Alternate Dosing Schedules Study for HPV Vaccine
Condition: Cervical Cancer; Genital Warts
MeSH terms: Condylomata Acuminata; Uterine Cervical Neoplasms
Intervention: Received HPV vaccine first; Received concomitant vaccines first
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: Female
Minimum age: 9 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Human papillomavirus; Cervical cancer; Genital warts; Vaccine; Immunogenicity

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.
    

Eligibility 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