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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 Haemophilus influenzae type b conjugate vaccine (tetanus toxoid conjugate) supplied as an injectable solution. It is a prescription‑only product marketed in the European Union and is administered intramuscularly or subcutaneously to stimulate active immunity against Hib infections in infants and young children.

Manufacturer / TM Owner

Smithkline Beecham Limited

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Indications & Clinical Uses

Hiberix is indicated for the prevention of disease caused by Haemophilus influenzae type b. It is used in routine childhood immunization programs and may be given as part of a combination schedule with other pediatric vaccines.

  • Primary immunization series for infants starting at 2 months of age
  • Booster doses to maintain protective antibody levels
  • Prevention of Hib meningitis, epiglottitis, pneumonia, and sepsis
  • Recommended for children at increased risk of Hib infection
  • May be used in catch‑up vaccination for children who missed earlier doses

How It Works

  • Hiberix contains a polysaccharide antigen from the Haemophilus influenzae type b capsule covalently linked to a tetanus toxoid protein carrier. The conjugate enables the polysaccharide to be processed by antigen‑presenting cells, eliciting a T‑cell dependent response that generates high‑affinity anti‑Hib antibodies and immunologic memory, thereby providing active protection against Hib disease.

Side Effects

Adverse reactions to Hiberix are generally mild and transient, but serious events can occur rarely.

Common

  • Injection site pain, redness, or swelling
  • Low‑grade fever
  • Irritability or fussiness in infants
  • Mild rash or erythema
  • Headache
  • Fatigue

Serious

  • Anaphylaxis or severe allergic reaction
  • Seizures (rare)
  • High‑grade fever persisting >24 hours
  • Persistent crying or inconsolable distress
  • Neurologic complications such as encephalopathy (extremely rare)

Precautions & Warnings

Before administering Hiberix, consider the following safety points:

  • Verify no known severe allergy to any vaccine component, especially tetanus toxoid.
  • Defer vaccination in children with a moderate or severe acute illness.
  • Use caution in individuals with a history of seizures or neurological disorders.
  • Monitor for signs of an allergic reaction for at least 15 minutes after injection.
  • Discuss with a healthcare professional if the child is immunocompromised.
  • Pregnant or breastfeeding status should be evaluated by a clinician.

Avoid Interactions

Hiberix may interact with other agents that affect immune response or increase the risk of adverse reactions.

Avoid

  • Simultaneous administration of live bacterial vaccines at the same injection site.
  • Use of immunosuppressive therapy that could diminish vaccine efficacy.

Use with caution

  • Concurrent administration of other injectable vaccines (schedule according to guidelines).
  • Antipyretics or analgesics taken prophylactically before vaccination.
  • Patients receiving blood products or immunoglobulins within 4 weeks of vaccination.
  • Children on high‑dose corticosteroids.

Frequently Asked Questions

The active ingredient is a Haemophilus influenzae type b conjugate vaccine, where the Hib polysaccharide is linked to tetanus toxoid protein.

The first dose is typically given to infants starting at 2 months of age as part of the primary immunization series.

A complete primary series usually consists of three doses, followed by a booster dose to maintain immunity.

Yes, Hiberix can be co‑administered with other injectable vaccines according to national immunization schedules, but injection sites should be separate.

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

Severe allergic reactions such as anaphylaxis are rare but possible; any signs of allergy should be evaluated immediately.

Vaccination is generally postponed if the child has a moderate or severe acute illness, including a high fever.

Hiberix specifically targets Haemophilus influenzae type b; it does not provide protection against other serotypes.

The safety of Hiberix during pregnancy has not been established; it should be administered only if the benefit outweighs potential risks, as determined by a healthcare professional.

A missed dose should be administered as soon as possible, followed by the remaining doses according to the recommended schedule.

Contraindications include a known severe allergy to any component of the vaccine, particularly tetanus toxoid.

Hiberix uses a conjugate (polysaccharide linked to protein) which induces a stronger, T‑cell dependent immune response and longer‑lasting protection compared with plain polysaccharide vaccines.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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