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 lyophilized powder for reconstitution that contains the Haemophilus influenzae type b (Hib) conjugate vaccine, using tetanus toxoid as a carrier protein. It is supplied in a single‑dose vial and is administered by intramuscular or subcutaneous injection. The product is authorized in the European Union and is prescribed for the active immunization of infants and young children against Hib disease through a standard immunization schedule.

Manufacturer / TM Owner

Smith Kline & French Portuguesa-Produtos Farmaceuticos Lda

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Indications & Clinical Uses

Hiberix is indicated for the prevention of infections caused by Haemophilus influenzae type b in pediatric populations.

  • Primary prevention of Hib meningitis, pneumonia, and epiglottitis in infants.
  • Use in routine childhood immunization programs according to national schedules.
  • Administration as part of a three‑dose primary series, typically at 2, 4, and 6 months of age.
  • Option to give a booster dose after the primary series, often at 12–15 months.
  • May be co‑administered with other pediatric vaccines such as DTaP, IPV, and PCV13.

How It Works

  • Hiberix works by linking the polyribosylribitol phosphate (PRP) capsular polysaccharide of Haemophilus influenzae type b to a tetanus toxoid carrier protein. The conjugate enables the polysaccharide to be processed by antigen‑presenting cells, eliciting a T‑cell‑dependent immune response. This stimulates the production of high‑affinity anti‑PRP antibodies and memory B cells, providing active, long‑lasting protection against Hib infection. The tetanus toxoid component also contributes to the overall immunogenicity without causing tetanus disease.

Side Effects

Local and systemic reactions may occur after Hiberix injection; most are mild and resolve without intervention.

Common

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

Serious

  • High fever (≥39 °C) persisting more than 48 hours.
  • Severe allergic reaction (e.g., urticaria, angioedema, bronchospasm).
  • Seizures associated with fever.
  • Persistent crying or inconsolable distress lasting >3 hours.

Precautions & Warnings

Healthcare providers should assess each patient before administering Hiberix to ensure safe use and to identify conditions that may require special attention.

  • Do not vaccinate children with a known severe allergy to any component of the vaccine, including tetanus toxoid.
  • Defer vaccination in individuals with a moderate or severe acute illness until recovery.
  • Observe the patient for at least 15 minutes after injection for immediate hypersensitivity reactions.
  • Use with caution in infants with a history of seizures or febrile convulsions.
  • Document previous Hib vaccination to avoid unnecessary repeat dosing.
  • Consider postponing the dose if the child is receiving immunosuppressive therapy.

Avoid Interactions

Hiberix does not have many documented drug‑drug interactions, but certain clinical situations warrant attention.

Avoid

  • Concurrent administration of live bacterial vaccines (e.g., oral typhoid) in the same limb, which may interfere with immune response.
  • Use in patients receiving high‑dose corticosteroids or other potent immunosuppressants without adjusting the schedule.

Use with caution

  • Simultaneous receipt of multiple injectable vaccines; monitor for increased local reactogenicity.
  • Infants on antipyretic therapy may have attenuated fever response, potentially masking early signs of infection.
  • Patients with a history of Guillain‑Barré syndrome should be evaluated before vaccination.

Frequently Asked Questions

Hiberix is recommended for infants starting at 2 months of age and for children up to 5 years, following the national immunization schedule.

A primary series of three doses is typical, given at 2, 4, and 6 months, followed by a booster dose around 12–15 months.

Yes, Hiberix may be co‑administered with other injectable vaccines such as DTaP, IPV, and PCV13 at separate injection sites.

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

The vaccine conjugates the Hib polysaccharide to tetanus toxoid, inducing a T‑cell‑dependent response that generates anti‑PRP antibodies and immune memory.

Children with a severe allergy to any vaccine component, especially tetanus toxoid, should not receive Hiberix. Mild allergies should be discussed with a healthcare professional.

A low‑grade fever is common and can be managed with age‑appropriate antipyretics. If the fever exceeds 39 °C or persists beyond 48 hours, seek medical advice.

Contraindications include a known severe allergic reaction to the vaccine or its ingredients and a current moderate or severe acute illness.

Immunity persists for several years after the primary series and booster; however, long‑term protection may be enhanced by the booster dose.

Vaccination can be considered, but timing may need adjustment and should be coordinated with the treating physician.

Hiberix is administered by intramuscular or subcutaneous injection, typically in the anterolateral thigh for infants.

A booster dose is recommended around 12–15 months of age to sustain protective antibody levels.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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