Clinical trials in healthy subjectsMore than 7,900 individuals have participated in clinical trials evaluating the reactogenicity profile of the vaccine administered alone or concomitantly with other vaccines.The safety profile presented below is based on a total of 5369 doses of Varilrix administered alone to children, adolescents and adults.The most common adverse reactions observed after vaccine administration were injection site pain (23.8%), redness (19.9%) and swelling (12.1%).Frequencies are reported as:
||≥1% and <10%
||≥0.1% and <1%
||≥0.01% and <0.1%
Blood and lymphatic system disordersUncommon: lymphadenopathy
Nervous system disordersUncommon: headache, somnolenceVery rare: dizziness
Eye disordersRare: conjunctivitis
Respiratory, thoracic and mediastinal disordersUncommon: cough, rhinitis
Gastrointestinal disordersUncommon: nausea, vomitingRare: abdominal pain, diarrhoea
Skin and subcutaneous tissue disordersCommon: rashUncommon: varicella-like rash, pruritus Rare: urticaria
Musculoskeletal and connective tissue disordersUncommon: arthralgia, myalgia
Infections and infestationsUncommon: upper respiratory tract infection, pharyngitis
General disorders and administration site conditionsVery common: pain, redness and swelling at the injection site*, fever (oral/axillary temperature ≥ 37.5°C or rectal temperature ≥ 38.0°C)*Uncommon: fever (oral/axillary temperature > 39.0°C or rectal temperature > 39.5°C), fatigue, malaiseVery rare: face oedema
Psychiatric disordersUncommon: irritability* Swelling at the injection site and fever were commonly reported in studies conducted in children ≤ 12 years.In general, the reactogenicity profile after the second dose was comparable to that after the first dose. However, the rates of injection site reactions (primarily redness and swelling) were higher after the second dose in children aged ≤12 years.No differences were seen in the reactogenicity profile between initially seropositive and initially seronegative subjects.
Nervous system disordersFebrile and non-febrile convulsions, cerebellar ataxia**
Infections and infestationsHerpes zoster**
Immune system disordersHypersensitivity, anaphylactic reactions** This reaction reported after vaccination is also a consequence of wild-type varicella infection. There is no indication of an increased risk of its occurrence following vaccination compared with wild-type disease.Transmission of the vaccine virus from healthy vaccinees to healthy contacts has been shown to occur very rarely.
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.