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NCT00943722 · OUTCOME

Base Study: Percentage of Participants With Systemic AEs

A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002) · Source last updated 2022-10-03

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 after any vaccination

What was measured

An AE was 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 was also an AE. Systemic AEs were those not categorized as injection-site AEs.

Analysis population: All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Per protocol, this outcome measure included data from 9- to 15-year-old females regardless of lot administered.

Groups in this outcome

9- to 15-Year-Old Females (Lots 1, 2 or 3)

9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3.

Base Study: 9- to 15-Year-Old Males (Lot 1)

9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.

Base Study: 16- to 26-Year-Old Females (Lot 1)

9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.

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

Analysis denominator · Participants

GroupSource count
9- to 15-Year-Old Females (Lots 1, 2 or 3)1923
Base Study: 9- to 15-Year-Old Males (Lot 1)662
Base Study: 16- to 26-Year-Old Females (Lot 1)466

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
9- to 15-Year-Old Females (Lots 1, 2 or 3)45.0Not reportedNot reportedNot reportedNot reported
Base Study: 9- to 15-Year-Old Males (Lot 1)41.8Not reportedNot reportedNot reportedNot reported
Base Study: 16- to 26-Year-Old Females (Lot 1)57.1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        45.0
      2. group Id
        OG001
        value
        41.8
      3. group Id
        OG002
        value
        57.1
denoms
  1. counts
    1. group Id
      OG000
      value
      1923
    2. group Id
      OG001
      value
      662
    3. group Id
      OG002
      value
      466
    units
    Participants
description
An AE was 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 was also an AE. Systemic AEs were those not categorized as injection-site AEs.
groups
  1. description
    9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3.
    id
    OG000
    title
    9- to 15-Year-Old Females (Lots 1, 2 or 3)
  2. description
    9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
    id
    OG001
    title
    Base Study: 9- to 15-Year-Old Males (Lot 1)
  3. description
    9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered was obtained from manufacturing Lot 1.
    id
    OG002
    title
    Base Study: 16- to 26-Year-Old Females (Lot 1)
param Type
NUMBER
population Description
All participants who received at least one dose of 9vHPV vaccine and had available follow-up data. Per protocol, this outcome measure included data from 9- to 15-year-old females regardless of lot administered.
reporting Status
POSTED
time Frame
Up to 15 days after any vaccination
title
Base Study: Percentage of Participants With Systemic AEs
type
PRIMARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice