days after the third dose. The intent-to-treat (ITT) analysis included all cases of invasive pneumococcal disease due to vaccine serotypes in children who received at least one dose of vaccine.

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.