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NCT00943722 · BASELINE

Baseline characteristics

A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002) · Source last updated 2022-10-03

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

denoms
  1. counts
    1. group Id
      BG000
      value
      648
    2. group Id
      BG001
      value
      643
    3. group Id
      BG002
      value
      644
    4. group Id
      BG003
      value
      669
    5. group Id
      BG004
      value
      470
    6. group Id
      BG005
      value
      3074
    units
    Participants
groups
  1. description
    9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
    id
    BG000
    title
    Base Study: 9- to 15-Year-Old Females (Lot 1)
  2. description
    9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 2.
    id
    BG001
    title
    Base Study: 9- to 15-Year-Old Females (Lot 2)
  3. description
    9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
    id
    BG002
    title
    Base Study: 9- to 15-Year-Old Females (Lot 3)
  4. description
    9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
    id
    BG003
    title
    Base Study: 9- to 15-Year-Old Males (Lot 1)
  5. description
    9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
    id
    BG004
    title
    Base Study: 16- to 26-Year-Old Females (Lot 1)
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          440
        2. group Id
          BG001
          value
          432
        3. group Id
          BG002
          value
          432
        4. group Id
          BG003
          value
          450
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1754
      title
      9 to 12 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          208
        2. group Id
          BG001
          value
          211
        3. group Id
          BG002
          value
          212
        4. group Id
          BG003
          value
          219
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          850
      title
      13 to 15 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          470
        6. group Id
          BG005
          value
          470
      title
      16 to 26 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          648
        2. group Id
          BG001
          value
          643
        3. group Id
          BG002
          value
          644
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          470
        6. group Id
          BG005
          value
          2405
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          669
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          669
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Per protocol, baseline characteristics were analyzed in all participants randomized in the base study.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      648
    2. group Id
      BG001
      value
      643
    3. group Id
      BG002
      value
      644
    4. group Id
      BG003
      value
      669
    5. group Id
      BG004
      value
      470
    6. group Id
      BG005
      value
      3074
    units
    Participants
groups
  1. description
    9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
    id
    BG000
    title
    Base Study: 9- to 15-Year-Old Females (Lot 1)
  2. description
    9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 2.
    id
    BG001
    title
    Base Study: 9- to 15-Year-Old Females (Lot 2)
  3. description
    9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 3.
    id
    BG002
    title
    Base Study: 9- to 15-Year-Old Females (Lot 3)
  4. description
    9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
    id
    BG003
    title
    Base Study: 9- to 15-Year-Old Males (Lot 1)
  5. description
    9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
    id
    BG004
    title
    Base Study: 16- to 26-Year-Old Females (Lot 1)
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          440
        2. group Id
          BG001
          value
          432
        3. group Id
          BG002
          value
          432
        4. group Id
          BG003
          value
          450
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1754
      title
      9 to 12 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          208
        2. group Id
          BG001
          value
          211
        3. group Id
          BG002
          value
          212
        4. group Id
          BG003
          value
          219
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          850
      title
      13 to 15 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          470
        6. group Id
          BG005
          value
          470
      title
      16 to 26 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          648
        2. group Id
          BG001
          value
          643
        3. group Id
          BG002
          value
          644
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          470
        6. group Id
          BG005
          value
          2405
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          669
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          669
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Per protocol, baseline characteristics were analyzed in all participants randomized in the base study.

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Preserved source evidence · Not medical advice