Guidance for the use of Infanrix Hexa (GSK) Queensland Immunisation Program, Queensland Health

With acknowledgements to Department of Human Services Victoria June 2005

This document is designed to assist Queensland practitioners considering use of privately purchased Infanrix Hexa
Infanrix Hexa vaccine is licensed for use for primary immunisation at 2, 4 and 6 months of age. It is a 6 antigen based combination vaccine. Antigens present in the vaccine are: Diphtheria Tetanus Pertussis (acellular) Haemophilus influenzae type b (Hib) Hepatitis B Poliomyelitis (inactivated) 5 Antigens are present in the pre-filled syringe. The 6th antigen (Hib) is presented separately as a pellet in a vial. The Hib pellet requires reconstitution with the contents of the pre-filled syringe just prior to administration. Important information about the Hib component: The Hib component in Infanrix Hexa is not currently recommended for use in Aboriginal and Torres Strait Islander infants, as it does not provide the rapid early protection against Hib disease that this group requires. The Hib component in Infanrix Hexa is a PRP-T type and Aboriginal and Torres Strait Islander infants require a PRP-OMP type of Hib vaccine (as is found in PedvaxHib and Comvax). The Hib antigen used in Infanrix Hexa (PRP-T) requires a primary course of 3 doses plus a separate Hib booster dose (ie. PedvaxHIB) at 12 months of age (ie. 4 dose course). PedvaxHib (PRP-OMP) only needs a 2 dose primary course (ie. 2 and 4 months) and a booster dose at 12 months of age (ie. 3 dose course). Factors to consider: Families considering the use of Infanrix Hexa for the primary course of vaccination at 2, 4 and 6 months of age should take into account the following. 1. The vaccine will reduce the number of injections required at the two and four month visits only. 2. The Australian Technical Advisory Group on Immunisation (ATAGI) recommends an Injectable Poliomyelitis Vaccine (IPV) in a combination vaccine is preferable to Oral Poliomyelitis Vaccine (OPV). This is because OPV has a 1 in 2.5 million risk of vaccine associated paralytic poliomyelitis (VAPP). Infanrix Hexa has the benefit of providing IPV in a combination vaccine. 3. The ATAGI recommends the primary course of a Hib schedule should be completed with the same brand of vaccine where possible. That is, if parents choose to purchase Infanrix Hexa for the 2 month immunisation encounter, it is preferable that they also purchase Infanrixi Hexa for the 4 and 6 month immunisations. 4. When Infanrix Hexa vaccine is used at any point in the primary schedule, a full 4 dose course of Hib vaccine must be followed. This requires the booster dose to be administered at 12 months of age, using PedvaxHIB. Even if only a single dose of Infanrix Hexa is provided, a 4 dose schedule of Hib vaccine (3 dose primary course plus a booster at 12 months) must still be completed to ensure adequate protection against Hib disease. Guidelines for various arrangements are shown in the table below.

When completing the primary course of vaccination at 2, 4 and 6 months of age regardless of vaccine/s chosen, the 4 year old schedule remains unchanged. As Infanrix Hexa is presented in parts ie freeze dried material and diluent, the batch number on the carton only should be recorded as this number represents the vaccine as a whole. Preliminary guidelines for the use of Infanrix Hexa vaccine The following table provides a guide to the immunisation schedule where Infanrix Hexa has been privately purchased and administered. As stated above, the ATAGI recommends that the primary course of a Hib schedule should be completed with the same brand of vaccine where possible. Schedule where Infanrix Hexa is used as recommended, for full primary course: 2 months Infanrix Hexa Prevenar 4 months Infanrix Hexa Prevenar 6 months Infanrix Hexa Prevenar 12 months MMR PedvaxHIB Men C 4 years Infanrix or Tripacel MMR Polio

Guidance when Infanrix hexa has been used for only one or two doses of primary course: 2 months Infanrix Hexa Prevenar 4 months Infanrix Hexa Prevenar 6 months Infanrix-HepB PedvaxHIB Prevenar OPV 6 months Infanrix-HepB PedvaxHIB Prevenar OPV 6 months Infanrix Hexa Prevenar 12 months MMR PedvaxHIB Men C 12 months MMR PedvaxHIB Men C 12 months MMR PedvaxHIB Men C 12 months MMR PedvaxHIB Men C 4 years Infanrix or Tripacel MMR OPV 4 years Infanrix or Tripacel MMR OPV 4 years Infanrix or Tripacel MMR OPV 4 year old Infanrix or Tripacel MMR OPV

2 months Infanrix Hexa Prevenar

4 months Infanrix-HepB PedvaxHIB Prevenar OPV 4 months Infanrix Hexa Prevenar

2 months Infanrix-HepB PedvaxHIB Prevenar OPV 2 months Infanrix-HepB PedvaxHIB Prevenar OPV 2 months Infanrix-HepB PedvaxHIB Prevenar OPV

4 months Infanrix-HepB PedvaxHIB Prevenar OPV 4 months Infanrix Hexa Prevenar

6 months Infanrix Hexa Prevenar

6 months Infanrix-HepB PedvaxHIB Prevenar OPV

12 months MMR PedvaxHIB Men C

4 year old Infanrix or Tripacel MMR OPV