Vaccine Information: BOOSTRIX (Page 5 of 5)

14.6 Concomitant Administration with Meningococcal Conjugate Vaccine

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 (NCT00282295). 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).

14.7 Concomitant Administration with FLUARIX (Inactivated Influenza Vaccine)

The concomitant use of BOOSTRIX and FLUARIX was evaluated in a multicenter, open-label, randomized, controlled study (NCT00385255) 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.

14.8 Concomitant Administration with SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted)

The concomitant use of BOOSTRIX and SHINGRIX was evaluated in an open-label clinical study (NCT 02052596) of subjects aged 50 years and older. Subjects in Group 1 received BOOSTRIX and the first dose of SHINGRIX at Month 0 and the second dose of SHINGRIX at Month 2 (n = 412; concomitant administration group). Subjects in Group 2 received BOOSTRIX at Month 0, the first dose of SHINGRIX at Month 2, and the second dose of SHINGRIX at Month 4 (n = 418; separate administration control group). The mean age of the subjects was 63 years; 54% were female. The majority of subjects were White (87%), followed by Black (11%), and other racial groups; 2% were of American Hispanic or Latino ethnicity.

The immune responses to BOOSTRIX (anti-D, anti-T, and antibodies to pertussis antigens) were measured 1 month after administration of the single dose of BOOSTRIX. The immune response to SHINGRIX was measured by anti-gE Ab concentrations 1 month after the second dose of SHINGRIX. Concomitant administration showed no evidence for interference in the immune response to the antigen contained in SHINGRIX or the antigens contained in BOOSTRIX, with the exception of one of the pertussis antigens (pertactin), which did not satisfy the noninferiority criterion: the UL of the 95% CI for the adjusted GMC ratio (separate administration control group/concomitant administration group) for anti-pertactin antibody was 1.58 (noninferiority criterion <1.5). The clinical significance of the reduced immune response to pertactin is unknown.

15 REFERENCES

1.
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.
2.
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.
3.
Vitek CR and Wharton M. Diphtheria Toxoid. In: Plotkin SA, Orenstein WA, and Offit PA, eds. Vaccines. 5th ed. Saunders; 2008:139-156.
4.
Skoff TH, Blain AE, Watt J, et al. Impact of the US maternal tetanus, diphtheria, and acellular pertussis vaccination program on preventing pertussis in infants <2 months of age: a case-control evaluation. Clin Infect Dis. 2017; 65 (12): 1977-83.
5.
Bellido-Blasco J, Guiral-Rodrigo S, Míguez-Santiyán A, Salazar-Cifre A, González-Morán F. A case-control study to assess the effectiveness of pertussis vaccination during pregnancy on newborns, Valencian community, Spain, 1 March 2015 to 29 February 2016. Euro Surveill. 2017;22(22).
6.
Saul N, Wang K, Bag S, Baldwin H, Alexander K, Chandra M, et al. Effectiveness of maternal pertussis vaccination in preventing infection and disease in infants: The NSW Public Health Network case-control study. Vaccine. 2018;36(14):1887-1892.
7.
Uriarte PS, Rodríguez SSJ, Sancristobal IG, Agirre NM. Effectiveness of dTpa vaccination during pregnancy in preventing whooping cough in infants under 3 months of age. Bizkaia, Basque Country, Spain. Heliyon. 2019;5(2):e01207.
8.
Andrews A, Campbell H, Riberio S, Fry N, Amirthalingham G. Boostrix-IPV Report: Effectiveness of Maternal Pertussis Vaccination in Prevention of Confirmed Pertussis in Children in England Using the Screening Method Report to 30 September 2018. Public Health England. Unpublished. 2020.

16 HOW SUPPLIED/STORAGE AND HANDLING

BOOSTRIX is available in 0.5-mL single-dose vials and single-dose, disposable, prefilled TIP‑LOK syringes (Luer Lock syringes) packaged without needles. TIP-LOK syringes are to be used with Luer Lock compatible needles. The tip cap and rubber plunger stopper of the prefilled syringe are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex.

NDC 58160-842-01 Vial in Package of 10: NDC 58160-842-11

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.

17 PATIENT COUNSELING INFORMATION

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, SHINGRIX, 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

Durham, NC 27701

©2023 GSK group of companies or its licensor.

BTX:37PI

PRINCIPAL DISPLAY PANEL

NDC 58160-842-11

BOOSTRIX

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed

Tdap

Rx only

For 10 Years of Age and Older

10 x 0.5-mL Single-Dose Vials

GSK

Boostrix

Made in Belgium

©2022 the GSK group of companies or its licensor.

Rev. 2/23

513414

Boostrix 10 count carton
(click image for full-size original)
BOOSTRIX tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:58160-842
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5 [iU] in 0.5 mL
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 2.5 [iU] in 0.5 mL
BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) (BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED)) BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED) 8 ug in 0.5 mL
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 8 ug in 0.5 mL
BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) (BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)) BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED) 2.5 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
ALUMINUM HYDROXIDE
FORMALDEHYDE
SODIUM CHLORIDE
POLYSORBATE 80
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58160-842-11 10 VIAL in 1 CARTON contains a VIAL (58160-842-01)
1 NDC:58160-842-01 0.5 mL in 1 VIAL This package is contained within the CARTON (58160-842-11)
2 NDC:58160-842-52 10 SYRINGE in 1 CARTON contains a SYRINGE (58160-842-43)
2 NDC:58160-842-43 0.5 mL in 1 SYRINGE This package is contained within the CARTON (58160-842-52)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125106 07/24/2009
Labeler — GlaxoSmithKline Biologicals SA (372748392)

Revised: 10/2023 GlaxoSmithKline Biologicals SA

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