Link to Home More than 14 million doses of Pentacel vaccine have been distributed during a decade of use in Canada. References
 
Confident
Proven pertussis protection
Pentacel vaccine contains the same 5 acellular pertussis antigens, manufactured by the same process, as DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Absorbed). But Pentacel vaccine contains twice as much inactivated PTa and 4 times as much FHAb as DAPTACEL vaccine.1

Pentacel vaccine offers comparable immunogenicity to separately administered DAPTACEL vaccine, ActHIB® (Haemophilus b Conjugate Vaccine [Tetanus Toxoid Conjugate]), and IPOL® (Poliovirus Vaccine Inactivated).1 Pentacel vaccine:

  • Contains ActHIB vaccine which provides proven protection against invasive Haemophilus influenzae type b (Hib) disease2-4
Chart showing Rates of Antibody Responses Chart showing Pertussis Seroprotection Rates Chart showing Hib Seroprotection Rates
a PT = Detoxified pertussis toxin.
b FHA = Filamentous hemagglutinin.
c Number of subjects evaluated for antibody responses to each vaccine antigen ranges between 113-1097.1
d PRN = Pertactin.
e FIM = Fimbriae types 2 and 3.
f GMCs = Geometric mean antibody concentrations.
g Noninferiority criterion is not met for anti-PRN GMCs post-dose 4 Pentacel vaccine relative to post-dose 4 DAPTACEL vaccine (upper limit of 90% confidence interval [CI] for GMC ratio [DAPTACEL/Pentacel vaccines] = 2.25).1
h Number of subjects evaluated for antibody responses to Hib vaccine antigen ranges between 291-1128.1
i PRP = Polyribosylribitol-phosphate.
j Percent achieving specified level following Pentacel vaccine not inferior to ActHIB vaccine (upper limit of 90% CI for difference in rates [ActHIB vaccine minus Pentacel vaccine] <10%).1
k Noninferiority criterion not met for percent achieving anti-PRP ≥1.0 μg/mL following Pentacel vaccine relative to ActHIB vaccine (upper limit of 90% CI for differences in rates [ActHIB vaccine minus Pentacel vaccine], 12.9%, exceeds the noninferiority criterion <10%).1
l HCPDT = Non-US licensed DTaP vaccine that is identical to the DTaP component of Pentacel vaccine.
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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.

Copyright © 2009 Sanofi Pasteur Inc. Privacy Policy | Legal Notice | Safety Information | Site Map This page last updated 04.17.2009 References