Participant flow

HPV Vaccine Therapy in Interrupting Progression in Patients With High-Grade Vulvar or Anal Lesions · Source last updated 2024-02-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM

   id

   FG000

   title

   Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)

2. description

   Patients receive placebo IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Placebo Administration: Given IM Questionnaire Administration: Ancillary studies

   id

   FG001

   title

   Arm II (Placebo)

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         93

      2. group Id

         FG001

         num Subjects

         95

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         93

      2. group Id

         FG001

         num Subjects

         95

      type

      Vaccination 1

   3. achievements

      1. group Id

         FG000

         num Subjects

         91

      2. group Id

         FG001

         num Subjects

         94

      type

      Vaccination 2

   4. achievements

      1. group Id

         FG000

         num Subjects

         83

      2. group Id

         FG001

         num Subjects

         90

      type

      Vaccination 3

   5. achievements

      1. group Id

         FG000

         num Subjects

         80

      2. group Id

         FG001

         num Subjects

         87

      type

      Month 7 Follow-Up

   6. achievements

      1. group Id

         FG000

         num Subjects

         78

      2. group Id

         FG001

         num Subjects

         81

      type

      Month 12 Follow-Up

   7. achievements

      1. group Id

         FG000

         num Subjects

         66

      2. group Id

         FG001

         num Subjects

         75

      type

      Month 18 Follow-Up

   8. achievements

      1. group Id

         FG000

         num Subjects

         59

      2. group Id

         FG001

         num Subjects

         70

      type

      Month 24 Follow-Up

   9. achievements

      1. group Id

         FG000

         num Subjects

         44

      2. group Id

         FG001

         num Subjects

         53

      type

      Month 36 Follow-Up

   10. achievements

       1. group Id

          FG000

          num Subjects

          38

       2. group Id

          FG001

          num Subjects

          42

       type

       COMPLETED

   11. achievements

       1. group Id

          FG000

          num Subjects

          55

       2. group Id

          FG001

          num Subjects

          53

       type

       NOT COMPLETED

   title

   Overall Study

recruitment Details

Study recruitment was open between August 2017 and December 2021. Potential participants were recruited through the Fred Hutchinson Cancer Surveillance System and referral by local healthcare providers. Screening took place via phone interviews and in-person visits at the study clinics. Enrollment took place at the two study clinics: Virology Research Center at the University of Washington, and the Center for Women's Reproductive Health at the University of Alabama Birmingham.

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Preserved source evidence · Not medical advice