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Drug Details

VAQTA Paediatric

• Drug Class Description
  Inactivated viruses (vaccines).
• Generic Name
  Hepatitis a vaccine, purified inactivated
• Presentation
  VAQTA Paediatric is a sterile suspension for intramuscular use
• Description
  Each 0.5ml dose contains: Strain CR 326F Hepatitis A virus, inactivated……………..25U Adsorbed onto approximately 0.225 mg of aluminium provided as amorphous aluminium hydroxyphosphate sulphate
• Indications
  

  VAQTA Paediatric is indicated for active pre-exposure prophylaxis of children and adolescents 12 months of age up to and including 17 years of age, against disease caused by hepatitis A virus.

• Adult Dosage
  

  For Paediatric use.

• Child Dosage
  

  Posology

  Children and adolescents aged 12 months to 17 years of age should receive a single 0.5 millilitre (25U) dose of vaccine at an elected date and a second (booster) dose of 0.5 millilitre (25U) 6 to 18 months after the first dose.

  The vaccine should not be used in children under 12 months old since safety and immunogenicity have not been evaluated in this age group.

  A single dose of VAQTA Paediatric may also be given at 6 to 12 months following the administration of a single (first) dose of another inactivated hepatitis A vaccine in order to complete the vaccination series.

  In studies of healthy children and adolescents who received two doses (25U) of VAQTA Paediatric at 0 and 6 to 18 months, the hepatitis A antibody response has been shown to persist for at least 10 years.

  It is not yet established whether booster doses are needed after completion of a two-dose vaccination course (see section 5.1).

  The International Consensus Group on Hepatitis A Virus Immunity does not currently recommend the administration of further booster doses to immunocompetent individuals who have completed the initial two-dose vaccination course.

  Method of administration

  VAQTA Paediatric should be injected INTRAMUSCULARLY in the deltoid region. The vaccine should not be administered subcutaneously or intradermally since administration by these routes may result in a less than optimal antibody response.

  VAQTA Paediatric must not be administered intravenously.

• Elderly Dosage
  

  For Paediatric use.

• Contra Indications
  

  VAQTA Paediatric should not be administered to subjects with known hypersensitivity to any component of the vaccine, to subjects who showed signs of hypersensitivity after a previous dose of the vaccine or to subjects who are hypersensitive to neomycin or formaldehyde.

  As with other vaccines, administration of VAQTA Paediatric should be postponed in subjects suffering from an acute severe febrile illness. The presence of a minor infection, however, is not a contra-indication for vaccination.

• Special Precautions
  

  As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.

  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.

  Testing for antibodies to hepatitis A prior to a decision on immunisation should be performed in patients born 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 induction occurs.

  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.

  VAQTA Paediatric will not prevent hepatitis caused by infectious agents other than hepatitis A virus.

  In subjects with an impaired immune system, adequate anti-HAV antibody titres may not be obtained. If the immunosuppression is due to medical treatment, vaccination should be delayed if possible until the completion of therapy and immune system recovery.

  The vaccine has been evaluated in human immunodeficiency virus (HIV) infected adults. There are no data on the use of VAQTA Paediatric in HIV infected subjects.

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

  As no studies have been performed with VAQTA Paediatric in subjects with liver disease, caution is advised if administering the vaccine in these subjects.

• Interactions
  

  VAQTA Paediatric must not be mixed with other vaccines or medicinal products in the same syringe.

  VAQTA Paediatric may be given concomitantly with measles, mumps, rubella, varicella, pneumococcal 7-valent conjugate and inactivated polio vaccines.

  VAQTA Paediatric may be administered concomitantly with immunoglobulin using separate syringes and separate limbs for the injections when combined intermediate and longer-term protection is desirable.

  In a clinical study conducted in healthy adults seropositivity rates for hepatitis A when VAQTA, yellow fever and polysaccharide typhoid vaccines were administered concomitantly were generally similar to when VAQTA was given alone. Also antibody response rates for yellow fever and typhoid vaccines were equivalent when administered with and without VAQTA.

  Immunogenicity data are insufficient to support concomitant administration of VAQTA with DTaP (Diphtheria, Tetanus and acellular Pertussis) vaccine.

  Other interaction studies have not been performed. However, interactions with other vaccines are not anticipated when vaccines are administered at different injection sites

• Adverse Drug Reactions
  

  Clinical Studies

  Children and adolescents from 12 months to 17 years of age

  In combined clinical trials involving 706 healthy children 12 months to 23 months of age and 2595 healthy children (2 years of age) and adolescents who received one or more 25U doses of hepatitis A vaccine with or without other paediatric vaccines, subjects were followed for elevated temperature and local reactions during a 5-day period post vaccination and systemic adverse experiences including fever during a 14 day period post vaccination. Of the 706 children, 241 received VAQTA without other paediatric vaccines for both doses and 309 received VAQTA without other paediatric vaccines for one of the two doses. Fever and injection-site reactions, generally mild and transient were the most frequently reported adverse experiences. Adverse experiences reported as vaccine related for the two age groups (12 months to 23 months and 2 to 17 years of age) are listed below in decreasing order of frequency within each system organ classification.

  [Very common: (>1/10), Common: (>1/100, <1/10), Uncommon: (>1/1000, <1/100 and Rare: ( 1/10,000, <1/1000)]

  Children aged 12 months up to and including 23 months of age

  Metabolism and nutrition disorders:

  Uncommon:anorexia.

  Psychiatric disorders:

  Common: irritability.

  Uncommon: crying; nervousness; insomnia; agitation.

  Nervous system disorders:

  Uncommon: somnolence;dizziness; hypersomnia; loss of balance.

  Respiratory, thoracic and mediastinal disorders:

  Uncommon: rhinorrhea; cough; respiratory congestion.

  Gastrointestinal disorders:

  Uncommon: diarrhea; vomiting; eructation; flatulence; abdominal distension.

  Skin and subcutaneous tissue disorders:

  Common: rash.

  Uncommon: miliaria rubra; sweating; clammy skin; eczema.

  General disorders and administrative site conditions:

  Common: fever, injection-site pain/tenderness/soreness, swelling, erythema, and warmth.

  Uncommon: gait abnormality; injection-site ecchymosis; malaise.

  In more recent clinical trials involving 2424 healthy children 12 through 23 months of age who received one or two doses of VAQTA 6 months apart with or without other vaccines, the incidence of adverse experiences appeared to be consistent with that reported in the prior trials with the exception of the following adverse experiences which were reported very commonly: injection-site pain/tenderness/soreness, injection-site erythema, and injection-site swelling.

  Children/Adolescents (2 years up to and including 17 years of age)

  Metabolism and nutrition disorders:

  Rare: anorexia.

  Psychiatric disorders:

  Uncommon: irritability.

  Rare: nervousness.

  Nervous system disorders:

  Common: headache.

  Uncommon: dizziness.

  Rare: somnolence; paraesthesia.

  Ear and labyrinth disorders:

  Rare: ear pain.

  Vascular disorders:

  Rare: flushing.

  Respiratory, thoracic and mediastinal disorders:

  Rare: nasal congestion; cough; rhinorrhea.

  Gastrointestinal disorders:

  Uncommon: abdominal pain; vomiting; diarrhoea; nausea.

  Skin and subcutaneous tissue disorders:

  Uncommon: rash; pruritus.

  Rare: urticaria; sweating.

  Musculoskeletal, connective tissue and bone disorders:

  Uncommon: arm pain (in the injected limb); arthralgia; myalgia.

  Rare: stiffness.

  General disorders and administrative site conditions:

  Very common: injection-site pain and tenderness.

  Common: injection-site warmth, erythema and swelling; fever; injection-site ecchymosis.

  Uncommon: asthenia/fatigue; injection-site pruritus and pain/soreness.

  Rare: injection-site induration; flu-like illness; chest pain; pain; warm sensation; injection-site scab; stiffness/tightness and stinging.

  Additional complaints not reported in infants, children and adolescents have been reported in clinical trials involving adult subjects.

  Should anaphylactic reactions occur see Precautions.

  Marketed experience

  As with other vaccines, single cases of central or peripheral affections of the nervous system including Guillain-Barré Syndrome and haematologic autoimmune diseases like thrombocytopenia have been reported.

  Post-marketing Safety Study

  In a post-marketing safety study, a total of 42,110 individuals > 2 years of age received 1 or 2 doses of VAQTA. There were no vaccine related serious adverse reactions in the 30 days after vaccination.