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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 containing the active ingredient Haemophilus influenzae type b polysaccharide linked to tetanus toxoid, supplied as an injectable solution. The product is authorized in the European Union and is prescribed by healthcare professionals for intramuscular or subcutaneous administration. Strength is not specified on the label, and the vaccine is classified as a prescription (Rx) preventive immunization for infants and toddlers.

Manufacturer / TM Owner

Glaxosmithkline Biologicals S.A.

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Indications & Clinical Uses

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

  • Primary immunization series in infants and young children.
  • Booster doses as recommended by national immunization schedules.
  • Use in children older than 12 months who have not completed the primary series.
  • Administration to adults at increased risk of Hib disease, such as those with certain immunodeficiencies.
  • Co‑administration with other routine childhood vaccines when appropriate.
  • May be given to travelers to regions where Hib disease remains endemic.

How It Works

  • Hiberix works by coupling the capsular polysaccharide polyribosylribitol phosphate (PRP) of Haemophilus influenzae type b to a carrier protein, tetanus toxoid. This conjugate enables the antigen to be processed by antigen‑presenting cells and presented to T‑helper cells, which in turn stimulate B‑cell production of high‑affinity anti‑PRP antibodies. The resulting humoral response provides active immunity that prevents invasive Hib disease. Memory B cells generated by the vaccine contribute to long‑term protection.

Side Effects

Local and systemic reactions may occur after injection of Hiberix; most are mild and resolve without medical intervention. These reactions are typically self‑limited and do not require specific treatment. Healthcare providers monitor patients after vaccination to ensure any adverse event is promptly addressed.

Common

  • Pain, redness, or swelling at the injection site.
  • Low‑grade fever (≤38.5 °C).
  • Irritability or fussiness in infants.
  • Mild headache or fatigue.
  • Mild muscle aches.
  • Temporary loss of appetite.

Serious

  • Severe allergic reaction (anaphylaxis) with difficulty breathing, hives, or swelling of the face.
  • High fever (≥39 °C) persisting more than 24 hours.
  • Seizures associated with fever.
  • Persistent crying or inconsolable distress.
  • Guillain‑Barré syndrome (very rare).
  • Encephalopathy (very rare).

Precautions & Warnings

Before administering Hiberix, clinicians should evaluate the patient’s medical history and current health status to minimize risk.

  • Confirm no severe allergic reaction to any component of the vaccine, especially tetanus toxoid.
  • Defer vaccination in individuals with acute moderate or severe illness until recovery.
  • Use caution in patients with a known immunodeficiency, as response may be reduced.
  • Discuss with pregnant or breastfeeding women; safety data are limited, and vaccination should follow professional guidance.
  • Observe the patient for at least 15 minutes after injection for immediate hypersensitivity.
  • Record any previous Hib vaccination to avoid unnecessary repeat dosing.

Avoid Interactions

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

Avoid

  • Concurrent administration of other live vaccines at the same anatomical site; separate sites or timing is recommended.
  • Use with immunosuppressive therapies that may markedly diminish the vaccine’s immunogenicity.
  • Simultaneous intramuscular injection with other vaccines containing adjuvants that may increase reactogenicity.

Use with caution

  • Simultaneous receipt of other inactivated vaccines; monitor for increased local reactions.
  • Administration in patients receiving high‑dose steroids; assess antibody response.
  • Co‑administration with antipyretics may mask low‑grade fever, though it does not affect efficacy.
  • Administration in patients on anticoagulant therapy; apply pressure to injection site to reduce bruising.

Frequently Asked Questions

The active ingredient is the Haemophilus influenzae type b polysaccharide conjugated to tetanus toxoid.

Hiberix is given as an injectable solution, administered either intramuscularly or subcutaneously by a healthcare professional.

Hiberix is used to prevent infections caused by Haemophilus influenzae type b, including meningitis, pneumonia, epiglottitis, and septicemia.

Yes, Hiberix may be administered to adults who are at increased risk of Hib disease, such as those with certain immunodeficiencies or chronic health conditions.

Hiberix can be co‑administered with other inactivated vaccines, but live vaccines should be given at separate sites or spaced according to local guidelines.

Common reactions include pain, redness, or swelling at the injection site, low‑grade fever, irritability in infants, mild headache, fatigue, mild muscle aches, and temporary loss of appetite.

Serious events are rare but can include severe allergic reactions (anaphylaxis), high fever lasting more than 24 hours, seizures associated with fever, persistent crying, Guillain‑Barré syndrome, and encephalopathy.

Yes, individuals with a known severe allergic reaction to any component of Hiberix, especially tetanus toxoid, should not receive the vaccine.

Safety data for use during pregnancy are limited; vaccination should be considered only if the potential benefit outweighs any potential risk and in consultation with a healthcare provider.

Hiberix is a conjugate vaccine, meaning the Hib polysaccharide is linked to a protein carrier (tetanus toxoid), which enhances the immune response, especially in young children, compared with a polysaccharide‑only vaccine.

Immediate medical attention is required; the patient should be treated for anaphylaxis or other serious reactions according to standard emergency protocols.

Antipyretics such as acetaminophen may be used to manage low‑grade fever, but they can mask mild fever and should not be given prophylactically before vaccination.

Published by

GNH India Pharmaceuticals Limited

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Last updated:

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