Company:

Sanofi Pasteur

Vaccine (DTaP-IPV + Hib/PRP-T)

Diphtheria and tetanus toxoids + acellular pertussis adsorbed + inactivated poliovirus vaccine (susp); Hib conjugate (tetanus toxoid conjugate, PRP) (lyophilized pwd); 0.5mL/dose; for IM inj after mixing; contains residual trace amounts of formaldehyde, 2-phenoxy-ethanol, neomycin, polymyxin B.

Active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenze type b in infants and children 6 weeks through 4 years of age (prior to 5th birthday).

Pentacel is a combination vaccine that can replace the separate injections of DTaP, IPV and Hib conjugate vaccines that are recommended for children through 2 years of age. It 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.

Pentacel was approved based on studies that established its immunogenicity for the five separate components compared to those of the separately-administered vaccines that are the current standard of care in the US: Daptacel (DTaP), IPOL (trivalent inactivated polio-virus vaccine), 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 (eg, MMR, varicella, hepatitis B, 7-valent pneumococcal conjugate vaccines).

Not recommended.

Each dose is 0.5mL IM, in anterolateral thigh (infants) or deltoid muscle. Give as a 4 dose series at 2 months, 4 months, 6 months, and 15–18 months of age. May give 1st dose as early as 6 weeks of age. Previously vaccinated with ≥1 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 inj site).

Anaphylaxis associated with previous dose or component. Encephalopathy within 7 days of a previous dose of a pertussis-containing vaccine. Progressive neurological disorder (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy).

Fever (≥105°F within 48hrs), persistent inconsolable crying (lasting ≥3hrs within 48hrs), shock (within 48hrs), convulsions (within 3 days), or Guillain-Barre syndrome (within 6 weeks) of previous pertussis vaccine. Seizure risk (may pretreat with antipyretics, eg, acetaminophen). May defer in acute febrile illness. Have epinephrine (1:1000) available. Immune deficiency. Pregnancy (Cat.C): not recommended.

Immunosuppressants: may get suboptimal response.

Local reactions: injection site erythema, swelling, tenderness. Systemic reactions: fever, crying, fussiness.

Report adverse events to VAERS at (800) 822-7967 and to Sanofi Pasteur at (800) 822-2463.

Doses—5 (2 vials/dose)

7/11/08