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NCT01245764 · OUTCOME

GMT of Anti-HPV Type 11 Antibody

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
GEOMETRIC_MEAN
Unit
milli Merck U/mL
Interval / dispersion
95% Confidence Interval
Time frame
Month 7 (1 month postdose 3 in study Phase A)

What was measured

Anti-HPV Type 11 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 16 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 milli Merck U/mL · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
GARDASIL 9 to 26 Years Old626Not reported545718Not reported
Placebo 9 to 12 Years OldNANot reportedNANAGMT value was \<7 milli Merck U/mL
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        545
        upper Limit
        718
        value
        626
      2. comment
        GMT value was \<7 milli Merck U/mL
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      147
    2. group Id
      OG001
      value
      13
    units
    Participants
description
Anti-HPV Type 11 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 16 milli Merck U/mL.
dispersion Type
95% Confidence Interval
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
GEOMETRIC_MEAN
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
GMT of Anti-HPV Type 11 Antibody
type
SECONDARY
unit Of Measure
milli Merck U/mL

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

Preserved source evidence · Not medical advice