Act-HIBâ„¢

Act-HIBâ„¢

Haemophillus influenzae type b (Hib)

  • Overview
  • In Depth
  • Ingredients
Medsafe Datasheet

Act-HIB™ is used for primary and booster vaccination of infants and children up to their 5th birthday to protect against disease caused by Haemophilus influenzae type b.The vaccine is also used for primary vaccination of children aged 5 years of age and over and adults with some chronic medical conditions. Act-HIB™ is licensed for use in infants and children 2 months to 5 years of age. It is used out of licensure in children 5 years of age and over and adults as there is no alternative vaccine available in New Zealand for these age groups. When children/individuals are older than the age to which the vaccine is licensed, use will be outside of current licensure. No safety concerns are expected for use in older age groups.

Vaccine Schedule
  • Recommended and offered free on the New Zealand Immunisation Schedule to all children at 15 months of age.
  • Recommended and offered free on the New Zealand Pre/Post Splenectomy Immunisation Programme to all children and adults.
Who should get the vaccine
  • All children up to their 5th birthday.
  • All children, up to their 16th birthday, with functional asplenia or who are pre/post splenectomy.
  • All adults who are pre/post splenectomy.
Who should not get the vaccine
  • Anyone with severe allergy (anaphylaxis) to a previous dose of this vaccine or other Hib containing vaccine, or a component of the vaccine.
  • Administration of Act-HIB™ 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.
How effective is the vaccine

Almost all children are protected from Haemophilus influenzae type b after the Haemophilus influenzae type b booster dose of Act-HIB™ in their second year of life.

How safe is the vaccine?

For all vaccines, similar to most medications, an extremely rare allergic reaction called ‘anaphylaxis’ can occur. Anaphylaxis after immunisation occurs about 1-3 times in every one million vaccine doses. All vaccinators will have training and equipment to deal with this situation in the unlikely event of it occurring. No other serious responses to the vaccine have been identified.

What if my child misses a dose?

All children can catch up missed doses of this vaccine anytime before their 5th birthday. Children and adults with medical conditions eligible for the New Zealand Pre/Post Splenectomy Immunisation Programme can catch up a missed dose at any time.

Recommendations

A single dose of Act-HIB™ is recommended and offered free to adults eligible for the Pre/Post Splenectomy Immunisation Programme regardless of their previous Haemophilus influenzae type b vaccination history. Where possible the vaccine should be administered 14 days prior to splenectomy.

Act-HIB™ is licensed for use in infants and children 2 months to 5 years of age. It is used out of licensure in adults as there is no alternative vaccine available in New Zealand for this age group.
When individuals are older than the age to which the vaccine is licensed, use will be outside of current licensure. There are not expected to be any safety concerns for use in older age groups.

Act-HIB™ is not funded for children (from 5 years of age) and adults requesting Haemophilus influenzae type B immunisation for any other reason.

Possible vaccine side effects
Common side effectsUncommon side effectsRare/very rare side effects
Soreness/pain, redness, swelling and/or induration (area of hard inflammation) around the injection site.
Fever less than 39°C.
Irritability.
Drowsiness.
Fever above 39°C.
Uncontrollable or unusual crying.
Anaphylaxis.
Urticaria.
Pruritus.
Oedema in one or both lower limbs within the first few hours after the first Haemophilus influenzae type b immunisation. Colour changes of the skin, transient bruising and severe crying may also occur. All events resolve spontaneously without long term consequences within 24 hours.
Convulsion (with or without fever).

References

Medical Advisory Committee of Haemophilia Foundation of New Zealand. National guidelines management of haemophilia - treatment protocols. Christchurch: Haemophilia Foundation of New Zealand; 2005.
sanofi-aventis australia pty ltd. Act-HIB datasheet [Home page on the Internet]. Wellington: Medsafe; 2011 [cited 2011, May 5]. Available from: http://www.medsafe.govt.nz/profs/Datasheet/a/acthibinj.pdf.
Sanofi Pasteur Inc. Package insert and patient information - ActHIB [Homepage on the Internet]. Silver Spring, MD: U.S. Food and Drug Administration; 2009 [cited 2011, June 4]. Available from: http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM109841.pdf.
Sanofi Pasteur Limited. Product monograph Act-HIB [Homepage on the Internet]. Ottawa, Ontario: Health Canada; 2005 [cited 2011, June 10]. Available from: http://webprod.hc-sc.gc.ca/dpd-bdpp/info.do?lang=eng&code=13140.
Other Vaccine Brands

Act-HIB™

Dosage and Administration

In children, 12 months of age and over, and adults a single dose of Act-HIB™ is required.

  • Intramuscular injection is the preferred method of administration for Act-HIB™. It can be administered subcutaneously when clinically indicated e.g., the vacinee has a serious bleeding disorder.
  • In children, aged 12 months and over, and adults the deltoid muscle is the preferred injection site. The vastus lateralis muscle can be used when the child's deltoid muscle bulk is small and multiple injections are required.
  • Act-HIB™ should be administered to children and adults with thrombocytopenia or bleeding disorders, e.g. haemophilia, in accordance with their haematologist's instructions. The vaccine may be given subcutaneously if the person's haematologist has advised against intramuscular injection of immunisations. Firm pressure should be applied to the injection site (without rubbing) for at least ten minutes following either intramuscular or subcutaneous injection.
  • Act-HIB™ can be administered at the same visit as other live or non-live vaccines using a different syringe and separate injection site.
  • Act-HIB™ is licensed for use in infants and children 2 months to 5 years of age. It is used out of licensure in children 5 years of age and over and adults as there is no alternative vaccine available in New Zealand for these age groups. When children/individuals are older than the age to which the vaccine is licensed, use will be outside of current licensure. No safety concerns are expected for use in older age groups.
  • Women who are breast feeding can safely have Act-HIB™. No adverse consequences for a breast feeding infant have been observed following vaccination of lactating women.
  • Act-HIB™ can be administered concurrently with other vaccines, including all the National Immunisation Schedule vaccines. Separate syringes and different injection sites should be used.
  • Store between +2°C to +8°C. The expiry date of the vaccine is the last day of the month in the year indicated on the packaging.
Efficacy/Effectiveness

As with any vaccine, Act-HIB™ may not protect 100% of vaccinated individuals.

Almost all children are protected from Haemophilus influenzae type b after a booster of Act-HIB™ in their second year of life.

Catch-Up

Refer to the catch up section of the current Immunisation Handbook for age appropriate catch up schedules. Missed doses of Act-HIB™ on the Pre/Post Splenectomy Immunisation Prorgramme can be offered to children and adults at anytime.

Contraindications
  • A severe allergy (anaphylaxis) to a previous dose of this vaccine or a component of the vaccine.
  • Administration of Act-HIB™ should be postponed in individuals suffering from acute severe febrile illness (fever over 38°C). The presence of a minor infection is not a contraindication.

Vaccine type: Subunit

Ingredients Quantity/dose (0.5ml) Function
Active substances    
Haemophilus influenzae type b (Hib) polysaccharide,

10 micrograms (μg)

Antigen

conjugated to tetanus toxoid 18-30 μg Carrier protein
     
Adjuvants    
Nil    
     
Excipients    
Culture media  Residual Grow Haemophilus influenzae type b (Hib) and Clostridium tetani (tetanus)
Ammonium sulfate Residual  Protein fractionation
Formaldehyde  Less than 0.5 µg Antimicrobial; stabiliser; toxin inactivation
Trometamol  0.6 mg  Buffer
Sucrose 42.5 mg Stabiliser
Sodium chloride 0.4%     Diluent