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Alternate Dosing Schedules Study for HPV Vaccine (ADS)

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ClinicalTrials.gov Identifier: NCT00862810
Recruitment Status : Completed
First Posted : March 17, 2009
Results First Posted : September 25, 2014
Last Update Posted : November 20, 2014
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Duke University

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 titers to HPV 6,11,16, and 18 as measured one month after receipt of a 3rd dose of HPV vaccine) when compared to vaccine delivered according to the recommended dosing schedule. This is a prospective observational study of healthy 9-18 year old female patients receiving either a second or third dose of HPV vaccine as part of their well child care. 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.

Girls receiving a 3rd dose of HPV vaccine in addition to concomitantly administered vaccines by injection were randomized to receive either the HPV vaccine first or their concomitantly administered vaccines first. Pain following vaccination was assessed in each arm using the Faces Pain Scale - Revised.

Please note: This record refers only to the randomized portion of the study where pain following vaccination was assessed. Please refer to NCT02280642 for the observational portion of the study.


Condition or disease Intervention/treatment Phase
Cervical Cancer Genital Warts Biological: Received HPV vaccine first Biological: Received concomitant vaccines first Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Alternate Dosing Schedules Study for HPV Vaccine
Study Start Date : March 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
Received HPV vaccine first Biological: Received HPV vaccine first
Received concomitant vaccines first Biological: Received concomitant vaccines first



Primary Outcome Measures :
  1. Pain Following HPV Vaccine [ Time Frame: 10 minutes following vaccination ]

    Participants with Faces Pain Scale - Revised (FPS-R) score higher in arm where HPV received compared to arm where concomitant vaccines received.

    The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain.




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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862810


Locations
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United States, North Carolina
Chapel Hill Pediatrics
Chapel Hill, North Carolina, United States, 27514
Duke Children's Primary Care
Durham, North Carolina, United States, 27704
Durham Pediatrics
Durham, North Carolina, United States, 27704
Sponsors and Collaborators
Duke University
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Emmanuel B Walter, MD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00862810     History of Changes
Other Study ID Numbers: Pro00014388
CDC#U36/CCU319276 CFDA 93.283
First Posted: March 17, 2009    Key Record Dates
Results First Posted: September 25, 2014
Last Update Posted: November 20, 2014
Last Verified: September 2014

Keywords provided by Duke University:
Human papillomavirus
Cervical cancer
Genital warts
Vaccine
Immunogenicity

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Condylomata Acuminata
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs