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NCT03546842 · OUTCOME

Geometric Mean Titers of Antibodies to HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7

Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam (V503-017) · Source last updated 2020-02-25

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 (Month 7)

What was measured

Anti-HPV Type 6, 11, 16, 18, 31, 33, 45, 52, and 58 antibodies are measured using a Competitive Luminex Immunoassay. Titers are reported in mMU/mL.

Analysis population: All allocated participants who were seronegative to the appropriate HPV type at Day 1, received all 3 vaccinations with the correct dose within acceptable day ranges, provided a serum sample within 21 to 49 days postdose 3, and had no protocol deviations that could interfere with the evaluation of participant's immune response to 9vHPV vaccination.

Groups in this outcome

9vHPV Vaccine

Participants received a single 0.5-mL intramuscular injection of the 9vHPV vaccine at Day 1, Month 2, and Month 6

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

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine195

Reported measurements

Anti-HPV 6

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine190
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV Vaccine1008.2Not reported921.91102.6Not reported
Anti-HPV 11

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine190
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV Vaccine796.3Not reported722.2878.0Not reported
Anti-HPV 16

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine187
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV Vaccine4605.4Not reported4163.75093.9Not reported
Anti-HPV 18

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine190
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV Vaccine1621.6Not reported1441.21824.5Not reported
Anti-HPV 31

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine188
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV Vaccine1137.9Not reported1017.21273.0Not reported
Anti-HPV 33

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine194
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV Vaccine507.8Not reported458.5562.4Not reported
Anti-HPV 45

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine193
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV Vaccine579.2Not reported511.7655.6Not reported
Anti-HPV 52

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine192
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV Vaccine500.8Not reported450.5556.7Not reported
Anti-HPV 58

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine190
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV Vaccine701.8Not reported628.5783.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        921.9
        upper Limit
        1102.6
        value
        1008.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        190
      units
      Participants
    title
    Anti-HPV 6
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        722.2
        upper Limit
        878.0
        value
        796.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        190
      units
      Participants
    title
    Anti-HPV 11
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4163.7
        upper Limit
        5093.9
        value
        4605.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        187
      units
      Participants
    title
    Anti-HPV 16
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1441.2
        upper Limit
        1824.5
        value
        1621.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        190
      units
      Participants
    title
    Anti-HPV 18
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1017.2
        upper Limit
        1273.0
        value
        1137.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        188
      units
      Participants
    title
    Anti-HPV 31
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        458.5
        upper Limit
        562.4
        value
        507.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        194
      units
      Participants
    title
    Anti-HPV 33
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        511.7
        upper Limit
        655.6
        value
        579.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        193
      units
      Participants
    title
    Anti-HPV 45
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        450.5
        upper Limit
        556.7
        value
        500.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        192
      units
      Participants
    title
    Anti-HPV 52
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        628.5
        upper Limit
        783.7
        value
        701.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        190
      units
      Participants
    title
    Anti-HPV 58
denoms
  1. counts
    1. group Id
      OG000
      value
      195
    units
    Participants
description
Anti-HPV Type 6, 11, 16, 18, 31, 33, 45, 52, and 58 antibodies are measured using a Competitive Luminex Immunoassay. Titers are reported in mMU/mL.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received a single 0.5-mL intramuscular injection of the 9vHPV vaccine at Day 1, Month 2, and Month 6
    id
    OG000
    title
    9vHPV Vaccine
param Type
GEOMETRIC_MEAN
population Description
All allocated participants who were seronegative to the appropriate HPV type at Day 1, received all 3 vaccinations with the correct dose within acceptable day ranges, provided a serum sample within 21 to 49 days postdose 3, and had no protocol deviations that could interfere with the evaluation of participant's immune response to 9vHPV vaccination.
reporting Status
POSTED
time Frame
4 weeks postdose 3 (Month 7)
title
Geometric Mean Titers of Antibodies to HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7
type
SECONDARY
unit Of Measure
mMU/mL

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Preserved source evidence · Not medical advice