Gardasil 9
STN: 125508
Proper Name: Human Papillomavirus 9-valent Vaccine, Recombinant
Tradename: Gardasil 9
Manufacturer: Merck & CO., Inc.
Indications:
Indicated in girls and women 9 through 45 years of age for the prevention of the following diseases:
- Cervical, vulvar, vaginal, and anal cancer caused by Human Papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58. (1.1)
- Genital warts (condyloma acuminata) caused by HPV types 6 and 11. (1.1)
And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
- Cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical adenocarcinoma in situ (AIS). (1.1)
- Cervical intraepithelial neoplasia (CIN) grade 1. (1.1)
- Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3. (1.1)
- Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3. (1.1)
- Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3. (1.1)
GARDASIL 9 is indicated in boys and men 9 through 45 years of age for the prevention of the following diseases:
- Anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58. (1.2)
- Genital warts (condyloma acuminata) caused by HPV types 6 and 11. (1.2)
And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58:
- Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3. (1.2)
Product Information
Supporting Documents
- October 5, 2018 Approval Letter - Gardasil 9
- October 5, 2018 Summary Basis of Regulatory Action - GARDASIL 9
- February 9, 2018 Approval Letter - Gardasil 9
To revise Sections 2.3 and 14.4 of the Gardasil 9 package insert to clarify information regarding the study conducted to assess the safety and immunogenicity of Gardasil 9 in individuals who were previously vaccinated with Gardasil. - Statistical Review - GARDASIL 9
- Clinical Review - GARDASIL 9
- October 7, 2016 Approval Letter - GARDASIL 9
To include a 2-dose regimen for individuals 9 through 14 years of age. - October 6, 2016 Summary Basis of Regulatory Action - GARDASIL 9
- December 14, 2015 Summary Basis of Regulatory Action - GARDASIL 9
- December 14, 2015 Approval Letter - GARDASIL 9
To extend the indication by including boys and men 16 through 26 years of age. - December 10, 2014 Approval Letter -GARDASIL 9
- December 9, 2014 Summary Basis for Regulatory Action - GARDASIL 9
- Clinical Review (STN 125508/0) - GARDASIL 9
- Statistical Review (STN 125508/0) - GARDASIL 9
- Approval History, Letters, Reviews, and Related Documents - GARDASIL 9