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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
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
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.
