Regulatory Decision Summary for Proquad

Proquad (measles, mumps, rubella and varicella virus live) is a vaccine indicated for the prevention of measles, mumps, rubella, and varicella in children 12 months through 6 years of age.

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

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

Study V221-036 was an open label clinical trial conducted in children 12 to 18 months of age, who received two doses of Proquad, either intramuscularly or subcutaneously 30 days apart. Antibody responses to measles, mumps, rubella and varicella viruses were measured 30 days post-dose 1, and 6 weeks post-dose 2. Non-inferiority of the immune responses 30 days after the first dose of the vaccine administered by the intramuscular compared to the subcutaneous route was evaluated. The seroresponse rates to measles, mumps, rubella and varicella viruses after Dose 1 were noninferior in the intramuscular group compared to the subcutaneous group.

With regards to safety, the vaccine was overall well tolerated. Injection site adverse reactions appear to occur overall at a lower rate in the intramuscular group in comparison to the subcutaneous group; but pain was reported most frequently in the intramuscular group. In both groups, most of injection-site adverse reactions were of mild intensity. Fever was the mostly frequently reported solicited systemic adverse reaction. The rates of reported serious adverse events were low and none of these events were considered related to the study vaccine. No deaths were reported in the study.

The immunogenicity of Proquad 30 days after the first dose, administered by the intramuscular route compared to subcutaneous route was non-inferior and the vaccine was overall well tolerated regardless of administration route.

The benefit-risk ratio remains favourable for Proquad.

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

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