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NCT00943722 · OUTCOME

Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])

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.

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
4 weeks post-vaccination 3 (Month 7)

What was measured

Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.

Analysis population: 9-15-year-old females and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.

Groups in this outcome

Base Study: 9- to 15-Year-Old Females (Lot 1)

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.

Base Study: 9- to 15-Year-Old Males (Lot 1)

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Base Study: 9- to 15-Year-Old Females (Lot 1)535
Base Study: 9- to 15-Year-Old Males (Lot 1)378

Reported measurements

Anti-HPV 6 cLIA ≥30 mMU/mL

Analysis denominator · Participants

GroupSource count
Base Study: 9- to 15-Year-Old Females (Lot 1)517
Base Study: 9- to 15-Year-Old Males (Lot 1)328
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Base Study: 9- to 15-Year-Old Females (Lot 1)99.8Not reported98.9100Not reported
Base Study: 9- to 15-Year-Old Males (Lot 1)99.7Not reported98.3100Not reported
Anti-HPV 11 cLIA ≥16 mMU/mL

Analysis denominator · Participants

GroupSource count
Base Study: 9- to 15-Year-Old Females (Lot 1)517
Base Study: 9- to 15-Year-Old Males (Lot 1)332
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Base Study: 9- to 15-Year-Old Females (Lot 1)100Not reported99.3100.0Not reported
Base Study: 9- to 15-Year-Old Males (Lot 1)100Not reported98.9100.0Not reported
Anti-HPV 16 cLIA ≥20 mMU/mL

Analysis denominator · Participants

GroupSource count
Base Study: 9- to 15-Year-Old Females (Lot 1)529
Base Study: 9- to 15-Year-Old Males (Lot 1)329
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Base Study: 9- to 15-Year-Old Females (Lot 1)100Not reported99.3100.0Not reported
Base Study: 9- to 15-Year-Old Males (Lot 1)100Not reported98.9100.0Not reported
Anti-HPV 18 cLIA ≥24 mMU/mL

Analysis denominator · Participants

GroupSource count
Base Study: 9- to 15-Year-Old Females (Lot 1)531
Base Study: 9- to 15-Year-Old Males (Lot 1)345
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Base Study: 9- to 15-Year-Old Females (Lot 1)99.8Not reported99.0100.0Not reported
Base Study: 9- to 15-Year-Old Males (Lot 1)99.7Not reported98.4100.0Not reported
Anti-HPV 31 cLIA ≥10 mMU/mL

Analysis denominator · Participants

GroupSource count
Base Study: 9- to 15-Year-Old Females (Lot 1)522
Base Study: 9- to 15-Year-Old Males (Lot 1)340
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Base Study: 9- to 15-Year-Old Females (Lot 1)100.0Not reported99.3100.0Not reported
Base Study: 9- to 15-Year-Old Males (Lot 1)99.7Not reported98.4100.0Not reported
Anti-HPV 33 cLIA ≥8 mMU/mL

Analysis denominator · Participants

GroupSource count
Base Study: 9- to 15-Year-Old Females (Lot 1)534
Base Study: 9- to 15-Year-Old Males (Lot 1)354
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Base Study: 9- to 15-Year-Old Females (Lot 1)100.0Not reported99.3100.0Not reported
Base Study: 9- to 15-Year-Old Males (Lot 1)99.7Not reported98.4100.0Not reported
Anti-HPV 45 cLIA ≥8 mMU/mL

Analysis denominator · Participants

GroupSource count
Base Study: 9- to 15-Year-Old Females (Lot 1)534
Base Study: 9- to 15-Year-Old Males (Lot 1)368
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Base Study: 9- to 15-Year-Old Females (Lot 1)99.8Not reported99.0100.0Not reported
Base Study: 9- to 15-Year-Old Males (Lot 1)99.5Not reported98.199.9Not reported
Anti-HPV 52 cLIA ≥8 mMU/mL

Analysis denominator · Participants

GroupSource count
Base Study: 9- to 15-Year-Old Females (Lot 1)533
Base Study: 9- to 15-Year-Old Males (Lot 1)337
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Base Study: 9- to 15-Year-Old Females (Lot 1)100.0Not reported99.3100.0Not reported
Base Study: 9- to 15-Year-Old Males (Lot 1)99.7Not reported98.4100.0Not reported
Anti-HPV 58 cLIA ≥8 mMU/mL

Analysis denominator · Participants

GroupSource count
Base Study: 9- to 15-Year-Old Females (Lot 1)531
Base Study: 9- to 15-Year-Old Males (Lot 1)332
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Base Study: 9- to 15-Year-Old Females (Lot 1)100.0Not reported99.3100.0Not reported
Base Study: 9- to 15-Year-Old Males (Lot 1)100.0Not reported98.9100.0Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -0.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.5
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
    group Description
    Anti-HPV 6
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    < 0.001
    param Type
    Percentage Point Difference
    param Value
    0.1
    statistical Method
    Miettinen and Nurminen
  2. ci Lower Limit
    -0.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.2
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
    group Description
    Anti-HPV 11
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    < 0.001
    param Type
    Percentage Point Difference
    param Value
    0.0
    statistical Method
    Miettinen and Nurminen
  3. ci Lower Limit
    -0.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.2
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
    group Description
    Anti-HPV 16
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    < 0.001
    param Type
    Percentage Point Difference
    param Value
    0.0
    statistical Method
    Miettinen and Nurminen
  4. ci Lower Limit
    -0.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.5
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
    group Description
    Anti-HPV 18
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    < 0.001
    param Type
    Percentage Point Difference
    param Value
    0.1
    statistical Method
    Miettinen and Nurminen
  5. ci Lower Limit
    -0.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.7
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
    group Description
    Anti-HPV 31
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    < 0.001
    param Type
    Percentage Point Difference
    param Value
    0.3
    statistical Method
    Miettinen and Nurminen
  6. ci Lower Limit
    -0.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.6
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
    group Description
    Anti-HPV 33
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    < 0.001
    param Type
    Percentage Point Difference
    param Value
    0.3
    statistical Method
    Miettinen and Nurminen
  7. ci Lower Limit
    -0.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.8
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
    group Description
    Anti-HPV 45
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    < 0.001
    param Type
    Percentage Point Difference
    param Value
    0.4
    statistical Method
    Miettinen and Nurminen
  8. ci Lower Limit
    -0.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.7
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
    group Description
    Anti-HPV 52
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    < 0.001
    param Type
    Percentage Point Difference
    param Value
    0.3
    statistical Method
    Miettinen and Nurminen
  9. ci Lower Limit
    -0.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.2
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
    group Description
    Anti-HPV 58
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    < 0.001
    param Type
    Percentage Point Difference
    param Value
    0.0
    statistical Method
    Miettinen and Nurminen
Complete source fields
analyses
  1. ci Lower Limit
    -0.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.5
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
    group Description
    Anti-HPV 6
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    < 0.001
    param Type
    Percentage Point Difference
    param Value
    0.1
    statistical Method
    Miettinen and Nurminen
  2. ci Lower Limit
    -0.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.2
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
    group Description
    Anti-HPV 11
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    < 0.001
    param Type
    Percentage Point Difference
    param Value
    0.0
    statistical Method
    Miettinen and Nurminen
  3. ci Lower Limit
    -0.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.2
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
    group Description
    Anti-HPV 16
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    < 0.001
    param Type
    Percentage Point Difference
    param Value
    0.0
    statistical Method
    Miettinen and Nurminen
  4. ci Lower Limit
    -0.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.5
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
    group Description
    Anti-HPV 18
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    < 0.001
    param Type
    Percentage Point Difference
    param Value
    0.1
    statistical Method
    Miettinen and Nurminen
  5. ci Lower Limit
    -0.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.7
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
    group Description
    Anti-HPV 31
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    < 0.001
    param Type
    Percentage Point Difference
    param Value
    0.3
    statistical Method
    Miettinen and Nurminen
  6. ci Lower Limit
    -0.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.6
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
    group Description
    Anti-HPV 33
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    < 0.001
    param Type
    Percentage Point Difference
    param Value
    0.3
    statistical Method
    Miettinen and Nurminen
  7. ci Lower Limit
    -0.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.8
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
    group Description
    Anti-HPV 45
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    < 0.001
    param Type
    Percentage Point Difference
    param Value
    0.4
    statistical Method
    Miettinen and Nurminen
  8. ci Lower Limit
    -0.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.7
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
    group Description
    Anti-HPV 52
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    < 0.001
    param Type
    Percentage Point Difference
    param Value
    0.3
    statistical Method
    Miettinen and Nurminen
  9. ci Lower Limit
    -0.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.2
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 16- to 26-Year-Old Females (Lot 1)
    group Description
    Anti-HPV 58
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Noninferiority is demonstrated if the lower limit of the 95% CI for the percentage point difference is greater than -5.
    non Inferiority Type
    NON_INFERIORITY
    p Value
    < 0.001
    param Type
    Percentage Point Difference
    param Value
    0.0
    statistical Method
    Miettinen and Nurminen
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        98.9
        upper Limit
        100
        value
        99.8
      2. group Id
        OG001
        lower Limit
        98.3
        upper Limit
        100
        value
        99.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        517
      2. group Id
        OG001
        value
        328
      units
      Participants
    title
    Anti-HPV 6 cLIA ≥30 mMU/mL
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.3
        upper Limit
        100.0
        value
        100
      2. group Id
        OG001
        lower Limit
        98.9
        upper Limit
        100.0
        value
        100
    denoms
    1. counts
      1. group Id
        OG000
        value
        517
      2. group Id
        OG001
        value
        332
      units
      Participants
    title
    Anti-HPV 11 cLIA ≥16 mMU/mL
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.3
        upper Limit
        100.0
        value
        100
      2. group Id
        OG001
        lower Limit
        98.9
        upper Limit
        100.0
        value
        100
    denoms
    1. counts
      1. group Id
        OG000
        value
        529
      2. group Id
        OG001
        value
        329
      units
      Participants
    title
    Anti-HPV 16 cLIA ≥20 mMU/mL
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.0
        upper Limit
        100.0
        value
        99.8
      2. group Id
        OG001
        lower Limit
        98.4
        upper Limit
        100.0
        value
        99.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        531
      2. group Id
        OG001
        value
        345
      units
      Participants
    title
    Anti-HPV 18 cLIA ≥24 mMU/mL
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.3
        upper Limit
        100.0
        value
        100.0
      2. group Id
        OG001
        lower Limit
        98.4
        upper Limit
        100.0
        value
        99.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        522
      2. group Id
        OG001
        value
        340
      units
      Participants
    title
    Anti-HPV 31 cLIA ≥10 mMU/mL
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.3
        upper Limit
        100.0
        value
        100.0
      2. group Id
        OG001
        lower Limit
        98.4
        upper Limit
        100.0
        value
        99.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        534
      2. group Id
        OG001
        value
        354
      units
      Participants
    title
    Anti-HPV 33 cLIA ≥8 mMU/mL
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.0
        upper Limit
        100.0
        value
        99.8
      2. group Id
        OG001
        lower Limit
        98.1
        upper Limit
        99.9
        value
        99.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        534
      2. group Id
        OG001
        value
        368
      units
      Participants
    title
    Anti-HPV 45 cLIA ≥8 mMU/mL
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.3
        upper Limit
        100.0
        value
        100.0
      2. group Id
        OG001
        lower Limit
        98.4
        upper Limit
        100.0
        value
        99.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        533
      2. group Id
        OG001
        value
        337
      units
      Participants
    title
    Anti-HPV 52 cLIA ≥8 mMU/mL
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.3
        upper Limit
        100.0
        value
        100.0
      2. group Id
        OG001
        lower Limit
        98.9
        upper Limit
        100.0
        value
        100.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        531
      2. group Id
        OG001
        value
        332
      units
      Participants
    title
    Anti-HPV 58 cLIA ≥8 mMU/mL
denoms
  1. counts
    1. group Id
      OG000
      value
      535
    2. group Id
      OG001
      value
      378
    units
    Participants
description
Serum antibody titers for HPV virus-like particles (VLPs), Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. The serostatus cutoffs (milli Merck U/mL) for HPV types were as follows: HPV Type 6: ≥30, HPV Type 11: ≥16; HPV Type 16: ≥20, HPV Type 18: ≥24, HPV Type 31: ≥10, HPV Type 33: ≥8, HPV Type 45: ≥8, HPV Type 52: ≥8, and HPV Type 58: ≥8.
dispersion Type
95% Confidence Interval
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
    OG000
    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 1.
    id
    OG001
    title
    Base Study: 9- to 15-Year-Old Males (Lot 1)
param Type
NUMBER
population Description
9-15-year-old females and 16-26-year-old females who received 3 vaccinations from Lot 1 and met following criteria for at least 1 of the 9 HPV types: no general protocol violations, received all 3 vaccinations within acceptable day ranges, seronegative at Day 1 for HPV type(s), and had a Month 7 serum sample collected within an acceptable day range.
reporting Status
POSTED
time Frame
4 weeks post-vaccination 3 (Month 7)
title
Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1])
type
SECONDARY
unit Of Measure
Percentage of Participants

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