VAQTA PAEDIATRIC Suspension for injection Ref.[50245] Active ingredients: Hepatitis A, inactivated vaccine

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.

Individuals who develop symptoms suggestive of hypersensitivity after an injection of VAQTA Paediatric should not receive further injections of the vaccine. This vaccine may contain traces of neomycin and formaldehyde which are used during the manufacturing process (see sections 2 and 4.3).

VAQTA Paediatric must not be administered into a blood vessel.

Use caution when vaccinating latex-sensitive individuals since the syringe plunger stopper and tip cap contain dry natural latex rubber that may cause allergic reactions.

Qualitative testing for antibodies to hepatitis A prior to immunisation should be considered based on the probability of previous hepatitis A virus infection in patients who grew up in areas of high endemicity, and/or with a history of jaundice.

VAQTA Paediatric does not cause immediate protection against hepatitis A, and there may be a period of 2 to 4 weeks before antibody becomes detectable.

VAQTA Paediatric will not prevent hepatitis caused by infectious agents other than hepatitis A virus. Because of the long incubation period (approximately 20 to 50 days) for hepatitis A, it is possible for unrecognised hepatitis A infection to be present at the time the vaccine is given. The vaccine may not prevent hepatitis A in such individuals.

As with any vaccine, adequate treatment provisions, including epinephrine (adrenaline), should be available for immediate use should an anaphylactic or anaphylactoid reaction occur.

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

Excipient(s) with known effect:

This medicinal product contains less than 1mmol (23mg) sodium per dose and is considered to be essentially sodium free.

If VAQTA Paediatric is used in individuals with malignancies or those receiving immunosuppressive therapy or who are otherwise immunocompromised, the expected immune response may not be obtained.

Known or presumed exposure to HAV/Travel to endemic areas

Use with immune globulin

For individuals requiring either post-exposure prophylaxis or combined immediate and longer term protection (e.g., travelers departing on short notice to endemic areas), in countries where IG is available VAQTA Paediatric may be administered concomitantly with IG using separate sites and syringes. Although the antibody titre obtained is likely to be lower than when the vaccine is given alone. The clinical relevance of this observation has not been established.

Use with other vaccines

Hepatitis A response has been shown to be similar when VAQTA Paediatric was given alone or concomitantly with measles, mumps, rubella, varicella, pneumococcal 7-valent conjugate, inactivated polio, diphtheria toxoid, tetanus toxoid, acellular pertussis, or Haemophilus influenzae b vaccine. Responses to measles, mumps, rubella, varicella, pneumococcal 7-valent conjugate, inactivated polio, diphtheria toxoid, tetanus toxoid, acellular pertussis, and Haemophilus influenzae b vaccine were not affected by concomitant administration with VAQTA Paediatric. Studies in adults 18 to 54 years of age have shown that VAQTA may be administered concomitantly with yellow fever and polysaccharide typhoid vaccines.

VAQTA Paediatric must not be mixed with other vaccines in the same syringe. When concurrent administration is necessary, different injection sites and separate syringes must be used for each vaccine.

Pregnancy

It is not known whether VAQTA Paediatric can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity. VAQTA Paediatric is not recommended in pregnancy unless there is a high risk of hepatitis A infection, and the attending physician judges that the possible benefits of vaccination outweigh the risks to the foetus.

Breast-feeding

It is not known whether VAQTA Paediatric is excreted in human milk, and the effect on breastfed infants following administration of VAQTA Paediatric to mothers has not been studied. Hence, VAQTA Paediatric should be used with caution in women who are breastfeeding.

Fertility

VAQTA Paediatric has not been evaluated in fertility studies.

Animal reproduction studies have not been conducted with VAQTA Paediatric.

No studies on the effects on the ability to drive and use machines have been performed. However, VAQTA Paediatric is expected to have no or negligible influence on the ability to drive and use machines.

Summary of the safety profile

Children 12 months through 23 months of age

In 5 combined clinical trials, 4,374 children 12 through 23 months of age received one or two 25 U doses of VAQTA Paediatric. Out of the 4,374 children who received VAQTA Paediatric, 3,885 (88.8%) children received 2 doses of VAQTA Paediatric and 1,250 (28.6%) children received VAQTA Paediatric concomitantly with other vaccines. Children were followed for elevated temperature and injection-site adverse reactions during a 5-day period postvaccination and systemic adverse events including fever during a 14-day period postvaccination.

In three of the five protocols which specifically prompted for injection-site erythema, pain/tenderness, and swelling daily for Day 1 through Day 5 postvaccination, the most frequently reported injection-site adverse reaction after any dose of VAQTA Paediatric was injection-site pain/tenderness.

The most common systemic adverse events among recipients of VAQTA Paediatric alone were fever and irritability. The data from the five protocols were combined as similar methods for collecting systemic adverse events were used.

Children/adolescents (2 years through 17 years of age)

In clinical trials with 2,595 healthy children (≥2 years of age) and adolescents who received one or more doses of hepatitis A vaccine, subjects were followed for elevated temperature and local reactions during a 5-day period postvaccination and systemic adverse events including fever during a 14-day period postvaccination. Injection-site reactions, generally mild and transient, were the most frequently reported adverse events.

Adverse reactions reported as vaccine related are listed below in decreasing order of frequency within each system organ classification.

Post-marketing Safety Study

In a post-marketing safety study, a total of 12,523 individuals 2 through 17 years of age received 1 or 2 doses of VAQTA Paediatric. There was no serious, vaccine-related, adverse event identified. There was no non-serious, vaccine-related, adverse event resulting in outpatient visits.

Tabulated summary of adverse reactions

The tables below present adverse reactions reported as vaccine related observed in clinical trials, and in a post-authorisation safety study and adverse reactions spontaneously reported after use of the marketed vaccine.

Adverse reactions are ranked under headings of frequency using the following convention:

[Very Common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very Rare (<1/10,000); Not Known (cannot be estimated from the available data)].

Children 12 months through 23 months of age:

¹ Spontaneous reporting after use of marketed vaccine

Children/adolescents (2 years through 17 years of age):

¹ Spontaneous reporting after use of marketed vaccine

Description of selected adverse reactions

As with all vaccines, allergic reactions, in rare cases leading to shock, may occur (see section 4.4).

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.