Pentacel - The Benefits of Pentacel: Confirmed

The Benefits of Pentacel Vaccine

Why Should I Switch to Pentacel vaccine?

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Pentacel vaccine—safety established in more than 5000 infants 2-18 months of age who received at least 1 dose¹

The most common local and systemic adverse reactions to Pentacel vaccine include injection site redness, swelling, and tenderness; fever, fussiness, and crying.¹

In clinical trials, most cases of fever were mild to moderate^1,6
Safety established in an ethnically diverse pediatric population¹

Chart Illustrating that in Clinical Trials, the Percentage of Subjects Reporting Fever with Pentacel Vaccine Was Comparable to Separately Administered DAPTACEL, ActHIB, and IPOL Vaccines

Chart Illustrating that in Clinical Trials, the Percentage of Subjects Reporting Local and Systemic Reactions After the Fourth Dose of Pentacel Vaccine Was Comparable to Separately Administered DAPTACEL, ActHIB, and IPOL Vaccines

^a Number of subjects evaluated for fever (mild = ≥38°C; moderate = >38.5°C; severe = >39.5°C) ranges between 434-1406 for doses 1-3 and 376-398 for dose 4. Fever is based on actual temperatures recorded with no adjustments to the measurement route. Following doses 1-3 combined, the proportion of temperature measurements were Pentacel vaccine: 46% axillary, 53% rectal, 1% other, and 0% not recorded; DAPTACEL + IPOL + ActHIB vaccines: 44.8% axillary, 54% rectal, 1% other, and 0% not recorded. Following Dose 4, the proportion of temperature measurements were: Pentacel vaccine: 62.7% axillary, 34.4% rectal, 2.4% other, and 0.5% not recorded; DAPTACEL + ActHIB vaccines: 61.1% axillary, 36.6% rectal, 1.7% other, and 0.5% not recorded.¹

^b DAPTACEL, ActHIB, and IPOL vaccines.
^c DAPTACEL and ActHIB vaccines.
^d Number of subjects evaluated for local and systemic reactions ranges between 376-398.¹
^e DAPTACEL vaccine.
^f Mild = >5-20mm; moderate = >20-40mm; severe = >40mm.
^g Mild = >5-25mm; moderate = >25-50mm; severe = >50mm.
^h Mild = whimpers when site is touched; moderate = cries when site is touched; severe = cries when leg or arm is moved.
ⁱ Mild = usual daily activity is not affected; moderate = interferes with or limits usual daily activity; severe = disabling, not
interested in usual daily activity.
^j Mild = <1 hour; moderate = 1-3 hours; severe = >3 hours.

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 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 accompanying full Prescribing Information.

This page last updated 04.17.2009

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