The concomitant use of BOOSTRIX and a tetravalent meningococcal (groups A, C, Y, and W-135) conjugate vaccine (Sanofi Pasteur) was evaluated in a randomized study in healthy adolescents aged 11 to 18 years. A total of 1,341 adolescents were vaccinated with BOOSTRIX. Of these, 446 subjects received BOOSTRIX administered concomitantly with meningococcal conjugate vaccine at different injection sites, 446 subjects received BOOSTRIX followed by meningococcal conjugate vaccine 1 month later, and 449 subjects received meningococcal conjugate vaccine followed by BOOSTRIX 1 month later.
Immune responses to diphtheria and tetanus toxoids (% of subjects with anti-tetanus and anti-diphtheria 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. For BOOSTRIX given concomitantly with meningococcal conjugate vaccine compared with BOOSTRIX administered first, non-inferiority was demonstrated for all antigens, with the exception of the anti-PRN GMC. The lower limit of the 95% CI for the GMC ratio was 0.54 for anti-PRN (pre-specified limit ≥0.67). For the anti-PRN booster response, non-inferiority was demonstrated. It is not known if the efficacy of BOOSTRIX is affected by the reduced response to PRN.
There was no evidence that BOOSTRIX interfered with the antibody responses to the meningococcal antigens when measured by rabbit serum bactericidal assays (rSBA) when given concomitantly or sequentially (meningococcal conjugate vaccine followed by BOOSTRIX or BOOSTRIX followed by meningococcal conjugate vaccine).
The concomitant use of BOOSTRIX and FLUARIX was evaluated in a multicenter, open-label, randomized, controlled study of 1,497 adults aged 19 to 64 years. In one group, subjects received BOOSTRIX and FLUARIX concurrently (n = 748). The other group received FLUARIX at the first visit, then 1 month later received BOOSTRIX (n = 749). 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.
Immune responses following concurrent administration of BOOSTRIX and FLUARIX were non-inferior to separate administration for diphtheria (seroprotection defined as ≥0.1 IU/mL), tetanus (seroprotection defined as ≥0.1 IU/mL and based on concentrations ≥1.0 IU/mL), PT antigen (anti-PT GMC), and influenza antigens (percent of subjects with hemagglutination-inhibition [HI] antibody titer ≥1:40 and ≥4-fold rise in HI titer). Non-inferiority criteria were not met for the anti-pertussis antigens FHA and PRN. The lower limit of the 95% CI of the GMC ratio was 0.64 for anti-FHA and 0.60 for anti-PRN and the pre-specified limit was ≥0.67. It is not known if the efficacy of BOOSTRIX is affected by the reduced response to FHA and PRN.
- Institute of Medicine (IOM). Stratton KR, Howe CJ, Johnston RB, eds. Adverse events associated with childhood vaccines. Evidence bearing on causality. Washington, DC: National Academy Press; 1994.
- Wassilak SGF, Roper MH, Kretsinger K, and Orenstein WA. Tetanus Toxoid. In: Plotkin SA, Orenstein WA, and Offit PA, eds. Vaccines. 5th ed. Saunders; 2008:805-839.
- Vitek CR and Wharton M. Diphtheria Toxoid. In: Plotkin SA, Orenstein WA, and Offit PA, eds. Vaccines. 5th ed. Saunders; 2008:139-156.
BOOSTRIX is available in 0.5-mL single-dose vials and single-dose, disposable, prefilled TIP-LOK syringes (packaged without needles):
NDC 58160-842-01 Vial in Package of 10: NDC 58160-842-11
NDC 58160-842-05 Syringe in Package of 1: NDC 58160-842-34
NDC 58160-842-43 Syringe in Package of 10: NDC 58160-842-52
Store refrigerated between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen.
Provide the following information to the vaccine recipient, parent, or guardian:
- 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 [see Use in Specific Populations (8.1)].
- 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).
BOOSTRIX, FLUARIX, INFANRIX, PEDIARIX, and TIP‑LOK are trademarks owned by or licensed to the GSK group of companies. The other brands listed are trademarks owned by or licensed to their respective owners and are not owned by or licensed to the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.
Manufactured by GlaxoSmithKline Biologicals
Rixensart, Belgium, U.S. License 1617, and
GSK Vaccines GmbH
Marburg, Germany, U.S. License 1617
Distributed by GlaxoSmithKline
Research Triangle Park, NC 27709
©2020 GSK group of companies or its licensor.
PRINCIPAL DISPLAY PANEL
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
For 10 Years of Age and Older
10 x 0.5-mL Single-Dose Vials
Made in Belgium
©2019 the GSK group of companies or its licensor.
- 496044 Rev. 2/19
|BOOSTRIX tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed suspension|
|Labeler — GlaxoSmithKline Biologicals SA (372748392)|
Revised: 09/2020 GlaxoSmithKline Biologicals SA
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