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NCT03546842 · OUTCOME

Geometric Mean Titers of Serotype-specific Antibodies: Predose Day 1

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
Day 1 (predose)

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 milli Merck units/mL (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 VaccineNANot reportedNANA\< Lower Limit of Quantification (LLOQ) of 20 mMU/mL
Anti-HPV 11

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine190
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV VaccineNANot reportedNANA\< LLOQ of 16 mMU/mL
Anti-HPV 16

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine187
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV VaccineNANot reportedNANA\< LLOQ of 20 mMU/mL
Anti-HPV 18

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine190
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV Vaccine29.3Not reported27.731.1Not reported
Anti-HPV 31

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine188
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV VaccineNANot reportedNANA\< LLOQ of 10 mMU/mL
Anti-HPV 33

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine194
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV VaccineNANot reportedNA8.3\< LLOQ of 8 mMU/mL
Anti-HPV 45

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine193
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV VaccineNANot reportedNANA\< LLOQ of 8 mMU/mL
Anti-HPV 52

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine192
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV VaccineNANot reportedNANA\< LLOQ of 8 mMU/mL
Anti-HPV 58

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine190
Values in mMU/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV VaccineNANot reportedNANA\< LLOQ of 8 mMU/mL
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        \< Lower Limit of Quantification (LLOQ) of 20 mMU/mL
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        190
      units
      Participants
    title
    Anti-HPV 6
  2. categories
    1. measurements
      1. comment
        \< LLOQ of 16 mMU/mL
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        190
      units
      Participants
    title
    Anti-HPV 11
  3. categories
    1. measurements
      1. comment
        \< LLOQ of 20 mMU/mL
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    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
        27.7
        upper Limit
        31.1
        value
        29.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        190
      units
      Participants
    title
    Anti-HPV 18
  5. categories
    1. measurements
      1. comment
        \< LLOQ of 10 mMU/mL
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        188
      units
      Participants
    title
    Anti-HPV 31
  6. categories
    1. measurements
      1. comment
        \< LLOQ of 8 mMU/mL
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        8.3
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        194
      units
      Participants
    title
    Anti-HPV 33
  7. categories
    1. measurements
      1. comment
        \< LLOQ of 8 mMU/mL
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        193
      units
      Participants
    title
    Anti-HPV 45
  8. categories
    1. measurements
      1. comment
        \< LLOQ of 8 mMU/mL
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        192
      units
      Participants
    title
    Anti-HPV 52
  9. categories
    1. measurements
      1. comment
        \< LLOQ of 8 mMU/mL
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    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 milli Merck units/mL (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
Day 1 (predose)
title
Geometric Mean Titers of Serotype-specific Antibodies: Predose Day 1
type
SECONDARY
unit Of Measure
mMU/mL

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Preserved source evidence · Not medical advice