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NCT00543543 · OUTCOME

Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (End-of-study Update)

Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) · Source last updated 2018-11-27

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

Measure
NUMBER
Unit
Cases per 10,000 person-years follow-up
Interval / dispersion
Not reported
Time frame
Up to Month 54 in the base study

What was measured

HPV Type 31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), vulvar cancer, or vaginal cancer were determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. This outcome measure reports cumulative study data through 10 March 2014. Disease incidence was defined as the number of primary efficacy cases per 10,000 person-years of follow-up in a treatment arm.

Analysis population: The Per-protocol Efficacy population included all participants who received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable day ranges, were seronegative at Day 1 and PCR negative at Day 1 through Day 7 to the relevant HPV types, and had at least 1 follow-up visit following Month 7.

Groups in this outcome

Mid-dose V503

V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.

Gardasil

Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension 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
Mid-dose V5036016
Gardasil6017

Reported measurements

Source class 1
Values in Cases per 10,000 person-years follow-up · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Mid-dose V5030.5Not reportedNot reportedNot reportedNot reported
Gardasil19.0Not 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
    85.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    99.9
    estimate Comment
    Vaccine efficacy = 100 \* \[1 - (incidence rate with V503 / incidence rate with Gardasil)\]. The pre-specified success criterion was a lower bound of the 95% confidence interval of observed efficacy of \>25%.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Vaccine efficacy
    param Value
    97.4
    statistical Method
    Exact test, 1-sided
Complete source fields
analyses
  1. ci Lower Limit
    85.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    99.9
    estimate Comment
    Vaccine efficacy = 100 \* \[1 - (incidence rate with V503 / incidence rate with Gardasil)\]. The pre-specified success criterion was a lower bound of the 95% confidence interval of observed efficacy of \>25%.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Vaccine efficacy
    param Value
    97.4
    statistical Method
    Exact test, 1-sided
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.5
      2. group Id
        OG001
        value
        19.0
denoms
  1. counts
    1. group Id
      OG000
      value
      6016
    2. group Id
      OG001
      value
      6017
    units
    Participants
description
HPV Type 31/33/45/52/58-related high-grade Cervical Intraepithelial Neoplasia (CIN 2/3), Adenocarcinoma in Situ (AIS), Invasive Cervical Carcinoma, high-grade Vulvar Intraepithelial Neoplasia (VIN 2/3), high-grade Vaginal Intraepithelial Neoplasia (VaIN 2/3), vulvar cancer, or vaginal cancer were determined by clinical/pathologic criteria and positive Polymerase Chain Reaction (PCR) assay for virus subtype. This outcome measure reports cumulative study data through 10 March 2014. Disease incidence was defined as the number of primary efficacy cases per 10,000 person-years of follow-up in a treatment arm.
groups
  1. description
    V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study. A subset of participants (Cohort 1) received a fourth V503 mid-dose vaccination in the extension study.
    id
    OG000
    title
    Mid-dose V503
  2. description
    Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study. Participants (Cohort 2) were offered the V503 mid-dose 3-dose regimen in the extension study.
    id
    OG001
    title
    Gardasil
param Type
NUMBER
population Description
The Per-protocol Efficacy population included all participants who received all 3 vaccinations of mid-dose V503 or Gardasil within acceptable day ranges, were seronegative at Day 1 and PCR negative at Day 1 through Day 7 to the relevant HPV types, and had at least 1 follow-up visit following Month 7.
reporting Status
POSTED
time Frame
Up to Month 54 in the base study
title
Base Study: Combined Incidence of HPV Type 31/33/45/52/58-related Disease (End-of-study Update)
type
PRIMARY
unit Of Measure
Cases per 10,000 person-years follow-up

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Preserved source evidence · Not medical advice