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NCT00851643 · OUTCOME

Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A

Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002) · Source last updated 2016-02-03

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
4 weeks postdose 3 (Phase A)

What was measured

The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using a competitive Luminex immunoassay (cLIA) after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.

Analysis population: Per Protocol Immunogenicity (PPI) population: participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and polymerase chain reaction (PCR)-negative Day 1 through Month 7 for the relevant HPV type(s), had a valid Month 7 serology result collected in the appropriate day range.

Groups in this outcome

qHPV (GARDASIL™) - Phase A Control

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase A

Octavalent HPV With 15 mcg IMX / AAHS

Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™(IMX)

Octavalent HPV With 30 mcg IMX / AAHS

Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 30 mcg ISCOMATRIX™ (IMX)

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

Analysis denominator · Participants

GroupSource count
qHPV (GARDASIL™) - Phase A Control15
Octavalent HPV With 15 mcg IMX / AAHS30
Octavalent HPV With 30 mcg IMX / AAHS30

Reported measurements

Anti-HPV 6 (N=11, N=21, N=22)
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase A Control1273.3Not reported704.92300.1Not reported
Octavalent HPV With 15 mcg IMX / AAHS2203.0Not reported1658.92925.6Not reported
Octavalent HPV With 30 mcg IMX / AAHS4784.7Not reported3741.56118.8Not reported
Anti-HPV 11 (N=11, N=21, N=22)
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase A Control1991.6Not reported1096.33618.2Not reported
Octavalent HPV With 15 mcg IMX / AAHS2564.3Not reported1940.83388.3Not reported
Octavalent HPV With 30 mcg IMX / AAHS3921.6Not reported2964.45188.0Not reported
Anti-HPV 16 (N=11, N=23, N=24)
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase A Control2381.9Not reported1558.53640.4Not reported
Octavalent HPV With 15 mcg IMX / AAHS3961.8Not reported2982.65262.4Not reported
Octavalent HPV With 30 mcg IMX / AAHS7484.4Not reported5493.910196.1Not reported
Anti-HPV 18 (N=11, N=24, N=24)
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase A Control568.7Not reported284.81135.7Not reported
Octavalent HPV With 15 mcg IMX / AAHS1375.7Not reported966.41958.2Not reported
Octavalent HPV With 30 mcg IMX / AAHS2315.3Not reported1453.43688.3Not reported
Anti-HPV 31(N=11, N=24, N=23)
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase A Control24.3Not reportedNA79.1The lower bound of the 95% confidence interval is below the level of detectability (\<8).
Octavalent HPV With 15 mcg IMX / AAHS2037.5Not reported1502.42763.0Not reported
Octavalent HPV With 30 mcg IMX / AAHS4782.3Not reported3282.46967.5Not reported
Anti-HPV 45 (N=11, N=26, N=25)
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase A Control10.8Not reportedNA52.7The lower bound of the 95% confidence interval is below the level of detectability (\<4).
Octavalent HPV With 15 mcg IMX / AAHS1042.8Not reported760.81429.1Not reported
Octavalent HPV With 30 mcg IMX / AAHS2116.5Not reported1329.73368.8Not reported
Anti-HPV 52 (N=9, N=23, N=25)
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase A ControlNANot reportedNANAThe lower and upper bounds of the 95% confidence interval are below the level of detectability (\<16 to \<16).
Octavalent HPV With 15 mcg IMX / AAHS2531.1Not reported1798.63561.9Not reported
Octavalent HPV With 30 mcg IMX / AAHS4292.0Not reported2997.76145.2Not reported
Anti-HPV 58 (N=10, N=24, N=22)
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase A Control17.7Not reportedNA86.1The lower bound of the 95% confidence interval is below the level of detectability (\<6).
Octavalent HPV With 15 mcg IMX / AAHS1759.2Not reported1276.52424.4Not reported
Octavalent HPV With 30 mcg IMX / AAHS3146.4Not reported2335.44428.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        704.9
        upper Limit
        2300.1
        value
        1273.3
      2. group Id
        OG001
        lower Limit
        1658.9
        upper Limit
        2925.6
        value
        2203.0
      3. group Id
        OG002
        lower Limit
        3741.5
        upper Limit
        6118.8
        value
        4784.7
    title
    Anti-HPV 6 (N=11, N=21, N=22)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1096.3
        upper Limit
        3618.2
        value
        1991.6
      2. group Id
        OG001
        lower Limit
        1940.8
        upper Limit
        3388.3
        value
        2564.3
      3. group Id
        OG002
        lower Limit
        2964.4
        upper Limit
        5188.0
        value
        3921.6
    title
    Anti-HPV 11 (N=11, N=21, N=22)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1558.5
        upper Limit
        3640.4
        value
        2381.9
      2. group Id
        OG001
        lower Limit
        2982.6
        upper Limit
        5262.4
        value
        3961.8
      3. group Id
        OG002
        lower Limit
        5493.9
        upper Limit
        10196.1
        value
        7484.4
    title
    Anti-HPV 16 (N=11, N=23, N=24)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        284.8
        upper Limit
        1135.7
        value
        568.7
      2. group Id
        OG001
        lower Limit
        966.4
        upper Limit
        1958.2
        value
        1375.7
      3. group Id
        OG002
        lower Limit
        1453.4
        upper Limit
        3688.3
        value
        2315.3
    title
    Anti-HPV 18 (N=11, N=24, N=24)
  5. categories
    1. measurements
      1. comment
        The lower bound of the 95% confidence interval is below the level of detectability (\<8).
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        79.1
        value
        24.3
      2. group Id
        OG001
        lower Limit
        1502.4
        upper Limit
        2763.0
        value
        2037.5
      3. group Id
        OG002
        lower Limit
        3282.4
        upper Limit
        6967.5
        value
        4782.3
    title
    Anti-HPV 31(N=11, N=24, N=23)
  6. categories
    1. measurements
      1. comment
        The lower bound of the 95% confidence interval is below the level of detectability (\<4).
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        52.7
        value
        10.8
      2. group Id
        OG001
        lower Limit
        760.8
        upper Limit
        1429.1
        value
        1042.8
      3. group Id
        OG002
        lower Limit
        1329.7
        upper Limit
        3368.8
        value
        2116.5
    title
    Anti-HPV 45 (N=11, N=26, N=25)
  7. categories
    1. measurements
      1. comment
        The lower and upper bounds of the 95% confidence interval are below the level of detectability (\<16 to \<16).
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        1798.6
        upper Limit
        3561.9
        value
        2531.1
      3. group Id
        OG002
        lower Limit
        2997.7
        upper Limit
        6145.2
        value
        4292.0
    title
    Anti-HPV 52 (N=9, N=23, N=25)
  8. categories
    1. measurements
      1. comment
        The lower bound of the 95% confidence interval is below the level of detectability (\<6).
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        86.1
        value
        17.7
      2. group Id
        OG001
        lower Limit
        1276.5
        upper Limit
        2424.4
        value
        1759.2
      3. group Id
        OG002
        lower Limit
        2335.4
        upper Limit
        4428.8
        value
        3146.4
    title
    Anti-HPV 58 (N=10, N=24, N=22)
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      30
    3. group Id
      OG002
      value
      30
    units
    Participants
description
The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using a competitive Luminex immunoassay (cLIA) after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent.
dispersion Type
95% Confidence Interval
groups
  1. description
    Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase A
    id
    OG000
    title
    qHPV (GARDASIL™) - Phase A Control
  2. description
    Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™(IMX)
    id
    OG001
    title
    Octavalent HPV With 15 mcg IMX / AAHS
  3. description
    Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 30 mcg ISCOMATRIX™ (IMX)
    id
    OG002
    title
    Octavalent HPV With 30 mcg IMX / AAHS
param Type
GEOMETRIC_MEAN
population Description
Per Protocol Immunogenicity (PPI) population: participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and polymerase chain reaction (PCR)-negative Day 1 through Month 7 for the relevant HPV type(s), had a valid Month 7 serology result collected in the appropriate day range.
reporting Status
POSTED
time Frame
4 weeks postdose 3 (Phase A)
title
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A
type
PRIMARY
unit Of Measure
mMU/mL

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Preserved source evidence · Not medical advice