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SAFETY PROFILE

Safety profile of BOOSTRIX in adolescents 10-18 years of age and adults 19-64 years of age

  • In clinical studies in adolescents 10-18 years of age, 4949 adolescents were vaccinated with a single dose of BOOSTRIX1
  • In clinical studies in adults 19 years of age and older, 4076 adults were vaccinated with a single dose of BOOSTRIX. Of these participants, 1104 adults were 65 years of age and older1

Solicited local adverse reactions or general adverse events within 15 days* of vaccination1

Adolescents 10-18 years of age (TVC)
  BOOSTRIX Td vaccine
LOCAL (N=3032) (N=1013)
Pain, any† 75% 72%
Pain, Grade 2 or 3† 51% 43%
Pain, Grade 3‡ 5% 4%
Redness, any 23% 20%
Redness, >20 mm 4% 4%
Redness, ≥50 mm 2% 2%
Swelling, any 21% 20%
Swelling, >20 mm 5% 5%
Swelling, ≥50 mm 3% 3%
Arm circumference increase >5 mm§ 28% 30%
Arm circumference increase, >20 mm§ 2% 2%
Arm circumference increase, >40 mm§ 1% 0.3%
GENERAL (N=3032) (N=1013)
Headache, any 43% 42%
Headache, Grade 2 or 3† 16% 13%
Headache, Grade 3 4% 3%
Fatigue, any 37% 37%
Fatigue, Grade 2 or 3 14% 13%
Fatigue, Grade 3 4% 3%
Gastrointestinal symptoms, any|| 26% 26%
Gastrointestinal symptoms, Grade 2 or 3|| 10% 10%
Gastrointestinal symptoms, Grade 3|| 3% 3%
Fever, ≥99.5°F (37.5°C) 14% 13%
Fever, >100.4°F (38.0°C) 5% 5%
Fever, >102.2°F (39.0°C) 1% 1%

Adults 19-64 years of age (TVC)
  BOOSTRIX Tdap vaccine
LOCAL (N=1480) (N=741)
Pain, any 61% 69%
Pain, Grade 2 or 3 35% 44%
Pain, Grade 3 2% 2%
Redness, any 21% 27%
Redness, >20 mm 4% 6%
Redness, ≥50 mm 2% 2%
Swelling, any 18% 26%
Swelling, >20 mm 4% 6%
Swelling, ≥50 mm 1% 3%
GENERAL (N=1480) (N=741)
Headache, any 30% 31%
Headache, Grade 2 or 3 11% 11%
Headache, Grade 3 2% 2%
Fatigue, any 28% 29%
Fatigue, Grade 2 or 3 9% 9%
Fatigue, Grade 3 3% 1%
Gastrointestinal symptoms, any|| 16% 18%
Gastrointestinal symptoms, Grade 2 or 3|| 4% 6%
Gastrointestinal symptoms, Grade 3|| 1% 1%
Fever, ≥99.5°F (37.5°C) 6% 8%
Fever, >100.4°F (38.0°C) 1% 2%
Fever, >102.2°F (39.0°C) 0.1% 0.4%
  • *

    Day of vaccination and the next 14 days.

  • †

    Statistically significantly higher (P<0.05) following BOOSTRIX as compared with Td vaccine.

  • ‡

    Grade 3 injection site pain following BOOSTRIX was not inferior to Td vaccine (upper limit of 2-sided 95% CI for the difference [BOOSTRIX minus Td] in the percentage of participants ≤4%).

  • §

    Mid-upper region of the vaccinated arm.

  • ‖

    Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.

  • For adolescents 10-18 years of age: oral temperature or axillary temperature. For adults 19-64 years of age: oral temperature.

Td = Tetanus and Diphtheria Toxoids Adsorbed manufactured by MassBiologics.

Tdap = Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed), a Tdap [tetanus, diphtheria, and acellular pertussis] vaccine manufactured by Sanofi Pasteur.

TVC = total vaccinated cohort.

Safety profile of BOOSTRIX in adults 65 years of age and older

  • In a clinical trial in adults 65 years of age and older, 887 patients were vaccinated with a single dose of BOOSTRIX compared with 445 adults who received a US-licensed comparator Td vaccine1
  • The incidence of unsolicited adverse events reported in the 31 days after vaccination was comparable between the two groups (17.1% and 14.4% for BOOSTRIX and Td vaccine, respectively)1

Solicited local adverse reactions or general adverse events within 4 days* of vaccination1

Adults 65 years of age and older (TVC)
  BOOSTRIX Td vaccine
LOCAL (N=882) (N=444)
Pain, any 22% 28%
Pain, Grade 2 or 3 8% 10%
Pain, Grade 3 0.2% 1%
Redness, any 11% 13%
Redness, >20 mm 1% 3%
Redness, ≥50 mm 1% 1%
Swelling, any 8% 12%
Swelling, >20 mm 2% 3%
Swelling, ≥50 mm 1% 1%
GENERAL (N=882) (N=445)
Fatigue, any 13% 15%
Fatigue, Grade 2 or 3 3% 3%
Fatigue, Grade 3 1% 1%
Headache, any 12% 12%
Headache, Grade 2 or 3 2% 2%
Headache, Grade 3 1% 0%
Gastrointestinal symptoms, any† 8% 9%
Gastrointestinal symptoms, Grade 2 or 3† 2% 2%
Gastrointestinal symptoms, Grade 3† 0.3% 0.4%
Fever, ≥99.5°F (37.5°C)‡ 2% 3%
Fever, >100.4°F (38.0°C)‡ 0.2% 0.2%
Fever, >102.2°F (39.0°C)‡ 0% 0%
  • *

    Day of vaccination and the next 3 days.

  • †

    Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.

  • ‡

    Oral temperatures.

Td = Decavac (Tetanus and Diphtheria Toxoids Adsorbed), a U.S.-licensed Td [tetanus and diphtheria toxoids adsorbed] vaccine, manufactured by Sanofi Pasteur.

TVC = total vaccinated cohort.

REVACCINATION STUDIES

Safety Profile of BOOSTRIX in adults 20-73 years of age

Solicited local adverse reactions or general adverse events within 4 days* of vaccination in adults aged 20 to 29 years1

Adults Aged 20 to 29 Years (TVC)
Adverse Reactions / Adverse Events BOOSTRIX† Td vaccine‡
LOCAL (N=125) (N=36)
Pain, any 78% 58%
Pain, Grade 2 or 3 33% 19%
Pain, Grade 3 5% 6%
Redness, any 38% 42%
Redness, >20 mm 4% 0%
Redness, ≥50 mm§ 1% 0%
Swelling, any 24% 19%
Swelling, >20 mm 2% 3%
Swelling, ≥50 mm|| 0% 0%
GENERAL (N=125) (N=36)
Headache, any 32% 22%
Headache, Grade 2 or 3 10% 3%
Headache, Grade 3 2% 0%
Fatigue, any 30% 22%
Fatigue, Grade 2 or 3 14% 3%
Fatigue, Grade 3 2% 0%
Gastrointestinal symptoms, any 9% 3%
Gastrointestinal symptoms, Grade 2 or 3 2% 0%
Gastrointestinal symptoms, Grade 3 2% 0%
Fever, ≥100.4°F (38.0°C)# 1% 0%
Fever, >102.2°F (39.0°C)# 0% 0%

Solicited local adverse reactions or general adverse events within 4 days* of vaccination in adults aged 28 to 73 years1

Adults Aged 28 to 73 Years (TVC)
Adverse Reactions / Adverse Events BOOSTRIX** Tdap vaccine†† Control‡‡
LOCAL (N=306) (N=137) (N=358)
Pain, any 59% 61% 37%
Pain, Grade 2 or 3 17% 15% 9%
Pain, Grade 3 1% 1% 1%
Redness, any 24% 23% 15%
Redness, >20 mm 6% 4% 1%
Redness, ≥50 mm§ 2% 2% 0%
Swelling, any 19% 19% 12%
Swelling, >20 mm 3% 3% 3%
Swelling, ≥50 mm|| 1% 2% 1%
GENERAL (N=306) (N=137) (N=358)
Headache, any 17% 18% 15%
Headache, Grade 2 or 3 4% 4% 2%
Headache, Grade 3 0% 1% 0.3%
Fatigue, any 23% 17% 14%
Fatigue, Grade 2 or 3 8% 7% 3%
Fatigue, Grade 3 1% 1% 0%
Gastrointestinal symptoms, any 9% 3% 8%
Gastrointestinal symptoms, Grade 2 or 3 2% 0% 3%
Gastrointestinal symptoms, Grade 3 0% 0% 0%
Fever, ≥ 100.4°F (38.0°C)# 1% 0% 1%
Fever, >102.2°F (39.0°C)# 0.3% 0% 0%
  • *

    Day of vaccination and the next 3 days.

  • ‡

    Participants who were revaccinated with BOOSTRIX 10 years after initial vaccination with BOOSTRIX.

  • †

    Participants who received a dose of BOOSTRIX 10 years after initial vaccination with Td vaccine.

  • §

    In the study of adults aged 20 to 29 years, redness >50 mm was recorded.

  • ‖

    In the study of adults aged 20 to 29 years, swelling >50 mm was recorded.

  • Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.

  • #

    Oral temperatures.

  • **

    Participants who were revaccinated with BOOSTRIX 9 years after initial vaccination with BOOSTRIX.

  • ††

    Participants who received a dose of BOOSTRIX 9 years after initial vaccination with Tdap vaccine.

  • ‡‡

    Control Group = Newly enrolled Participants who received an initial dose of BOOSTRIX.

Td = Tetanus and Diphtheria Toxoids Adsorbed for Adult Use manufactured by MassBiologics.

Tdap = Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed, a Tdap vaccine manufactured by Sanofi Pasteur).

TVC = total vaccinated cohort.

N = Number of Participants with a documented dose.

Grade 2 = Local: painful when limb moved and interfered with normal activities; General: interfered with normal activity.

Grade 3 = Local: significant pain at rest and/or prevented normal activity; General: prevented normal activity.

Safety profile of BOOSTRIX during pregnancy

  • In a 1:1 randomized, controlled study of 687 individuals in their third trimester of pregnancy, 341 received the non-U.S. formulation of BOOSTRIX (containing 0.5 mg aluminum/per dose) and 346 received placebo (saline)1
    • The non-U.S. formulation contains the same antigens and in the same quantities as the U.S. formulation of BOOSTRIX1
    • Placebo recipients received the non-U.S. formulation of BOOSTRIX postpartum1
    • Safety data from this study did not reveal any vaccine-related adverse effects on pregnancy or on the fetus/newborn child1
    • Safety data from prospective clinical studies on the use of BOOSTRIX during the first and second trimester of pregnancy are not available1

Indication & Important Safety Info

Indication

Important Safety Information

Indication

BOOSTRIX is indicated for:

  • active booster immunization against tetanus, diphtheria, and pertussis in individuals aged 10 years and older;
  • immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age. 

Important Safety Information

  • Contraindications for BOOSTRIX are: a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of any tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine; and encephalopathy within 7 days of administration of a previous dose of a pertussis antigen-containing vaccine
  • Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of BOOSTRIX
  • 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
  • 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
  • Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to BOOSTRIX
  • Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting
  • Common solicited adverse reactions (≥15%) in adolescents (aged 10 to 18 years) were pain, redness, and swelling at the injection site; increase in arm circumference of the injected arm; headache; fatigue; and gastrointestinal symptoms
  • Common solicited adverse reactions (≥15%) in adults (aged 19 to 64 years) were pain, redness, and swelling at the injection site; headache; fatigue; and gastrointestinal symptoms
  • The most common solicited adverse reaction (≥15%) in the elderly (aged 65 years and older) was pain at the injection site
  • Pregnancy: Available data from a controlled clinical study showed that the use of the non-U.S. formulation of BOOSTRIX* during the third trimester of pregnancy did not reveal any vaccine-related adverse effects on pregnancy or on the fetus/newborn child
  • Pregnancy Registry: HCPs are encouraged to register pregnant individuals by calling 1-888-452-9622 or visiting http://pregnancyregistry.gsk.com/boostrix.html
  • Vaccination with BOOSTRIX may not result in protection in all vaccine recipients

 

* The non-U.S. formulation of BOOSTRIX is manufactured to contain 0.5 mg aluminum per dose. The U.S. formulation is manufactured to contain 0.3 mg aluminum per dose.

 

Please see full Prescribing Information for BOOSTRIX.

References

  1. Prescribing Information for BOOSTRIX.