Boostrix (Tdap) Consent

Last Updated: Nov 15, 2023
———

Description of Boostrix (Tdap Vaccine)

BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) is a noninfectious, sterile, vaccine for intramuscular administration. It contains tetanus toxoid, diphtheria toxoid, and pertussis antigens (inactivated pertussis toxin [PT] and formaldehyde-treated FHA and PRN). The antigens are the same as those in INFANRIX, but BOOSTRIX is formulated with reduced quantities of these antigens.

  • Tetanus toxin is produced by growing Clostridium tetani (C. tetani) in a modified Latham medium derived from bovine casein. The diphtheria toxin is produced by growing Corynebacterium diphtheriae (C. diphtheriae) in Fenton medium containing a bovine extract. The bovine materials used in these extracts are sourced from countries which the United States Department of Agricultl;54ure (USDA) has determined neither have nor are at risk of bovine spongiform encephalopathy (BSE). Both toxins are detoxified with formaldehyde, concentrated by ultrafiltration, and purified by precipitation, dialysis, and sterile filtration. 19 The acellular pertussis antigens (PT, FHA, and PRN) are isolated from Bordetella pertussis (B. pertussis) culture grown in modified Stainer-Scholte liquid medium. PT and FHA are isolated from the fermentation broth; PRN is extracted from the cells by heat treatment and flocculation. The antigens are purified in successive chromatographic and precipitation steps. PT is detoxified using glutaraldehyde and formaldehyde. FHA and PRN are treated with formaldehyde.

  • Each antigen is individually adsorbed onto aluminum hydroxide. Each 0.5-mL dose is formulated to contain 5 Lf of tetanus toxoid, 2.5 Lf of diphtheria toxoid, 8 mcg of inactivated PT, 8 mcg of FHA, and 2.5 mcg of PRN (69 kiloDalton outer membrane protein).

  • Tetanus and diphtheria toxoid potency is determined by measuring the amount of neutralizing antitoxin in previously immunized guinea pigs. The potency of the acellular pertussis components (inactivated PT and formaldehyde-treated FHA and PRN) is determined by enzyme linked immunosorbent assay (ELISA) on sera from previously immunized mice.

  • Each 0.5-mL dose contains aluminum hydroxide as adjuvant (formulated to contain 0.3 mg aluminum) and 4.4 mg of sodium chloride. The aluminum content is measured by assay. Each dose also contains ≤100 mcg of residual formaldehyde and ≤100 mcg of polysorbate 80 (Tween 80).

  • BOOSTRIX is available in vials and prefilled syringes. The tip caps of the prefilled syringes contain natural rubber latex; the plungers are not made with natural rubber latex. The vial stoppers are not made with natural rubber latex. BOOSTRIX is formulated without preservatives.

Contraindications

Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any tetanus toxoid-, diphtheria toxoid-, or pertussis antigen-containing vaccine or to any component of BOOSTRIX. Encephalopathy within 7 days of administration of a previous pertussis antigen-containing vaccine.

Warnings and Precautions

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

  • 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.

  • Progressive or unstable neurologic conditions are reasons to defer vaccination with a pertussis-containing vaccine, including BOOSTRIX.

  • Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine should not receive BOOSTRIX unless at least 10 years have elapsed since the last dose of a tetanus toxoid-containing vaccine

Adverse Reactions

Common solicited adverse reactions (≥15%) in adolescents (aged 10 to 18 years) were pain, redness, and swelling at the injection site; increase in arm circumference of the injected arm; headache; fatigue; and gastrointestinal symptoms.

Common solicited adverse reactions (≥15%) in adults (aged 19 to 64 years) were pain, redness, and swelling at the injection site; headache; fatigue; and gastrointestinal symptoms.

The most common solicited adverse reaction (≥15%) in the elderly (aged 65 years and older) was pain at the injection site.

*To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.*

Pre-Vaccination Telehealth Screening

I consent to a telehealth screening appointment with a healthcare provider. A consultation is required prior to the vaccine to assure the safety and discuss any possible questions related to the vaccine.

Post Vaccination On-Site Monitoring

The post vaccination on-site monitoring pertains to all persons receiving a vaccine. This consists of remaining on the premises for 15 minutes after vaccination, so that staff may monitor you for any adverse reactions. This is recommended for the benefit of the patient, as with any vaccination there is always a rare risk or fainting or an allergic reaction. Note that an individual may refuse or leave early, so long as they understand we will be unable to monitor them.

Consent for Services

I have been presented with and read (or read to me) the Vaccine Information Statement(s), Vaccine Information Fact Sheet(s) and/or Patient Fact Sheet(s) relating to the vaccine(s). I acknowledge the risks and benefits of vaccination. I willingly assume full responsibility for any reactions or consequences that may result. I request the vaccine be administered to me (or the person named, whom I am authorized to make this request). In the event of any side effects, I understand I should contact the pharmacy, my doctor, or call 911. I certify that the information provided regarding eligibility for the vaccine is accurate. State of California only: I agree to have CAIR share my immunization data with Health Care Providers, schools or agencies.

Authorization to Request Insurance

I authorize Rume Health to release medical information to Medicaid, Medicare, or any other third party payer as required and to request payment of authorized benefits made on my behalf to Rume Health. I verify that the information given regarding my Medicaid, Medicare, or other coverages is accurate.

Disclosure of Records

I understand that Rume Health may be required to or voluntarily disclose my health information with regard to this vaccine to my healthcare providers, insurance plan, or other third party payer, hospitals, health systems, and/or federal or state registries. I understand that Rume Health will disclose and use my health information as set forth in the Rume Use and Disclosure of Health Information Document (copy available online or physical copy per request).

By consenting, I am indicating my consent to the vaccination as indicated above. I have read through this entire consent form and have the had the opportunity to ask questions and get answers prior. I acknowledge my written/electronic signature is the legal equivalent of my manual signature of this agreement. If I am consenting on behalf of another person (including a minor), I certify that I have the authority to do so.