Boostrix FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 12, 2022.
FDA Approved: Yes (First approved May 3, 2005)
Brand name: Boostrix
Generic name: tetanus, diphtheria, acellular pertussis vaccine (Tdap)
Dosage form: Injection
Treatment for: Diphtheria Prophylaxis, Tetanus Prophylaxis, Pertussis Prophylaxis
Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed; Tdap) is a combination vaccine that provides immunization against pertussis (whooping cough) in combination with tetanus and diphtheria.
- Boostrix is indicated for active booster immunization against tetanus, diphtheria, and pertussis in individuals aged 10 years and older; and immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age.
- Boostrix is administered via intramuscular injection.
- 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.
Development timeline for Boostrix
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