Regulatory Decision Summary for Varivax III

Varivax III is indicated for vaccination against varicella in individuals 12 months of age and older. The vaccine is currently authorized for administration by the subcutaneous route.

The purpose of this submission is to update the product monograph for Varivax with an additional intramuscular route of administration.

After evaluation of the submitted data package, Health Canada authorized the proposed update.

Study V205C-011 was submitted to support the product monograph update. This was an open-label, randomized, comparative, multicentre study conducted in 752 children 12-18 months old. This study evaluated the non-inferiority (similarity) of immune responses of Varivax III and M-M-R II (a measles, mumps and rubella vaccine) and the safety profile of the vaccines when they were administered concomitantly but at separate injection site, as a single dose, by the subcutaneous (SC) versus the intramuscular (IM) route.

Antibody response rates at Day 42 in the set of children initially seronegative to varicella, measles, mumps and rubella vaccine antigens were measured. Non-inferiority of immune responses was concluded between the IM and SC groups as per the pre-specified criterion of non-inferiority was met.

The immunogenicity of Varivax administered by the intramuscular route compared to the subcutaneous route was non-inferior and the vaccine was overall well tolerated regardless of the route of administration.

The above thus supports the update of the product monograph with an alternate intramuscular route of administration in the product monograph.

For further details about Varivax III, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.