Product image of Havrix Junior Monodose (Hepatitis A Virus (Inactivated), Algeldrate) supplied by GNH India

Havrix Junior Monodose

Active Ingredient:
Hepatitis A Virus (Inactivated), Algeldrate
Origin:
EU

Havrix Junior Monodose (Hepatitis A Virus (Inactivated), Algeldrate)

Havrix Junior Monodose is a lyophilized, single‑dose hepatitis A vaccine that contains inactivated hepatitis A virus and the adjuvant algeldrate. It is supplied as a sterile powder for reconstitution and given by intramuscular injection. Marketed in the European Union and available by prescription, the vaccine is intended for children to stimulate protective antibodies and provide long‑term immunity against hepatitis A infection in the pediatric population.

Manufacturer / TM Owner

Glaxosmithkline Biologicals S.A.

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Indications & Clinical Uses

Havrix Junior Monodose is indicated for active immunization against hepatitis A virus infection in children according to national immunization schedules.

  • Primary prophylaxis of hepatitis A in children aged 12 months and older.
  • Completion of a two‑dose series to achieve long‑term protection.
  • Use in travelers to regions where hepatitis A is endemic.
  • Administration in outbreak settings to quickly raise community immunity.
  • Inclusion in combination vaccination programs when approved by health authorities.

Side Effects

Following intramuscular administration, Havrix Junior Monodose may be associated with transient local and systemic reactions, most of which are mild and resolve without intervention.

Common

  • Pain, redness, or swelling at the injection site.
  • Low‑grade fever occurring within 24‑48 hours.
  • Headache or mild fatigue.
  • Nausea or mild gastrointestinal discomfort.

Serious

  • Allergic reactions such as urticaria, angioedema, or anaphylaxis.
  • Neurological events including Guillain‑Barré syndrome (rare).
  • Persistent high fever or severe systemic illness.
  • Severe local reaction with extensive necrosis (very rare).

Precautions & Warnings

Healthcare providers should evaluate individual risk factors and medical history before administering Havrix Junior Monodose to ensure safe use.

  • Defer vaccination in persons with a known severe allergy to any vaccine component, including algeldrate.
  • Postpone administration in individuals with acute moderate or severe illness until recovery.
  • Use caution in children with immunodeficiency or receiving immunosuppressive therapy.
  • Monitor for signs of an allergic reaction for at least 15 minutes after injection.
  • Discuss the vaccination schedule with caregivers, especially regarding the timing of the second dose.
  • Consider hepatitis A serology testing in those with prior exposure or vaccination.

Avoid Interactions

Havrix Junior Monodose does not have extensive documented drug‑drug interactions, but certain concomitant therapies may influence immune response or safety.

Avoid

  • Simultaneous administration with live viral vaccines (e.g., measles, mumps, rubella) unless recommended by guidelines.
  • Use in individuals receiving high‑dose immunoglobulin therapy within 2 weeks of vaccination.

Use with caution

  • Concurrent use of immunosuppressive agents may reduce antibody response.
  • Antipyretics (acetaminophen, ibuprofen) can be given to manage post‑vaccination fever, but should not be prophylactically administered before injection.
  • Blood products or plasma containing hepatitis A antibodies may interfere with vaccine efficacy if given within 4 weeks before or after vaccination.

Frequently Asked Questions

Havrix Junior Monodose is approved for active immunization of children aged 12 months and older, according to European Union guidelines.

A complete hepatitis A vaccination schedule with Havrix Junior Monodose typically consists of two doses administered several months apart to achieve long‑term immunity.

The vaccine may be administered at the same visit as other non‑live vaccines, but simultaneous use with live viral vaccines should follow national recommendations.

A low‑grade fever is a common reaction; caregivers can use age‑appropriate antipyretics such as acetaminophen, but should not give medication prophylactically before vaccination.

The vaccine should not be given to individuals with a known severe allergy to any component, including algeldrate, or to those with a history of anaphylaxis to a previous hepatitis A vaccine dose.

Children with immunodeficiency may receive the vaccine, but the immune response could be reduced; clinicians should assess the risk‑benefit balance.

The lyophilized vaccine should be stored in a refrigerator between 2 °C and 8 °C and protected from light until it is reconstituted for injection.

Blood products containing hepatitis A antibodies may interfere with vaccine efficacy if given within four weeks before or after vaccination.

Typical side effects include mild pain, redness, or swelling at the injection site, low‑grade fever, headache, fatigue, and occasional mild gastrointestinal discomfort.

After completing the two‑dose series, protection against hepatitis A infection is expected to last for at least 10‑20 years, with evidence of long‑term immunity.

Yes, vaccinating children at least two weeks before travel to regions with high hepatitis A prevalence is recommended to ensure adequate antibody development.

Serology testing is not routinely required, but it may be considered for children with uncertain vaccination history or possible prior exposure.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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