• †If Hep B vaccine was administered simultaneously, it was administered into the same limb as the DTP-HbOC vaccine. If reactions occurred at either or both sites on that limb, the more severe reaction was recorded.
• ‡P<0.05 when Prevnar^® site compared with the DTP-HbOC site using the sign test.

• †HbOC was administered in the same limb as Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM₁₉₇ Protein), Prevnar^®. If reactions occured at either or both sites on that limb, the more severe reaction was recorded.
• ‡If Hep B vaccine was administered simultaneously, it was administered into the same limb as DTaP. If reactions occurred at either or both sites on that limb, the more severe reaction was recorded.
• §Subjects may have received DTP or a mixed DTP/DTaP regimen for the primary series. Thus, this is the 4th dose of a pertussis vaccine, but not a 4th dose of DTaP.
• ║P<0.05 when Prevnar^® site compared to DTaP site using the sign test.

• ‡Total from which reaction data are available varies between reactions from 3,121-3,848 doses. Data from studies 118-8, 118-12, 118-16.
• §Total from which reaction data are available varies between reactions from 295-538 doses. Data from studies 118-12 and 118-16.

• ‡Total from which reaction data are available varies between reactions from 269-270 doses. Data from studies 118-7 and 118-8.
• §Total from which reaction data are available varies between reactions from 725-727 doses. Data from studies 118-7 and 118-8.

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.