Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Prevention	Active	9 to 15	Other	Pro00014388 CDC#U36/CCU319276 CFDA 93.283, NCT00862810

Trial Description

Summary

To determine if recombinant human papillomavirus (HPV) quadrivalent (Types 6, 11, 16, and 18) vaccine administered according to two pre-specified longer dosing intervals in 9-15 year old girls elicits an equivalent immune responses (geometric mean titers to HPV 6,11,16, and 18 measured one month after receipt of a 3rd dose of HPV vaccine) to vaccine delivered according to the recommended dosing schedule. This is a cross sectional study of healthy 9-15 year old female patients (n=750) who are receiving either a second or third dose of HPV vaccine as part of their well child care at one of several local pediatric practices. Immune responses to HPV types 6, 11, 16 and 18 will be measured both before and 1 month after the third dose of HPV vaccine with the purpose of comparing the immune responses to HPV vaccine when administered at naturally occurring longer dosing intervals to the immune response to HPV vaccine when administered as routinely recommended. Needle associated fear and anxiety will be measured in subjects prior to receipt of a 3rd dose of HPV vaccine and pain assessments will be done prior to and following receipt of a the 3rd dose of HPV vaccine.

Eligibility Criteria

Inclusion Criteria:

1. A healthy, medically well female between the ages of 9 - 15 years. (Must be between 9 years and younger than 16 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)

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Duke Comprehensive Cancer Center

Emmanuel B Walter, MD

Principal Investigator

Emmanuel B Walter, MD		Ph: 919-620-5374
		Email: walte002@mc.duke.edu

U.S.A.
North Carolina
	Durham
	Duke Comprehensive Cancer Center
	Durham Pediatrics
	Regional Pediatric Associates, PA

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00862810
Information obtained from ClinicalTrials.gov on May 13, 2009