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NCT03158220 · OUTCOME

Percentage of Participants Who Seroconverted to Each of the Anti-HPV Types

Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004) · Source last updated 2019-11-21

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

Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. The percentage of participants who were seronegative on Day 1 and have anti-HPV titer greater or equal to the type-specific serostatus cutoff at 4 weeks postdose 3 was assessed.

Analysis population: Received all 3 vaccinations of the correct dose and within acceptable day ranges, had evaluable serology results at Day 1 and Month 7, must have been seronegative to the appropriate HPV type at Day 1 and had no protocol deviations that could interfere with the evaluation of participant's immune response to the 9vHPV vaccine.

Groups in this outcome

Women 16-26 Years of Age

Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.

Women 27-45 Years of Age

Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.

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

Analysis denominator · Participants

GroupSource count
Women 16-26 Years of Age485
Women 27-45 Years of Age533

Reported measurements

Anti HPV 6

Analysis denominator · Participants

GroupSource count
Women 16-26 Years of Age421
Women 27-45 Years of Age448
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Women 16-26 Years of Age99.8Not reported98.7100.0Not reported
Women 27-45 Years of Age100.0Not reported99.2100.0Not reported
Anti HPV 11

Analysis denominator · Participants

GroupSource count
Women 16-26 Years of Age421
Women 27-45 Years of Age448
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Women 16-26 Years of Age100.0Not reported99.1100.0Not reported
Women 27-45 Years of Age99.8Not reported98.8100.0Not reported
Anti HPV 16

Analysis denominator · Participants

GroupSource count
Women 16-26 Years of Age436
Women 27-45 Years of Age448
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Women 16-26 Years of Age100.0Not reported99.2100.0Not reported
Women 27-45 Years of Age100.0Not reported99.2100.0Not reported
Anti HPV 18

Analysis denominator · Participants

GroupSource count
Women 16-26 Years of Age421
Women 27-45 Years of Age471
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Women 16-26 Years of Age100.0Not reported99.1100.0Not reported
Women 27-45 Years of Age99.6Not reported98.599.9Not reported
Anti HPV 31

Analysis denominator · Participants

GroupSource count
Women 16-26 Years of Age447
Women 27-45 Years of Age488
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Women 16-26 Years of Age100.0Not reported99.2100.0Not reported
Women 27-45 Years of Age99.8Not reported98.9100.0Not reported
Anti HPV 33

Analysis denominator · Participants

GroupSource count
Women 16-26 Years of Age457
Women 27-45 Years of Age493
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Women 16-26 Years of Age100.0Not reported99.2100.0Not reported
Women 27-45 Years of Age99.8Not reported98.9100.0Not reported
Anti HPV 45

Analysis denominator · Participants

GroupSource count
Women 16-26 Years of Age470
Women 27-45 Years of Age515
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Women 16-26 Years of Age99.6Not reported98.599.9Not reported
Women 27-45 Years of Age99.2Not reported98.099.8Not reported
Anti HPV 52

Analysis denominator · Participants

GroupSource count
Women 16-26 Years of Age456
Women 27-45 Years of Age496
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Women 16-26 Years of Age100.0Not reported99.2100.0Not reported
Women 27-45 Years of Age100.0Not reported99.3100.0Not reported
Anti HPV 58

Analysis denominator · Participants

GroupSource count
Women 16-26 Years of Age451
Women 27-45 Years of Age478
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Women 16-26 Years of Age100.0Not reported99.2100.0Not reported
Women 27-45 Years of Age99.8Not reported98.8100.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        98.7
        upper Limit
        100.0
        value
        99.8
      2. group Id
        OG001
        lower Limit
        99.2
        upper Limit
        100.0
        value
        100.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        421
      2. group Id
        OG001
        value
        448
      units
      Participants
    title
    Anti HPV 6
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.1
        upper Limit
        100.0
        value
        100.0
      2. group Id
        OG001
        lower Limit
        98.8
        upper Limit
        100.0
        value
        99.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        421
      2. group Id
        OG001
        value
        448
      units
      Participants
    title
    Anti HPV 11
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.2
        upper Limit
        100.0
        value
        100.0
      2. group Id
        OG001
        lower Limit
        99.2
        upper Limit
        100.0
        value
        100.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        436
      2. group Id
        OG001
        value
        448
      units
      Participants
    title
    Anti HPV 16
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.1
        upper Limit
        100.0
        value
        100.0
      2. group Id
        OG001
        lower Limit
        98.5
        upper Limit
        99.9
        value
        99.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        421
      2. group Id
        OG001
        value
        471
      units
      Participants
    title
    Anti HPV 18
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.2
        upper Limit
        100.0
        value
        100.0
      2. group Id
        OG001
        lower Limit
        98.9
        upper Limit
        100.0
        value
        99.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        447
      2. group Id
        OG001
        value
        488
      units
      Participants
    title
    Anti HPV 31
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.2
        upper Limit
        100.0
        value
        100.0
      2. group Id
        OG001
        lower Limit
        98.9
        upper Limit
        100.0
        value
        99.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        457
      2. group Id
        OG001
        value
        493
      units
      Participants
    title
    Anti HPV 33
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        98.5
        upper Limit
        99.9
        value
        99.6
      2. group Id
        OG001
        lower Limit
        98.0
        upper Limit
        99.8
        value
        99.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        470
      2. group Id
        OG001
        value
        515
      units
      Participants
    title
    Anti HPV 45
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.2
        upper Limit
        100.0
        value
        100.0
      2. group Id
        OG001
        lower Limit
        99.3
        upper Limit
        100.0
        value
        100.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        456
      2. group Id
        OG001
        value
        496
      units
      Participants
    title
    Anti HPV 52
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.2
        upper Limit
        100.0
        value
        100.0
      2. group Id
        OG001
        lower Limit
        98.8
        upper Limit
        100.0
        value
        99.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        451
      2. group Id
        OG001
        value
        478
      units
      Participants
    title
    Anti HPV 58
denoms
  1. counts
    1. group Id
      OG000
      value
      485
    2. group Id
      OG001
      value
      533
    units
    Participants
description
Antibodies to the HPV types contained in V503 were measured using a competitive luminex immunoassay. The percentage of participants who were seronegative on Day 1 and have anti-HPV titer greater or equal to the type-specific serostatus cutoff at 4 weeks postdose 3 was assessed.
dispersion Type
95% Confidence Interval
groups
  1. description
    Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
    id
    OG000
    title
    Women 16-26 Years of Age
  2. description
    Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
    id
    OG001
    title
    Women 27-45 Years of Age
param Type
NUMBER
population Description
Received all 3 vaccinations of the correct dose and within acceptable day ranges, had evaluable serology results at Day 1 and Month 7, must have been seronegative to the appropriate HPV type at Day 1 and had no protocol deviations that could interfere with the evaluation of participant's immune response to the 9vHPV vaccine.
reporting Status
POSTED
time Frame
4 weeks post vaccination 3 (Month 7)
title
Percentage of Participants Who Seroconverted to Each of the Anti-HPV Types
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice