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NCT01245764 · OUTCOME

Number of Participants With Injection-site Adverse Experiences

GARDASIL™ Study in Healthy Females Between 9 and 26 Years of Age in Sub-Saharan Africa (V501-046) · Source last updated 2018-11-14

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to Day 5 after any vaccination in study Phase A

What was measured

Participants were prompted to report injection-site experiences of pain, erythema, or swelling and were also asked to report any other injection-site adverse experiences

Analysis population: The analysis included all participants receiving at least 1 vaccination in study Phase A and who had postvaccination follow-up

Groups in this outcome

GARDASIL 9 to 12 Years Old

GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A

Placebo 13 to 15 Years Old

GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A

GARDASIL 16 to 26 Years Old

GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A

Placebo 9 to 12 Years Old

Placebo to match GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A

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

Analysis denominator · Participants

GroupSource count
GARDASIL 9 to 12 Years Old79
Placebo 13 to 15 Years Old29
GARDASIL 16 to 26 Years Old119
Placebo 9 to 12 Years Old19

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GARDASIL 9 to 12 Years Old54Not reportedNot reportedNot reportedNot reported
Placebo 13 to 15 Years Old21Not reportedNot reportedNot reportedNot reported
GARDASIL 16 to 26 Years Old88Not reportedNot reportedNot reportedNot reported
Placebo 9 to 12 Years Old9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        54
      2. group Id
        OG001
        value
        21
      3. group Id
        OG002
        value
        88
      4. group Id
        OG003
        value
        9
denoms
  1. counts
    1. group Id
      OG000
      value
      79
    2. group Id
      OG001
      value
      29
    3. group Id
      OG002
      value
      119
    4. group Id
      OG003
      value
      19
    units
    Participants
description
Participants were prompted to report injection-site experiences of pain, erythema, or swelling and were also asked to report any other injection-site adverse experiences
groups
  1. description
    GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
    id
    OG000
    title
    GARDASIL 9 to 12 Years Old
  2. description
    GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
    id
    OG001
    title
    Placebo 13 to 15 Years Old
  3. description
    GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
    id
    OG002
    title
    GARDASIL 16 to 26 Years Old
  4. description
    Placebo to match GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
    id
    OG003
    title
    Placebo 9 to 12 Years Old
param Type
NUMBER
population Description
The analysis included all participants receiving at least 1 vaccination in study Phase A and who had postvaccination follow-up
reporting Status
POSTED
time Frame
Up to Day 5 after any vaccination in study Phase A
title
Number of Participants With Injection-site Adverse Experiences
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice