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NCT00943722 · OUTCOME

Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)

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- to 15-year-old females who received 3 vaccinations from Lots 1, 2, and 3 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 Females (Lot 2)

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.

Base Study: 9- to 15-Year-Old Females (Lot 3)

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.

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 Females (Lot 2)549
Base Study: 9- to 15-Year-Old Females (Lot 3)565

Reported measurements

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 Females (Lot 2)536
Base Study: 9- to 15-Year-Old Females (Lot 3)544
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Base Study: 9- to 15-Year-Old Females (Lot 1)99.8Not reported98.9100.0Not reported
Base Study: 9- to 15-Year-Old Females (Lot 2)99.8Not reported99.0100.0Not reported
Base Study: 9- to 15-Year-Old Females (Lot 3)99.3Not reported98.199.8Not reported
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 Females (Lot 2)536
Base Study: 9- to 15-Year-Old Females (Lot 3)544
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 Females (Lot 2)100.0Not reported99.3100.0Not reported
Base Study: 9- to 15-Year-Old Females (Lot 3)99.6Not reported98.7100.0Not reported
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 Females (Lot 2)542
Base Study: 9- to 15-Year-Old Females (Lot 3)556
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 Females (Lot 2)100.0Not reported99.3100.0Not reported
Base Study: 9- to 15-Year-Old Females (Lot 3)99.6Not reported98.7100.0Not reported
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 Females (Lot 2)547
Base Study: 9- to 15-Year-Old Females (Lot 3)563
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 Females (Lot 2)100.0Not reported99.3100.0Not reported
Base Study: 9- to 15-Year-Old Females (Lot 3)99.6Not reported98.7100.0Not reported
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 Females (Lot 2)542
Base Study: 9- to 15-Year-Old Females (Lot 3)553
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 Females (Lot 2)100.0Not reported99.3100.0Not reported
Base Study: 9- to 15-Year-Old Females (Lot 3)99.8Not reported99.0100.0Not reported
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 Females (Lot 2)543
Base Study: 9- to 15-Year-Old Females (Lot 3)560
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 Females (Lot 2)100.0Not reported99.3100.0Not reported
Base Study: 9- to 15-Year-Old Females (Lot 3)99.6Not reported98.7100.0Not reported
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 Females (Lot 2)548
Base Study: 9- to 15-Year-Old Females (Lot 3)565
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 Females (Lot 2)100.0Not reported99.3100.0Not reported
Base Study: 9- to 15-Year-Old Females (Lot 3)99.6Not reported98.7100.0Not reported
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 Females (Lot 2)547
Base Study: 9- to 15-Year-Old Females (Lot 3)562
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 Females (Lot 2)100.0Not reported99.3100.0Not reported
Base Study: 9- to 15-Year-Old Females (Lot 3)99.6Not reported98.7100.0Not reported
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 Females (Lot 2)539
Base Study: 9- to 15-Year-Old Females (Lot 3)560
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 Females (Lot 2)100.0Not reported99.3100.0Not reported
Base Study: 9- to 15-Year-Old Females (Lot 3)99.6Not reported98.7100.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    -0.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.9
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
    group Description
    Anti-HPV 6
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    0.0
  2. 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 9- to 15-Year-Old Females (Lot 3)
    group Description
    Anti-HPV 6
    group Ids
    1. OG000
    2. OG002
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    0.5
  3. 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 2) minus 9- to 15-Year-Old Females (Lot 3)
    group Description
    Anti-HPV 6
    group Ids
    1. OG001
    2. OG002
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    0.6
  4. ci Lower Limit
    -0.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.7
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
    group Description
    Anti-HPV 11
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    0.0
  5. ci Lower Limit
    -0.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.3
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
    group Description
    Anti-HPV 11
    group Ids
    1. OG000
    2. OG002
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    0.4
  6. ci Lower Limit
    -0.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.3
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
    group Description
    Anti-HPV 11
    group Ids
    1. OG001
    2. OG002
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    0.4
  7. ci Lower Limit
    -0.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.7
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
    group Description
    Anti-HPV 16
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    0.0
  8. ci Lower Limit
    -0.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.3
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
    group Description
    Anti-HPV 16
    group Ids
    1. OG000
    2. OG002
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    0.4
  9. ci Lower Limit
    -0.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.3
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
    group Description
    Anti-HPV 16
    group Ids
    1. OG001
    2. OG002
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    0.4
  10. ci Lower Limit
    -1.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.5
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
    group Description
    Anti-HPV 18
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    -0.2
  11. ci Lower Limit
    -0.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.1
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
    group Description
    Anti-HPV 18
    group Ids
    1. OG000
    2. OG002
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    0.2
  12. ci Lower Limit
    -0.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.3
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
    group Description
    Anti-HPV 18
    group Ids
    1. OG001
    2. OG002
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    0.4
Complete source fields
analyses
  1. ci Lower Limit
    -0.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.9
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
    group Description
    Anti-HPV 6
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    0.0
  2. 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 9- to 15-Year-Old Females (Lot 3)
    group Description
    Anti-HPV 6
    group Ids
    1. OG000
    2. OG002
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    0.5
  3. 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 2) minus 9- to 15-Year-Old Females (Lot 3)
    group Description
    Anti-HPV 6
    group Ids
    1. OG001
    2. OG002
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    0.6
  4. ci Lower Limit
    -0.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.7
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
    group Description
    Anti-HPV 11
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    0.0
  5. ci Lower Limit
    -0.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.3
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
    group Description
    Anti-HPV 11
    group Ids
    1. OG000
    2. OG002
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    0.4
  6. ci Lower Limit
    -0.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.3
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
    group Description
    Anti-HPV 11
    group Ids
    1. OG001
    2. OG002
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    0.4
  7. ci Lower Limit
    -0.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.7
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
    group Description
    Anti-HPV 16
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    0.0
  8. ci Lower Limit
    -0.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.3
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
    group Description
    Anti-HPV 16
    group Ids
    1. OG000
    2. OG002
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    0.4
  9. ci Lower Limit
    -0.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.3
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
    group Description
    Anti-HPV 16
    group Ids
    1. OG001
    2. OG002
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    0.4
  10. ci Lower Limit
    -1.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.5
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 2)
    group Description
    Anti-HPV 18
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    -0.2
  11. ci Lower Limit
    -0.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.1
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 1) minus 9- to 15-Year-Old Females (Lot 3)
    group Description
    Anti-HPV 18
    group Ids
    1. OG000
    2. OG002
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    0.2
  12. ci Lower Limit
    -0.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.3
    estimate Comment
    Percentage Point Difference = 9- to 15-Year-Old Females (Lot 2) minus 9- to 15-Year-Old Females (Lot 3)
    group Description
    Anti-HPV 18
    group Ids
    1. OG001
    2. OG002
    non Inferiority Comment
    equivalence requires that the two-sided 95% CI for the difference in percentages between lots be entirely contained within the interval (-5, 5).
    non Inferiority Type
    EQUIVALENCE
    param Type
    Percentage Point Difference
    param Value
    0.4
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        98.9
        upper Limit
        100.0
        value
        99.8
      2. group Id
        OG001
        lower Limit
        99.0
        upper Limit
        100.0
        value
        99.8
      3. group Id
        OG002
        lower Limit
        98.1
        upper Limit
        99.8
        value
        99.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        517
      2. group Id
        OG001
        value
        536
      3. group Id
        OG002
        value
        544
      units
      Participants
    title
    HPV 6 cLIA ≥30 mMU/mL
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.3
        upper Limit
        100.0
        value
        100.0
      2. group Id
        OG001
        lower Limit
        99.3
        upper Limit
        100.0
        value
        100.0
      3. group Id
        OG002
        lower Limit
        98.7
        upper Limit
        100.0
        value
        99.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        517
      2. group Id
        OG001
        value
        536
      3. group Id
        OG002
        value
        544
      units
      Participants
    title
    HPV 11 cLIA ≥16 mMU/mL
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.3
        upper Limit
        100.0
        value
        100.0
      2. group Id
        OG001
        lower Limit
        99.3
        upper Limit
        100.0
        value
        100.0
      3. group Id
        OG002
        lower Limit
        98.7
        upper Limit
        100.0
        value
        99.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        529
      2. group Id
        OG001
        value
        542
      3. group Id
        OG002
        value
        556
      units
      Participants
    title
    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
        99.3
        upper Limit
        100.0
        value
        100.0
      3. group Id
        OG002
        lower Limit
        98.7
        upper Limit
        100.0
        value
        99.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        531
      2. group Id
        OG001
        value
        547
      3. group Id
        OG002
        value
        563
      units
      Participants
    title
    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
        99.3
        upper Limit
        100.0
        value
        100.0
      3. group Id
        OG002
        lower Limit
        99.0
        upper Limit
        100.0
        value
        99.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        522
      2. group Id
        OG001
        value
        542
      3. group Id
        OG002
        value
        553
      units
      Participants
    title
    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
        99.3
        upper Limit
        100.0
        value
        100.0
      3. group Id
        OG002
        lower Limit
        98.7
        upper Limit
        100.0
        value
        99.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        534
      2. group Id
        OG001
        value
        543
      3. group Id
        OG002
        value
        560
      units
      Participants
    title
    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
        99.3
        upper Limit
        100.0
        value
        100.0
      3. group Id
        OG002
        lower Limit
        98.7
        upper Limit
        100.0
        value
        99.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        534
      2. group Id
        OG001
        value
        548
      3. group Id
        OG002
        value
        565
      units
      Participants
    title
    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
        99.3
        upper Limit
        100.0
        value
        100.0
      3. group Id
        OG002
        lower Limit
        98.7
        upper Limit
        100.0
        value
        99.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        533
      2. group Id
        OG001
        value
        547
      3. group Id
        OG002
        value
        562
      units
      Participants
    title
    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
        99.3
        upper Limit
        100.0
        value
        100.0
      3. group Id
        OG002
        lower Limit
        98.7
        upper Limit
        100.0
        value
        99.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        531
      2. group Id
        OG001
        value
        539
      3. group Id
        OG002
        value
        560
      units
      Participants
    title
    HPV 58 cLIA ≥8 mMU/mL
denoms
  1. counts
    1. group Id
      OG000
      value
      535
    2. group Id
      OG001
      value
      549
    3. group Id
      OG002
      value
      565
    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 2.
    id
    OG001
    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
    OG002
    title
    Base Study: 9- to 15-Year-Old Females (Lot 3)
param Type
NUMBER
population Description
9- to 15-year-old females who received 3 vaccinations from Lots 1, 2, and 3 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 (Lot Consistency Study)
type
SECONDARY
unit Of Measure
Percentage of Participants

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