Rely on safety established in over 5000 infants1,a

Fever in subjects was reported at rates similar to those who were administered separate DAPTACEL, ActHIB, and IPOL vaccines.1,3

This figure illustrates that the percentage of subjects with fever following administration of Pentacel vaccine was comparable to that after separately administered DAPTACEL, ActHIB, and IPOL vaccines.1,3 Most cases of fever reported in clinical trials were mild to moderate.1,3

• In clinical studies, a total of 5980 subjects received at least 1 dose of Pentacel vaccine, including 4198 who were enrolled in 1 of 3 US trials designed to evaluate the safety of 4 consecutive doses of Pentacel vaccine administered at 2, 4, 6, and 15-16 months of age.1
• The most common local and systemic adverse reactions to Pentacel vaccine include injection site redness, swelling, and tenderness; fever, fussiness, and crying.1

For a full description and data information on the Pentacel vaccine safety profile, go to Prescribing Information.

a

Number of subjects evaluated for fever (mild = ≥38ºC; moderate = >38.5ºC; severe = >39.5ºC) ranged between 435-1406 for doses 1-3 and 379-398 for dose 4. Fever is based upon actual temperatures recorded with no adjustments to the measurement route. Following doses 1-3 combined, the proportion of temperature measurements that were taken by axillary, rectal, or other routes, or not recorded, were 46%, 53%, 1%, and 0%, respectively, for Pentacel vaccine and 44.8%, 54%, 1%, and 0.1%, respectively, for DAPTACEL + IPOL + ActHIB vaccines. Following dose 4, the proportion of temperature measurements that were taken by axillary, rectal, or other routes, or not recorded, were 62.7%, 34.4%, 2.4%, and 0.5%, respectively, for Pentacel vaccine, and 61.1%, 36.6%, 1.7%, and 0.5%, respectively, for DAPTACEL + ActHIB vaccines.1 b DAPTACEL, ActHIB, and IPOL vaccines. c DAPTACEL and ActHIB vaccines.

Indication
Pentacel vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b. Pentacel vaccine is approved for use as a 4-dose series in children 6 weeks through 4 years of age (prior to fifth birthday).

Safety Information
The most common local and systemic adverse reactions to Pentacel vaccine include injection site redness, swelling, and tenderness; fever, fussiness, and crying. Other adverse reactions may occur. Known systemic hypersensitivity reaction to any component of Pentacel vaccine or a life-threatening reaction after previous administration of the vaccine or a vaccine containing the same substances are contraindications to vaccination.

The decision to give Pentacel vaccine should be based on the potential benefits and risks; if Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid; or if adverse events have occurred in temporal relation to receipt of pertussis-containing vaccine. Encephalopathy within 7 days of administration of a previous dose of a pertussis-containing vaccine or a progressive neurologic disorder is a contraindication. Vaccination with Pentacel vaccine may not protect all individuals.

Before administering Pentacel vaccine, please see the full Prescribing Information.

Pentacel vaccine is manufactured by Sanofi Pasteur Limited and Sanofi Pasteur SA and distributed by Sanofi Pasteur Inc.