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
Original Date: 
February 1995
Revised Date: 
November 2022
  • Pre-exposure immunization and post exposure protection
  • IM: anterolateral thigh muscle
  • Administer at a different site than HBIG

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. Please refer to each province's guidelines for exact timing/intervals.
Side Effects: 
  • Pain at injection site
  • Low grade fever
Reconstitution and Stability: 
  • Refrigerate


  • 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
  • Pickering LK, ed. 2012 Red Book: Report of the Committee on Infectious Diseases, 29th ed. Elk Grove Village: American Academy of Pediatrics; 2012.
  • Canadian Immunization Guide: Part 4 - Active Vaccines (Hepatitis B). Accessed online Nov 2022. 

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