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
GlaxoSmithKline Biologicals SA
1 INDICATIONS AND USAGE
BOOSTRIX is indicated for:
• active booster immunization against tetanus, diphtheria, and pertussis in individuals aged 10 years and older,
• immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age.
2 DOSAGE AND ADMINISTRATION
For intramuscular use only.
2.1 Preparation for Administration
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the vaccine if either of these conditions exist. Shake vigorously to obtain a homogeneous, turbid, white suspension before administration. Do not use if resuspension does not occur with vigorous shaking.
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.
2.2 Administration, Dose, and Schedule
BOOSTRIX is administered as a 0.5-mL intramuscular injection into the deltoid muscle of the upper arm.
Active Booster Immunization
An initial dose of BOOSTRIX is administered 5 years or more after the last dose of the Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) series or 5 years or more after a dose of Tetanus and Diphtheria Toxoids Adsorbed (Td).
BOOSTRIX may be administered as an additional dose 9 years or more after the initial dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap).
BOOSTRIX may be administered for tetanus prophylaxis for wound management. For management of a tetanus-prone wound, a dose of BOOSTRIX may be administered if at least 5 years have elapsed since previous receipt of a tetanus toxoid-containing vaccine.
Immunization During the Third Trimester of Pregnancy
To prevent pertussis in infants younger than 2 months of age, administer BOOSTRIX to pregnant individuals during the third trimester of pregnancy.
2.3 Additional Dosing Information
The use of BOOSTRIX as a primary series or to complete the primary series for diphtheria, tetanus, or pertussis has not been established.
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 Severe Allergic Reaction
Do not administer BOOSTRIX to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of BOOSTRIX or after a previous dose of any tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine [see Description (11)].
4.2 Encephalopathy
Encephalopathy 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 Management of Acute Allergic Reactions
Appropriate medical treatment to manage allergic reactions must be immediately available in the event an acute allergic reaction occurs following administration of BOOSTRIX.
5.2 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 Guillain-Barré syndrome and brachial neuritis.1
5.3 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.
5.4 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.
5.5 Altered Immunocompetence
As with any vaccine, if administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the expected immune response may not be obtained.
5.6 Syncope
Syncope (fainting) may occur in association with administration of injectable vaccines, including BOOSTRIX. Procedures should be in place to avoid injury from fainting.
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.
Table 1 provides an overview of the studies that evaluated the safety of BOOSTRIX in various populations.
a Non-U.S. formulation of BOOSTRIX contains the same antigens and in the same quantities as BOOSTRIX. The non-U.S. formulation is manufactured to contain 0.5 mg aluminum per dose. The U.S. formulation is manufactured to contain 0.3 mg aluminum per dose. | ||
Clinical Studies | Age | Trial Arms (Number of Subjects Vaccinated) |
Initial-Dose Studies | ||
U.S. Adolescent Study (NCT00109330) | 10 to 18Years | BOOSTRIX (3,080) Td (1,034) |
German Adolescent Study (NCT00263679) | 10 to 12Years | BOOSTRIX (319) |
U.S. Adult Study (NCT00346073) | 19 to 64Years | BOOSTRIX (1,522) Tdap (762) |
U.S. Elderly Study (NCT00835237) | ≥65Years | BOOSTRIX (887) Td (445) |
Revaccination Studies (all subjects were vaccinated with BOOSTRIX and trial arms were defined based on initial-dose vaccination; subjects in the Control trial arm received a first dose of BOOSTRIX) | ||
U.S. Revaccination Study – 10 Years after Initial Td or BOOSTRIX Dose (NCT01738477) | 20 to 29Years | BOOSTRIX (128) Td (37) |
U.S. Revaccination Study – 9 Years after Initial BOOSTRIX or Tdap Dose (NCT00489970) | 28 to 73Years | BOOSTRIX (309) Tdap (138) Control (362) |
Concomitant Vaccine Studies | ||
Concomitant Vaccination with Meningococcal Conjugate Vaccine (MCV4) (NCT00282295) | 11 to 18Years | BOOSTRIX+MCV4 (446) BOOSTRIX→MCV4 (446) MCV4→BOOSTRIX (449) |
Concomitant Vaccination with Inactivated Trivalent Influenza Vaccine (TIV) (NCT00385255) | 19 to 64Years | BOOSTRIX+TIV (748) TIV→BOOSTRIX (749) |
Concomitant Vaccination with SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) (NCT02052596) | ≥50Years | BOOSTRIX+SHINGRIX (412) BOOSTRIX→SHINGRIX (418) |
Study in Pregnant Women | ||
Vaccination during the Third Trimester of Pregnancy (NCT02377349) | 18 to 45Years | Non-U.S. formulation of BOOSTRIX/Tdapa (341) Placebo (346) |
In these studies, subjects were monitored for solicited adverse events using standardized diary cards during the 4 days (Days 0 to 3), 7 days (Days 0 to 6), 8 days (Days 0 to 7), or 15 days (Days 0 to 14) following vaccination. Unsolicited adverse events were monitored for the 30-day period following vaccination (Days 0 to 29) or for the 31-day period following vaccination (Days 0 to 30).
Serious adverse events were monitored for 6 months post-vaccination in the initial-dose studies (NCT00109330, NCT00263679, NCT00346073, NCT00835237), for the 31-day (Days 0 to 30) period post-vaccination in the revaccination (NCT01738477, NCT00489970), and the concomitant-vaccine administration studies with MCV4 and TIV (NCT00282295, NCT00385255), for up to 12 months (Day 0 up to study end) post-vaccination in the concomitant administration study with SHINGRIX (NCT02052596), and from vaccination through 2 months after delivery in the study of pregnant individuals (NCT02377349).
Initial-Dose Studies
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 Clinical Studies (14.5)]. Of these adults, 1,104 were aged 65 years and older [see Clinical Studies (14.2)]. A total of 860 adults aged 19 years and older received concomitant vaccination with BOOSTRIX and influenza vaccines in a coadministration study [see Clinical Studies (14.6)].
Solicited Adverse Events in the U.S. Adolescent Study: Table 2 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% Confidence Interval [CI] for the difference [BOOSTRIX minus Td] ≤4%).
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 | 72 | |||
Pain, Grade 2 or 3b | 51 | 43 | |||
Pain, Grade 3c | 5 | 4 | |||
Redness, any | 23 | 20 | |||
Redness, >20 mm | 4 | 4 | |||
Redness, ≥50 mm | 2 | 2 | |||
Swelling, any | 21 | 20 | |||
Swelling, >20 mm | 5 | 5 | |||
Swelling, ≥50 mm | 3 | 3 | |||
Arm circumference increase, >5 mmd | 28 | 30 | |||
Arm circumference increase, >20 mmd | 2 | 2 | |||
Arm circumference increase, >40 mmd | 1 | 0.3 | |||
General | |||||
Headache, any | 43 | 42 | |||
Headache, Grade 2 or 3b | 16 | 13 | |||
Headache, Grade 3 | 4 | 3 | |||
Fatigue, any | 37 | 37 | |||
Fatigue, Grade 2 or 3 | 14 | 13 | |||
Fatigue, Grade 3 | 4 | 3 | |||
Gastrointestinal symptoms, anye | 26 | 26 | |||
Gastrointestinal symptoms, Grade 2 or 3e | 10 | 10 | |||
Gastrointestinal symptoms, Grade 3e | 3 | 3 | |||
Fever, ≥99.5°F (37.5°C)f | 14 | 13 | |||
Fever, >100.4°F (38.0°C)f | 5 | 5 | |||
Fever, >102.2°F (39.0°C)f | 1 | 1 |
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: 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 received 5 doses of INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed). Table 3 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.
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 | ||||||
Pain, Grade 2 or 3 | 33 | ||||||
Pain, Grade 3 | 6 | ||||||
Redness, any | 48 | ||||||
Redness, >20 mm | 15 | ||||||
Redness, ≥50 mm | 11 | ||||||
Swelling, any | 39 | ||||||
Swelling, >20 mm | 18 | ||||||
Swelling, ≥50 mm | 14 | ||||||
Fever, ≥99.5°F (37.5°C)b | 9 | ||||||
Fever, >100.4°F (38.0°C)b | 4 | ||||||
Fever, >102.2°F (39.0°C)b | 1 |
Solicited Adverse Events in the U.S. Adult (Aged 19 to 64 Years) Study: Table 4 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.
Tdap = ADACEL (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 | 69 | ||||||||
Pain, Grade 2 or 3 | 35 | 44 | ||||||||
Pain, Grade 3 | 2 | 2 | ||||||||
Redness, any | 21 | 27 | ||||||||
Redness, >20 mm | 4 | 6 | ||||||||
Redness, ≥50 mm | 2 | 2 | ||||||||
Swelling, any | 18 | 26 | ||||||||
Swelling, >20 mm | 4 | 6 | ||||||||
Swelling, ≥50 mm | 1 | 3 | ||||||||
General | ||||||||||
Headache, any | 30 | 31 | ||||||||
Headache, Grade 2 or 3 | 11 | 11 | ||||||||
Headache, Grade 3 | 2 | 2 | ||||||||
Fatigue, any | 28 | 29 | ||||||||
Fatigue, Grade 2 or 3 | 9 | 9 | ||||||||
Fatigue, Grade 3 | 3 | 1 | ||||||||
Gastrointestinal symptoms, anyb | 16 | 18 | ||||||||
Gastrointestinal symptoms, Grade 2 or 3b | 4 | 6 | ||||||||
Gastrointestinal symptoms, Grade 3b | 1 | 1 | ||||||||
Fever, ≥99.5°F (37.5°C)c | 6 | 8 | ||||||||
Fever, >100.4°F (38.0°C)c | 1 | 2 | ||||||||
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 5 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.
Td = DECAVAC (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 | 22 | 28 | |||||||||||
Pain, Grade 2 or 3 | 8 | 10 | |||||||||||
Pain, Grade 3 | 0.2 | 1 | |||||||||||
Redness, any | 11 | 13 | |||||||||||
Redness, >20 mm | 1 | 3 | |||||||||||
Redness, ≥50 mm | 1 | 1 | |||||||||||
Swelling, any | 8 | 12 | |||||||||||
Swelling, >20 mm | 2 | 3 | |||||||||||
Swelling, ≥50 mm | 1 | 1 | |||||||||||
General | (n = 882) | (n = 445) | |||||||||||
Fatigue, any | 13 | 15 | |||||||||||
Fatigue, Grade 2 or 3 | 3 | 3 | |||||||||||
Fatigue, Grade 3 | 1 | 1 | |||||||||||
Headache, any | 12 | 12 | |||||||||||
Headache, Grade 2 or 3 | 2 | 2 | |||||||||||
Headache, Grade 3 | 1 | 0 | |||||||||||
Gastrointestinal symptoms, anyb | 8 | 9 | |||||||||||
Gastrointestinal symptoms, Grade 2 or 3b | 2 | 2 | |||||||||||
Gastrointestinal symptoms, Grade 3b | 0.3 | 0.4 | |||||||||||
Fever, ≥99.5°F (37.5°C)c | 2 | 3 | |||||||||||
Fever, >100.4°F (38.0°C)c | 0.2 | 0.2 | |||||||||||
Fever, >102.2°F (39.0°C)c | 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.
Revaccination Studies
U.S. Revaccination Studies in Adults: In 2 clinical studies, 974 adults (aged 20 years and older) were vaccinated with a dose of BOOSTRIX [see Clinical Studies (14.4)].
Solicited Adverse Events in the U.S. Revaccination Studies: Table 6 presents solicited local adverse reactions and general adverse events within 4 days of vaccination with BOOSTRIX for the total vaccinated cohort in both studies.
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.a Day of vaccination and the next 3 days.b Subjects who were revaccinated with BOOSTRIX 10 years after initial vaccination with BOOSTRIX.c Subjects who received a dose of BOOSTRIX 10 years after initial vaccination with Td vaccine.d Subjects who were revaccinated with BOOSTRIX 9 years after initial vaccination with BOOSTRIX.e Subjects who received a dose of BOOSTRIX 9 years after initial vaccination with Tdap vaccine.f Control Group = Newly enrolled subjects who received an initial dose of BOOSTRIX.g In the study of adults aged 20 to 29 years, redness >50 mm was recorded.h In the study of adults aged 20 to 29 years, swelling >50 mm was recorded.i Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal pain.j Oral temperatures. | |||||||||||||||||||
Adverse Reactions/ Adverse Events | Adults Aged 20 to 29 Years | Adults Aged 28 to 73 Years | |||||||||||||||||
BOOSTRIXb (n = 125) % | Tdc (n = 36) % | BOOSTRIXd (n = 306) % | Tdape (n = 137) % | Controlf (n = 358) % | |||||||||||||||
Local | |||||||||||||||||||
Pain, any | 78 | 58 | 59 | 61 | 37 | ||||||||||||||
Pain, Grade 2 or 3 | 33 | 19 | 17 | 15 | 9 | ||||||||||||||
Pain, Grade 3 | 5 | 6 | 1 | 1 | 1 | ||||||||||||||
Redness, any | 38 | 42 | 24 | 23 | 15 | ||||||||||||||
Redness, >20 mm | 4 | 0 | 6 | 4 | 1 | ||||||||||||||
Redness, ≥50 mmg | 1 | 0 | 2 | 2 | 0 | ||||||||||||||
Swelling, any | 24 | 19 | 19 | 19 | 12 | ||||||||||||||
Swelling, >20 mm | 2 | 3 | 3 | 3 | 3 | ||||||||||||||
Swelling, ≥50 mmh | 0 | 0 | 1 | 2 | 1 | ||||||||||||||
General | |||||||||||||||||||
Headache, any | 32 | 22 | 17 | 18 | 15 | ||||||||||||||
Headache, Grade 2 or 3 | 10 | 3 | 4 | 4 | 2 | ||||||||||||||
Headache, Grade 3 | 2 | 0 | 0 | 1 | 0.3 | ||||||||||||||
Fatigue, any | 30 | 22 | 23 | 17 | 14 | ||||||||||||||
Fatigue, Grade 2 or 3 | 14 | 3 | 8 | 7 | 3 | ||||||||||||||
Fatigue, Grade 3 | 2 | 0 | 1 | 1 | 0 | ||||||||||||||
Gastrointestinal symptoms, anyi | 9 | 3 | 9 | 3 | 8 | ||||||||||||||
Gastrointestinal symptoms, Grade 2 or 3i | 2 | 0 | 2 | 0 | 3 | ||||||||||||||
Gastrointestinal symptoms, Grade 3i | 2 | 0 | 0 | 0 | 0 | ||||||||||||||
Fever, ≥100.4°F (38.0°C)j | 1 | 0 | 1 | 0 | 1 | ||||||||||||||
Fever, >102.2°F (39.0°C)j | 0 | 0 | 0.3 | 0 | 0 |
Concomitant Vaccination with Meningococcal Conjugate Vaccine in Adolescents
Table 7 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.
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) % | BOOSTRIX →MCV4b (n = 432-433) % | MCV4 →BOOSTRIXc (n = 441) % | ||||||||||||||||||||
Local (at injection site for BOOSTRIX) | |||||||||||||||||||||||
Pain, any | 70 | 70 | 48 | ||||||||||||||||||||
Redness, any | 23 | 26 | 18 | ||||||||||||||||||||
Swelling, any | 18 | 18 | 12 | ||||||||||||||||||||
General (following administration of BOOSTRIX) | |||||||||||||||||||||||
Fatigue | 34 | 32 | 20 | ||||||||||||||||||||
Headache | 34 | 31 | 17 | ||||||||||||||||||||
Gastrointestinal symptomsd | 15 | 15 | 8 | ||||||||||||||||||||
Fever, ≥99.5°F (37.5°C)e | 5 | 4 | 2 |
Concomitant Vaccination with SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) in Adults ≥50 Years
Table 8 presents the percentage of subjects experiencing local reactions at the injection site for BOOSTRIX and SHINGRIX, respectively, and solicited general events following BOOSTRIX and SHINGRIX vaccination when administered concomitantly or separately. The incidence of unsolicited adverse events within the 30-day post‑vaccination period was similar in the concomitant administration and the separate administration control groups.
a Concomitant Administration Group = Dose 1: BOOSTRIX + SHINGRIX, Dose 2: SHINGRIXb Separate Administration Control Group = Dose 1: BOOSTRIX, Dose 2: SHINGRIXn = number of subjects with at least one documented dose% = percentage of subjects reporting the symptom at least oncec Gastrointestinal symptoms included nausea, vomiting, diarrhea, and/or abdominal paind Fever was defined as temperature ≥ 37.5°C for oral, axillary or tympanic route | |||||||||||||||||||||||||||
Adverse Reactions/Adverse Events | Concomitant Administration Groupa (n=406-407) % | Separate Administration Control Groupb | |||||||||||||||||||||||||
BOOSTRIX (n=409) % | SHINGRIX (n= 403, first dose) % | ||||||||||||||||||||||||||
Local/ injection site | |||||||||||||||||||||||||||
Pain, any | |||||||||||||||||||||||||||
BOOSTRIX | 45 | 38 | – | ||||||||||||||||||||||||
SHINGRIX | 71 | – | 74 | ||||||||||||||||||||||||
Redness, any | |||||||||||||||||||||||||||
BOOSTRIX | 8 | 4 | – | ||||||||||||||||||||||||
SHINGRIX | 27 | – | 25 | ||||||||||||||||||||||||
Swelling, any | |||||||||||||||||||||||||||
BOOSTRIX | 6 | 5 | – | ||||||||||||||||||||||||
SHINGRIX | 17 | – | 17 | ||||||||||||||||||||||||
General | |||||||||||||||||||||||||||
Myalgia, any | 44 | 25 | 39 | ||||||||||||||||||||||||
Fatigue, any | 32 | 16 | 27 | ||||||||||||||||||||||||
Headache, any | 26 | 15 | 20 | ||||||||||||||||||||||||
Gastrointestinal symptomsc , any | 13 | 9 | 11 | ||||||||||||||||||||||||
Fever, ≥ 99.5 ° F (37.5°C )d | 9 | 2 | 6 | ||||||||||||||||||||||||
Shivering, any | 16 | 4 | 9 |
Vaccination During Pregnancy
Safety of non-U.S. formulation BOOSTRIX (0.5 mg aluminum/per dose) during the third trimester of pregnancy was evaluated in study NCT02377349. The safety data with the non-U.S. formulation are relevant because the non-U.S. formulation of BOOSTRIX contains the same antigens and in the same quantities as BOOSTRIX. However, the non-U.S. formulation contains more aluminum per dose (see Table 1).
In the randomized, controlled study NCT02377349, 687 pregnant individuals received the non-U.S. formulation of BOOSTRIX or placebo during the third trimester (341 non-U.S. formulation of BOOSTRIX, 346 placebo [saline]). The placebo recipients received the non-U.S. formulation of BOOSTRIX postpartum. 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. For further information about pregnancy outcomes [see Use in Specific Populations (8.1)].
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