BEXSERO is indicated for active immunization of individuals from 2 months through 25 years old against invasive disease caused by N. meningitidis serogroup B strains.
As the expression of antigens included in the vaccine is epidemiologically variable in circulating B strains, meningococci that express them at sufficient levels are predicted to be susceptible to killing by vaccine-elicited antibodies.
The most frequent local and systemic adverse reactions after vaccination with BEXSERO were:
Infants and children (less than 2 years of age):
Adolescents and adults:
Infants aged 2 months through 5 months of age at the time of first dose:
The recommended immunization series consists of three or four doses, each of 0.5 mL. It consists of two or three primary doses. The interval between vaccinations should be at least 2 months if two primary doses are given or at least 1 month if three primary doses are given. A booster will be given in the second year of life with an interval of at least 6 months between the primary series and booster dose.*
Infants aged 6 months through 11 months of age at the time of first dose:
The vaccination schedule consists a total of three doses, each of 0.5 mL. It consists of two primary doses, given not less than 2 months between doses, followed by a booster in the second year of life with an interval of at least 2 months between the primary doses and the booster.*
Children aged 12 months through 23 months of age at the time of first dose:
The vaccination schedule consists of two primary doses, each of 0.5 mL, given not less than with 2 months between doses, followed by a booster given at an interval of 12 to 23 months between the primary series and booster.*
Children, adolescents and adults aged 2 years through 25 years of age at the time of first dose:
The vaccination schedule consists of two primary doses, each of 0.5 mL, given not less than 1 month between doses. A booster dose should be considered in individuals at continued risk of exposure to meningococcal disease, based on guideline recommendations.
BEXSERO should be given by deep intramuscular injection, preferably in the anterolateral aspect of the thigh in infants or in the non-dominant deltoid muscle region of the upper arm in older subjects.
Separate injection sites must be used if more than one vaccine is administered at the same time.
The vaccine must not be injected intravenously, subcutaneously or intradermally and must not be mixed with other vaccines in the same syringe.
BEXSERO must not be mixed with other medicinal products.
Please consult the Product Monograph at gsk.ca/bexsero/pm for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling Medical Information at 1-800-387-7374.
To report an adverse event, please call 1-800-387-7374.
* The need for, and timing of further doses has not yet been determined.