DTPa-HB-IPV-Hib vaccine (Vaxelis® and Infanrix hexa®) – frequently asked questions

Key points

  • There are two hexavalent combination vaccines – Vaxelis® and Infanrix hexa® – available on the National Immunisation Program (NIP) that protect against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, polio and Haemophilus influenzae type b (Hib).
     
  • Vaxelis® is a combination vaccine that was added to the NIP on 1 July 2023 as an alternative vaccine for use in for children at 2, 4 and 6 months of age.
     
  • Vaxelis® is available as an NIP-funded alternative vaccine to Infanrix hexa®. It is not a replacement for Infanrix hexa®. There is no preferred vaccine to use between these two products.
     
  • Vaxelis® and Infanrix hexa® can be given at the same time as all other vaccines on the NIP – at the 2-, 4- and 6-month schedule points – including Bexsero® (4CMenB) and influenza vaccine (which are funded for some at-risk groups).

How is Vaxelis® administered?

Vaxelis® is given as an intramuscular injection. When administered at 2, 4 or 6 months, it is usually given as an injection into the thigh.


What are some common side effects after receiving Vaxelis®?

In clinical trials, the most common side effects reported after receiving a dose of Vaxelis® included irritability, crying, drowsiness, injection site reactions (such as pain, redness and swelling) and low-grade fever. These reactions were usually mild and short-lived, lasting for 1 or 2 days. They were consistent with reactions typically seen following other childhood vaccines against these six conditions.

The Therapeutic Goods Administration continues to monitor reports of reactions to all vaccines in Australia, including Vaxelis®. The AusVaxSafety program also collects information on side effects after vaccination at the 2-, 4- and 6-month NIP schedule points. The first set of data relating to Vaxelis® is to be made available on the AusVaxSafety website from November 2023.


When is the earliest my baby can receive their first dose of Vaxelis®?

Vaxelis® can be given under the NIP from 6 weeks of age.


What if my baby does not receive their doses of Vaxelis® on time?

Catch-up vaccines are funded under the NIP for all children under 10 years. If a child does not receive a dose of Vaxelis® on time, it is important to see a vaccination provider to organise an individualised catch-up schedule to ensure the child is protected as early as possible. The timing of catch-up doses will depend on the child’s age and the interval required between doses.


My baby has already received 1 or 2 doses of Infanrix hexa® or Vaxelis®. Can they receive the other brand for future scheduled dose(s)?

The preference is to complete the vaccination course with the same brand of vaccine. However, if the same brand is not available, vaccination should not be delayed and the other brand can be used. To date, there have been no clinical trials studying Vaxelis® and Infanrix hexa® using an alternating schedule; however, both vaccines have been used interchangeably overseas for several years and no safety signals have been identified. The evidence assessment using the GRADE framework for the Vaxelis® vaccine is available here.


Can my baby have other vaccines at the same time as Vaxelis®?

Vaxelis® can be given at the same time as all other vaccines on the NIP Schedule – at the 2-, 4-, and 6-month schedule points. This includes Bexsero®, the meningococcal B vaccine, which is on the NIP for Aboriginal and Torres Strait Islander children at 2, 4 and 6 months and is available through the private market to all children from 2 months of age.

Evidence shows that there are no safety concerns and no reduction in the immune responses to either vaccine when Vaxelis® and Bexsero® are given at the same time. Children aged <2 years are recommended to receive prophylactic paracetamol with every dose of Bexsero®. This is because of the increased risk of fever, including high fever, after receiving Bexsero®.

The seasonal influenza vaccine can also be given to children from 6 months of age and can be given at the same time as Vaxelis® safely and effectively.


Why do we have two brands of vaccine against the same diseases given at the same schedule points?

It is not uncommon for two brands of the same vaccine to be used at the same schedule points. This supports the sustainability of the NIP.


How is the preparation for Vaxelis® different to Infanrix hexa®?

Vaxelis® is supplied as a single-dose, 0.5 mL pre-filled syringe in a ready-to-use formulation containing all components and does not need to be reconstituted.

Infanrix hexa® consists of a single-dose, 0.5 mL pre-filled syringe and a vial containing a lyophilised (i.e. freeze-dried) pellet. The pellet is the Hib component that needs to be reconstituted with the DTPa-hepB-IPV components (a liquid).


What is the scientific evidence behind the ATAGI recommendations for Vaxelis®?

The ATAGI recommendations included in the Australian Immunisation Handbook were made following a thorough review of global evidence by immunisation experts using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology. A summary of the GRADE process for Vaxelis® is available here.


Further resources