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NCT00543543 · OUTCOME

Base Study: Percentage of Participants With One or More Vaccine-related Adverse Event

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
Percentage of participants
Interval / dispersion
Not reported
Time frame
Up to Month 7 (low- and high-dose V503) or up to Month 54 (mid-dose V503 and Gardasil)

What was measured

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. An AE that is judged by the investigator to be "definitely related," "probably related," or "possibly related" to the study drug is defined as a vaccine-related AE.

Analysis population: The analysis population included all participants who received \>=1 vaccination and had safety follow-up

Groups in this outcome

Low-dose V503

V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.

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.

High-dose V503

V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base 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
Low-dose V503310
Mid-dose V5037071
High-dose V503305
Gardasil7078

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Low-dose V50390.0Not reportedNot reportedNot reportedNot reported
Mid-dose V50392.2Not reportedNot reportedNot reportedNot reported
High-dose V50392.8Not reportedNot reportedNot reportedNot reported
Gardasil87.6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        90.0
      2. group Id
        OG001
        value
        92.2
      3. group Id
        OG002
        value
        92.8
      4. group Id
        OG003
        value
        87.6
denoms
  1. counts
    1. group Id
      OG000
      value
      310
    2. group Id
      OG001
      value
      7071
    3. group Id
      OG002
      value
      305
    4. group Id
      OG003
      value
      7078
    units
    Participants
description
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. An AE that is judged by the investigator to be "definitely related," "probably related," or "possibly related" to the study drug is defined as a vaccine-related AE.
groups
  1. description
    V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study.
    id
    OG000
    title
    Low-dose V503
  2. 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
    OG001
    title
    Mid-dose V503
  3. description
    V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study.
    id
    OG002
    title
    High-dose V503
  4. 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
    OG003
    title
    Gardasil
param Type
NUMBER
population Description
The analysis population included all participants who received \>=1 vaccination and had safety follow-up
reporting Status
POSTED
time Frame
Up to Month 7 (low- and high-dose V503) or up to Month 54 (mid-dose V503 and Gardasil)
title
Base Study: Percentage of Participants With One or More Vaccine-related Adverse Event
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice