Boostrix

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  • Vaccines
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Boostrix Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Tetanus and reduced diphtheria toxoid, acellular pertussis vaccine (aluminum hydroxide adsorbed); susp for IM inj; preservative-free.

    Pharmacological Class

    Tdap.

    How Supplied

    Single-dose vials or prefilled syringes (without needles)—10

    Storage

    • Store refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen.

    Manufacturer

    GlaxoSmithKline

    Boostrix Indications

    Indications

    Diphtheria, tetanus, and pertussis booster immunization in patients ≥10 years of age. Immunization during the 3rd trimester of pregnancy to prevent pertussis in infants <2 months of age.

    Boostrix Dosage and Administration

    Adults and Children

    Booster immunization: <10yrs: not recommended. ≥10yrs (≥5yrs after last childhood DTwP or DTaP or adult Td vaccine): 0.5mL IM once into deltoid muscle.  Immunization during 3rd trimester of pregnancy: 0.5mL IM once into deltoid muscle.

    Adults and Children

    Administer Boostrix as a 0.5mL intramuscular injection into the deltoid muscle of the upper arm.

    Active Booster Immunization

    • <10 years of age: not recommended.

    • ≥10 years of age: administer initial dose 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).

    • 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).

    • 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

    • Administer Boostrix to pregnant women during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age.

    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.

    Administration

    • Visually inspect parenteral drug products for particulate matter and discoloration prior to administration. Do not use the vaccine if either of these conditions exist.

    • Shake vigorously to obtain a homogenous, 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.

    Boostrix Contraindications

    Contraindications

    Encephalopathy within 7 days after previous DTaP or DTwP vaccination.

    Boostrix Boxed Warnings

    Not Applicable

    Boostrix Warnings/Precautions

    Warnings/Precautions

    Guillain-Barre syndrome (within 6 weeks) after previous tetanus toxoid vaccine: see full labeling. Progressive or unstable neurologic disorders (eg, cerebrovascular events, acute encephalopathic conditions). Previous Arthus-type hypersensitivity reaction: not recommended until ≥10yrs after prior dose of tetanus toxoid-containing vaccine. Immunosuppressed. Have epinephrine available. Latex allergy. Pregnancy: see full labeling. Nursing mothers.

    Warnings/Precautions

    Management of Acute Allergic Reactions

    • Have appropriate medical treatment immediately available to manage allergic reactions in the event an acute allergic reaction occurs after administration.

    Latex

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

    Guillain-Barré Syndrome and Brachial Neuritis

    • The risk of Guillain-Barré Syndrome (GBS) may be increased following subsequent dose of tetanus toxoid-containing vaccine, including Boostrix if GBS occurred within 6 weeks of previous vaccine containing tetanus toxoid.

    • Evidence has been found for a causal relation between tetanus toxoid and both GBS and brachial neuritis. 

    Progressive or Unstable Neurologic Disorders

    • Defer vaccination with a pertussis-containing vaccine, including Boostrix, in patients with progressive or unstable neurologic conditions (eg, cerebrovascular events, acute encephalopathic conditions).

    • Administration of Boostrix to persons with an unstable or progressive neurologic disorder is not known whether it will hasten manifestations of the disorder or affect the prognosis. The administration of Boostrix in this patient population may lead to diagnostic confusion.

    Arthus-Type Hypersensitivity

    • Patients who experienced an Arthus-type hypersensitivity reaction after a previous dose of a tetanus toxoid-containing vaccine should not receive Boostrix or other tetanus-containing vaccines unless at least 10 years have elapsed since the last dose.

    Altered Immunocompetence

    • Immunosuppressed persons, including those receiving immunosuppressive therapy may not obtain the expected immune response.

    Syncope

    • Syncope may occur. Procedures should be in place to avoid injury from fainting.

    Pregnancy Considerations

    Pregnancy Exposure Registry

    • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Boostrix during pregnancy. Healthcare providers are encouraged to register women by calling 1-888-452-9622 or visiting http://pregnancyregistry.gsk.com/boostrix.html.

    Risk Summary

    • All pregnancies have a risk of birth defect, loss, or other adverse outcomes. 

    • In a clinical study evaluating the non-US formulation of Boostrix administered during the third trimester of pregnancy, there were no identified vaccine-related adverse effects on pregnancy or on the fetus/newborn child.

    • In female rat studies, there was no evidence of harm to the fetus due to Boostrix.

    Nursing Mother Considerations

    • Not known whether Boostrix is excreted in human milk.

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Boostrix and any potential adverse effects on the breastfed child from Boostrix or from the underlying maternal condition. 

    Pediatric Considerations

    • Not indicated for use in children 10 years of age and younger. 

    • Safety and efficacy of Boostrix has not been established in children 10 years of age and younger.

    Boostrix Pharmacokinetics

    See Literature

    Boostrix Interactions

    Interactions

    Concomitant vaccines: see full labeling. Immunosuppressants (eg, radiation, chemotherapy, high-dose steroids): may get suboptimal response.

    Boostrix Adverse Reactions

    Adverse Reactions

    Local reactions (eg, pain, redness, swelling), fever, headache, fatigue, GI upset.

    Boostrix Clinical Trials

    Clinical Trials

    Effectiveness of Boostrix, Infanrix, and Pediarix

    Effectiveness of Boostrix

    • The effectiveness of the tetanus and diphtheria toxoid components of Boostrix is based on the immunogenicity of the individual antigens compared with US-licensed vaccines using established serologic correlates of protection. 

    • The effectiveness of the pertussis components of Boostrix was evaluated by comparison of the immune response of adolescents and adults following an initial dose of Boostrix to the immune response of infants following a 3-dose primary series of Infanrix or by comparison of the immune response of adults following an additional dose of Boostrix to the immune response of infants following a 3-dose primary series of Pediarix. In addition, the ability of Boostrix to induce a booster response to each of the antigens was evaluated.

    Immune Responses to Pertussis Antigens of Boostrix Compared with Infanrix or Pediarix

    • Although a serologic correlate of protection for pertussis has not been established, serological data from a subset of infants immunized with a 3-dose primary series of Infanrix in the German household contact study were compared with the sera of adolescents and adults immunized with an initial dose of Boostrix.

    • Serological data from infants immunized with a 3-dose primary series of Pediarix in an additional pediatric study were compared with the sera of adults immunized with an additional dose of Boostrix.

    • The majority of subjects in the study of Infanrix had only anti-PT (pertussin toxin) serology data.

     

    Immunological Evaluation following an Initial Dose of Boostrix

    Adolescents (Aged 10 to 18 years)

    • In a multicenter, randomized, observer-blinded, controlled US study, the immune responses to each of the antigens in Boostrix were evaluated in sera obtained approximately 1 month after administration of a single dose of vaccine to adolescent subjects (aged 10 to 18 years).

    • 98% of participants received the recommended series of 4 or 5 doses of either DTwP or a combination of DTwP and DTaP in childhood.

    • Boostrix and the comparator Td vaccine had comparable anti-tetanus and anti-diphtheria seroprotective rates ((≥0.1 IU/mL by ELISA) and booster response rates 1 month after a single dose.

    • Response to Pertussis Antigens:

      • One month after a single dose of Boostrix in adolescents: anti-PT, anti-FHA, and anti-PRN antibody concentrations were noninferior to those infants after a primary vaccinations series with Infanrix.

    Adults (Aged 19 to 64 Years)

    • The multicenter, randomized, observer-blinded US study compared the immunogenicity of Boostrix to the licensed comparator Tdap vaccine (Sanofi Pasteur). Patients who did not receive a tetanus-diphtheria booster within 5 years were given a single dose of the vaccines. 

    • The immune responses to each of the antigens in Boostrix were evaluated in sera obtained approximately 1 month after administration.

    • Response to Tetanus and Diphtheria Toxoids:

      • The anti-tetanus and anti-diphtheria seroprotective rates (≥0.1 IU/mL by ELISA) were comparable between Boostrix and the comparator Tdap vaccine 1 month after a single dose.

    • Response to Pertussis Antigens:

      • The PT antigen booster response lower limit of the 95% CI (74.9%) for Boostrix did not exceed the pre-defined limit of 80%.

      • The GMCs to each of the pertussis antigens 1 month following a single dose of Boostrix were compared with the GMCs of a subset of infants following a 3-dose primary series of Infanrix in the German household contact study. Anti-PT, anti-FHA, and anti-PRN antibody concentrations observed in adults 1 month after a single dose of Boostrix were non-inferior to those infants following a primary vaccination series with Infanrix.

    Elderly (Aged 65 Years and Older)

    • In a randomized, observer-blinded US study, the immunogenicity of Boostrix was compared to a US-licensed comparator TD vaccine in elderly patients 65 years of age and older. Patients who did not receive a tetanus-diphtheria booster within 5 years were given a single dose of the vaccines.

    • The immune responses to each of the antigens contained in Boostrix were evaluated in sera obtained approximately 1 month after administration.

    • Response to Tetanus and Diphtheria Toxoids:

      • The anti-tetanus and anti-diphtheria seroprotective rates (≥0.1 IU/mL by ELISA) were comparable between Boostrix and the comparator Tdap vaccine 1 month after a single dose.

    • Response to Pertussis Antigens:

      • The PT antigen booster response lower limit of the 95% CI (74.9%) for Boostrix did not exceed the pre-defined limit of 80%.

      • The GMCs to each of the pertussis antigens 1 month following a single dose of Boostrix were compared with the GMCs of a subset of infants following a 3-dose primary series of Infanrix in the German household contact study. Anti-PT, anti-FHA, and anti-PRN antibody concentrations observed in the elderly 1 month after a single dose of Boostrix were non-inferior to those infants following a primary vaccination series with Infanrix.

    Study in Pregnant Women

    • In a re-analysis within a Bayesian meta-analysis framework of the BOOSTRIX-relevant data from an observational case-control study of Tdap vaccine effectiveness, the efficacy of Boostrix was evaluated during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age.

    • The preliminary vaccine efficacy estimate for Boostrix was 78% (95% CI, -38.0, 96.5) during the third trimester of pregnancy. This preliminary effectiveness estimate was updated using a Bayesian meta-analysis with an informative prior constructed from four observational studies that provided estimates of the vaccine effectiveness of the non-U.S. formulation of Boostrix against pertussis in infants whose mothers were immunized during pregnancy.

    • To account for potential publication bias, this informative prior was downweighted by combining it with an uninformative prior. When the informative prior has 20% weight, the vaccine efficacy estimate was 81.5% (95% credible interval: 12.9, 94.5) during the third trimester of pregnancy. When the informative prior has 90% weight, the vaccine efficacy estimate was 83.4% (95% credible interval: 12.9, 94.5) during the third trimester of pregnancy.

    Immune Responses to Vaccination in Infants Born to Mothers Who Received Boostrix During Pregnancy 

    • In infants whose mothers received Boostrix (non-US formulation) during the third trimester of pregnancy, antibody responses to a non-US licensed DTaP-containing vaccine were diminished for anti-PT, anti-FHA and anti-PRN following the primary series (NCT 02422264), and for anti-PT and anti-FHA following a booster dose (NCT 02853929) compared to infants who received the same vaccine but whose mothers received placebo during pregnancy.

    • It is not known whether the diminished immune response observed in vaccinated infants whose mothers received Boostrix (non-US formulation) during pregnancy result in diminished efficacy of pertussis vaccination in infants.

    Immunological Evaluation following Revaccination with Boostrix

    • The multicenter, open-label, controlled US study evaluated the immunogenicity of Boostrix in adults 20 to 29 years of age who received an initial dose of Boostrix or the comparator Td vaccine (MassBiologics) in the US adolescent (10 to 18 years of age) study (NCT01738477). All patients received Boostrix 10 years after the initial vaccination. 

    • The immune responses to each of the antigens contained in Boostrix were evaluated in sera obtained approximately 1 month after vaccine administration.

    • Response to Tetanus and Diphtheria Toxoids:

      • The anti-tetanus and anti-diphtheria seroprotective rates (≥0.1 IU/mL by ELISA) were comparable between Boostrix and the comparator Td vaccine 1 month after a single dose.

    • Response to Pertussis Antigens:

      • The GMCs to each of the pertussis antigens 1 month following revaccination of Boostrix were compared with the GMCs of infants following a 3-dose primary series of Pediarix. Anti-PT, anti-FHA, and anti-PRN antibody concentrations observed in the adults 1 month after revaccination of Boostrix were noninferior to those infants following a primary vaccination series with Pediarix.

    Adults (Aged 28 to 73 Years)

    • The multicenter, open-label, controlled US study evaluated the immunogenicity of Boostrix in adults 28 to 73 years of age who received an initial dose of Boostrix or the license comparator Tdap vaccine (Sanofi Pasteur) in the US adult (19 to 64 years of age) study (NCT00489970). All patients received Boostrix 9 years after initial vaccination.

    • The immune responses to each of the antigens contained in Boostrix were evaluated in sera obtained approximately 1 month after vaccine administration.

    • Response to Tetanus and Diphtheria Toxoids:

      • The anti-tetanus and anti-diphtheria seroprotective rates (≥0.1 IU/mL by ELISA) were comparable between Boostrix and the comparator Tdap vaccine 1 month after a single dose.

    • Response to Pertussis Antigens: 

      • The GMCs to each of the pertussis antigens 1 month following a dose of Boostrix in patients who received an initial dose of Boostrix or the licensed comparator Tdap vaccine (Sanofi Pasteur) 9 years earlier were compared with the GMCs of infants following a 3-dose primary series of Pediarix. Anti-PT, anti-FHA, and anti-PRN antibody concentrations observed in the adults 1 month after revaccination of Boostrix were noninferior to those infants following a primary vaccination series with Pediarix.

    Concomitant Administration with Meningococcal Conjugate Vaccine

    • A randomized study evaluated the concomitant use of Boostrix and a tetravalent meningococcal (groups A, C, Y, and W-135) conjugate vaccine (Sanofi Pasteur) in 1341 healthy adolescents aged 11 to 18 years (NCT00282295). 

    • Patients were randomly assigned 1:1:1 to receive Boostrix concomitantly with meningococcal conjugate vaccine at different injection sites (n=446), Boostrix followed by meningococcal conjugate vaccine 1 month later (n=446), and meningococcal conjugate vaccine followed by Boostrix 1 month later (n=449). 

    • Immune responses to diphtheria and tetanus toxoids (% of subjects with anti-tetanus and antidiphtheria antibodies ≥1.0 IU/mL by ELISA), pertussis antigens (booster responses and GMCs), and meningococcal antigens (vaccine responses) were measured 1 month (range: 30 to 48 days) after concomitant or separate administration of Boostrix and meningococcal conjugate vaccine. 

    • Noninferiority for all antigens (with the exception of the anti-PRN CMC) was demonstrated for Boostrix given concomitantly with meningococcal conjugate vaccine vs with Boostrix given first. Noninferiority was demonstrated for the anti-PRN booster response.

    Concomitant Administration with Fluarix (Inactivated Influenza Vaccine)

    • In a multicenter, open-label, randomized, controlled study (NCT00385255), the concomitant use of Boostrix and Fluarix was evaluated in 1497 adults 19 to 64 years of age. Patients received either Boostrix concomitantly with Fluarix or Fluarix first followed by Boostrix 1 month later.

    • Sera was obtained prior to and 1 month following concomitant or separate administration of Boostrix and/or Fluarix , as well as 1 month after the separate administration of Fluarix.

    • Noninferiority was demonstrated for immune responses following concurrent administration of Boostrix and Fluarix to separate administration for diphtheria, tetanus, PT antigen, and influenza antigens. 

    • Noninferiority was not met for the anti-pertussis antigens FHA and PRN.

    Boostrix Note

    Notes

    Register pregnant patients exposed to Boostrix by calling (888) 452-9622. Report adverse events to VAERS by calling (800) 822-7967.

    Boostrix Patient Counseling

    Patient Counseling

    • Inform of the potential benefits and risks of immunization with Boostrix. 

    • Inform about the potential for adverse reactions that have been temporally associated with administration of Boostrix or other vaccines containing similar components. 

    • Instruct vaccine recipient to report any adverse events to their healthcare provider. 

    • Advise women who receive Boostrix during pregnancy to enroll in the pregnancy registry. 

    • Give the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

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