Product image of Hiberix (Haemophilus Type B Conjugate Vaccine (Tetanus Toxoid Conjugate)) supplied by GNH India

Hiberix

Active Ingredient:
Haemophilus Type B Conjugate Vaccine (Tetanus Toxoid Conjugate)
Origin:
EU

Hiberix (Haemophilus Type B Conjugate Vaccine (Tetanus Toxoid Conjugate))

Hiberix is a prescription injectable solution that contains the Haemophilus influenzae type b (Hib) conjugate vaccine, a tetanus toxoid‑conjugated polysaccharide. The vaccine is supplied in a standard strength (strength not specified) for intramuscular or subcutaneous administration. It is marketed in the European Union and is used to stimulate active immunity against invasive Hib disease in infants and children. The product is classified under ATC code J07AG and intended for immunization schedules.

Manufacturer / TM Owner

Glaxosmithkline (Ireland) Limited

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Indications & Clinical Uses

Hiberix is indicated for the prevention of invasive disease caused by Haemophilus influenzae type b in infants and children.

  • Primary series of three doses given at 2, 4, and 12‑15 months of age.
  • A single booster dose administered at 12‑15 months or later, according to local schedule.
  • Recommended for children from 6 weeks up to 5 years of age who have not previously received Hib vaccine.
  • Administered by intramuscular or subcutaneous injection into the anterolateral thigh or deltoid muscle.
  • Can be co‑administered with other routine pediatric vaccines such as DTaP, IPV, or pneumococcal conjugate vaccine.

How It Works

  • Hiberix contains the capsular polysaccharide of Haemophilus influenzae type b covalently linked to tetanus toxoid protein. The conjugate converts the polysaccharide into a T‑cell‑dependent antigen, enabling B‑cell activation and class‑switching. This stimulates production of high‑affinity anti‑PRP (polyribosyl‑ribitol‑phosphate) antibodies and immunologic memory, providing active protection against invasive Hib disease. The immune response also involves helper T‑cell activation and cytokine release, which further enhances antibody maturation and long‑term protection.

Side Effects

Like all vaccines, Hiberix may cause local or systemic reactions, most of which are mild and transient.

Common

  • Pain, redness, or swelling at the injection site.
  • Low‑grade fever (≤38.5 °C) within 24‑48 hours after vaccination.
  • Irritability or fussiness in infants.
  • Mild fatigue or decreased appetite.

Serious

  • Severe allergic reaction (anaphylaxis) with hives, airway swelling, or hypotension.
  • High fever (>40 °C) persisting more than 24 hours.
  • Seizure (febrile convulsion) associated with fever.
  • Persistent crying or inconsolable behavior lasting >3 hours.

Precautions & Warnings

Healthcare providers should assess individual risk factors before administering Hiberix and follow recommended safety guidelines.

  • Do not vaccinate children with a known severe allergy to any vaccine component, including tetanus toxoid.
  • Postpone vaccination in persons experiencing moderate or severe acute illness with fever.
  • Observe the patient for at least 15 minutes after injection to monitor for immediate allergic reactions.
  • Use caution in individuals with a history of seizures or neurologic disorders; discuss benefits versus risks.
  • Consider deferring vaccination in immunocompromised patients until clinical stability is achieved.
  • Ensure proper storage and handling of the vaccine according to the manufacturer’s instructions.

Avoid Interactions

Hiberix generally has a low potential for drug interactions, but certain circumstances warrant caution.

Avoid

  • Concurrent administration of live bacterial vaccines (e.g., oral typhoid) within 4 weeks, as immune response may be altered.
  • Simultaneous use of immunosuppressive therapies (e.g., high‑dose corticosteroids) that could diminish vaccine efficacy.

Use with caution

  • Administration with other inactivated vaccines; monitor for increased local reactogenicity.
  • Patients receiving antipyretics (e.g., acetaminophen) prophylactically; may reduce antibody response.
  • Individuals on biologic agents targeting B‑cell function; assess timing relative to vaccination.

Frequently Asked Questions

Hiberix is approved for use in infants and children from 6 weeks up to 5 years of age who have not previously received a Hib vaccine.

The primary series consists of three separate injections, typically administered at 2, 4, and 12‑15 months of age.

Yes, Hiberix may be co‑administered with other inactivated pediatric vaccines such as DTaP, IPV, and pneumococcal conjugate vaccine.

Hiberix is administered by intramuscular or subcutaneous injection, usually into the anterolateral thigh in infants or the deltoid muscle in older children.

Common reactions include pain, redness, or swelling at the injection site, low‑grade fever, irritability, and mild fatigue.

Serious events such as anaphylaxis, high fever lasting more than 24 hours, febrile seizures, or prolonged inconsolable crying should be reported to a healthcare professional immediately.

Vaccination can be delayed if the child has a moderate or severe acute illness with fever; mild illness without fever generally does not require postponement.

Yes, children with a known severe allergy to tetanus toxoid or any component of the vaccine should not receive Hiberix.

Immunosuppressive therapies, especially high‑dose corticosteroids or biologics that affect B‑cell function, may reduce the immune response to Hiberix and should be considered when scheduling vaccination.

Hiberix should be stored in a refrigerator between 2 °C and 8 °C, protected from light, and not frozen.

Routine prophylactic use of antipyretics like acetaminophen is not recommended, as it may diminish the antibody response; they can be used after vaccination if needed for symptom relief.

The ATC code for Hiberix is J07AG, indicating it is a bacterial vaccine.

Published by

GNH India Pharmaceuticals Limited

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Last updated:

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