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NCT01209325 · OUTCOME

Geometric Mean Titers for HPV 16

Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males · Source last updated 2020-08-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
GEOMETRIC_MEAN
Unit
mMU/mL
Interval / dispersion
95% Confidence Interval
Time frame
Baseline through 24 months

What was measured

Geometric mean concentration of antibodies for HPV 16 at each visit

Analysis population: Eligible participants who received at least one vaccination with evaluable serum assessments.

Groups in this outcome

HPV 16 Sero-negative at Baseline

Sero-negative for HPV 16 at baseline.

HPV 16 Sero-positive at Baseline

Sero-positive for HPV 16 at baseline

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

Analysis denominator · Participants

GroupSource count
HPV 16 Sero-negative at Baseline92
HPV 16 Sero-positive at Baseline51

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
HPV 16 Sero-negative at Baseline92
HPV 16 Sero-positive at Baseline51
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
HPV 16 Sero-negative at Baseline0Not reported00Not reported
HPV 16 Sero-positive at Baseline66.6Not reported46.795.1Not reported
Month 7

Analysis denominator · Participants

GroupSource count
HPV 16 Sero-negative at Baseline82
HPV 16 Sero-positive at Baseline45
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
HPV 16 Sero-negative at Baseline1535.6Not reported1272.51853.1Not reported
HPV 16 Sero-positive at Baseline2947.8Not reported2249.03863.6Not reported
Month 12

Analysis denominator · Participants

GroupSource count
HPV 16 Sero-negative at Baseline76
HPV 16 Sero-positive at Baseline42
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
HPV 16 Sero-negative at Baseline451.6Not reported352.5578.5Not reported
HPV 16 Sero-positive at Baseline1436.6Not reported1095.21884.6Not reported
Month 18

Analysis denominator · Participants

GroupSource count
HPV 16 Sero-negative at Baseline73
HPV 16 Sero-positive at Baseline38
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
HPV 16 Sero-negative at Baseline309.5Not reported237.6403.1Not reported
HPV 16 Sero-positive at Baseline1242.9Not reported892.21731.5Not reported
Month 24

Analysis denominator · Participants

GroupSource count
HPV 16 Sero-negative at Baseline67
HPV 16 Sero-positive at Baseline37
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
HPV 16 Sero-negative at Baseline272.4Not reported195.5379.6Not reported
HPV 16 Sero-positive at Baseline1079.5Not reported771.81510.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0
      2. group Id
        OG001
        lower Limit
        46.7
        upper Limit
        95.1
        value
        66.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        92
      2. group Id
        OG001
        value
        51
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1272.5
        upper Limit
        1853.1
        value
        1535.6
      2. group Id
        OG001
        lower Limit
        2249.0
        upper Limit
        3863.6
        value
        2947.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        82
      2. group Id
        OG001
        value
        45
      units
      Participants
    title
    Month 7
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        352.5
        upper Limit
        578.5
        value
        451.6
      2. group Id
        OG001
        lower Limit
        1095.2
        upper Limit
        1884.6
        value
        1436.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        76
      2. group Id
        OG001
        value
        42
      units
      Participants
    title
    Month 12
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        237.6
        upper Limit
        403.1
        value
        309.5
      2. group Id
        OG001
        lower Limit
        892.2
        upper Limit
        1731.5
        value
        1242.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        73
      2. group Id
        OG001
        value
        38
      units
      Participants
    title
    Month 18
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        195.5
        upper Limit
        379.6
        value
        272.4
      2. group Id
        OG001
        lower Limit
        771.8
        upper Limit
        1510.0
        value
        1079.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        67
      2. group Id
        OG001
        value
        37
      units
      Participants
    title
    Month 24
denoms
  1. counts
    1. group Id
      OG000
      value
      92
    2. group Id
      OG001
      value
      51
    units
    Participants
description
Geometric mean concentration of antibodies for HPV 16 at each visit
dispersion Type
95% Confidence Interval
groups
  1. description
    Sero-negative for HPV 16 at baseline.
    id
    OG000
    title
    HPV 16 Sero-negative at Baseline
  2. description
    Sero-positive for HPV 16 at baseline
    id
    OG001
    title
    HPV 16 Sero-positive at Baseline
param Type
GEOMETRIC_MEAN
population Description
Eligible participants who received at least one vaccination with evaluable serum assessments.
reporting Status
POSTED
time Frame
Baseline through 24 months
title
Geometric Mean Titers for HPV 16
type
SECONDARY
unit Of Measure
mMU/mL

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

Preserved source evidence · Not medical advice