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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

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Resources for You

Gardasil

Proper Name: Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant
Tradename: Gardasil
Manufacturer: Merck & Co., Inc, License #0002
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
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Supporting Documents

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Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448