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NCT00943722 · OUTCOME

Base Study: GMTs for 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
GEOMETRIC_MEAN
Unit
milli Merck Units/mL
Interval / dispersion
95% Confidence Interval
Time frame
4 weeks post-vaccination 3 (Month 7)

What was measured

Serum antibody titers for HPV VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers were reported in milli Merck Units/mL.

Analysis population: 9-15-year-old females who received 3 vaccinations from Lots 1, 2, or 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

Anti-HPV 6

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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Base Study: 9- to 15-Year-Old Females (Lot 1)1715.4Not reported1588.71852.2Not reported
Base Study: 9- to 15-Year-Old Females (Lot 2)1763.3Not reported1635.41901.3Not reported
Base Study: 9- to 15-Year-Old Females (Lot 3)1659.9Not reported1540.31788.7Not reported
Anti-HPV 11

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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Base Study: 9- to 15-Year-Old Females (Lot 1)1295.1Not reported1197.81400.3Not reported
Base Study: 9- to 15-Year-Old Females (Lot 2)1311.7Not reported1214.91416.3Not reported
Base Study: 9- to 15-Year-Old Females (Lot 3)1232.0Not reported1141.71329.5Not reported
Anti-HPV 16

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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Base Study: 9- to 15-Year-Old Females (Lot 1)6979.8Not reported6476.17522.8Not reported
Base Study: 9- to 15-Year-Old Females (Lot 2)7292.9Not reported6772.77853.1Not reported
Base Study: 9- to 15-Year-Old Females (Lot 3)6948.2Not reported6458.77474.9Not reported
Anti-HPV 18

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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Base Study: 9- to 15-Year-Old Females (Lot 1)2153.7Not reported1970.92353.5Not reported
Base Study: 9- to 15-Year-Old Females (Lot 2)2134.1Not reported1955.62329.0Not reported
Base Study: 9- to 15-Year-Old Females (Lot 3)1966.6Not reported1804.32143.5Not reported
Anti-HPV 31

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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Base Study: 9- to 15-Year-Old Females (Lot 1)1891.6Not reported1738.52058.2Not reported
Base Study: 9- to 15-Year-Old Females (Lot 2)1867.8Not reported1719.32029.1Not reported
Base Study: 9- to 15-Year-Old Females (Lot 3)1879.0Not reported1731.02039.6Not reported
Anti-HPV 33

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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Base Study: 9- to 15-Year-Old Females (Lot 1)980.4Not reported909.21057.2Not reported
Base Study: 9- to 15-Year-Old Females (Lot 2)922.7Not reported856.2994.4Not reported
Base Study: 9- to 15-Year-Old Females (Lot 3)931.1Not reported865.01002.3Not reported
Anti-HPV 45

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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Base Study: 9- to 15-Year-Old Females (Lot 1)714.4Not reported650.1785.0Not reported
Base Study: 9- to 15-Year-Old Females (Lot 2)827.7Not reported754.1908.5Not reported
Base Study: 9- to 15-Year-Old Females (Lot 3)678.4Not reported619.0743.6Not reported
Anti-HPV 52

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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Base Study: 9- to 15-Year-Old Females (Lot 1)932.9Not reported860.81011.0Not reported
Base Study: 9- to 15-Year-Old Females (Lot 2)1007.9Not reported931.01091.2Not reported
Base Study: 9- to 15-Year-Old Females (Lot 3)971.2Not reported898.11050.3Not reported
Anti-HPV 58

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 milli Merck Units/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Base Study: 9- to 15-Year-Old Females (Lot 1)1286.7Not reported1190.01391.3Not reported
Base Study: 9- to 15-Year-Old Females (Lot 2)1344.9Not reported1244.61453.3Not reported
Base Study: 9- to 15-Year-Old Females (Lot 3)1208.1Not reported1119.61303.6Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.88
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.08
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    0.97
  2. ci Lower Limit
    0.93
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.16
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    1.03
  3. ci Lower Limit
    0.95
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.19
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    1.06
  4. ci Lower Limit
    0.90
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.11
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    1.00
  5. ci Lower Limit
    0.95
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.20
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    1.07
  6. ci Lower Limit
    0.95
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.20
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    1.07
  7. ci Lower Limit
    0.86
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.06
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    0.96
  8. ci Lower Limit
    0.90
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.12
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    1.00
  9. ci Lower Limit
    0.94
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.17
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    1.05
  10. ci Lower Limit
    0.89
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.14
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    1.00
  11. ci Lower Limit
    0.98
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.26
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    1.11
  12. ci Lower Limit
    0.97
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.26
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    1.11
Complete source fields
analyses
  1. ci Lower Limit
    0.88
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.08
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    0.97
  2. ci Lower Limit
    0.93
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.16
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    1.03
  3. ci Lower Limit
    0.95
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.19
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    1.06
  4. ci Lower Limit
    0.90
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.11
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    1.00
  5. ci Lower Limit
    0.95
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.20
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    1.07
  6. ci Lower Limit
    0.95
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.20
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    1.07
  7. ci Lower Limit
    0.86
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.06
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0).
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    0.96
  8. ci Lower Limit
    0.90
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.12
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    1.00
  9. ci Lower Limit
    0.94
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.17
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    1.05
  10. ci Lower Limit
    0.89
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.14
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    1.00
  11. ci Lower Limit
    0.98
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.26
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 1) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    1.11
  12. ci Lower Limit
    0.97
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.26
    estimate Comment
    GMT ratio = GMT for 9- to 15-Year-Old Females (Lot 2) divided by GMT for 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 ratio of the GMTs be entirely contained within the interval (0.5, 2.0)
    non Inferiority Type
    EQUIVALENCE
    param Type
    GMT ratio
    param Value
    1.11
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1588.7
        upper Limit
        1852.2
        value
        1715.4
      2. group Id
        OG001
        lower Limit
        1635.4
        upper Limit
        1901.3
        value
        1763.3
      3. group Id
        OG002
        lower Limit
        1540.3
        upper Limit
        1788.7
        value
        1659.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        517
      2. group Id
        OG001
        value
        536
      3. group Id
        OG002
        value
        544
      units
      Participants
    title
    Anti-HPV 6
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1197.8
        upper Limit
        1400.3
        value
        1295.1
      2. group Id
        OG001
        lower Limit
        1214.9
        upper Limit
        1416.3
        value
        1311.7
      3. group Id
        OG002
        lower Limit
        1141.7
        upper Limit
        1329.5
        value
        1232.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        517
      2. group Id
        OG001
        value
        536
      3. group Id
        OG002
        value
        544
      units
      Participants
    title
    Anti-HPV 11
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6476.1
        upper Limit
        7522.8
        value
        6979.8
      2. group Id
        OG001
        lower Limit
        6772.7
        upper Limit
        7853.1
        value
        7292.9
      3. group Id
        OG002
        lower Limit
        6458.7
        upper Limit
        7474.9
        value
        6948.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        529
      2. group Id
        OG001
        value
        542
      3. group Id
        OG002
        value
        556
      units
      Participants
    title
    Anti-HPV 16
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1970.9
        upper Limit
        2353.5
        value
        2153.7
      2. group Id
        OG001
        lower Limit
        1955.6
        upper Limit
        2329.0
        value
        2134.1
      3. group Id
        OG002
        lower Limit
        1804.3
        upper Limit
        2143.5
        value
        1966.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        531
      2. group Id
        OG001
        value
        547
      3. group Id
        OG002
        value
        563
      units
      Participants
    title
    Anti-HPV 18
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1738.5
        upper Limit
        2058.2
        value
        1891.6
      2. group Id
        OG001
        lower Limit
        1719.3
        upper Limit
        2029.1
        value
        1867.8
      3. group Id
        OG002
        lower Limit
        1731.0
        upper Limit
        2039.6
        value
        1879.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        522
      2. group Id
        OG001
        value
        542
      3. group Id
        OG002
        value
        553
      units
      Participants
    title
    Anti-HPV 31
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        909.2
        upper Limit
        1057.2
        value
        980.4
      2. group Id
        OG001
        lower Limit
        856.2
        upper Limit
        994.4
        value
        922.7
      3. group Id
        OG002
        lower Limit
        865.0
        upper Limit
        1002.3
        value
        931.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        534
      2. group Id
        OG001
        value
        543
      3. group Id
        OG002
        value
        560
      units
      Participants
    title
    Anti-HPV 33
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        650.1
        upper Limit
        785.0
        value
        714.4
      2. group Id
        OG001
        lower Limit
        754.1
        upper Limit
        908.5
        value
        827.7
      3. group Id
        OG002
        lower Limit
        619.0
        upper Limit
        743.6
        value
        678.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        534
      2. group Id
        OG001
        value
        548
      3. group Id
        OG002
        value
        565
      units
      Participants
    title
    Anti-HPV 45
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        860.8
        upper Limit
        1011.0
        value
        932.9
      2. group Id
        OG001
        lower Limit
        931.0
        upper Limit
        1091.2
        value
        1007.9
      3. group Id
        OG002
        lower Limit
        898.1
        upper Limit
        1050.3
        value
        971.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        533
      2. group Id
        OG001
        value
        547
      3. group Id
        OG002
        value
        562
      units
      Participants
    title
    Anti-HPV 52
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1190.0
        upper Limit
        1391.3
        value
        1286.7
      2. group Id
        OG001
        lower Limit
        1244.6
        upper Limit
        1453.3
        value
        1344.9
      3. group Id
        OG002
        lower Limit
        1119.6
        upper Limit
        1303.6
        value
        1208.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        531
      2. group Id
        OG001
        value
        539
      3. group Id
        OG002
        value
        560
      units
      Participants
    title
    Anti-HPV 58
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 VLPs, Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 were determined 4 weeks post-vaccination 3 using cLIA. Titers were reported in milli Merck Units/mL.
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
GEOMETRIC_MEAN
population Description
9-15-year-old females who received 3 vaccinations from Lots 1, 2, or 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: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
type
PRIMARY
unit Of Measure
milli Merck Units/mL

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