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NCT00543543 · OUTCOME

Base Study: Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58

Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) · Source last updated 2018-11-27

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 postdose 3

What was measured

Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. 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 Types 33, 45, 52, and 58: ≥8.

Analysis population: The Per-protocol Immunogenicity population included all participants who were not protocol violators, received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable ranges, were seronegative at Day 1 and PCR negative from Day 1 - Month 7 for the relevant HPV types, and had a Month 7 serum sample collected within an acceptable range

Groups in this outcome

Mid-dose V503

V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.

Gardasil

Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.

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

Analysis denominator · Participants

GroupSource count
Mid-dose V5036792
Gardasil6795

Reported measurements

Anti-HPV Type 6 (n=3993, 3975)
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Mid-dose V50399.8Not reported99.699.9Not reported
Gardasil99.8Not reported99.799.9Not reported
Anti-HPV Type 11 (n=3995, 3982)
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Mid-dose V503100Not reported99.9100Not reported
Gardasil99.9Not reported99.8100Not reported
Anti-HPV Type 16 (n=4032, 4062)
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Mid-dose V503100Not reported99.9100Not reported
Gardasil100Not reported99.8100Not reported
Anti-HPV Type 18 (n=4539, 4541)
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Mid-dose V50399.8Not reported99.799.9Not reported
Gardasil99.7Not reported99.599.8Not reported
Anti-HPV Type 31 (n=4466, 4377)
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Mid-dose V50399.8Not reported99.699.9Not reported
Gardasil50.1Not reported48.751.6Not reported
Anti-HPV Type 33 (n=4702, 4691)
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Mid-dose V50399.7Not reported99.599.9Not reported
Gardasil12.7Not reported11.813.7Not reported
Anti-HPV Type 45 (n=4792, 4750)
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Mid-dose V50399.6Not reported99.499.8Not reported
Gardasil9.2Not reported8.410.0Not reported
Anti-HPV Type 52 (n=4455, 4335)
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Mid-dose V50399.8Not reported99.699.9Not reported
Gardasil2.6Not reported2.23.1Not reported
Anti-HPV Type 58 (n=4486, 4446)
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Mid-dose V50399.8Not reported99.699.9Not reported
Gardasil20.4Not reported19.221.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.6
        upper Limit
        99.9
        value
        99.8
      2. group Id
        OG001
        lower Limit
        99.7
        upper Limit
        99.9
        value
        99.8
    title
    Anti-HPV Type 6 (n=3993, 3975)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.9
        upper Limit
        100
        value
        100
      2. group Id
        OG001
        lower Limit
        99.8
        upper Limit
        100
        value
        99.9
    title
    Anti-HPV Type 11 (n=3995, 3982)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.9
        upper Limit
        100
        value
        100
      2. group Id
        OG001
        lower Limit
        99.8
        upper Limit
        100
        value
        100
    title
    Anti-HPV Type 16 (n=4032, 4062)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.7
        upper Limit
        99.9
        value
        99.8
      2. group Id
        OG001
        lower Limit
        99.5
        upper Limit
        99.8
        value
        99.7
    title
    Anti-HPV Type 18 (n=4539, 4541)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.6
        upper Limit
        99.9
        value
        99.8
      2. group Id
        OG001
        lower Limit
        48.7
        upper Limit
        51.6
        value
        50.1
    title
    Anti-HPV Type 31 (n=4466, 4377)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.5
        upper Limit
        99.9
        value
        99.7
      2. group Id
        OG001
        lower Limit
        11.8
        upper Limit
        13.7
        value
        12.7
    title
    Anti-HPV Type 33 (n=4702, 4691)
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.4
        upper Limit
        99.8
        value
        99.6
      2. group Id
        OG001
        lower Limit
        8.4
        upper Limit
        10.0
        value
        9.2
    title
    Anti-HPV Type 45 (n=4792, 4750)
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.6
        upper Limit
        99.9
        value
        99.8
      2. group Id
        OG001
        lower Limit
        2.2
        upper Limit
        3.1
        value
        2.6
    title
    Anti-HPV Type 52 (n=4455, 4335)
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        99.6
        upper Limit
        99.9
        value
        99.8
      2. group Id
        OG001
        lower Limit
        19.2
        upper Limit
        21.6
        value
        20.4
    title
    Anti-HPV Type 58 (n=4486, 4446)
denoms
  1. counts
    1. group Id
      OG000
      value
      6792
    2. group Id
      OG001
      value
      6795
    units
    Participants
description
Serum antibodies to HPV types were measured with a Competitive Luminex Immunoassay. 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 Types 33, 45, 52, and 58: ≥8.
dispersion Type
95% Confidence Interval
groups
  1. description
    V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
    id
    OG000
    title
    Mid-dose V503
  2. description
    Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
    id
    OG001
    title
    Gardasil
param Type
NUMBER
population Description
The Per-protocol Immunogenicity population included all participants who were not protocol violators, received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable ranges, were seronegative at Day 1 and PCR negative from Day 1 - Month 7 for the relevant HPV types, and had a Month 7 serum sample collected within an acceptable range
reporting Status
POSTED
time Frame
4 weeks postdose 3
title
Base Study: Percentage of Participants Who Are Seropositive for HPV Types 6/11/16/18/31/33/45/52/58
type
SECONDARY
unit Of Measure
Percentage of participants

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