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AVAXIM® Junior is indicated for active immunisation against infection caused by hepatitis A virus (HAV) in children aged 1 - 15 years.1
Before you prescribe this vaccine please refer to the Prescribing Information and SmPC link.
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AVAXIM® Junior confers immunity through inducing the production of anti-HAV antibodies.1
A full immunisation course consists of 2 doses, 1 primary dose followed by a booster dose, for full protection.1
AVAXIM® Junior paediatric vaccine can be used for both primary and booster immunisation.
The vaccine is a ready-to-use suspension for injection containing 80 antigen units of inactivated HAV, half the antigen dose of the adult AVAXIM® (hepatitis A vaccine [inactivated, adsorbed]) vaccine.1,2
Why help protect your patients with AVAXIM® Junior?
Hepatitis A remains one of the most common travel-related vaccine preventable diseases, although the incidence in travellers is declining.3
Hepatitis A is caused by a virus which is usually acquired through the consumption of food or water contaminated by human faeces. Foods such as undercooked meat and fish can be a risk as well as foods that grow close to the ground such as lettuce and strawberries. It can also be acquired through person to person contact.3
The risk of acquiring hepatitis A is highest in low-income countries with poor sanitary conditions. Regions where hepatitis A is highly endemic include the Indian sub-continent (particularly Bangladesh, India, Nepal and Pakistan), Sub-Saharan and North Africa, parts of the Far East (except Japan), South and Central America and the Middle East.3
There is no specific treatment for hepatitis A. Protection is through effective personal and food and water hygiene and immunisation.3
Watch the video below to learn more about hepatitis A in children and the protection that AVAXIM® Junior can offer them.
Prescribing Information can be accessed via the below link
AVAXIM® Prescribing Information UK
AVAXIM® Jr Prescribing Information UK
Evidence
AVAXIM® Junior offers rapid protection against hepatitis A as early as 2 weeks from the first dose.1,4,5
Seroconversion rates across different ages after primary immunisation with AVAXIM® Junior*✝4
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Study Design 1
Open-label, monocentric, non-controlled trial to investigate the safety and immunogenicity of AVAXIM® Junior, conducted in children in Southern Israel.4
Immunogenicity was evaluated at Weeks 2, 24 and 28 after initial immunisation.
Seroprotection rates and GMCs in a subgroup of Argentinian children after primary and booster doses of AVAXIM® Junior.‡5
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Study Design 2
Open-label, monocentric, non-controlled trial to investigate the safety and immunogenicity of AVAXIM® Junior, conducted in children at Hospital de Niños Dr. Ricardo Gutiérrez, Argentina.5
Immunogenicity was evaluated at Weeks 0, 2, 24 and 27 after initial immunisation.*
*Of 537 children aged 1–15 years initially enrolled in the study, immunogenicity statistical analysis was performed only on a subgroup of 111 children aged 1–3 years who were seronegative (<20 mIU/ml) for anti HAV antibodies at inclusion.
AVAXIM® Junior offers long-lasting protection against hepatitis A.1,7,8
GMCs in Argentinian children followed after immunisation with AVAXIM® Junior.**7,8
In a follow-up study in Argentinian children, 97.9% (47/48) of children with data available 10 years after primary immunisation with AVAXIM® Junior were seropositive for anti-HAV antibodies (≥20 mIU/ml). Up to 15 years after initial immunisation, all of the 30 children with data still available were found to be seropositive for anti-HAV antibodies.7,8
AVAXIM® Junior offers rapid protection against hepatitis A as early as 2 weeks from the first dose.1,4,5
Seroconversion rates across different ages after primary immunisation with AVAXIM® Junior*✝4
Study Design 1
Open-label, monocentric, non-controlled trial to investigate the safety and immunogenicity of AVAXIM® Junior, conducted in children in Southern Israel.4
Immunogenicity was evaluated at Weeks 2, 24 and 28 after initial immunisation.
Seroprotection rates and GMCs in a subgroup of Argentinian children after primary and booster doses of AVAXIM® Junior.‡5
Study Design 2
Open-label, monocentric, non-controlled trial to investigate the safety and immunogenicity of AVAXIM® Junior, conducted in children at Hospital de Niños Dr. Ricardo Gutiérrez, Argentina.5
Immunogenicity was evaluated at Weeks 0, 2, 24 and 27 after initial immunisation.*
*Of 537 children aged 1–15 years initially enrolled in the study, immunogenicity statistical analysis was performed only on a subgroup of 111 children aged 1–3 years who were seronegative (<20 mIU/ml) for anti HAV antibodies at inclusion.
AVAXIM® Junior offers long-lasting protection against hepatitis A.1,7,8
GMCs in Argentinian children followed after immunisation with AVAXIM® Junior.**7,8
In a follow-up study in Argentinian children, 97.9% (47/48) of children with data available 10 years after primary immunisation with AVAXIM® Junior were seropositive for anti-HAV antibodies (≥20 mIU/ml). Up to 15 years after initial immunisation, all of the 30 children with data still available were found to be seropositive for anti-HAV antibodies.7,8
Usage
AVAXIM® Junior offers a flexible timing for booster immunisation.1
In order to provide long-term protection, a booster dose should be given between 6 months to 10 years after the first dose.1
For further details on the clinical rationale for this please see the Evidence and Sustained Seroprotection section.
AVAXIM® Junior can be used as a booster in children who have previously been immunised with another inactivated hepatitis A vaccine.1
Seroprotection rates 4 weeks after 2 doses of a paediatric inactivated hepatitis A vaccines.6§
§Data from initially HAV-seronegative children. Local and systemic adverse events were reported in 17% (72/424) of subjects following the first dose and in 19% of (80/415) subjects following the second dose. Pain was the most commonly reported adverse event (11.5% of all vaccinated subjects). All the reported local and systemic adverse events were mild in nature. No subjects were withdrawn from the study because of serious adverse events after any vaccine dose.
Turkish children aged 1-15 years who had received a primary dose of either AVAXIM® Junior, Havrix Junior Monodose® or VAQTA® Paediatric were then given a booster dose of either the same vaccine or AVAXIM® Junior 6 months later. 4 weeks after the booster dose, seroprotection rates were 100% regardless of the immunisation combination used.6
Study Design 3
Randomised, observer-blind trial to investigate the safety, immunogenicity and interchangeability of 3 paediatric inactivated hepatitis A vaccines, conducted in children at Marmara University Hospital, Turkey.6
Immunogenicity was evaluated at Weeks 2, 24 and 28 after initial immmunisation
AVAXIM® Junior offers a flexible timing for booster immunisation.1
In order to provide long-term protection, a booster dose should be given between 6 months to 10 years after the first dose.1
For further details on the clinical rationale for this please see the Evidence and Sustained Seroprotection section.
AVAXIM® Junior can be used as a booster in children who have previously been immunised with another inactivated hepatitis A vaccine.1
Seroprotection rates 4 weeks after 2 doses of a paediatric inactivated hepatitis A vaccines.6§
§Data from initially HAV-seronegative children. Local and systemic adverse events were reported in 17% (72/424) of subjects following the first dose and in 19% of (80/415) subjects following the second dose. Pain was the most commonly reported adverse event (11.5% of all vaccinated subjects). All the reported local and systemic adverse events were mild in nature. No subjects were withdrawn from the study because of serious adverse events after any vaccine dose.
Turkish children aged 1-15 years who had received a primary dose of either AVAXIM® Junior, Havrix Junior Monodose® or VAQTA® Paediatric were then given a booster dose of either the same vaccine or AVAXIM® Junior 6 months later. 4 weeks after the booster dose, seroprotection rates were 100% regardless of the immunisation combination used.6
Study Design 3
Randomised, observer-blind trial to investigate the safety, immunogenicity and interchangeability of 3 paediatric inactivated hepatitis A vaccines, conducted in children at Marmara University Hospital, Turkey.6
Immunogenicity was evaluated at Weeks 2, 24 and 28 after initial immmunisation
Safety Profile
Safety Profile and Tolerability
AVAXIM® Junior is generally well tolerated in children aged 1–15 years.1
Based on data from a pooled analysis‡‡, most undesirable effects following administration of AVAXIM® Junior were limited to the first few days following immunisation, with spontaneous recovery. Reactions were more rarely reported after the booster dose than after the first dose.1
|
Adverse reactions |
Frequency after any given doses §§ |
|---|---|
| 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 |
| Vomiting | Common |
| Nausea | 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 |
Before you prescribe this vaccine please refer to the Prescribing Information above.
*Seroconversion defined as anti-HAV antibody titers rising from <20 mIU/ml (seronegative) to ≥20 mIU/ml.
✝Data from initially HAV-seronegative Israeli children. Rates of systemic reactions were 23.8% after the 1st dose and 11.4% after the booster dose. Pain at the injection site was the most common local reaction, though this did not persist longer than 3 days. Gastrointestinal tract disorder, headache and fever were the most common systemic reactions.
‡Immediate adverse reactions were observed in 0.6% (3/537) of subjects after the first dose. Local reactions were mild and transient and did not increase with subsequent doses. Among the systemic events reported during the 7-day follow-up period, 37 cases of fever after the first dose and 22 cases after the second dose were reported. Only 3 cases of fever were clearly related to immunisation (≤38.2°C) after the first injection, all of which subsided in less than 1 day.
§Data from initially HAV-seronegative children. Local and systemic adverse events were reported in 17% (72/424) of subjects following the first dose and in 19% of (80/415) subjects following the second dose. Pain was the most commonly reported adverse event (11.5% of all vaccinated subjects). All the reported local and systemic adverse events were mild in nature. No subjects were withdrawn from the study because of serious adverse events after any vaccine dose.
**GMC values may differ from initial studies due to a different number of children included in the follow-up studies.
‡‡Pooled analysis integrated data from 5,458 children aged 1–15 years, who received at least one injection of AVAXIM® Junior during clinical trials.
§§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 Council for International Organizations of Medical Sciences frequency rating: Very common ≥10%; Common ≥1 and <0.1%; Very rare < 0.01%; Not known (cannot be estimated from available data).
HAV, hepatitis A virus; GMC, geometric mean concentration
References
- AVAXIM® Junior Summary of Product Characteristics.
- AVAXIM® Summary of Product Characteristics.
- Travel Health Pro. Hepatitis A. Available at: https://travelhealthpro.org.uk/factsheet/21/hepatitis-a (Accessed October 2024).
- Dagan R, et al. Vaccine. 1999;17(15–16):1919–25.
- López EL,et al. Pediatr Infect Dis J. 2001;20(1):48–52.
- Soysal A, et al. Eur J Pediatr. 2007;166(6):533–9.
- López EL, et al. Pediatr Infect Dis J. 2010;29(6):568–70
- López EL, et al. Pediatr Infect Dis J. 2015;34(4):417–25.
MAT-XU-2301296 (v4.0) Date of preparation: October 2024