Regulatory Decision Summary for M-M-R II
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Contact:
Medicinal Ingredient(s):
Measles Virus Live Attenuated (Edmonston Strain)
Mumps Virus Live Attenuated (Jeryl Lynn Strain)
Rubella Virus Live Attenuated (Wistar Ra27/3 Strain)
Control Number:
282235
Brand/Product Name:
M-M-R II
Therapeutic Area:
Vaccines
Type of Submission:
Supplement to a New Drug Submission
Decision Issued:
Authorized; issued a Notice of Compliance in accordance with the Food and Drug Regulations
What was the purpose of this submission?
Measles, mumps and rubella ([M-M-R II ) virus vaccine, live, attenuated) is a vaccine indicated for simultaneous vaccination against measles, mumps, and rubella in persons 12 months of age or older.
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.
Why was the decision issued?
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 M-M-R II and VARIVAX III (a live, attenuated varicella virus 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 measles, mumps, rubella and varicella 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 M-M-R II 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.
Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.
Overall, the benefit-harm-uncertainty profile was favourable for M-M-R II for the approved indication when used under the conditions of use recommended in the approved Product Monograph. Therefore, a Notice of Compliance (NOC) was recommended.
For further details about M-M-R II, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
2024-12-03
Manufacturer/Sponsor:
Drug Identification Number(s) Issued:
00466085
Prescription Status:
Schedule D drug
Date Filed:
2023-12-19
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| M-M-R II | 00466085 | MERCK CANADA INC | MEASLES VIRUS LIVE ATTENUATED (EDMONSTON STRAIN) 1000 CCID50 / 0.5 ML MUMPS VIRUS LIVE ATTENUATED (JERYL LYNN STRAIN) 5000 CCID50 / 0.5 ML RUBELLA VIRUS LIVE ATTENUATED (WISTAR RA27/3 STRAIN) 1000 CCID50 / 0.5 ML |