Alternate Dosing Schedules Study for HPV Vaccine

Inclusion Criteria:

1. A healthy, medically well female between the ages of 9 - 18 years. (Must be between
9 years and younger than 19 years of age) at time of enrollment

2. Must be receiving either a 3rd dose of HPV vaccine (All Groups) or a 2nd dose of HPV
vaccine (Group 2 only)

- For Group 1 - EITHER 1) The second dose of HPV vaccine must not have been
administered and it must be within the specified dosing interval for the second
dose of HPV vaccine (> 90 days since the first dose of HPV vaccine) OR 2) The
second dose of HPV vaccine must have been administered > 90 days after the first
dose of HPV vaccine and it must be within the specified dosing interval for the
third dose of HPV vaccine (> 60 days - < 180 days since the second dose of HPV)

- For Group 2 - The second dose of HPV vaccine must have been administered > 30
days and < 90 days after the first dose of HPV vaccine and it must be within the
specified dosing interval for the third dose (> 180 days since the second dose
of HPV)

- For Group 3 - The second dose of HPV vaccine must have been administered > 30
days and < 90 days after the first dose of HPV vaccine and it must be within the
specified dosing interval for the third dose (> 60 days - < 180 days since the
second dose of HPV)

- For Group 4- The second dose of HPV vaccine must have been administered > 90
days after the first dose of HPV of HPV vaccine and it must be within the
specified dosing interval for the third dose (> 180 days since the second dose
of HPV)

3. Ability and willingness to participate in the study by providing written informed
assent. Verbal assent is acceptable for subjects less than 12 years of age.

4. Parent/guardian provides informed consent

5. Anticipated ability and willingness to complete all study visits and evaluations

Exclusion Criteria:

1. Unable to comply with the study protocol

2. Receipt of three or more doses of HPV vaccine or receipt of doses of HPV vaccine
outside the pre-specified time windows

3. Receipt of blood and or blood products (including immunoglobulin) in the past 3
months or anticipated receipt during the study period

4. Receipt of a live virus vaccine (varicella virus containing vaccine, any measles,
mumps, or rubella virus containing vaccine such as MMR, or yellow fever vaccine but
not including live attenuated influenza virus vaccine) within 4 weeks of receipt of
the 3rd dose of HPV vaccine or anticipated receipt of a live virus vaccine within 4
weeks after the 3rd dose of HPV vaccine

5. History of any physical, mental, or developmental disorder that study personnel
believe may hinder a participant's ability to comply with the study requirements

6. History of malignancy or confirmed or suspected immunodeficient condition such as HIV
infection

7. Receipt of or history of receipt of any medications or treatments that affect the
immune system, such as immune globulin, interferon, immunomodulators, cytotoxic drugs
or other drugs known to be frequently associated with significant major organ
toxicity since six months prior to the first HPV vaccine dose. Receipt of long-term
(greater than or equal to 2 weeks) potentially immunosuppressive corticosteroid use
within six months prior to HPV vaccine dose 1 and enrollment or anticipated receipt
during the study period. Specifically, potentially immunosuppressive corticosteroids
are any parenteral corticosteroid, high dose (>800 mcg/day) beclomethasone
dipropionate or equivalent medication. Nasal and topical steroids are allowed.

8. Current or former participation in HPV vaccine related research.

9. Receipt of an investigational or alternate HPV vaccine