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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 prescription‑only injectable solution that contains the Haemophilus influenzae type b conjugate vaccine, a tetanus toxoid‑conjugated polysaccharide. The vaccine is supplied in a single‑dose vial for intramuscular or subcutaneous administration. It is marketed in the European Union and is classified under ATC code J07AG02. Hiberix is used to stimulate active immunity against Haemophilus influenzae type b infections. The preparation is used in pediatric immunization programs.

Manufacturer / TM Owner

Glaxosmithkline Biologicals S.A.

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Indications & Clinical Uses

Hiberix is indicated for the prevention of disease caused by Haemophilus influenzae type b (Hib).

  • Primary immunization of infants according to national vaccination schedules.
  • Booster doses in children who have completed the primary series.
  • Immunization of adolescents who have not previously received Hib vaccine.
  • Use in travelers to regions where Hib disease remains endemic.
  • Administration to individuals with certain immunodeficiency conditions when recommended by a healthcare professional.

How It Works

  • The vaccine contains Hib capsular polysaccharide (polyribosyl‑ribitol‑phosphate) covalently linked to tetanus toxoid protein. After intramuscular or subcutaneous injection, antigen‑presenting cells process the conjugate and present peptide fragments to helper T cells. This T‑cell help drives B‑cell activation and class‑switching, resulting in the production of high‑affinity anti‑PRP IgG antibodies that neutralize the bacterium and prevent invasive disease. The immune memory generated provides long‑term protection.

Side Effects

Local and systemic reactions may occur after injection of Hiberix, most of which are mild and self‑limiting.

Common

  • Pain, redness, or swelling at the injection site.
  • Low‑grade fever (up to 38 °C) within 24 hours.
  • Irritability or fussiness in infants.
  • Decreased appetite or mild malaise.
  • Headache or mild malaise.

Serious

  • Anaphylactic or severe allergic reaction.
  • High fever (≥40 °C) or febrile seizures.
  • Seizures not associated with fever.
  • Hypotension or shock.
  • Rare neurologic events such as Guillain‑Barré syndrome.

Precautions & Warnings

Healthcare providers should assess each patient’s medical history before administering Hiberix to minimize the risk of adverse events.

  • Do not give to individuals with a known severe allergy to any vaccine component.
  • Postpone vaccination in persons with moderate or severe acute illness.
  • Observe the patient for at least 15 minutes after injection for immediate reactions.
  • Use caution in patients with a history of seizures or neurologic disorders.
  • Consider deferring vaccination in immunocompromised patients unless benefits outweigh risks.
  • Document any prior Hib vaccination to avoid unnecessary repeat dosing.

Avoid Interactions

Hiberix does not have many documented drug‑drug interactions, but certain concomitant therapies may influence its safety profile.

Avoid

  • Administration of other live bacterial vaccines (e.g., oral typhoid) within 4 weeks before or after Hiberix.

Use with caution

  • Concurrent use of immunosuppressive agents may reduce antibody response.
  • Antipyretics (acetaminophen, ibuprofen) may mask fever after vaccination.
  • Blood products or immunoglobulins given within 3 months may interfere with vaccine efficacy.
  • Severe allergic reactions to previous vaccines may warrant extended observation.

Frequently Asked Questions

Hiberix is a conjugate vaccine that links Hib polysaccharide to tetanus toxoid, enhancing immune response. Its formulation and licensing are specific to the European market, but the core antigen is similar to other Hib conjugate vaccines.

Hiberix is recommended for infants and children according to national immunization schedules, as well as for unvaccinated adolescents and travelers to areas where Hib disease is still common.

In most EU countries, Hiberix is given as a primary series at 2, 3, and 4 months of age, followed by a booster dose at 12–15 months, but exact timing may vary by local guidelines.

Full protection typically requires three primary doses plus a booster dose, although the exact number may be adjusted for children who start the series later or have special health considerations.

Yes, Hiberix can be co‑administered with other routine vaccines such as DTaP, polio, and pneumococcal vaccines, provided injection sites are separate.

Common reactions include pain, redness or swelling at the injection site, low‑grade fever, irritability in infants, decreased appetite, and mild headache.

Medical attention is advised if the patient develops signs of a severe allergic reaction (e.g., difficulty breathing, swelling of the face), high fever above 40 °C, or any neurologic symptoms such as seizures.

Hiberix can be administered to children with a seizure history, but clinicians should monitor closely for febrile seizures, especially if the child has a known predisposition.

Linking the Hib polysaccharide to tetanus toxoid creates a protein‑polysaccharide conjugate that engages helper T cells, leading to stronger, longer‑lasting antibody production compared with polysaccharide alone.

No significant drug‑drug interactions are documented, but concurrent immunosuppressive therapy may reduce the vaccine’s effectiveness, and antipyretics can mask post‑vaccination fever.

If a scheduled dose is missed, it should be given as soon as possible. The series does not need to be restarted, but the remaining doses should follow the recommended interval.

The safety of Hiberix during pregnancy has not been established. Vaccination is generally deferred until after delivery unless the benefits outweigh potential risks, as determined by a healthcare provider.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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