Regulatory Decision Summary for Trumenba
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.
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What was the purpose of this submission?
Trumenba is currently authorized for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B, for use in individuals 10 through 25 years of age. The vaccine has been approved to be used according to either a two- (0 and 6 months) or a three-dose schedule (2 doses administered at least 1 month apart, followed by a third dose at least 4 months after the second dose).
The purpose of this Supplement to a New Drug Submission (SNDS) is to update the product monograph for Trumenba with a booster dose following either of the dosing regimen currently approved and to provide additional immunogenicity and safety data on the vaccine.
After evaluation of the submitted data package, Health Canada authorized the proposed updates.
Why was the decision issued?
- Authorization of the booster dose was based on an open-label, follow-up study of subjects previously enrolled in a primary study. 698 subjects were enrolled and 89.3 % completed visits over 4 years for collection of blood samples. Eligible subjects received a single booster dose of Trumenba approximately 4 years after receipt of a primary series of 2 or 3 doses of Trumenba. The antibody responses 4 years after the primary series and up to 26 months after the booster dose were described.
Booster vaccination responses in 300 subjects who completed the vaccination, were robust with predominantly higher proportion of subjects achieving protective antibody levels 1 month after booster vaccination compared to 1 month after completing the primary series and persisted in a much higher proportion of subjects through 12 and 26 months compared to persistence after the primary series.
Adverse reactions following booster vaccination were similar to adverse reactions observed during the primary Trumenba vaccination series approximately 4 years earlier.
The booster vaccination was well tolerated.
- Data from a phase 3, randomized active-controlled, observer-blinded, multicenter study were also provided to further support the current two-dose vaccination schedule (0- and 6-month schedule) of Trumenba, as the original data in support of this dosing were limited. 1057 subjects 10 through 25 years of age received at least 1 dose of Trumenba on a 0- and 6-month schedule. Trumenba was co-administered with meningococcal serogroups A, C, W, Y conjugate vaccine for the first dose or an investigational vaccine at 0 and 6 months. The results obtained in this study were considered comparable to those from the previous study.
Overall the observed safety profile remain acceptable and it is in line with the results of the previous studies on Trumenba.
The above thus supports the update of the product monograph for Trumenba with a booster dose and the addition of immunogenicity and safety information.
Decision issued
Authorized; issued a Notice of Compliance (NOC) in accordance with the Food and Drug Regulations.