Status:
COMPLETED
Alternate Dosing Schedules Study for HPV Vaccine
Lead Sponsor:
Duke University
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
Cervical Cancer
Genital Warts
Eligibility:
FEMALE
9-18 years
Phase:
PHASE4
Brief Summary
To determine if delayed dosing of recombinant human papillomavirus (HPV) quadrivalent (Types 6, 11, 16, and 18) vaccine in 9-18 year old girls elicits an equivalent immune response (geometric mean tit...
Eligibility Criteria
Inclusion
- 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
- 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)
- 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.
- Parent/guardian provides informed consent
- Anticipated ability and willingness to complete all study visits and evaluations
Exclusion
- Unable to comply with the study protocol
- Receipt of three or more doses of HPV vaccine or receipt of doses of HPV vaccine outside the pre-specified time windows
- Receipt of blood and or blood products (including immunoglobulin) in the past 3 months or anticipated receipt during the study period
- 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
- History of any physical, mental, or developmental disorder that study personnel believe may hinder a participant's ability to comply with the study requirements
- History of malignancy or confirmed or suspected immunodeficient condition such as HIV infection
- 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.
- Current or former participation in HPV vaccine related research.
- Receipt of an investigational or alternate HPV vaccine
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00862810
Start Date
March 1 2009
End Date
September 1 2012
Last Update
November 20 2014
Active Locations (3)
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1
Chapel Hill Pediatrics
Chapel Hill, North Carolina, United States, 27514
2
Duke Children's Primary Care
Durham, North Carolina, United States, 27704
3
Durham Pediatrics
Durham, North Carolina, United States, 27704