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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 vaccine that contains the active ingredient Haemophilus influenzae type b conjugate (tetanus toxoid conjugate). It is supplied as an injectable formulation, typically administered intramuscularly or subcutaneously, and is marketed in the European Union. The vaccine is designed to stimulate active immunity against Haemophilus influenzae type b, a bacterial pathogen that can cause serious infections in young children and reduce morbidity and mortality rates.

Manufacturer / TM Owner

Glaxosmithkline S.P.A.

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Indications & Clinical Uses

Hiberix is indicated for the prevention of infections caused by Haemophilus influenzae type b (Hib) in pediatric and at‑risk populations.

  • Primary immunization series in infants starting at 2 months of age.
  • Booster dose to maintain protective antibody levels.
  • Use in children who have not completed a Hib vaccine series.
  • Administration to individuals with certain immunodeficiencies when recommended by a healthcare professional.
  • Inclusion in combination vaccine schedules where compatible.
  • Vaccination of travelers to regions with higher Hib disease prevalence, as part of routine immunization.
  • Administration prior to exposure to environments such as daycare centers where Hib transmission risk is elevated.

How It Works

  • Hiberix contains polysaccharide capsular antigen of Haemophilus influenzae type b covalently linked to tetanus toxoid protein. The conjugate enables the polysaccharide to be processed by antigen‑presenting cells and presented to T‑helper cells, inducing a T‑cell‑dependent immune response. This results in the generation of high‑affinity IgG antibodies and immunological memory that neutralize the Hib organism upon subsequent exposure in the bloodstream and mucosal surfaces.

Side Effects

The most frequently reported reactions to Hiberix are mild and transient, reflecting typical vaccine administration responses. These reactions are generally self‑limiting and resolve without medical intervention.

Common

  • Pain, redness, or swelling at the injection site.
  • Low‑grade fever (temperature ≤38.5 °C).
  • Irritability or fussiness in infants.
  • Mild headache or fatigue.
  • Redness or bruising that may last a few days.
  • Mild muscle aches near the injection area.
  • Temporary loss of appetite.
  • Mild fever accompanied by chills that subsides within 24 hours.
  • Transient rash that appears near the injection site and fades quickly.

Serious

  • Anaphylactic or severe allergic reaction (e.g., urticaria, airway swelling).
  • Seizure (rare) possibly associated with high fever.
  • Guillain‑Barré syndrome reported rarely after vaccination.
  • High‑grade fever (>40 °C) with possible convulsions.

Precautions & Warnings

Healthcare providers should assess individual health status before administering Hiberix to ensure safe vaccination.

  • Verify that the patient has no known severe allergy to any vaccine component, especially tetanus toxoid.
  • Defer vaccination in individuals with acute moderate or severe illness until recovery.
  • Use caution in infants with a history of seizures or febrile convulsions.
  • Consider postponing the dose if the child has received another vaccine within the previous 4 weeks, unless co‑administration is recommended.
  • Monitor the injection site and overall condition for at least 15 minutes after administration.
  • Document any adverse reactions and report them to pharmacovigilance authorities.

Avoid Interactions

Because Hiberix is a vaccine, its interaction profile focuses on timing with other immunizations and certain medications.

Avoid

  • Simultaneous administration with live bacterial vaccines (e.g., oral polio vaccine) unless specifically approved.
  • Co‑administration with immunosuppressive biologics (e.g., rituximab) during the initial priming series.

Use with caution

  • Administration in patients receiving high‑dose corticosteroids; monitor antibody response.
  • Vaccination shortly after receipt of blood products or immunoglobulins may reduce immunogenicity.
  • Use in individuals on antipyretic therapy; antipyretics may mask fever post‑vaccination.
  • Concomitant use of other pediatric vaccines; follow recommended schedules to avoid interference.
  • Consider spacing intervals of at least 2 weeks when combining with live attenuated vaccines to ensure optimal immune response.

Frequently Asked Questions

The active ingredient is a Haemophilus influenzae type b polysaccharide conjugated to tetanus toxoid, forming a conjugate vaccine.

Hiberix is given by intramuscular or subcutaneous injection, typically in the thigh or upper arm.

Hiberix is recommended for infants starting at 2 months of age and for children who have not completed a Hib vaccine series.

Yes, Hiberix can be co‑administered with other pediatric vaccines according to recommended schedules, though spacing may be advised for live vaccines.

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

Serious reactions, though rare, may include anaphylaxis, seizures, Guillain‑Barré syndrome, and high‑grade fever with convulsions.

Vaccination should be deferred in children with moderate or severe acute illness until they have recovered.

The safety of Hiberix during pregnancy has not been established; it should be used only if the potential benefit justifies the potential risk.

The vaccine induces an immune response that produces antibodies targeting the Hib polysaccharide, providing protection against infection.

If signs of a severe allergic reaction appear, seek immediate medical attention and report the event to healthcare authorities.

Use with caution; antibody response may be reduced, and timing should be coordinated with the treating physician.

The ATC classification code for Hiberix is J07AG02.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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