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NCT00543543 · FLOW

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Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) · Source last updated 2018-11-27

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

groups
  1. description
    V503 (9-Valent Human Papillomavirus \[HPV\] Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
    id
    FG000
    title
    Low-dose V503
  2. description
    V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
    id
    FG001
    title
    Mid-dose V503
  3. description
    V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
    id
    FG002
    title
    High-dose V503
  4. description
    Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
    id
    FG003
    title
    Gardasil
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        5
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        749
      3. group Id
        FG002
        num Subjects
        9
      4. group Id
        FG003
        num Subjects
        701
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        7
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        6
      type
      Protocol Violation
    5. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        482
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        503
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        315
      2. group Id
        FG001
        num Subjects
        7106
      3. group Id
        FG002
        num Subjects
        310
      4. group Id
        FG003
        num Subjects
        7109
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        300
      2. group Id
        FG001
        num Subjects
        6928
      3. group Id
        FG002
        num Subjects
        297
      4. group Id
        FG003
        num Subjects
        6934
      type
      Completed 3 Vaccinations
    3. achievements
      1. comment
        Follow-up was up to 7 months
        group Id
        FG000
        num Subjects
        295
      2. comment
        Follow-up was up to 54 months
        group Id
        FG001
        num Subjects
        5854
      3. comment
        Follow-up was up to 7 months
        group Id
        FG002
        num Subjects
        296
      4. comment
        Follow-up was up to 54 months
        group Id
        FG003
        num Subjects
        5887
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        1252
      3. group Id
        FG002
        num Subjects
        14
      4. group Id
        FG003
        num Subjects
        1222
      type
      NOT COMPLETED
    title
    Base Study
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        5
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        77
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        7
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        6
      type
      Pregnancy
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        11
      type
      Protocol Violation
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        120
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. comment
        This group did not participate in the Extension Study
        group Id
        FG000
        num Subjects
        0
      2. comment
        Cohort 1
        group Id
        FG001
        num Subjects
        150
      3. comment
        This group did not participate in the Extension Study
        group Id
        FG002
        num Subjects
        0
      4. comment
        Cohort 2
        group Id
        FG003
        num Subjects
        3050
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        150
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2824
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        226
      type
      NOT COMPLETED
    title
    Extension Study
pre Assignment Details
A total of 15,334 participants were screened and 14,840 were randomized into the study.
Complete source fields
groups
  1. description
    V503 (9-Valent Human Papillomavirus \[HPV\] Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
    id
    FG000
    title
    Low-dose V503
  2. description
    V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
    id
    FG001
    title
    Mid-dose V503
  3. description
    V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
    id
    FG002
    title
    High-dose V503
  4. description
    Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
    id
    FG003
    title
    Gardasil
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        11
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        5
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        749
      3. group Id
        FG002
        num Subjects
        9
      4. group Id
        FG003
        num Subjects
        701
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        7
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        6
      type
      Protocol Violation
    5. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        482
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        503
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        315
      2. group Id
        FG001
        num Subjects
        7106
      3. group Id
        FG002
        num Subjects
        310
      4. group Id
        FG003
        num Subjects
        7109
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        300
      2. group Id
        FG001
        num Subjects
        6928
      3. group Id
        FG002
        num Subjects
        297
      4. group Id
        FG003
        num Subjects
        6934
      type
      Completed 3 Vaccinations
    3. achievements
      1. comment
        Follow-up was up to 7 months
        group Id
        FG000
        num Subjects
        295
      2. comment
        Follow-up was up to 54 months
        group Id
        FG001
        num Subjects
        5854
      3. comment
        Follow-up was up to 7 months
        group Id
        FG002
        num Subjects
        296
      4. comment
        Follow-up was up to 54 months
        group Id
        FG003
        num Subjects
        5887
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        1252
      3. group Id
        FG002
        num Subjects
        14
      4. group Id
        FG003
        num Subjects
        1222
      type
      NOT COMPLETED
    title
    Base Study
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        5
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        77
      type
      Lost to Follow-up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        7
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        6
      type
      Pregnancy
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        11
      type
      Protocol Violation
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        120
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. comment
        This group did not participate in the Extension Study
        group Id
        FG000
        num Subjects
        0
      2. comment
        Cohort 1
        group Id
        FG001
        num Subjects
        150
      3. comment
        This group did not participate in the Extension Study
        group Id
        FG002
        num Subjects
        0
      4. comment
        Cohort 2
        group Id
        FG003
        num Subjects
        3050
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        150
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2824
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        226
      type
      NOT COMPLETED
    title
    Extension Study
pre Assignment Details
A total of 15,334 participants were screened and 14,840 were randomized into the study.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice