Company: Sanofi Pasteur
Pharmacologic class: Vaccine (diphtheria, tetanus, and pertussis [DTaP]-inactivated polio vaccine [IPV] + Hemophilus influenzae type b [Hib]/polysaccharide tetanus conjugate [PRP-T])
Active ingredients: Diphtheria and tetanus toxoids + acellular pertussis adsorbed + inactivated poliovirus vaccine (suspension); Hib conjugate (tetanus toxoid conjugate, PRP) (lyophilized powder); 0.5 mL/dose; for IM injection after mixing; contains residual trace amounts of formaldehyde, 2-phenoxyethanol, neomycin, polymyxin B.
Indication: Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Hemophilus influenzae type b in infants and children aged six weeks through four years (prior to fifth birthday).
Pharmacology: Pentacel is a combination vaccine that can replace the separate injections of DTaP, IPV, and Hib conjugate vaccines that are recommended for children through two years of age. Pentacel was developed to align well with the existing childhood vaccination schedule. Pentacel contains the same five acellular pertussis antigens as Daptacel (DTaP, also from Sanofi Pasteur), but Pentacel has a higher concentration of two of the antigens.
Clinical trials: Pentacel was approved based on studies that established its immunogenicity for the five separate components compared with those of the separately-administered vaccines that are the current standard of care in the U.S.: Daptacel (DTaP), trivalent inactivated polio-virus vaccine (IPOL), and ActHIB (Hib/PRP-T). A bridging study was also used to support the conclusion that Pentacel will provide protection against pertussis disease comparable to that established for Daptacel. Pentacel may be given concurrently with other vaccines (e.g., MMR, varicella, hepatitis B, 7-valent pneumococcal conjugate vaccines).
Adults: Not recommended.
Children: Each dose is 0.5 mL IM, in anterolateral thigh (infants) or deltoid muscle. Give as a four-dose series at two months, four months, six months, and 15-18 months of age. May give first dose as early as six weeks of age. Previously vaccinated with ³1 dose of Daptacel, IPV, or Hib conjugate vaccine: Pentacel may be used to complete vaccination series; see literature. May give other vaccines concurrently (use separate injection site).
Contraindication: Anaphylaxis associated with previous dose or component. Encephalopathy within seven days of a previous dose of a pertussis-containing vaccine. Progressive neurological disorder (e.g., infantile spasms, uncontrolled epilepsy, progressive encephalopathy).
Precautions: Fever (>105°F within 48 hours), persistent inconsolable crying (lasting three hours or more within 48 hours), shock (within 48 hours), convulsions (within three days), or Guillain-Barré syndrome (within six weeks) of previous pertussis vaccine. Seizure risk (may pretreat with antipyretics, e.g., acetaminophen). May defer in acute febrile illness. Have epinephrine (1:1,000) available. Immune deficiency. Pregnancy (Cat. C): not recommended.
Interactions: Immunosuppressants: may get suboptimal response.
Adverse reactions: Local reactions: injection site erythema, swelling, tenderness. Systemic reactions: fever, crying, fussiness.
Notes: Report adverse events to VAERS at 800.822.7967 and to Sanofi Pasteur at 800.822.2463.
How supplied: Doses—5 (two vials/dose)
For more information,
or visit www.Pentacel.com