Gardasil
STN: 125126
Proper Name: Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
Tradename: Gardasil
Manufacturer: Merck & Co., Inc
Indications:
- Prevention of vulvar and vaginal cancer
- Vaccination in females 9 through 26 years of age for prevention of the following diseases caused by Human Papillomavirus (HPV) Types 6, 11, 16, and 18:
- Cervical cancer
- Genital warts (condyloma acuminata) and the following precancerous or dysplastic lesions:
- Cervical adenocarcinoma in situ (AIS)
- Cervical intraepithelial neoplasia (CIN) grade 2 and grade 3
- Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3
- Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3
- Cervical intraepithelial neoplasia (CIN) grade 1
- Vaccination in boys and men 9 through 26 years of age for the prevention of genital warts caused by HPV types 6 and 11
- Vaccination in people ages 9 through 26 years for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18
Product Information
Supporting Documents
- Approval History, Letters, Reviews, and Related Documents - Gardasil
- Supporting Documents older than three years - Gardasil
Related Information
- FDA Information on Gardasil - Presence of DNA Fragments Expected, No Safety Risk
- Gardasil Vaccine Safety
- Reports of Health Concerns Following HPV Vaccination (CDC)
- FDA Sentinel study finds no association between venous thromboembolism and Gardasil vaccination
- Two FDA CBER Mini-Sentinel Studies Completed on the Safety of Gardasil and Rotavirus Vaccines