GNH USA

Europe — EMA

Hiberix

Hiberix is a prescription Hib conjugate vaccine used to prevent Haemophilus influenzae type b infection. Learn its uses, safety, and FAQs.

Haemophilus Type B Conjugate Vaccine (Tetanus Toxoid Conjugate)

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What is 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.

What is Haemophilus Type B Conjugate Vaccine (Tetanus Toxoid Conjugate) used for?

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.

What are the side effects of Haemophilus Type B Conjugate Vaccine (Tetanus Toxoid Conjugate)?

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.

What precautions apply to Haemophilus Type B Conjugate Vaccine (Tetanus Toxoid Conjugate)?

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.

What does Haemophilus Type B Conjugate Vaccine (Tetanus Toxoid Conjugate) interact with?

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

What is Hiberix and how does it differ from other Hib vaccines?+
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.
Who should receive the Hiberix vaccine?+
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.
At what ages is Hiberix administered in the EU schedule?+
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.
How many doses of Hiberix are required for full protection?+
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.
Can Hiberix be given together with other childhood vaccines?+
Yes, Hiberix can be co‑administered with other routine vaccines such as DTaP, polio, and pneumococcal vaccines, provided injection sites are separate.
What are the most common side effects after Hiberix injection?+
Common reactions include pain, redness or swelling at the injection site, low‑grade fever, irritability in infants, decreased appetite, and mild headache.
When should a healthcare professional seek medical attention after Hiberix?+
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.
Is Hiberix safe for children with a history of 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.
How does tetanus toxoid conjugation improve the immune response in Hiberix?+
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.
Are there any known drug interactions with Hiberix?+
No significant drug‑drug interactions are documented, but concurrent immunosuppressive therapy may reduce the vaccine’s effectiveness, and antipyretics can mask post‑vaccination fever.
What should be done if a dose of Hiberix is missed?+
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.
Can pregnant women receive Hiberix?+
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.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Haemophilus Type B Conjugate Vaccine (Tetanus Toxoid Conjugate)
Route
Intramuscular Use , Subcutaneous Use
Manufacturer
Glaxosmithkline Biologicals S.A.
Origin
EU

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