Neonatal Drug Therapy Manual

Hepatitis B Vaccine (recombinant)

Disclaimer: Official controlled document is the CHEO and Ottawa Hospital online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
Engerix B, Recombivax HB
Classification: 
Vaccine
Original Date: 
February 1995
Revised Date: 
November 2018
Indications: 
  • Pre-exposure immunization and post exposure protection
Administration: 
  • IM: anterolateral thigh muscle
  • Administer at a different site than HBIG
Dosage: 

Infants of HbsAg+ve mothers or unknown status:

  • Dose:
    • 5 mcg (0.5 mL) of Recombivax HB 10 mcg/mL OR
    • 10 mcg (0.5 mL) of Engerix-B 20 mcg/mL
    • First dose to be given within 12 hours of birth
  • Schedule:
    • Term: 0, 1, 6 months
    • Preterm infants < 2 kg at birth: 0, 1, 2, 6 months

Pre-exposure immunization (high risk infants of HbsAv-ve mothers):

  • Dose:
    • 5 mcg (0.5 mL) of Recombivax HB 10 mcg/mL OR
    • 10 mcg (0.5 mL) of Engerix B 20 mcg/mL
  • Schedule: 0,1,6 months
    • For preterm infants weighing < 2 kg: delay initiation of immunization until infant reaches 1 month of age
    • Immunize with a total of 3 doses: 1 month, 2 - 4 months, 6 - 18 months
Side Effects: 
  • Pain at injection site
  • Low grade fever
Reconstitution and Stability: 
  • Refrigerate
Compatibility: 

N/A

Notes: 
  • These recommendations are based on the latest US recommendations (Redbook). Older Canadian recommendations should be updated shortly.
  • Recombivax HB is preferable for neonates, as it is a thimerosal-free vaccine
  • When a mother is infected with HBV, testing of the infant for HB serology is recommended 1 month after completion of the vaccine series
References: 

Pickering LK, ed. 2012 Red Book: Report of the Committee on Infectious Diseases, 29th ed. Elk Grove Village: American Academy of Pediatrics; 2012.

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