Vaccine type: Combination subunit protein and inactivated virus vaccines
Vaccine schedule and administration
Infanrix®-hexa is funded as part of the primary immunisation series from 6 weeks of age and is adminstered at 6 weeks, 3 and 5 months.
Infanrix-hexa is not funded for special groups.
Infanrix-hexa is funded for use in catch-up schedules for children up to their 10th birthday.
Vaccine preparation and storage
Store as per cold chain between 2°C to 8°C.
The vaccine MUST be reconstituted by adding the entire contents of the supplied syringe to the vial containing the Hib pellet. After reconstitution, the vaccine should be injected promptly.
Infanrix-hexa can be administered concurrently with other vaccines, including all the National Immunisation Schedule vaccines. Separate syringes and different injection sites should be used.
The vaccine is administered intramuscularly, into the vastus lateralis.
Three doses are required for an infant or child to be fully immunised.
Infanrix-hexa is funded for use in catch-up schedules in infants and children up to 10th birthday. Infanrix-hexa should not be administered to children after their 10th birthday, or to adults. Refer to Appendix 2 in the current Immunisation Handbook for further details on catch-up schedules and doses.
Infanrix-hexa should not be given to:
- Anyone with severe allergy (anaphylaxis) to a previous dose of this vaccine or other diphtheria, tetanus, pertussis, polio, hepatitis B or Hib containing vaccine, or a component of the vaccine
- Administration of Infanrix-hexa should be postponed in individuals suffering from a fever over 38°C. The presence of a minor infection is not a reason to delay immunisation
Specialist advice should be sought for the following groups:
- Those with bleeding disorders, such as haemophilia The vaccine should be administered in accordance with the haematologist’s instructions. It may, in this situation only, be given subcutaneously
In the case of a child with a clinically unstable evolving neurological disorder, withholding vaccination until the clinical situation has stabilised should be considered on an individual basis after careful consideration of the risks and benefits.
Infanrix-hexa can be given to:
- Premature children. The benefit of vaccination is high in this group of infants, and vaccination should not be withheld or delayed. However, a lower immune response may be observed and the level of clinical protection remains unknown. The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity
- A child with a history of a hypotonic, hyporesponsive episode (HHE) within 48 hours of a previous pertussis vaccination
- A child with a history of convulsions, with or without fever, within three days of a previous pertussis vaccination
- A child with a family history of Sudden Unexplained Death of an lnfant (SUDI)
- A child with a family history of convulsions following a diphtheria, tetanus and pertussis vaccination
Diphtheria: The vaccine gives 87–98% protection from diphtheria and the disease is less severe in the 2–13% who have been immunised but who are not fully protected. However, the vaccine does not eliminate carriage of C. diphtheriae in the throat, nose or skin. The duration of protection is expected to be around 10 years.
Tetanus: Almost 100% of infants have protection after three doses of vaccine. The duration of protection is expected to last at least 20 years.
Pertussis (whooping cough): A long-term clinical trial of children showed that 84% have protection against the disease up to the age of 4 years, following 3 doses. The duration of protection starts to wane after about 6 years. Another study showed vaccine effectiveness to be up to 68% after one dose, 91.* after a second dose and 99.8% and 98.6% after 3 and 4 doses, respectively.
Polio: Over 90% of children are protected. The duration of protection is expected to last at least 18 years.
Hepatitis B: About 95% of infants and children develop protection after three doses of vaccine. The duration of protection is expected to be greater than 20 years.
Haemophilus influenzae type b (Hib): Almost 100% of children are protected. It is only in very rare cases that the vaccine fails to protect against the disease. The duration of protection is expected to last more than 9 years.
One month after the three-dose primary vaccination course, protective antibody are detected in 95-100% of vaccinated infants for each of the vaccine components. Although there is no serological correlation of protection for the pertussis antigens, the response rate is more than 95%. In households where there was an index case with pertussis, the protective efficacy of the vaccine was shown to be 84-88.7% in vaccinated secondary contacts.