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NCT01245764 · FLOW

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GARDASIL™ Study in Healthy Females Between 9 and 26 Years of Age in Sub-Saharan Africa (V501-046) · Source last updated 2018-11-14

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

groups
  1. description
    GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
    id
    FG000
    title
    GARDASIL 9 to 12 Years Old
  2. description
    GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
    id
    FG001
    title
    GARDASIL 13 to 15 Years Old
  3. description
    GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
    id
    FG002
    title
    GARDASIL 16 to 26 Years Old
  4. description
    Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. Safety evaluation continued to Month 7 of study Phase B (total study duration up to 19 months)
    id
    FG003
    title
    Placebo 9 to 12 Years Old
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        1
      type
      Other
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        2
      type
      Protocol Violation
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        80
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        120
      4. group Id
        FG003
        num Subjects
        20
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        77
      2. group Id
        FG001
        num Subjects
        28
      3. group Id
        FG002
        num Subjects
        117
      4. group Id
        FG003
        num Subjects
        19
      type
      Completed Vaccinations in Study Phase A
    3. achievements
      1. group Id
        FG000
        num Subjects
        71
      2. group Id
        FG001
        num Subjects
        25
      3. group Id
        FG002
        num Subjects
        110
      4. group Id
        FG003
        num Subjects
        17
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Study Phase A
  2. milestones
    1. 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
        17
      type
      STARTED
    2. 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
        17
      type
      Completed Vaccinations in Study Phase B
    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
        17
      type
      COMPLETED
    4. 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
        0
      type
      NOT COMPLETED
    title
    Study Phase B
Complete source fields
groups
  1. description
    GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
    id
    FG000
    title
    GARDASIL 9 to 12 Years Old
  2. description
    GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
    id
    FG001
    title
    GARDASIL 13 to 15 Years Old
  3. description
    GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
    id
    FG002
    title
    GARDASIL 16 to 26 Years Old
  4. description
    Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. Safety evaluation continued to Month 7 of study Phase B (total study duration up to 19 months)
    id
    FG003
    title
    Placebo 9 to 12 Years Old
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        1
      type
      Other
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        2
      type
      Protocol Violation
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        0
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        80
      2. group Id
        FG001
        num Subjects
        30
      3. group Id
        FG002
        num Subjects
        120
      4. group Id
        FG003
        num Subjects
        20
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        77
      2. group Id
        FG001
        num Subjects
        28
      3. group Id
        FG002
        num Subjects
        117
      4. group Id
        FG003
        num Subjects
        19
      type
      Completed Vaccinations in Study Phase A
    3. achievements
      1. group Id
        FG000
        num Subjects
        71
      2. group Id
        FG001
        num Subjects
        25
      3. group Id
        FG002
        num Subjects
        110
      4. group Id
        FG003
        num Subjects
        17
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        5
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Study Phase A
  2. milestones
    1. 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
        17
      type
      STARTED
    2. 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
        17
      type
      Completed Vaccinations in Study Phase B
    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
        17
      type
      COMPLETED
    4. 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
        0
      type
      NOT COMPLETED
    title
    Study Phase B

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Preserved source evidence · Not medical advice