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Institute for Vaccine Safety

Johns Hopkins Bloomberg School of Public Health

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Components of
HPV Vaccine

Excipients Table
Allergens Table
Components Table

Indication

For the prevention, in females 9-25 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

CIN grade 1

For the prevention, in girls and women 9-26 years of age, of the following diseases caused by HPV types included in the vaccine:

  Cervical, vulvar, and vaginal cancer caused by HPV 16 and 18

  Genital warts (condyloma acuminata) caused by HPV 6 and 11

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

  CIN grade 2/3 and Cervical adenocarcinoma in situ

  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

For the prevention, in boys and men 9-26 years of age, of the following diseases caused by HPV types included in the vaccine:

Anal cancer caused by HPV 16 and 18

Genital warts (condyloma acuminata) caused by HPV 6 and 11

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

  AIN grades 1, 2, and 3

Proprietary Name

Cervarix

Gardasil

Manufacturer

GlaxoSmithLKline

Merck

Viability

Inactivated

Inactivated

Dose

0.5 mL

0.5 mL

Route

Intramuscular

Intramuscular

Dose form

Suspension

Suspension

Appearance

Homogeneous, turbid, white suspension.  Upon storage, a fine, white deposit with a clear, colorless supernatant may be observed. This does not constitute a sign of deterioration

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

L-histindine, 0.78 mg

Sodium Borate, 35 mcg

Sodium Chloride, 9.56 mg

Yeast, <7 mcg 

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

PI updated

Aug 2012

Mar 2013

updated Sep 2013

This page was last updated on September 27 2013

2014 Institute for Vaccine Safety