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Safety Profile of BOOSTRIX

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 adults, 1104 were 65 years of age and older1

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

Adolescents 10-18 years of age

  BOOSTRIX Td vaccine
LOCAL
(N=3032) (N=1013)
Pain, any* 75.3%
71.7%
Redness, any 22.5% 19.8%
Swelling, any 21.1% 20.1%
Arm circumference increase >5 mm 28.3% 29.5%
GENERAL
(N=3032) (N=1013)
Headache, any 43.1%
41.5%
Fatigue, any 37% 36.7%
Gastrointestinal symptoms, any‡ 26% 25.8%
Fever ≥ 99.5 ℉ (37.5 ℃) § 13.5% 13.1%

Adults 19-64 years of age

  BOOSTRIX Tdap vaccine
LOCAL
(N=1480) (N=741)
Pain, any 61%
69.2%
Redness, any 21.1% 27.1%
Swelling, any 17.6% 25.6%
GENERAL
(N=1480) (N=741)
Headache, any 30.1%
31%
Fatigue, any 28.1% 28.9%
Gastrointestinal symptoms, any‡ 15.9% 17.5%
Fever ≥ 99.5 ℉ (37.5 ℃) § 5.5% 8%

* P<0.05.
Mid-upper region of the vaccinated arm.
Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.
§ Oral temperatures or axillary temperatures.
Td = tetanus and diphtheria.
Tdap = tetanus, diphtheria, and acellular pertussis.

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 BOOSTRIX1
  • Overall safety profile in this age group was comparable between BOOSTRIX and Td vaccine1
  • No increase in local and general reactogenicity compared to Td vaccine1

Solicited local reactions or general adverse events within 4 days of vaccination

Adults 65 years of age and older

  BOOSTRIX Td vaccine
LOCAL
(N=882) (N=444)
Pain, any 21.5%
27.7%
Redness, any 10.8% 12.6%
Swelling, any 7.5% 11.7%
GENERAL
(N=882) (N=445)
Fatigue, any 12.5%
14.8%
Headache, any 11.5% 11.7%
Gastrointestinal symptoms, any* 7.6% 9.2%
Fever ≥ 99.5 ℉ (37.5 ℃)  2% 2.5%

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

Revaccination Studies

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

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

Adults Aged 20 to 29 Years

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, >20mm
4% 0%
Redness, ≥50mm§ 1% 0%
Swelling, any
24% 19%
Swelling, >20mm
2% 3%
Swelling, ≥50mm|| 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 ℉ (38.0 ℃) # 1% 0%
Fever > 102.2 ℉ (39.0 ℃) #
0% 0%

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

Adults Aged 28 to 73 Years

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, >20mm
6% 4% 1%
Redness, ≥50mm§ 2% 2% 0%
Swelling, any 19% 19% 12%
Swelling, >20mm
3% 3% 3%
Swelling, ≥50mm|| 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 ℉ (38.0 ℃) # 1% 0% 1%
Fever > 102.2 ℉ (39.0 ℃) # 0.3% 0% 0%

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).
n = Number of subjects 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.

* Day of vaccination and the next 3 days.
Subjects who were revaccinated with BOOSTRIX 10 years after initial vaccination with BOOSTRIX.
Subjects 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.
** Subjects who were revaccinated with BOOSTRIX 9 years after initial vaccination with BOOSTRIX.
†† Subjects who received a dose of BOOSTRIX 9 years after initial vaccination with Tdap vaccine.
‡‡ Control Group = Newly enrolled subjects who received an initial dose of BOOSTRIX.

BOOSTRIX may be administered as an additional dose 9 years or more after the initial dose of Tdap

References:

  1. Prescribing Information for BOOSTRIX.
  2. Prescribing Information for Adacel.
  3. American Medical Association. 2013 Current Procedural Terminology (CPT) Professional Edition. 4th rev ed. Chicago, IL: American Medical Association; 2012.