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Sponsors and Collaborators: |
Duke University Centers for Disease Control and Prevention |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00862810 |
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.
Condition |
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Cervical Cancer Genital Warts |
Study Type: | Observational |
Study Design: | Cross-Sectional |
Official Title: | Alternate Dosing Schedules Study for HPV Vaccine |
Serum
Estimated Enrollment: | 750 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1. Delayed 2nd Dose Group
Receives the second dose of HPV vaccine at longer than the recommended dosing interval and the third dose of HPV vaccine according to the recommended dosing interval
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2. Delayed 3rd Dose Group
Receives the second dose of HPV vaccine according to the recommended dosing interval and the third dose of HPV at longer than the recommended dosing interval
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3. Control Group
Receives second and third doses of HPV vaccine according to recommended dosing intervals
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Ages Eligible for Study: | 9 Years to 15 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Adolescent females attending primary care clinics in central North Carolina
Inclusion Criteria:
Must be receiving either a 3rd dose of HPV vaccine (All Groups) or a 2nd dose of HPV vaccine (Group 2 only)
Exclusion Criteria:
Contact: Emmanuel B Walter, MD | 919-620-5374 | walte002@mc.duke.edu |
United States, North Carolina | |
Duke Children's Primary Care | Recruiting |
Durham, North Carolina, United States, 27704 | |
Durham Pediatrics | Recruiting |
Durham, North Carolina, United States, 27704 | |
Regional Pediatrics | Recruiting |
Durham, North Carolina, United States, 27704 |
Principal Investigator: | Emmanuel B Walter, MD | Duke University |
Responsible Party: | Duke University Medical Center ( Emmanuel Walter MD, MPH ) |
Study ID Numbers: | Pro00014388, CDC#U36/CCU319276 CFDA 93.283 |
Study First Received: | March 15, 2009 |
Last Updated: | March 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00862810 History of Changes |
Health Authority: | United States: Institutional Review Board |
Human papillomavirus Cervical cancer Genital warts Vaccine Immunogenicity |
Virus Diseases Skin Diseases, Infectious Sexually Transmitted Diseases, Viral Warts Skin Diseases Condylomata Acuminata |
Condyloma Acuminatum Sexually Transmitted Diseases Condyloma DNA Virus Infections Papillomavirus Infections |
Skin Diseases, Viral Virus Diseases Skin Diseases, Infectious Sexually Transmitted Diseases, Viral Warts Skin Diseases |
Condylomata Acuminata Sexually Transmitted Diseases Tumor Virus Infections DNA Virus Infections Papillomavirus Infections |