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Safety and tolerability profile

  • BEXSERO was generally well tolerated in clinical trials.

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Local and systemic reactions in infants ≥2 months of age

Percentage of infants with local and systemic reactions reported 1-7 days after administration of BEXSERO with routine vaccines (Infanrix-hexa, Prevnar-7) at 2, 4, and 6 months of age 1*

The table shows the Local and systemic reactions in infants greater than or equal to 2 months of age. For a detailed description of the table, please contact GSK customer service at 1-800-387-7374.

Adapted from BEXSERO Product Monograph.

Local and systemic reactions in children 24 to 26 months of age, and adolescents 11 to 17 years of age

Percentage of children with local and systemic reactions reported 1-7 days after administration of BEXSERO 1*

The table shows the Percentage of children with local and systemic reactions reported 1 to 7 days after administration of BEXSERO. For a detailed description of the table, please contact GSK customer service at 1-800-387-7374.

Percentage of adolescents with local and systemic reactions reported 1-7 days after administration of BEXSERO (combined month 0, 0-1, 0-2) 1††

The table shows the Percentage of adolescents with local and systemic reactions reported 1 to 7 days after administration of BEXSERO (combined month 0, 0-1, 0-2). For a detailed description of the table, please contact GSK customer service at 1-800-387-7374.

Local and systemic reactions in adults 18 to 24 years of age

Percentage of adults with local and systemic reactions reported 1-7 days after administration of BEXSERO 1*

The table shows the Percentage of adults with local and systemic reactions reported 1 to 7 days after administration of BEXSERO. For a detailed description of the table, please contact GSK customer service at 1-800-387-7374.

* Study V72P12E2
† Study V72P10
‡ Severe erythema, induration and swelling – >100 mm; severe pain and systemic reactions – unable to perform normal daily activity
§ Administered in month 0-1
‖ Collected as yes or no
¶ Studies V72_29 + V102_03
** Studies V72P4 + V72P5 + V72_59
†† Studies V72_29 + V72_59 + V72P4 + V72P5 + V102_03

Reference:

  1. BEXSERO Product Monograph. March 31, 2022.

This page is for Healthcare Professionals only. If you are not a Healthcare Professional, please visit our consumer website BEXSERO.ca.

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