Canada Communicable Disease Report
Vol. 25 (ACS-4)
1 June 1999

An Advisory Committee Statement (ACS)
National Advisory Committee on Immunization (NACI)*

SUPPLEMENTARY STATEMENT ON HEPATITIS PREVENTION - HEPATITIS A AND HEPATITIS B COMBINATION VACCINE FOR CHILDREN

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PREAMBLE

The National Advisory Committee on Immunization (NACI) provides Health Canada with ongoing and timely medical, scientific, and public-health advice relating to immunization. Health Canada acknowledges that the advice and recommendations set out in this statement are based upon the best current available scientific knowledge, and is disseminating this document for information purposes. Persons administering or using the vaccine(s) should also be aware of the contents of the relevant product monograph(s). Recommendations for use and other information set out herein may differ from that set out in the product monograph(s) of the Canadian licensed manufacturer(s) of the vaccine(s). Manufacturer(s) have only sought approval of the vaccine(s) and provided evidence as to its safety and efficacy when used in accordance with the product monographs.

INTRODUCTION

This statement addresses the licensure of a combined hepatitis A and hepatitis B vaccine (TWINRIX^® JUNIOR, SmithKline Beecham Pharma Inc.) for use in children. Additional information about hepatitis vaccines can be found in the Canadian Immunization Guide⁽¹⁾.

TWINRIX^® JUNIOR,
SmithKline Beecham Pharma Inc.

TWINRIX^® JUNIOR is a combined vaccine against hepatitis A and hepatitis B for children aged 1 to 18 years, formulated from the same bulk vaccines that are used to produce HAVRIX^TM (SmithKline Beecham Pharma Inc.) (inactivated hepatitis A vaccine)^(2,3) and ENGERIX^®-B (SmithKline Beecham Pharma Inc.) (hepatitis B surface antigen, recombinant). Each 0.5 mL dose contains 360 enzyme-linked immunosorbent assay units of inactivated hepatitis A viral antigen and 10 mg of hepatitis B purified surface antigen protein, equivalent to one-half of the recommended adult dose. The viral proteins are adsorbed onto aluminum hydroxide and aluminum phosphate. The vaccine also contains 2-phenoxyethanol preservative and traces of formaldehyde, polysorbate 20, and neomycin sulfate.

The recommended dose is 0.5 mL, injected intra-muscularly, preferably in the deltoid region. Three primary doses are recom- mended, at intervals of 0, 1, and 6 months. The need for and timing of booster doses have not been established.

In clinical studies involving 60 children aged 1 to 5 years and 120 children aged 6 to 15 years, all healthy seronegative subjects, 100% had serum antibodies to hepatitis A virus (HAV) and 100% had antibodies to hepatitis B surface antigen 1 month after completing the series⁽⁴⁾.

The vaccine is well tolerated. The most common complaint is injection site soreness (21.7%)⁽⁴⁾. Side-effects of the combined vaccines do not differ in frequency or severity from the monovalent vaccines.

The combined vaccine is recommended for pre-exposure prophylaxis of HAV and hepatitis B virus infections in children and adolescents at risk, such as those residing in or travelling to areas where both infections are highly endemic or those frequently receiving blood products (e.g. hemophiliacs).

Details regarding vaccine use can be obtained from the product monograph. The product is supplied in single dose (0.5 mL) vials in packages of 1, 3, and 10, and in single dose pre-loaded syringes in packages of 1 and 10. Vaccine should be stored at 2º C to 8º C, avoiding freezing.

References

1. National Advisory Committee on Immunization. Canadian Immunization Guide. 5th Edition 1998. Ottawa, Ont.: Health Canada, 1998. (Minister of Public Works and Government Services Canada, Cat no.H49-8/998E.)

2. National Advisory Committee on Immunization. Statement on the prevention of hepatitis A infections. CCDR 1994;20:133-43.

3. National Advisory Committee on Immunization. Supplementary statement on hepatitis A prevention. CCDR 1996;22:1-3.

4. Diaz-Mitoma, F, Law B, Parsons J. Combined vaccine against hepatitis A and B in children and adolescents. Pediatr Infect Dis J 1999;18:109-114.

Members: Dr. V. Marchessault (Chairperson), Dr. J. Spika (Executive Secretary), N. Armstrong (Advisory Committee Secretariat Officer), Dr. G. De Serres, Dr. P. DeWals, Dr. I. Gemmill, Dr. B. Law, Dr. M. Naus, Dr. P. Orr, Dr. W. Schlech III, Dr. B. Ward.

Liaison Members: Dr. J. Carsley (CPHA), Dr. G. Delage (CPS), Dr. M. Douville-Fradet (ACE), Dr. T. Freeman (CFPC), Dr. J. Livengood (CDC), Dr. N. MacDonald (CIDS), Dr. A. McCarthy (ND), Dr. J. Salzman (CATMAT), Dr. J. Waters (ACE).

Ex-Officio Members: Dr. L. Palkonyay (LCDC), Dr. R. Pless (LCDC).

Our mission is to help the people of Canada maintain and improve their health.

Health Canada

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