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Boostrix

Boostrix

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice. As with any vaccine, there is the possibility that broad use of BOOSTRIX could reveal adverse reactions not observed in clinical trials.

In clinical studies, 4,949 adolescents (10 to 18 years of age) and 4,076 adults (19 years of age and older) were vaccinated with a single dose of BOOSTRIX. Of these adolescents, 1,341 were vaccinated with BOOSTRIX in a coadministration study with meningococcal conjugate vaccine [see DRUG INTERACTIONS and Clinical Studies]. Of these adults, 1,104 were 65 years of age and older [see Clinical Studies]. A total of 860 adults 19 years of age and older received concomitant vaccination with BOOSTRIX and influenza vaccines in a coadministration study [see DRUG INTERACTIONS and Clinical Studies]. An additional 1,092 adolescents 10 to 18 years of age received a non-US formulation of BOOSTRIX (formulated to contain 0.5 mg aluminum per dose) in non-US clinical studies.

In a randomized, observer-blinded, controlled study in the US, 3,080 adolescents 10 to 18 years of age received a single dose of BOOSTRIX and 1,034 received the comparator Td vaccine, manufactured by MassBioLogics. There were no substantive differences in demographic characteristics between the vaccine groups. Among BOOSTRIX and comparator vaccine recipients, approximately 75% were 10 to 14 years of age and approximately 25% were 15 to 18 years of age. Approximately 98% of participants in this study had received the recommended series of 4 or 5 doses of either Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTwP) or a combination of DTwP and DTaP in childhood. Subjects were monitored for solicited adverse events using standardized diary cards (day 0-14). Unsolicited adverse events were monitored for the 31-day period following vaccination (day 0-30). Subjects were also monitored for 6 months post-vaccination for non-routine medical visits, visits to an emergency room, onset of new chronic illness, and serious adverse events. Information regarding late onset adverse events was obtained via a telephone call 6 months following vaccination. At least 97% of subjects completed the 6-month follow-up evaluation.

In a study conducted in Germany, BOOSTRIX was administered to 319 children 10 to 12 years of age previously vaccinated with 5 doses of acellular pertussis antigen-containing vaccines; 193 of these subjects had previously received 5 doses of INFANRIX® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed). Adverse events were recorded on diary cards during the 15 days following vaccination. Unsolicited adverse events that occurred within 31 days of vaccination (day 0-30) were recorded on the diary card or verbally reported to the investigator. Subjects were monitored for 6 months post-vaccination for physician office visits, emergency room visits, onset of new chronic illness, and serious adverse events. The 6-month follow-up evaluation, conducted via telephone interview, was completed by 90% of subjects.

The US adult (19 to 64 years of age) study, a randomized, observer-blinded study, evaluated the safety of BOOSTRIX (N = 1,522) compared with ADACEL® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed) (N = 762), a Tdap vaccine manufactured by Sanofi Pasteur SA. Vaccines were administered as a single dose. There were no substantive differences in demographic characteristics between the vaccine groups. Subjects were monitored for solicited adverse events using standardized diary cards (day 0-14). Unsolicited adverse events were monitored for the 31-day period following vaccination (day 0-30). Subjects were also monitored for 6 months post-vaccination for serious adverse events, visits to an emergency room, hospitalizations, and onset of new chronic illness. Approximately 95% of subjects completed the 6-month follow-up evaluation.

The US elderly (65 years of age and older) study, a randomized, observer-blinded study, evaluated the safety of BOOSTRIX (N = 887) compared with DECAVAC® (Tetanus and Diphtheria Toxoids Adsorbed) (N = 445), a US-licensed Td vaccine, manufactured by Sanofi Pasteur SA. Vaccines were administered as a single dose. Among all vaccine recipients, the mean age was approximately 72 years; 54% were female and 95% were white. Subjects were monitored for solicited adverse events using standardized diary cards (day 0-3). Unsolicited adverse events were monitored for the 31-day period following vaccination (day 0-30). Subjects were also monitored for 6 months post-vaccination for serious adverse events. Approximately 99% of subjects completed the 6-month follow-up evaluation.

Solicited Adverse Events in the US Adolescent Study: Table 1 presents the solicited local adverse reactions and general adverse events within 15 days of vaccination with BOOSTRIX or Td vaccine for the total vaccinated cohort.

The primary safety endpoint was the incidence of grade 3 pain (spontaneously painful and/or prevented normal activity) at the injection site within 15 days of vaccination. Grade 3 pain was reported in 4.6% of those who received BOOSTRIX compared with 4.0% of those who received the Td vaccine. The difference in rate of grade 3 pain was within the pre-defined clinical limit for non-inferiority (upper limit of the 95% CI for the difference [BOOSTRIX minus Td] ≤ 4%).

Table 1. Rates of Solicited Local Adverse Reactions or General Adverse Events Within the 15-daya Post-Vaccination Period in Adolescents 10 to 18 Years of Age (Total Vaccinated Cohort)

  BOOSTRIX
(N = 3,032)
%
Td
(N = 1,013)
%
Local
  Pain, anyb 75.3 71.7
  Pain, grade 2 or 3b 51.2 42.5
  Pain, grade 3c 4.6 4.0
  Redness, any 22.5 19.8
  Redness, > 20 mm 4.1 3.9
  Redness, ≥ 50 mm 1.7 1.6
  Swelling, any 21.1 20.1
  Swelling, > 20 mm 5.3 4.9
  Swelling, ≥ 50 mm 2.5 3.2
  Arm circumference increase, > 5 mmd 28.3 29.5
  Arm circumference increase, > 20 mmd 2.0 2.2
  Arm circumference increase, > 40 mmd 0.5 0.3
General
  Headache, any 43.1 41.5
  Headache, grade 2 or 3b 15.7 12.7
  Headache, grade 3 3.7 2.7
  Fatigue, any 37.0 36.7
  Fatigue, grade 2 or 3 14.4 12.9
  Fatigue, grade 3 3.7 3.2
  Gastrointestinal symptoms, anye 26.0 25.8
  Gastrointestinal symptoms, grade 2 or 3e 9.8 9.7
  Gastrointestinal symptoms, grade 3e 3.0 3.2
  Fever, ≥ 99.5°F (37.5°C)f 13.5 13.1
  Fever, > 100.4°F (38.0°C)f 5.0 4.7
  Fever, > 102.2°F (39.0°C)f 1.4 1.0
Td = Tetanus and Diphtheria Toxoids Adsorbed For Adult Use manufactured by MassBioLogics.
N = Number of subjects in the total vaccinated cohort with local/general symptoms sheets completed.
Grade 2 = Local: painful when limb moved; General: interfered with normal activity.
Grade 3 = Local: spontaneously painful and/or prevented normal activity; General: prevented normal activity.
a Day of vaccination and the next 14 days.
b Statistically significantly higher (P < 0.05) following BOOSTRIX as compared to Td vaccine.
c Grade 3 injection site pain following BOOSTRIX was not inferior to Td vaccine (upper limit of two-sided 95% CI for the difference [BOOSTRIX minus Td] in the percentage of subjects ≤ 4%).
d Mid-upper region of the vaccinated arm.
e Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.
f Oral temperatures or axillary temperatures.

Unsolicited Adverse Events in the US Adolescent Study: The incidence of unsolicited adverse events reported in the 31 days after vaccination was comparable between the 2 groups (25.4% and 24.5% for BOOSTRIX and Td vaccine, respectively).

Solicited Adverse Events in the German Adolescent Study: Table 2 presents the rates of solicited local adverse reactions and fever within 15 days of vaccination for those subjects who had previously been vaccinated with 5 doses of INFANRIX. No cases of whole arm swelling were reported. Two individuals (2/193) reported large injection site swelling (range 110 to 200 mm diameter), in one case associated with grade 3 pain. Neither individual sought medical attention. These episodes were reported to resolve without sequelae within 5 days.

Table 2. Rates of Solicited Adverse Events Reported Within the 15-daya Post-Vaccination Period Following Administration of BOOSTRIX in Adolescents 10 to 12 Years of Age Who Had Previously Received 5 Doses of INFANRIX

  BOOSTRIX
(N = 193)
%
Pain, any 62.2
Pain, grade 2 or 3 33.2
Pain, grade 3 5.7
Redness, any 47.7
Redness, > 20 mm 15.0
Redness, ≥ 50 mm 10.9
Swelling, any 38.9
Swelling, > 20 mm 17.6
Swelling, ≥ 50 mm 14.0
Fever, ≥ 99.5°F (37.5°C)b 8.8
Fever, > 100.4°F (38.0°C)b 4.1
Fever, > 102.2°F (39.0°C)b 1.0
N = Number of subjects with local/general symptoms sheets completed.
Grade 2 = Painful when limb moved.
Grade 3 = Spontaneously painful and/or prevented normal activity.
a Day of vaccination and the next 14 days.
b Oral temperatures or axillary temperatures.

Solicited Adverse Events in the US Adult (19 to 64 Years of Age) Study: Table 3 presents solicited local adverse reactions and general adverse events within 15 days of vaccination with BOOSTRIX or the comparator Tdap vaccine for the total vaccinated cohort.

Table 3. Rates of Solicited Local Adverse Reactions or General Adverse Events Within the 15-daya Post-Vaccination Period in Adults 19 to 64 Years of Age (Total Vaccinated Cohort)

  BOOSTRIX
(N = 1,480)
%
Tdap
(N = 741)
%
Local
  Pain, any 61.0 69.2
  Pain, grade 2 or 3 35.1 44.4
  Pain, grade 3 1.6 2.3
  Redness, any 21.1 27.1
  Redness, > 20 mm 4.0 6.2
  Redness, ≥ 50 mm 1.6 2.3
  Swelling, any 17.6 25.6
  Swelling, > 20 mm 3.9 6.3
  Swelling, ≥ 50 mm 1.4 2.8
General
  Headache, any 30.1 31.0
  Headache, grade 2 or 3 11.1 10.5
  Headache, grade 3 2.2 1.5
  Fatigue, any 28.1 28.9
  Fatigue, grade 2 or 3 9.1 9.4
  Fatigue, grade 3 2.5 1.2
  Gastrointestinal symptoms, anyb 15.9 17.5
  Gastrointestinal symptoms, grade 2 or 3b 4.3 5.7
  Gastrointestinal symptoms, grade 3b 1.2 1.3
  Fever, ≥ 99.5°F (37.5°C)c 5.5 8.0
  Fever, > 100.4°F (38.0°C)c 1.0 1.5
  Fever, > 102.2°F (39.0°C)c 0.1 0.4
Tdap = Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed, a Tdap vaccine manufactured by Sanofi Pasteur SA.
N = Number of subjects in the total vaccinated cohort with local/general symptoms sheets completed.
Grade 2 = Local: painful when limb moved; General: interfered with normal activity.
Grade 3 = Local/General: prevented normal activity.
a Day of vaccination and the next 14 days.
b Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.
c Oral temperatures.

Unsolicited Adverse Events in the US Adult (19 to 64 Years of Age) Study: The incidence of unsolicited adverse events reported in the 31 days after vaccination was comparable between the 2 groups (17.8% and 22.2% for BOOSTRIX and Tdap vaccine, respectively).

Solicited Adverse Events in the US Elderly (65 Years of Age and Older) Study: Table 4 presents solicited local adverse reactions and general adverse events within 4 days of vaccination with BOOSTRIX or the comparator Td vaccine for the total vaccinated cohort.

Table 4. Rates of Solicited Local Adverse Reactions or General Adverse Events Within 4 Daysa of Vaccination in the Elderly 65 Years of Age and Older (Total Vaccinated Cohort)

  BOOSTRIX
%
Td
%
Local (N = 882) (N = 444)
  Pain, any 21.5 27.7
  Pain, grade 2 or 3 7.5 10.1
  Pain, grade 3 0.2 0.7
  Redness, any 10.8 12.6
  Redness, > 20 mm 1.4 2.5
  Redness, ≥ 50 mm 0.6 0.9
  Swelling, any 7.5 11.7
  Swelling, > 20 mm 2.2 3.4
  Swelling, ≥ 50 mm 0.7 0.7
General (N = 882) (N = 445)
  Fatigue, any 12.5 14.8
  Fatigue, grade 2 or 3 2.5 2.9
  Fatigue, grade 3 0.7 0.7
  Headache, any 11.5 11.7
  Headache, grade 2 or 3 1.9 2.2
  Headache, grade 3 0.6 0.0
  Gastrointestinal symptoms, anyb 7.6 9.2
  Gastrointestinal symptoms, grade 2 or 3b 1.7 1.8
  Gastrointestinal symptoms, grade 3b 0.3 0.4
  Fever, ≥ 99.5°F (37.5°C)c 2.0 2.5
  Fever, > 100.4°F (38.0°C)c 0.2 0.2
  Fever, > 102.2°F (39.0°C)c 0.0 0.0
Td = Tetanus and Diphtheria Toxoids Adsorbed, a US-licensed Td vaccine, manufactured by Sanofi Pasteur SA.
N = Number of subjects with a documented dose.
Grade 2 = Local: painful when limb moved; General: interfered with normal activity.
Grade 3 = Local/General: prevented normal activity.
a Day of vaccination and the next 3 days.
b Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.
c Oral temperatures.

Unsolicited Adverse Events in the US Elderly (65 Years of Age and Older) Study: 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).

Serious Adverse Events (SAEs): In the US and German adolescent safety studies, no serious adverse events were reported to occur within 31 days of vaccination. During the 6-month extended safety evaluation period, no serious adverse events that were of potential autoimmune origin or new onset and chronic in nature were reported to occur. In non-US adolescent studies in which serious adverse events were monitored for up to 37 days, one subject was diagnosed with insulin-dependent diabetes 20 days following administration of BOOSTRIX. No other serious adverse events of potential autoimmune origin or that were new onset and chronic in nature were reported to occur in these studies. In the US adult (19 to 64 years of age) study, serious adverse events were reported to occur during the entire study period (0-6 months) by 1.4% and 1.7% of subjects who received BOOSTRIX and the comparator Tdap vaccine, respectively. During the 6-month extended safety evaluation period, no serious adverse events of a neuroinflammatory nature or with information suggesting an autoimmune etiology were reported in subjects who received BOOSTRIX. In the US elderly (65 years of age and older) study, serious adverse events were reported to occur by 0.7% and 0.9% of subjects who received BOOSTRIX and the comparator Td vaccine, respectively, during the 31-day period after vaccination. Serious adverse events were reported to occur by 4.2% and 2.2% of subjects who received BOOSTRIX and the comparator Td vaccine, respectively, during the 6-month period after vaccination.

Concomitant Vaccination With Meningococcal Conjugate Vaccine in Adolescents: In a randomized study in the US, 1,341 adolescents (11 to 18 years of age) received either BOOSTRIX administered concomitantly with MENACTRA® (Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine), (Sanofi Pasteur SA), or each vaccine administered separately 1 month apart [see DRUG INTERACTIONS and Clinical Studies]. Safety was evaluated in 446 subjects who received BOOSTRIX administered concomitantly with meningococcal conjugate vaccine at different injection sites, 446 subjects who received BOOSTRIX followed by meningococcal conjugate vaccine 1 month later, and 449 subjects who received meningococcal conjugate vaccine followed by BOOSTRIX 1 month later. Solicited local adverse reactions and general adverse events were recorded on diary cards for 4 days (day 0-3) following each vaccination. Unsolicited adverse events were monitored for the 31-day period following each vaccination (day 0-30). Table 5 presents the percentages of subjects experiencing local reactions at the injection site for BOOSTRIX and solicited general events following BOOSTRIX. The incidence of unsolicited adverse events reported in the 31 days after any vaccination was similar following each dose of BOOSTRIX in all cohorts.

Table 5. Rates of Solicited Local Adverse Reactions or General Adverse Events Reported Within the 4-day Post-Vaccination Period following Administration of BOOSTRIX in Individuals 11 to 18 Years of Age (Total Vaccinated Cohort)

  BOOSTRIX+ MCV4a
(N = 441)
%
BOOSTRIX→ MCV4b
(N = 432-433)
%
MCV4→ BOOSTRIXc
(N = 441)
%
Local (at injection site for BOOSTRIX)
  Pain, any 70.1 70.4 47.8
  Redness, any 22.7 25.7 17.9
  Swelling, any 17.7 18.1 12.0
General (following administration of BOOSTRIX)
  Fatigue 34.0 32.1 20.4
  Headache 34.0 30.7 17.0
  Gastrointestinal symptomsd 15.2 14.5 7.7
  Fever, ≥ 99.5°F (37.5°C)e 5.2 3.5 2.3
MCV4 = MENACTRA (Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine), Sanofi Pasteur SA.
N = number of subjects in the total vaccinated cohort with local/general symptoms sheets completed.
a BOOSTRIX+MCV4 = concomitant vaccination with BOOSTRIX and MENACTRA.
b BOOSTRIX→MCV4 = BOOSTRIX followed by MCV4 1 month later.
c MCV4→BOOSTRIX = MCV4 followed by BOOSTRIX 1 month later.
d Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.
e Oral temperatures.

Postmarketing Experience

In addition to reports in clinical trials, worldwide voluntary reports of adverse events received for BOOSTRIX in persons 10 years of age and older since market introduction of this vaccine are listed below. This list includes serious events or events which have causal connection to components of this or other vaccines or drugs. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to the vaccine.

Blood and Lymphatic System Disorders: Lymphadenitis, lymphadenopathy.

Cardiac Disorders: Myocarditis.

General Disorders and Administration Site Conditions: Extensive swelling of the injected limb, injection site induration, injection site inflammation, injection site mass, injection site pruritus, injection site nodule, injection site warmth, local reaction.

Musculoskeletal and Connective Tissue Disorders: Arthralgia, back pain, myalgia.

Nervous System Disorders: Convulsion, encephalitis, facial palsy, paraesthesia. Skin and Subcutaneous Tissue Disorders: Exanthem, Henoch-Schonlein purpura, rash, urticaria.

Read the Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Concomitant Vaccine Administration

BOOSTRIX was administered concomitantly with MENACTRA in a clinical study of subjects 11 to 18 years of age [see Clinical Studies]. Post-vaccination geometric mean antibody concentrations (GMCs) to pertactin were lower following BOOSTRIX administered concomitantly with meningococcal conjugate vaccine compared to BOOSTRIX administered first. It is not known if the efficacy of BOOSTRIX is affected by the reduced response to pertactin.

BOOSTRIX was administered concomitantly with FLUARIX® (Influenza Virus Vaccine) in a clinical study of subjects 19 to 64 years of age [see Clinical Studies]. Lower GMCs for antibodies to the pertussis antigens filamentous hemagglutinin (FHA) and pertactin were observed when BOOSTRIX was administered concomitantly with FLUARIX as compared with BOOSTRIX alone. It is not known if the efficacy of BOOSTRIX is affected by the reduced response to FHA and pertactin.

When BOOSTRIX is administered concomitantly with other injectable vaccines or Tetanus Immune Globulin, they should be given with separate syringes and at different injection sites. BOOSTRIX should not be mixed with any other vaccine in the same syringe or vial.

Immunosuppressive Therapies

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to BOOSTRIX.

Read the Boostrix Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 7/21/2011
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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