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NCT03158220 · OUTCOME

Percentage of Participants That Reported at Least 1 Systemic Adverse Event

Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004) · Source last updated 2019-11-21

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 15 days post any vaccination

What was measured

An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Systemic AEs are those not categorized as injection-site AEs. The percentage of participants that reported at least 1 systemic AE was assessed

Analysis population: All participants that received at least 1 vaccination and had available data for endpoint.

Groups in this outcome

Women 16-26 Years of Age

Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.

Women 27-45 Years of Age

Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.

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

Analysis denominator · Participants

GroupSource count
Women 16-26 Years of Age570
Women 27-45 Years of Age640

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Women 16-26 Years of Age66.3Not reportedNot reportedNot reportedNot reported
Women 27-45 Years of Age64.4Not 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
    -7.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.4
    estimate Comment
    Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    Difference in Percentages
    param Value
    -1.9
Complete source fields
analyses
  1. ci Lower Limit
    -7.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.4
    estimate Comment
    Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    Difference in Percentages
    param Value
    -1.9
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        66.3
      2. group Id
        OG001
        value
        64.4
denoms
  1. counts
    1. group Id
      OG000
      value
      570
    2. group Id
      OG001
      value
      640
    units
    Participants
description
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Systemic AEs are those not categorized as injection-site AEs. The percentage of participants that reported at least 1 systemic AE was assessed
groups
  1. description
    Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
    id
    OG000
    title
    Women 16-26 Years of Age
  2. description
    Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
    id
    OG001
    title
    Women 27-45 Years of Age
param Type
NUMBER
population Description
All participants that received at least 1 vaccination and had available data for endpoint.
reporting Status
POSTED
time Frame
Up to 15 days post any vaccination
title
Percentage of Participants That Reported at Least 1 Systemic Adverse Event
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice