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NCT01245764 · OUTCOME

Number of Participants Who Seroconvert to Human Papillomavirus (HPV) Type 6

GARDASIL™ Study in Healthy Females Between 9 and 26 Years of Age in Sub-Saharan Africa (V501-046) · Source last updated 2018-11-14

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
Month 7 (1 month postdose 3 in study Phase A)

What was measured

Seroconversion was defined as achieving an anti-HPV Type 6 competitive Luminex Immunoassay (cLIA) level of \>=20 milli Merck U/mL. The dilution-corrected limit of detection for the Type 6 cLIA was 4.2 milli Merck U/mL.

Analysis population: Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.

Groups in this outcome

GARDASIL 9 to 26 Years Old

GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A.

Placebo 9 to 12 Years Old

Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A.

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

Analysis denominator · Participants

GroupSource count
GARDASIL 9 to 26 Years Old147
Placebo 9 to 12 Years Old13

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GARDASIL 9 to 26 Years Old147Not reportedNot reportedNot reportedNot reported
Placebo 9 to 12 Years Old1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        147
      2. group Id
        OG001
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      147
    2. group Id
      OG001
      value
      13
    units
    Participants
description
Seroconversion was defined as achieving an anti-HPV Type 6 competitive Luminex Immunoassay (cLIA) level of \>=20 milli Merck U/mL. The dilution-corrected limit of detection for the Type 6 cLIA was 4.2 milli Merck U/mL.
groups
  1. description
    GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A.
    id
    OG000
    title
    GARDASIL 9 to 26 Years Old
  2. description
    Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A.
    id
    OG001
    title
    Placebo 9 to 12 Years Old
param Type
NUMBER
population Description
Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo.
reporting Status
POSTED
time Frame
Month 7 (1 month postdose 3 in study Phase A)
title
Number of Participants Who Seroconvert to Human Papillomavirus (HPV) Type 6
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice