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NCT01047345 · OUTCOME

Percentage of Participants Who Experience a Severe Injection-site AE - Base Study

A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006) · 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 5 days after any vaccination - Base Study

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 vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Participants were instructed to estimate the severity of AEs such as pain at injection site as mild (awareness of symptom, but easily tolerated), moderate (discomfort enough to cause interference with usual activities), or severe (incapacitating with inability to work or do usual activity). Additionally, participants were instructed to measure any swelling and/or erythema at its greatest width. Swelling or erythema with diameter \>2 inches (\>5 cm) was recorded as severe. All AEs associated with the injection site and reported as severe were summarized.

Analysis population: All participants who received at least 1 vaccination and had available follow-up data.

Groups in this outcome

9vHPV Vaccine - Base Study

Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.

Placebo - Base Study

Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of 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
9vHPV Vaccine - Base Study608
Placebo - Base Study305

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
9vHPV Vaccine - Base Study11.2Not reportedNot reportedNot reportedNot reported
Placebo - Base Study1.0Not 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
    7.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    13.1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Difference in Percentages
    param Value
    10.2
    statistical Method
    Miettinen & Nurminen
Complete source fields
analyses
  1. ci Lower Limit
    7.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    13.1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Difference in Percentages
    param Value
    10.2
    statistical Method
    Miettinen & Nurminen
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11.2
      2. group Id
        OG001
        value
        1.0
denoms
  1. counts
    1. group Id
      OG000
      value
      608
    2. group Id
      OG001
      value
      305
    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 vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Participants were instructed to estimate the severity of AEs such as pain at injection site as mild (awareness of symptom, but easily tolerated), moderate (discomfort enough to cause interference with usual activities), or severe (incapacitating with inability to work or do usual activity). Additionally, participants were instructed to measure any swelling and/or erythema at its greatest width. Swelling or erythema with diameter \>2 inches (\>5 cm) was recorded as severe. All AEs associated with the injection site and reported as severe were summarized.
groups
  1. description
    Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
    id
    OG000
    title
    9vHPV Vaccine - Base Study
  2. description
    Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
    id
    OG001
    title
    Placebo - Base Study
param Type
NUMBER
population Description
All participants who received at least 1 vaccination and had available follow-up data.
reporting Status
POSTED
time Frame
up to 5 days after any vaccination - Base Study
title
Percentage of Participants Who Experience a Severe Injection-site AE - Base Study
type
PRIMARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice