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View Clinical Trial (Medical Research Study)
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Immunogenicity of Off-Schedule Dosing of HPV Vaccine - NCT01030562-15241 (Clinical Trial 447155)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy447155.aspx
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| City: |
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Pittsburgh |
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State:
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PA |
| Zip Code: |
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15241 |
| Conditions: |
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Human Papillomavirus |
| Purpose: |
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The purpose of this study is to gain a better understanding of the body's response to a
human papillomavirus (HPV) (sexually transmitted disease), vaccine and booster shot. The
study will also determine factors related to adolescents not following vaccination
schedules. The HPV vaccine requires 3 doses (shots). Girls sometimes receive the 3 shots at
the recommended time and sometimes girls receive the shots at non-recommended times. This
study will evaluate if getting the shots at non-recommended times affects the level of
protection provided by the vaccine. Participants will include about 1400 girls 9-17 years
old receiving a third dose of HPV vaccine from their primary care clinician. The
parent/legal guardian of each subject will answer a questionnaire related to the vaccine
schedule. Study procedures include: medical history, questionnaires and blood draws.
Participants will be involved in the study for about 6 months from time of enrollment.
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| Study summary: |
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The immune response to the quadrivalent Human Papillomavirus (HPV) vaccine in the
non-clinical trial settings is unknown. In addition, the immune response following
administration of vaccine at substantially prolonged intervals is unknown. Early indications
suggest that many girls will be receiving the vaccine at prolonged intervals and that this
timing may affect immunogenicity. The lack of knowledge about the immunogenicity of
prolonged intervals between vaccine doses precludes evidence based recommendations for
patients who are substantially late for their second or third dose. Some clinicians
currently restart the series while others give the doses at the incorrect interval
(unpublished observation) without the ability to counsel their patients as to their expected
level of immune response or protection. Examining the immune response prior to the third
dose and at one and six months after the third dose will allow a better understanding of the
immunogenicity of this vaccine and immune response to booster doses. Furthermore,
determining factors related to non-adherence in the adolescent age group is important and
timely. As an increasing number of vaccines are being recommended to the adolescent age
group, elucidating factors involved with non-adherence to the recommended dosing schedule is
now critical. This information can guide interventions that aim to increase adolescent
adherence to the recommended schedules. Eligible girls 9 - 17 years old receiving the
quadrivalent HPV vaccine from their primary care provider will be enrolled into this study
on the day of, but prior to, receiving their third HPV vaccine dose. Blood for
immunogenicity testing will be obtained up to three times throughout the study: one month
and six months after the third dose for all subjects and just prior to the third dose for
subjects on time for their third dose (regardless of the time interval between the first and
second dose). The primary analysis will be based on comparing the Geometric Mean Titer
(GMTs) and seroresponse rate of subjects receiving the vaccine doses at substantially
prolonged intervals to GMTs and seroresponse rate of subjects receiving the second and third
dose on time. In addition, on Study Day 0, patient and parent related factors known to
impact health care utilization will be measured using a questionnaire given to parents/legal
guardians and 14 to 17 year old subjects. Analysis based on a health care utilization model
will be used to determine factors associated with non-adherence to the vaccine schedule.
Initially, all subjects meeting eligibility criteria will be enrolled regardless of timing
of the second and third vaccine doses. When an arm accrues the assigned number of subjects
completing study visit 2 (one month post dose 3), enrollment into that arm will be closed.
Enrollment for the entire study will remain open until the control arm and experimental arms
have each accrued 211 subjects successfully completing visit 2. When two experimental arms
near final accrual goals, assessment of the potential for the third arm to reach 211
subjects will be assessed to ensure timely accrual will occur. The primary objective is to
compare the GMT one month after completing the three dose vaccination series in 9 to 17 year
old subjects who received the second and/or third dose at substantially prolonged intervals
to subjects who receive both the second and third dose on time after adjusting for age. |
| Criteria: |
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Inclusion Criteria:
Girls will be eligible if they are:
- 9 to 17 years of age (defined as between 9 years 0 days and younger than 18 years of
age);
- Receiving the third human papillomavirus (HPV) vaccine as part of routine health
care;
- Able and willing to complete all study visits and evaluations;
- Able and willing to participate in the study by providing written informed
assent/consent (as applicable);
- Parent or legal guardian provides permission (as applicable).
Parent/legal guardian:
Parent or legal guardian providing permission for their daughter to participate in the
study will be eligible to participate in the parental questionnaire if they are able to
provide informed consent for themselves.
Exclusion Criteria:
Girls meeting any of the following exclusion criteria at baseline will be excluded from
study participation.
- Unable to comply with the study protocol.
- Receipt of three or more doses of human papillomavirus (HPV) vaccine.
- Receipt of blood and or blood products (including immunoglobulin) in the past 3
months or anticipated receipt during the study period.
- 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
human immunodeficiency virus 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 or anticipated receipt during the study period.
Specifically, potentially immunosuppressive corticosteroids or 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.
- Receipt of a live virus vaccine (varicella virus vaccine, any measles, mumps, or
rubella virus vaccine, or yellow fever vaccine but not including live attenuated
influenza virus vaccine) within 4 weeks before or after the 3rd dose of HPV vaccine
or anticipated receipt of a live virus vaccine within 4 weeks after the 3rd dose of
HPV vaccine. However, subjects may receive any vaccine on the same day as the third
dose of HPV.
Parent/legal guardian exclusion criteria:
- Parents/legal guardians meeting any of the following exclusion criteria at baseline
will be excluded from filling out the study questionnaire examining factors
associated with adherence:
- History of any physical, mental or developmental disorder that study personnel
believe may hinder a participant's ability to comply with study requirements. |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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