4.1. Therapeutic indications

Active immunisation against infection caused by hepatitis A virus in children from 1 year up and including 15 years of age.

The use of Avaxim Junior should be based on official recommendations.

4.2. Posology and method of administration

Posology

The primary vaccination consists of one 0.5 ml dose of vaccine. Initial protection starts within 2 weeks after administration.

In order to provide a long-term protection, a second dose (booster) of vaccine is recommended. This booster dose should be given between 6 months and 15 years after the first dose (see section 5.1).

In line with WHO recommendation, in a setting transitioning from high to intermediate endemicity, in childhood immunization programmes either a single-dose or two-dose schedule (primary vaccination and booster) can be used.

This vaccine can be used as a booster in subjects previously vaccinated with another inactivated hepatitis A vaccine.

Method of administration

Avaxim Junior should be administered intramuscularly in the deltoid area in older children and adolescents, and anterolateral area of the thigh in young children.

Avaxim Junior must not be administered intradermally or intravascularly: ensure that the needle does not penetrate a blood vessel.

In exceptional circumstances (e.g. in patients with thrombocytopenia or in patients at risk of haemorrhage), the vaccine may be injected by the subcutaneous route.

The vaccine should not be administered into the buttocks, due to the varying amount of fatty tissue in this region, contributing to variability in effectiveness of the vaccine.

Precautions to be taken before handling or administering the medicinal product

For instructions on preparation of the medicinal product before administration, see section 6.6.

4.3. Contraindications

• Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 or to neomycin, which may be present in the vaccine in trace amounts.

• Hypersensitivity following a previous injection of this vaccine.

• Vaccination should be delayed in subjects with an acute severe febrile illness.

4.4. Special warnings and precautions for use

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Anaphylactic reaction

As with all vaccines, appropriate medical treatment and supervision should be readily available for immediate use in case of rare anaphylactic reaction following vaccination. Avaxim Junior should only be given by a physician or health care worker trained in the administration of vaccines.

Anxiety-related reactions

Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs and symptoms such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints.

Impaired immunity

Avaxim Junior has not been studied in patients with impaired immunity. The immune response to the vaccine could be impaired by immunosuppressive treatment or in immunodeficiency states. In such cases, it is recommended to measure the antibody response to be sure of protection and, if possible, to wait for the end of any suppressive treatment before vaccination. Nevertheless, vaccination of subjects with chronic immunodeficiency such as HIV infection is recommended although the antibody response may be limited.

Vaccination during incubation period

Because of the incubation period of hepatitis A, infection may be present but not clinically apparent at the time of vaccination. The effect of Avaxim Junior on individuals during the late stage of the incubation period of hepatitis A has not been documented. In such a case, vaccination may not modify the course of infection.

Vaccination of already immunized subjects

Individuals who have grown up in areas of high hepatitis A endemicity and/or with a history of jaundice may be immune to hepatitis A, in which case the vaccine is unnecessary. Testing for antibodies to hepatitis A prior to a decision on immunisation could be considered in such situations. In the absence of testing, seropositivity against hepatitis A is not a contraindication to vaccination.

Protection

Avaxim Junior does not provide protection against infection caused by hepatitis B virus, hepatitis C virus, hepatitis E virus or by other liver pathogens.

As with any vaccine, vaccination may not result in a protective response in all susceptible vaccinees.

Avaxim Junior contains phenylalanine, ethanol, potassium and sodium

• Avaxim Junior contains 10 microgram phenylalanine in each 0.5 ml dose which is equivalent to 0.17 microgram/kg for a 60 kg person. Phenylalanine may be harmful for people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

• Avaxim Junior contains 2 mg of alcohol (ethanol) in each 0.5 ml dose. The small amount of alcohol in this medicine will not have any noticeable effects.

• Avaxim Junior contains less than 1mmol of potassium (39 mg) and sodium (23 mg) per dose, that is to say it is essentially 'potassium-free' and 'sodium-free'.

4.5. Interaction with other medicinal products and other forms of interaction

Separate injection sites and separate syringes must be used in case of concomitant administration with other medicinal products.

The vaccine may be administered simultaneously with vaccines containing one or more of following valences: diphtheria, tetanus, pertussis (acellular or whole cells), Haemophilus influenzae of type b, inactivated or oral poliomyelitis, measles, mumps and rubella.

Concomitant administration of immunoglobulin has been studied with AVAXIM (corresponding to 160U) in adults, but not with Avaxim Junior in children. The results from AVAXIM in adults suggest that concomitant administration of immunoglobulin and Avaxim Junior at two separate sites may be performed. Seroconversion rates are not modified, but antibody titres could be lower than after vaccination with Avaxim Junior alone.

No interaction with other medicinal products is currently known.

4.6. Fertility, pregnancy and lactation

Pregnancy

Limited data are available on the use of AVAXIM vaccines in pregnant women. No animal reproductive studies have been conducted. However, no conclusions can be drawn regarding whether or not Avaxim Junior is safe for use during pregnancy.

Avaxim Junior should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the foetus.

Breast-feeding

Avaxim Junior can be used during breastfeeding.

Fertility

Avaxim Junior has not been evaluated for impairment of male or female fertility.

4.7. Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8. Undesirable effects

Summary of the safety profile

This summary of safety profile is based on pooled analysis that integrated data from 5458 children aged from 12 months through 15 years of age, who received at least one injection of Avaxim Junior during clinical trials.

Most undesirable effects were limited to the first few days following vaccination with spontaneous recovery. Reactions were more rarely reported after the booster dose than after the first dose.

In subjects seropositive against hepatitis A virus, Avaxim Junior was as well tolerated as in seronegative subjects.

Tabulated list of adverse reactions

Adverse event information is derived from clinical studies and worldwide post-marketing experience. Within each system organ class the adverse events are ranked under headings of frequency, using the following CIOMS frequency rating:

• Very common ≥10%;

• Common ≥ 1 and <10%;

• Uncommon ≥0.1 and <1%;

• Rare ≥0.01 and < 0.1%;

• Very rare < 0.01%;

• Not known (cannot be estimated from available data).

Adverse reactions

Frequency after any dose

Blood and Lymphatic system disorder

Lymphadenopathy

Not known

Immune system disorders

Anaphylactic reaction

Not known

Metabolism and nutrition disorders

Appetite decrease

Common

Psychiatric disorders

Abnormal crying

Very common

Irritability

Common

Insomnia

Common

Nervous system disorders

Headache

Very common

Vasovagal syncope in response to injection

Not known

Convulsions with or without fever

Not known

Gastrointestinal disorders

Abdominal pain

Common

Diarrhoea

Common

Nausea

Common

Vomiting

Common

Skin and subcutaneous tissue disorders

Rash

Uncommon

Urticaria

Uncommon

Musculoskeletal and connective tissue disorders

Arthralgia

Common

Myalgia

Common

General disorders and administration site conditions

Injection site pain

Very common

Malaise

Very common

Pyrexia

Common

Injection site erythema

Common

Asthenia or drowsiness

Common

Injection site induration or oedema

Common

Injection site haematoma

Common

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Medicines and Healthcare products Regulatory Agency (MHRA), Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

There have been reports of administration of higher than recommended doses of Avaxim Junior. Adverse events reported following overdosage were similar to those reported with normal vaccine administration.