• Vaccine Name: Pentacel
• Target Pathogen: Corynebacterium diphtheriae
• Target Disease: Diphtheria
• Product Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
• Tradename: Pentacel
• Manufacturer: Sanofi Pasteur Limited
• Vaccine Ontology ID: VO_0000084
• CDC CVX code: 120
• Type: Subunit vaccine + Inactivated or "killed" vaccine
• Status: Licensed
• Location Licensed: USA (License #1726), Canada
• Host Species for Licensed Use: Human
• Adjuvant:
  • Adjuvant name:
  • VO adjuvant ID: VO_0000128
  • Description: It consists of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus (DTaP-IPV) component and an ActHIB® vaccine component. Pentacel vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b (FDA: Pentacel).
• Preservative: 2 phenoxy ethanol
• Allergen: Polymyxin B, Neomycin
• Preparation: Corynebacterium diphtheriae is grown in modified Mueller’s growth medium. After purification by ammonium sulfate fractionation, the diphtheria toxin is detoxified with formaldehyde and diafiltered. (FDA: Pentacel).
• Immunization Route: Intramuscular injection (i.m.)
• Storage: Store at 2° to 8°C (35° to 46°F). Do not freeze.
• Approved Age for Licensed Use: 6 weeks to 4 years of age.
• Contraindication: A severe allergic reaction (e.g., anaphylaxis) after a previous dose of Pentacel vaccine, any ingredient of this vaccine, or any other tetanus toxoid, diphtheria toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine or H influenzae type b vaccine is a contraindication. (FDA: Pentacel).
• Description: It consists of a Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus (DTaP-IPV) component and an ActHIB® vaccine component. Pentacel vaccine is indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b (FDA: Pentacel).

Human Response

• Vaccination Protocol: A clinical study looked at anti-PRP seroprotection rates and GMCs one month following Dose 3 of Pentacel vaccine or separately administered ActHIB vaccine in studies P3T06 and M5A10 (FDA: Pentacel).
• Immune Response: After vaccination, subjects achieved 90% or greater anti-PRP ≥0.15 μg/mL (FDA: Pentacel).
• Side Effects: Injection site reactions include: Redness, swelling, tenderness, and an increase in arm circumference. The Systemic reactions include: fever, decreased activity, inconsolable crying, and irritability. (FDA: Pentacel).