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NCT00851643 · OUTCOME

Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During 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
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
4 weeks postdose 3 (Phase B)

What was measured

A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.

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 6 (N=10, N=19, N=23)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase B Control10Not reportedNot reportedNot reportedNot reported
Octavalent HPV With 60 mcg IMX / AAHS19Not reportedNot reportedNot reportedNot reported
Octavalent HPV With 120 mcg IMX / AAHS23Not reportedNot reportedNot reportedNot reported
Anti-HPV 11 (N=10, N=19, N=23)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase B Control10Not reportedNot reportedNot reportedNot reported
Octavalent HPV With 60 mcg IMX / AAHS19Not reportedNot reportedNot reportedNot reported
Octavalent HPV With 120 mcg IMX / AAHS23Not reportedNot reportedNot reportedNot reported
Anti-HPV 16 (N=7, N=19, N=20)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase B Control7Not reportedNot reportedNot reportedNot reported
Octavalent HPV With 60 mcg IMX / AAHS19Not reportedNot reportedNot reportedNot reported
Octavalent HPV With 120 mcg IMX / AAHS20Not reportedNot reportedNot reportedNot reported
Anti-HPV 18 (N=10, N=19, N=25)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase B Control10Not reportedNot reportedNot reportedNot reported
Octavalent HPV With 60 mcg IMX / AAHS19Not reportedNot reportedNot reportedNot reported
Octavalent HPV With 120 mcg IMX / AAHS25Not reportedNot reportedNot reportedNot reported
Anti-HPV 31 (N=11, N=22, N=24)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase B Control9Not reportedNot reportedNot reportedNot reported
Octavalent HPV With 60 mcg IMX / AAHS22Not reportedNot reportedNot reportedNot reported
Octavalent HPV With 120 mcg IMX / AAHS24Not reportedNot reportedNot reportedNot reported
Anti-HPV 45 (N=11, N=20, N=24)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase B Control2Not reportedNot reportedNot reportedNot reported
Octavalent HPV With 60 mcg IMX / AAHS20Not reportedNot reportedNot reportedNot reported
Octavalent HPV With 120 mcg IMX / AAHS24Not reportedNot reportedNot reportedNot reported
Anti-HPV 52 (N=10, N=20, N=23)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase B Control0Not reportedNot reportedNot reportedNot reported
Octavalent HPV With 60 mcg IMX / AAHS20Not reportedNot reportedNot reportedNot reported
Octavalent HPV With 120 mcg IMX / AAHS23Not reportedNot reportedNot reportedNot reported
Anti-HPV 58 (N=9, N=21, N=24)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
qHPV (GARDASIL™) - Phase B Control2Not reportedNot reportedNot reportedNot reported
Octavalent HPV With 60 mcg IMX / AAHS21Not reportedNot reportedNot reportedNot reported
Octavalent HPV With 120 mcg IMX / AAHS24Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        19
      3. group Id
        OG002
        value
        23
    title
    Anti-HPV 6 (N=10, N=19, N=23)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        19
      3. group Id
        OG002
        value
        23
    title
    Anti-HPV 11 (N=10, N=19, N=23)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        19
      3. group Id
        OG002
        value
        20
    title
    Anti-HPV 16 (N=7, N=19, N=20)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        19
      3. group Id
        OG002
        value
        25
    title
    Anti-HPV 18 (N=10, N=19, N=25)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        22
      3. group Id
        OG002
        value
        24
    title
    Anti-HPV 31 (N=11, N=22, N=24)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        24
    title
    Anti-HPV 45 (N=11, N=20, N=24)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        23
    title
    Anti-HPV 52 (N=10, N=20, N=23)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        21
      3. group Id
        OG002
        value
        24
    title
    Anti-HPV 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
A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively.
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
NUMBER
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
Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice