Gardasil HPV Vaccine Description

Merck's Gardasil vaccine consists of 4 proteins of HPV types 6, 11, 16, and 18, amorphous aluminum hydroxyphosphate sulfate, yeast protein, sodium chloride, L-histidine, polysorbate 80, sodium borate, and water.

The U.S. FDA initially approved Gardasil for use in the USA on June 8, 2006, and a final approval letter was issued on April 24, 2015.

Gardasil is endorsed by the WHO, which says HPV vaccines prevent cervical cancer by preventing infection by various HPV types. Two HPV vaccines are currently prequalified by WHO - a bivalent and a quadrivalent vaccine.

Both vaccines are highly efficacious in preventing infection with virus types 16 and 18, which are together responsible for approximately 70% of cervical cancer cases globally.

The quadrivalent vaccine is also highly efficacious in preventing anogenital warts, a common genital disease which is virtually always caused by infection with HPV types 6 and 11.

Merck & Co., Inc., d.b.a. Merck Sharp & Dohme outside the United States and Canada is an American multinational pharmaceutical company and one of the largest pharmaceutical companies in the world. Merck is incorporated in New Jersey.

Gardasil HPV Vaccine Indication

Gardasil is a vaccine indicated in girls and women 9 through 26 years of age for the prevention of the following diseases caused by 4 Human Papillomavirus (HPV) types included in the vaccine. 

• Cervical, vulvar, vaginal, and anal cancer caused by HPV types 16 and 18.
• Genital warts (condyloma acuminata) caused by HPV types 6 and 11.

And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18: 

• Cervical intraepithelial neoplasia (CIN) grade 2/3 and Cervical adenocarcinoma in situ (AIS)
• Cervical intraepithelial neoplasia (CIN) grade 1  
• Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3
• Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3
• Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3

Gardasil is indicated in boys and men 9 through 26 years of age for the prevention of the following diseases caused by HPV types included in the vaccine:

• Anal cancer caused by HPV types 16 and 18
• Genital warts (condyloma acuminata) caused by HPV types 6 and 11

And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, and 18

• Anal intraepithelial neoplasia (AIN) grades 1, 2, and 3

Gardasil HPV Vaccine Dosage

Gardasil should be administered intramuscularly as a 0.5-mL dose at the following schedule: 0, 2 months, 6 months.

Gardasil is not available in the USA. Gardasil 9 is the HPV vaccine in the US.

Gardasil HPV Vaccine Clinical Trials

The review of this vaccine was associated with the following National Clinical Trial number(s): NCT00092534, NCT00092547, NCT00090220, and NCT00090285.