Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03546842 · OUTCOME

Seroconversion Percentages to HPV Types 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
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
4 weeks postdose 3 (Month 7)

What was measured

Seroconversion was defined as a participant who was anti-HPV seronegative at Day 1 and became seropositive at 4 weeks postdose 3 (Month 7). Anti-HPV antibodies were measured using a Competitive Luminex Immunoassay.

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 Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV Vaccine100Not reported98.1100.0Not reported
Anti-HPV 11

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine190
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV Vaccine100Not reported98.1100.0Not reported
Anti-HPV 16

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine187
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV Vaccine100Not reported98.0100.0Not reported
Anti-HPV 18

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine190
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV Vaccine100.0Not reported98.1100.0Not reported
Anti-HPV 31

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine188
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV Vaccine100.0Not reported98.1100.0Not reported
Anti-HPV 33

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine194
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV Vaccine100.0Not reported98.1100.0Not reported
Anti-HPV 45

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine193
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV Vaccine100.0Not reported98.1100.0Not reported
Anti-HPV 52

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine192
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV Vaccine100.0Not reported98.1100.0Not reported
Anti-HPV 58

Analysis denominator · Participants

GroupSource count
9vHPV Vaccine190
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
9vHPV Vaccine100.0Not reported98.1100.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        98.1
        upper Limit
        100.0
        value
        100
    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
        98.1
        upper Limit
        100.0
        value
        100
    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
        98.0
        upper Limit
        100.0
        value
        100
    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
        98.1
        upper Limit
        100.0
        value
        100.0
    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
        98.1
        upper Limit
        100.0
        value
        100.0
    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
        98.1
        upper Limit
        100.0
        value
        100.0
    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
        98.1
        upper Limit
        100.0
        value
        100.0
    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
        98.1
        upper Limit
        100.0
        value
        100.0
    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
        98.1
        upper Limit
        100.0
        value
        100.0
    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
Seroconversion was defined as a participant who was anti-HPV seronegative at Day 1 and became seropositive at 4 weeks postdose 3 (Month 7). Anti-HPV antibodies were measured using a Competitive Luminex Immunoassay.
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
NUMBER
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
Seroconversion Percentages to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7
type
PRIMARY
unit Of Measure
Percentage of Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice