Clinical trial data
For more information about Pentacel vaccine and pertussis protection, you can read the following:
- Guerra FA, Blatter MM, Greenberg DP, Pichichero M, Noriega FR; Pentacel Study Group. Safety and Immunogenicity of a Pentavalent Vaccine Compared With Separate Administration of Licensed Equivalent Vaccines in US Infants and Toddlers and Persistence of Antibodies Before a Preschool Booster Dose: A Randomized, Clinical Trial. Pediatrics. 2009;123(1):301-312.
- Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With Pentacel™ View clinical trial results.
- Glanz JM, McClure DL, Magid DJ, et al. Parental Refusal of Pertussis Vaccination Is Associated With an Increased Risk of Pertussis Infection in Children. Pediatrics. 2009;123(6):1446-1451.
- Mitka M. Unvaccinated Children Face Pertussis Risk: Some Parents Fear Vaccine More Than Infection. JAMA. 2009;302(3):242-244.
- Omer SB, Salmon DA, Orenstein WA, deHart MP, Halsey N. Vaccine Refusal, Mandatory Immunization, and the Risks of Vaccine-Preventable Diseases. N Engl J Med. 2009;360:1981-1988.
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.

