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Safety Profile
- 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
Safety profile of BOOSTRIX in adolescents 10-18 years of age and adults 19-64 years of age
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% |
| Redness, any | 23% | 20% |
| Swelling, any | 21% | 20% |
| Arm circumference increase >5 mm‡ | 28% | 30% |
| GENERAL |
(N=3032) | (N=1013) |
| Headache, any | 43% |
42% |
| Fatigue, any | 37% | 37% |
| Gastrointestinal symptoms, any§ | 26% | 26% |
| Fever ≥ 99.5°F (37.5°C)‖ | 14% | 13% |
Adults 19-64 years of age (TVC)
| BOOSTRIX | Tdap vaccine | |
| LOCAL |
(N=1480) | (N=741) |
| Pain, any | 61% |
69% |
| Redness, any | 21% | 27% |
| Swelling, any | 18% | 26% |
| GENERAL |
(N=1480) | (N=741) |
| Headache, any | 30% |
31% |
| Fatigue, any | 28% | 29% |
| Gastrointestinal symptoms, any§ | 16% | 18% |
| Fever ≥ 99.5°F (37.5°C)‖ | 6% | 8% |
* Day of vaccination and the next 14 days.
† Statistically significantly higher (P <0.05) following BOOSTRIX as compared with Td vaccine.
‡ 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 vaccine.1
- The incidence of unsolicited adverse events reported in the 31 days after vaccination was comparable between the 2 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% |
| Redness, any | 11% | 13% |
| Swelling, any | 8% | 12% |
| GENERAL |
(N=882) | (N=445) |
| Fatigue, any | 13% |
15% |
| Headache, any | 12% | 12% |
| Gastrointestinal symptoms, any† | 8% | 9% |
| Fever ≥ 99.5°F (37.5°C)‡ | 2% | 3% |
* 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, >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°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, >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°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.
† 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.
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 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.
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 BOOSTRIX.1
- Placebo recipients received the non-U.S. formulation of BOOSTRIX postpartum.1
- The rates of reported solicited adverse reactions following receipt of the non-U.S. formulation of BOOSTRIX administered during pregnancy were consistent with the rates following receipt of the non-U.S. formulation of BOOSTRIX administered to study participants postpartum.1
- There were no vaccine-related adverse effects on pregnancy or on the fetus/newborn child.1
