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NCT00851643 · OUTCOME

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

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 B)

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

Groups in this outcome

qHPV (GARDASIL™) - Phase B Control

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

Octavalent HPV With 60 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 60 mcg ISCOMATRIX™(IMX)

Octavalent HPV With 120 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 120 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 B Control15
Octavalent HPV With 60 mcg IMX / AAHS30
Octavalent HPV With 120 mcg IMX / AAHS30

Reported measurements

Anti-HPV Type 6 (N=10, N=19, N=23)
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase B Control2350.9Not reported1581.63494.2Not reported
Octavalent HPV With 60 mcg IMX / AAHS6006.0Not reported3991.69037.0Not reported
Octavalent HPV With 120 mcg IMX / AAHS4484.8Not reported2791.77204.7Not reported
Anti-HPV Type 11 (N=10, N=19, N=23)
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase B Control3762.2Not reported2422.05844.1Not reported
Octavalent HPV With 60 mcg IMX / AAHS6514.2Not reported4520.89386.8Not reported
Octavalent HPV With 120 mcg IMX / AAHS6609.3Not reported5028.28687.5Not reported
Anti-HPV Type 16 (N=7, N=19, N=20)
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase B Control2783.6Not reported973.27961.8Not reported
Octavalent HPV With 60 mcg IMX / AAHS12947.5Not reported8856.518928.3Not reported
Octavalent HPV With 120 mcg IMX / AAHS10105.9Not reported6570.915542.6Not reported
Anti-HPV Type 18 (N=10, N=19, N=25)
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase B Control948.2Not reported403.72227.1Not reported
Octavalent HPV With 60 mcg IMX / AAHS5090.0Not reported3467.57471.7Not reported
Octavalent HPV With 120 mcg IMX / AAHS4070.9Not reported3135.25285.9Not reported
Anti-HPV Type 31 (N=11, N=22, N=24)
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase B Control36.9Not reported15.588.2Not reported
Octavalent HPV With 60 mcg IMX / AAHS7779.0Not reported4876.712408.5Not reported
Octavalent HPV With 120 mcg IMX / AAHS5487.3Not reported3683.08175.6Not reported
Anti-HPV Type 45 (N=11, N=20, N=24)
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase B Control4.7Not reportedNA10.9The lower bound of the 95% confidence interval is below the level of detectability (\<4).
Octavalent HPV With 60 mcg IMX / AAHS3974.8Not reported2680.55894.0Not reported
Octavalent HPV With 120 mcg IMX / AAHS4696.4Not reported3499.66302.5Not reported
Anti-HPV Type 52 (N=10, N=20, N=23)
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase B ControlNANot reportedNANAThe GMT is \<16, and the lower and upper bounds of the 95% confidence interval are below the level of detectability (\<16 to \<16).
Octavalent HPV With 60 mcg IMX / AAHS5714.9Not reported3962.48242.6Not reported
Octavalent HPV With 120 mcg IMX / AAHS6624.6Not reported4919.98919.9Not reported
Anti-HPV Type 58 (N=9, N=21, N=24)
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase B Control9.6Not reportedNA28.1The lower bound of the 95% confidence interval is below the level of detectability (\<6).
Octavalent HPV With 60 mcg IMX / AAHS4961.8Not reported3170.17766.1Not reported
Octavalent HPV With 120 mcg IMX / AAHS5191.2Not reported4036.36676.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1581.6
        upper Limit
        3494.2
        value
        2350.9
      2. group Id
        OG001
        lower Limit
        3991.6
        upper Limit
        9037.0
        value
        6006.0
      3. group Id
        OG002
        lower Limit
        2791.7
        upper Limit
        7204.7
        value
        4484.8
    title
    Anti-HPV Type 6 (N=10, N=19, N=23)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2422.0
        upper Limit
        5844.1
        value
        3762.2
      2. group Id
        OG001
        lower Limit
        4520.8
        upper Limit
        9386.8
        value
        6514.2
      3. group Id
        OG002
        lower Limit
        5028.2
        upper Limit
        8687.5
        value
        6609.3
    title
    Anti-HPV Type 11 (N=10, N=19, N=23)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        973.2
        upper Limit
        7961.8
        value
        2783.6
      2. group Id
        OG001
        lower Limit
        8856.5
        upper Limit
        18928.3
        value
        12947.5
      3. group Id
        OG002
        lower Limit
        6570.9
        upper Limit
        15542.6
        value
        10105.9
    title
    Anti-HPV Type 16 (N=7, N=19, N=20)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        403.7
        upper Limit
        2227.1
        value
        948.2
      2. group Id
        OG001
        lower Limit
        3467.5
        upper Limit
        7471.7
        value
        5090.0
      3. group Id
        OG002
        lower Limit
        3135.2
        upper Limit
        5285.9
        value
        4070.9
    title
    Anti-HPV Type 18 (N=10, N=19, N=25)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.5
        upper Limit
        88.2
        value
        36.9
      2. group Id
        OG001
        lower Limit
        4876.7
        upper Limit
        12408.5
        value
        7779.0
      3. group Id
        OG002
        lower Limit
        3683.0
        upper Limit
        8175.6
        value
        5487.3
    title
    Anti-HPV Type 31 (N=11, N=22, N=24)
  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
        10.9
        value
        4.7
      2. group Id
        OG001
        lower Limit
        2680.5
        upper Limit
        5894.0
        value
        3974.8
      3. group Id
        OG002
        lower Limit
        3499.6
        upper Limit
        6302.5
        value
        4696.4
    title
    Anti-HPV Type 45 (N=11, N=20, N=24)
  7. categories
    1. measurements
      1. comment
        The GMT is \<16, and 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
        3962.4
        upper Limit
        8242.6
        value
        5714.9
      3. group Id
        OG002
        lower Limit
        4919.9
        upper Limit
        8919.9
        value
        6624.6
    title
    Anti-HPV Type 52 (N=10, N=20, N=23)
  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
        28.1
        value
        9.6
      2. group Id
        OG001
        lower Limit
        3170.1
        upper Limit
        7766.1
        value
        4961.8
      3. group Id
        OG002
        lower Limit
        4036.3
        upper Limit
        6676.5
        value
        5191.2
    title
    Anti-HPV Type 58 (N=9, N=21, N=24)
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 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 B
    id
    OG000
    title
    qHPV (GARDASIL™) - Phase B 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 60 mcg ISCOMATRIX™(IMX)
    id
    OG001
    title
    Octavalent HPV With 60 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 120 mcg ISCOMATRIX™ (IMX)
    id
    OG002
    title
    Octavalent HPV With 120 mcg IMX / AAHS
param Type
GEOMETRIC_MEAN
population Description
PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7 for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range.
reporting Status
POSTED
time Frame
4 weeks postdose 3 (Phase B)
title
Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B
type
PRIMARY
unit Of Measure
mMU/mL

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Preserved source evidence · Not medical advice