BOOSTRIX is a vaccine indicated for active booster immunization against tetanus, diptheria, and pertussis. BOOSTRIX is approved for use as a single dose in individuals 10 years of age and older.

Severe allergic reaction after a previous dose of any tetanus toxoid-, diptheria toxoid-, or pertussis is antigen-containing vaccine, or to any component of BOOSTRIX, or encephalopathy within 7 days of a previous pertussis antigen-containing vaccine, is a contraindication.

Help protect patients 10 years of age and older with BOOSTRIX

BOOSTRIX is a vaccine indicated for active booster immunization against tetanus, diptheria, and pertussis. BOOSTRIX is approved for use as a single dose in individuals 10 years of age and older.

Severe allergic reaction after a previous dose of any tetanus toxoid-, diptheria toxoid-, or pertussis antigen-containing vaccine, or to any component of BOOSTRIX, or encephalopathy within 7 days of a previous pertussis antigen-containing vaccine, is a contraindication.

BOOSTRIX® provided uncompromised immunogenicity against tetanus and diptheria with added pertussis protection in adolescents and adults"toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"1

In separate clinical studies in adolescents 10-18 years of age, and adults 19-64 years of age, pertussis antibody concentrations (GMCs) following BOOSTRIX were noninferior to those observed in infants who received a 3-dose primary vaccination series with INFANRIX® (Diptheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed). "toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"3,4

Serologic correlates of protection for pertussis have not been established. Licensure of BOOSTRIX was based on immune response to the vaccine and bridging to clinical efficacy data."toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"1

In adolescents 10-18 years of age, antibody responses to tetanus and diphtheria toxoids 1 month following BOOSTRIX were compared with Td vaccine"toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"1
In adults 19-64 years of age, antibody responses to tetanus and diphtheria toxoids 1 month following BOOSTRIX were compared with Tdap vaccine"toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"1

In adolescents and adults, anti-tetanus and anti-diphtheria seroprotective rates (≥0.1 IU/mL) for BOOSTRIX were comparable to the control Td/Tdap vaccine 1 month after a single dose."toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"3,4

Help protect patients 65 years of age and older with BOOSTRIX

BOOSTRIX is the only Tdap vaccine that has demonstrated uncompromised immunogenicity against Td with added pertussis protection in individuals 65 years of age and older."toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"1

In a clinical study in adults 65 years of age and older, pertussis antibody concentrations (GMCs) following BOOSTRIX were noninferior to those observed in infants who received a 3-dose primary vaccination series with INFANRIX® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)."toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"1

Serologic correlates of protection for pertussis have not been established. Licensure of BOOSTRIX was based on immune response to the vaccine and bridging to clinical efficacy data."toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"1

In adults ≥65 years of age, antibody responses to tetanus and diphtheria toxoids 1 month following BOOSTRIX were comparable to Td vaccine"toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"1

Anti-tetanus and anti-diphtheria seroprotective rates (percentages of subjects with antibody levels ≥0.1 UI/mL) for BOOSTRIX were comparable to the control Td vaccine 1 month after a single dose."toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"1

Indication for BOOSTRIX

BOOSTRIX is a vaccine indicated for active booster immunization against tetanus, diphtheria, and pertussis. BOOSTRIX is approved for use as a single dose in individuals 10 years of age and older.

Important Safety Information for BOOSTRIX

  • Severe allergic reaction after a previous dose of any tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine, or to any component of BOOSTRIX, or encephalopathy within 7 days of a previous pertussis antigen-containing vaccine is a contraindication
  • The tip caps of the prefilled syringes for BOOSTRIX contain natural rubber latex, which may cause allergic reactions
  • The decision to give BOOSTRIX should be based on benefits and risks if Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior tetanus toxoid-containing vaccine
  • Syncope (fainting) can occur in association with administration of injectable vaccines. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope
  • Progressive or unstable neurologic conditions are reasons to defer vaccination with a pertussis-containing vaccine, including BOOSTRIX
  • Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of tetanus toxoid-containing vaccine should not receive BOOSTRIX unless 10 years have elapsed since the last dose of a tetanus toxoid-containing vaccine
  • In clinical studies, common adverse reactions were pain, redness, and swelling at the injection site, increase in arm circumference of injected arm, headache, fatigue, gastrointestinal symptoms, and fever
  • Vaccination with BOOSTRIX may not result in protection in all vaccine recipients

References

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825072R0 October 2017