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NCT03546842 · OUTCOME

Percentage of Participants With a Vaccine-related Serious Adverse Event

Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam (V503-017) · Source last updated 2020-02-25

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 4 weeks postdose 3 (Month 7)

What was measured

A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants that experience at least one SAE that was reported as at least possibly related to the study vaccine was summarized.

Analysis population: All participants that received at least 1 vaccination with 9vHPV vaccine and provided safety data at any time during the study.

Groups in this outcome

9vHPV Vaccine

Participants received a single 0.5-mL intramuscular injection of the 9vHPV vaccine at 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
9vHPV Vaccine200

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
9vHPV Vaccine0.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
denoms
  1. counts
    1. group Id
      OG000
      value
      200
    units
    Participants
description
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants that experience at least one SAE that was reported as at least possibly related to the study vaccine was summarized.
groups
  1. description
    Participants received a single 0.5-mL intramuscular injection of the 9vHPV vaccine at Day 1, Month 2, and Month 6
    id
    OG000
    title
    9vHPV Vaccine
param Type
NUMBER
population Description
All participants that received at least 1 vaccination with 9vHPV vaccine and provided safety data at any time during the study.
reporting Status
POSTED
time Frame
Up to 4 weeks postdose 3 (Month 7)
title
Percentage of Participants With a Vaccine-related Serious Adverse Event
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice