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Safety

Varilrix is generally well tolerated with an acceptable safety profile that has been documented for over 15 years.[1],[2]

Clinical trial data

Healthy subjects[2]

Very common adverse reactions in clinical trials with Varilrix (≥1/10) included pain and redness at the injection site.

Common adverse reactions in clinical trials with Varilrix (≥1/100 and <1/10) included:

  • Swelling at the injection site
  • Fever ≥38°C (rectal) or ≥37.5°C (axillary/oral)
  • Rash

Swelling at the injection site and fever were reported very commonly in studies conducted in adolescents and adults. Swelling was also reported very commonly after the second dose in children under 13 years of age.

High-Risk subjects[2]

There are only very limited data from clinical trials available in patients at high risk of severe varicella. However, vaccine-associated reactions (principally papulo-vesicular eruptions and fever) are usually mild. As in healthy subjects, redness, swelling and pain at the site of injection are mild and transient.

References:

  1. Kreth HW, Lee BW, Kosuwon P et al. Sixteen years of global experience with the first refrigerator-stable varicella vaccine (Varilrix). BioDrugs. 2008;22:387-402.
  2. Varilrix SmPC, available at http://www.medicines.org.uk/emc/medicine/9787, Last accessed October 2017.

Varilrix is a registered trademark of the GlaxoSmithKline group of companies