Vaccine Information: BOOSTRIX

BOOSTRIX- clostridium tetani toxoid antigen (formaldehyde inactivated), corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated), bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated), bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) and bordetella pertussis pertactin antigen (formaldehyde inactivated) suspension
A-S Medication Solutions

1 INDICATIONS AND USAGE

BOOSTRIX is indicated for active booster immunization against tetanus, diphtheria, and pertussis. BOOSTRIX is approved for use as a single dose in individuals aged 10 years and older.

2 DOSAGE AND ADMINISTRATION

2.1 Preparation for Administration

Shake vigorously to obtain a homogeneous, turbid, white suspension before administration. Do not use if resuspension does not occur with vigorous shaking. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If either of these conditions exists, the vaccine should not be administered.

For the prefilled syringes, attach a sterile needle and administer intramuscularly.

For the vials, use a sterile needle and sterile syringe to withdraw the 0.5‑mL dose and administer intramuscularly. Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. Use a separate sterile needle and syringe for each individual.

Do not administer this product intravenously, intradermally, or subcutaneously.

2.2 Dose and Schedule

BOOSTRIX is administered as a single 0.5-mL intramuscular injection into the deltoid muscle of the upper arm. There are no data to support repeat administration of BOOSTRIX.

Five years should elapse between the last dose of the recommended series of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) or Tetanus and Diphtheria Toxoids, Adsorbed (Td) vaccine and the administration of BOOSTRIX.

2.3 Additional Dosing Information

Primary Series

The use of BOOSTRIX as a primary series or to complete the primary series for diphtheria, tetanus, or pertussis has not been studied.

Wound Management

If tetanus prophylaxis is needed for wound management, BOOSTRIX may be given if no previous dose of any Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap) has been administered.

3 DOSAGE FORMS AND STRENGTHS

BOOSTRIX is a suspension for injection available in 0.5-mL single-dose vials and prefilled TIP-LOK syringes.

4 CONTRAINDICATIONS

4.1 Hypersensitivity

A severe allergic reaction (e.g., anaphylaxis) after a previous dose of any tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine or any component of this vaccine is a contraindication to administration of BOOSTRIX [see Description (11)]. Because of the uncertainty as to which component of the vaccine might be responsible, none of the components should be administered. Alternatively, such individuals may be referred to an allergist for evaluation if immunization with any of these components is considered.

4.2 Encephalopathy

Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis antigen-containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis antigen-containing vaccine, including BOOSTRIX.

5 WARNINGS AND PRECAUTIONS

5.1 Prevention and Management of Acute Allergic Reactions

Prior to administration, the healthcare provider should review the immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions to allow an assessment of benefits and risks. Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.

5.2 Latex

The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions.

5.3 Guillain-Barré Syndrome and Brachial Neuritis

If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk of Guillain-Barré syndrome may be increased following a subsequent dose of tetanus toxoid-containing vaccine, including BOOSTRIX. A review by the Institute of Medicine (IOM) found evidence for a causal relationship between receipt of tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome.1

5.4 Progressive or Unstable Neurologic Disorders

Progressive or unstable neurologic conditions (e.g., cerebrovascular events, acute encephalopathic conditions) are reasons to defer vaccination with a pertussis-containing vaccine, including BOOSTRIX. It is not known whether administration of BOOSTRIX to persons with an unstable or progressive neurologic disorder might hasten manifestations of the disorder or affect the prognosis. Administration of BOOSTRIX to persons with an unstable or progressive neurologic disorder may result in diagnostic confusion between manifestations of the underlying illness and possible adverse effects of vaccination.

5.5 Arthus-Type Hypersensitivity

Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine usually have a high serum tetanus antitoxin level and should not receive BOOSTRIX or other tetanus toxoid-containing vaccines unless at least 10 years have elapsed since the last dose of tetanus toxoid-containing vaccine.

5.6 Altered Immunocompetence

As with any vaccine, if administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the expected immune response may not be obtained.

5.7 Syncope

Syncope (fainting) can occur in association with administration of injectable vaccines, including BOOSTRIX. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.

6 ADVERSE REACTIONS

6.1 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 with rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

In clinical studies, 4,949 adolescents (aged 10 to 18 years) and 4,076 adults (aged 19 years 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 (7.1), Clinical Studies (14.5)]. Of these adults, 1,104 were aged 65 years and older [see Clinical Studies (14.4)]. A total of 860 adults aged 19 years and older received concomitant vaccination with BOOSTRIX and influenza vaccines in a coadministration study [see Drug Interactions (7.1), Clinical Studies (14.5)]. An additional 1,092 adolescents aged 10 to 18 years received a non-U.S. formulation of BOOSTRIX (formulated to contain 0.5 mg aluminum per dose) in non-U.S. clinical studies.

In a randomized, observer-blinded, controlled study in the U.S., 3,080 adolescents aged 10 to 18 years 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 recipients of BOOSTRIX and comparator vaccine, approximately 75% were aged 10 to 14 years and approximately 25% were aged 15 to 18 years. 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 (Days 0-14). Unsolicited adverse events were monitored for the 31-day period following vaccination (Days 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 aged 10 to 12 years 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 (Days 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 U.S. adult (aged 19 to 64 years) 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. 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 (Days 0-14). Unsolicited adverse events were monitored for the 31-day period following vaccination (Days 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 U.S. elderly (aged 65 years 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 U.S.-licensed Td vaccine, manufactured by Sanofi Pasteur. 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 (Days 0-3). Unsolicited adverse events were monitored for the 31-day period following vaccination (Days 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 U.S. 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 Aged 10 to 18 Years (Total Vaccinated Cohort)
Td = Tetanus and Diphtheria Toxoids Adsorbed 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 with Td vaccine.c 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 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.

Adverse Reactions/Adverse Events

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

Unsolicited Adverse Events in the U.S. 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

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 1 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 Local Adverse Reactions and Fever Reported within the 15-Daya Post-Vaccination Period following Administration of BOOSTRIX in Adolescents Aged 10 to 12 Years Who Had Previously Received 5 Doses of INFANRIX
INFANRIX = Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed manufactured by GlaxoSmithKline Biologics.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.

Adverse Reactions and Fever

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

Solicited Adverse Events in the U.S. Adult (Aged 19 to 64 Years) 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 Aged 19 to 64 Years (Total Vaccinated Cohort)
Tdap = Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed, a Tdap vaccine manufactured by Sanofi Pasteur.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.

Adverse Reactions/Adverse Events

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

Unsolicited Adverse Events in the U.S. Adult (Aged 19 to 64 Years) 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 U.S. Elderly (Aged 65 Years 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 Aged 65 Years and Older (Total Vaccinated Cohort)
Td = Tetanus and Diphtheria Toxoids Adsorbed, a U.S.-licensed Td vaccine, manufactured by Sanofi Pasteur.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.

Adverse Reactions/Adverse Events

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

Unsolicited Adverse Events in the U.S. Elderly (Aged 65 Years 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 U.S. 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-U.S. adolescent studies in which serious adverse events were monitored for up to 37 days, 1 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 U.S. adult (aged 19 to 64 years) 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 U.S. elderly (aged 65 years 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 U.S., 1,341 adolescents (aged 11 to 18 years) received either BOOSTRIX administered concomitantly with MENACTRA (Meningococcal [Groups A, C, Y, and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine), (Sanofi Pasteur), or each vaccine administered separately 1 month apart [see Drug Interactions (7.1), Clinical Studies (14.5)]. 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 (Days 0-3) following each vaccination. Unsolicited adverse events were monitored for the 31-day period following each vaccination (Days 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 Aged 11 to 18 Years (Total Vaccinated Cohort)
MCV4 = MENACTRA (Meningococcal [Groups A, C, Y, and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine), Sanofi Pasteur.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.

Adverse Reactions/Adverse Events

BOOSTRIX+MCV4a

(n = 441)

%

BOOSTRIXMCV4b

(n = 432-433)

%

MCV4BOOSTRIXc

(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

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