Institute for Vaccine Safety - Human Papillomavirus

Excipients Table
Allergens Table
Components Table

Indication	For the prevention, in females 10-25 years of age, of the following diseases caused by oncogenic human papillomavirus (HPV) types 16 and 18: • cervical cancer • cervical intraepithelial neoplasia (CIN) grade 2 or worse and adenocarcinoma in situ • cervical intraepithelial neoplasia (CIN) grade 1.	For the prevention, in girls and women 9-26 years of age, of the following diseases caused by Human Papillomavirus (HPV) types included in the vaccine: · Cervical, vulvar, and vaginal 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
Proprietary Name	Cervarix	Gardasil
Manufacturer	GlaxoSmithLKline	Merck
Viability	Inactivated	Inactivated
Microorganism		Saccharomyces cerevisiae
Dose	0.5 mL	0.5 mL
Schedule	0, 1, 6 months	0, 2, 6 months
Route	Intramuscular	Intramuscular
Dose form	Suspension	Suspension
Appearance	turbid, white suspension	White, cloudy liquid
Concentration (per 0.5 mL)	HPV type 16 L1 protein, 20 mcg HPV type 18 L1 protein, 20 mcg	HPV 6 L1 protein, 20 mcg HPV 11 L1 protein, 40 mcg HPV 16 L1 protein, 40 mcg HPV 18 L1 protein, 20 mcg
Preservatives	None	None
Adjuvants	Sodium chloride, 4.4 mg Sodium dihydrogen phosphate dihydrate, 0.624 mg	Amorphous aluminum hydroxyphosphate sulfate, 225 mcg aluminum
Excipients	3-O-desacyl-4’-monophosphoryl lipid A (MPL), 50 mcg Aluminum hydroxide, 0.5 mg May also contain residual amounts of: insect cell and viral protein, <40 ng Bacterial cell protein, <150 ng	Polysorbate 80, 50 mcg Sodium Borate, 35 mcg Sodium Chloride, 9.56 mg Yeast
Allergens	Tip cap and rubber plunger of the needleless prefilled syringes contain dry natural latex rubber	"The VLPs are released from the yeast cells by cell disruption and purified by a series of chemical and physical methods."
Media	Serum-free culture media composed of chemically-defined lipids, vitamins, amino acids, and mineral salts	Peptone-based Mueller and Miller (modified)
Packaging	Single-dose (0.5 mL) vials Disposable TIP-LOK syringes	Single-dose (0.5 mL) vials Disposable prefilled syringes
Routine storage	2 to 8° C (36-46° F) Do Not Freeze	2 to 8° C (36-46° F) Do Not Freeze
*updated* May 2010

This page was last updated on February 15, 2013