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NCT00851643 · BASELINE

Baseline characteristics

Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002) · Source last updated 2016-02-03

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
      15
    2. group Id
      BG001
      value
      30
    3. group Id
      BG002
      value
      30
    4. group Id
      BG003
      value
      15
    5. group Id
      BG004
      value
      30
    6. group Id
      BG005
      value
      30
    7. group Id
      BG006
      value
      150
    units
    Participants
groups
  1. description
    Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- Controls from Phase A. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
    id
    BG000
    title
    qHPV (GARDASIL™) - Phase A Control
  2. description
    Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate(AAHS) and 15 mcg ISCOMATRIX™ (IMX). A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
    id
    BG001
    title
    Octavalent HPV With 15 mcg IMX / AAHS
  3. description
    Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
    id
    BG002
    title
    Octavalent HPV With 30 mcg IMX / AAHS
  4. description
    Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- Controls from Phase B. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
    id
    BG003
    title
    qHPV (GARDASIL™) - Phase B Control
  5. description
    Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
    id
    BG004
    title
    Octavalent HPV With 60 mcg IMX / AAHS
  6. description
    Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
    id
    BG005
    title
    Octavalent HPV With 120 mcg IMX / AAHS
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.6
          value
          20.3
        2. group Id
          BG001
          spread
          1.8
          value
          20.8
        3. group Id
          BG002
          spread
          1.5
          value
          20.2
        4. group Id
          BG003
          spread
          1.6
          value
          19.9
        5. group Id
          BG004
          spread
          1.8
          value
          20.5
        6. group Id
          BG005
          spread
          2.0
          value
          20.8
        7. group Id
          BG006
          spread
          1.7
          value
          20.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          30
        6. group Id
          BG005
          value
          30
        7. group Id
          BG006
          value
          150
        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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          30
        6. group Id
          BG005
          value
          30
        7. group Id
          BG006
          value
          150
      title
      Australia
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      15
    2. group Id
      BG001
      value
      30
    3. group Id
      BG002
      value
      30
    4. group Id
      BG003
      value
      15
    5. group Id
      BG004
      value
      30
    6. group Id
      BG005
      value
      30
    7. group Id
      BG006
      value
      150
    units
    Participants
groups
  1. description
    Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- Controls from Phase A. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
    id
    BG000
    title
    qHPV (GARDASIL™) - Phase A Control
  2. description
    Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate(AAHS) and 15 mcg ISCOMATRIX™ (IMX). A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
    id
    BG001
    title
    Octavalent HPV With 15 mcg IMX / AAHS
  3. description
    Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
    id
    BG002
    title
    Octavalent HPV With 30 mcg IMX / AAHS
  4. description
    Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- Controls from Phase B. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
    id
    BG003
    title
    qHPV (GARDASIL™) - Phase B Control
  5. description
    Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
    id
    BG004
    title
    Octavalent HPV With 60 mcg IMX / AAHS
  6. description
    Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
    id
    BG005
    title
    Octavalent HPV With 120 mcg IMX / AAHS
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.6
          value
          20.3
        2. group Id
          BG001
          spread
          1.8
          value
          20.8
        3. group Id
          BG002
          spread
          1.5
          value
          20.2
        4. group Id
          BG003
          spread
          1.6
          value
          19.9
        5. group Id
          BG004
          spread
          1.8
          value
          20.5
        6. group Id
          BG005
          spread
          2.0
          value
          20.8
        7. group Id
          BG006
          spread
          1.7
          value
          20.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          30
        6. group Id
          BG005
          value
          30
        7. group Id
          BG006
          value
          150
        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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          15
        5. group Id
          BG004
          value
          30
        6. group Id
          BG005
          value
          30
        7. group Id
          BG006
          value
          150
      title
      Australia
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice