Effective
Pentacel vaccine—protection in 4 doses against 5 pediatric diseases1,8-10,a
Pentacel vaccine is the only combination vaccine that immunizes a child against pertussis, diphtheria, tetanus, polio, and invasive disease caused by Hib.1
In clinical studies conducted in the United States, the effectiveness of Pentacel vaccine was based on the immunogenicity of the individual antigens compared with separately administered vaccines.1 Results of these studies show that Pentacel vaccine immunogenicity is comparable to DAPTACEL, ActHIB, and IPOL vaccines.
For more information about the immunogenicity of Pentacel vaccine compared to comparable US-licensed control vaccines, go to the Pertussis, Diphtheria, and Tetanus; Haemophilus influenzae type b; and Polio tabs below.
Pertussis, diphtheria, and tetanus protection in 4 doses
Pentacel vaccine contains 5 acellular pertussis antigens and offers pertussis protection in 4 doses (with a DTaP booster at 4-6 years of age)1,2
This figure represents the percentage of subjects in a large clinical trial that achieved pertussis seroprotection after 4 doses of Pentacel vaccine compared with DAPTACEL vaccine.
This figure represents the percentage of subjects in a large clinical trial that achieved diphtheria and tetanus antibody responses after 3 doses of Pentacel vaccine compared with 4 doses of DAPTACEL vaccine.
To learn more, read the results of the clinical trial.
a Children who receive 4 doses of Pentacel vaccine require a fifth dose of DTaP at 4-6 years of age.2 b Number of subjects evaluated for antibody responses to each vaccine antigen ranges between 113-1097.1 c PRN = Pertactin. d FIM = Fimbriae types 2 and 3. e GMCs = Geometric mean antibody concentrations. f Noninferiority criterion is not met for anti-PRN GMCs post-dose 4 Pentacel vaccine (upper limit of 90% confidence interval) for GMC ratio [DAPTACEL/Pentacel vaccines] = 2.25).1
Hib protection
Pentacel vaccine contains an ActHIB component which provides proven protection against invasive disease8-10
This figure shows the percentage of subjects in large clinical trials that achieved Hib seroprotection after 3 doses of Pentacel vaccine compared with 3 doses of ActHIB vaccine.
To learn more, read the results of the clinical trial.
a Children who receive 4 doses of Pentacel vaccine require a fifth dose of DTaP at 4-6 years of age.2 b Number of subjects evaluated for antibody responses to Hib vaccine antigen ranges between 291-1128.1 c PRP = Polyribosylribitol-phosphate. d 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 e 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 f HCPDT = A DTaP vaccine that was manufactured for the clinical trial to match the DTaP component of Pentacel vaccine.
Polio protection
Pentacel vaccine provides protection against polio.1 When Pentacel vaccine is used to provide 4 doses of DTaP-IPV/Hib vaccine, the Centers for Disease Control and Prevention recommends a booster dose of IPV at 4-6 years of age.13
This figure shows the percentage of subjects in a large clinical trial that achieved polio antibody responses following 3 doses of Pentacel vaccine compared with 3 doses of IPOL vaccine.
To learn more, read the results of the clinical trial.
a Children who receive 4 doses of Pentacel vaccine require a fifth dose of DTaP at 4-6 years of age.2 b Number of subjects evaluated for antibody responses to each vaccine antigen ranges between 113-1907.1
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.
Not all parents choose to vaccinate their children against disease. The American Academy of Pediatrics Committee on Bioethics recommends that clinicians address vaccine refusal by respectfully listening to parental concerns and discussing the risks of nonvaccination.12
