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NCT00092521 · OUTCOME

Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer

Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED) · Source last updated 2015-09-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
incidence rate per 100 person-years
Interval / dispersion
Not reported
Time frame
Follow-up through end of study (4 years)

Analysis population: Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and Polymerase Chain Reaction (PCR) negative to the relevant type through Month 7, and must provide follow-up data. Group 2 Base Study Monovalent HPV Vaccine was not part of the pre-specified efficacy analysis population.

Groups in this outcome

Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

Group 3 - Base Study Placebo

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

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

Analysis denominator · Participants

GroupSource count
Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine2241
Group 3 - Base Study Placebo2258

Reported measurements

Source class 1
Values in incidence rate per 100 person-years · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine0Not reportedNot reportedNot reportedNot reported
Group 3 - Base Study Placebo1.2Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    95.1
    ci Pct Value
    95
    ci Upper Limit
    100
    estimate Comment
    Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Percent relative risk reduction
    param Value
    100
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    95.1
    ci Pct Value
    95
    ci Upper Limit
    100
    estimate Comment
    Confidence Interval (CI) based on binomial tail probabilities and not from a dispersion parameter
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Percent relative risk reduction
    param Value
    100
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1.2
denoms
  1. counts
    1. group Id
      OG000
      value
      2241
    2. group Id
      OG001
      value
      2258
    units
    Participants
groups
  1. description
    The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
    id
    OG000
    title
    Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine
  2. description
    The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
    id
    OG001
    title
    Group 3 - Base Study Placebo
param Type
NUMBER
population Description
Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and Polymerase Chain Reaction (PCR) negative to the relevant type through Month 7, and must provide follow-up data. Group 2 Base Study Monovalent HPV Vaccine was not part of the pre-specified efficacy analysis population.
reporting Status
POSTED
time Frame
Follow-up through end of study (4 years)
title
Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer
type
PRIMARY
unit Of Measure
incidence rate per 100 person-years

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

Preserved source evidence · Not medical advice