Federal Advisory Committee Votes to Include Newly Licensed Pentacel(R) Vaccine in Vaccines for Childr... (ination during theirvulnerable early mon...)

Federal Advisory Committee Votes to Include Newly Licensed Pentacel(R) Vaccine in Vaccines for Children Program

Date:6/26/2008

ination during their vulnerable early months. Additionally, a reduction in the overall number of shots given during one office or clinic visit is preferred by many immunization providers, parents and children. Other potential advantages of combination vaccines include reducing the cost of stocking and administering vaccines, as well as fewer office visits, which can save parents time and money.

About Pentacel vaccine

The FDA licensure of Pentacel vaccine is based on the results of multi- center clinical studies conducted in the U.S. and Canada involving more than 5,000 children who received at least one dose of Pentacel vaccine. The immunogenicity of Pentacel vaccine was compared to separately administered DAPTACEL(R),(a) IPOL(R)(b) and ActHIB(R)(c) vaccines (studies P3T06 and M5A10), as well as to other single-entity vaccine formulations (study 494-01). The safety of Pentacel vaccine was compared both to separately administered DAPTACEL, IPOL and ActHIB vaccines (study P3T06) and to other single-entity vaccine formulations (study 494-01).

In clinical studies, local and systemic reactions following administration of Pentacel vaccine were reported at rates consistent with those of the separately administered vaccines used in each trial. 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-Barre 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-con
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