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NCT01047345 · OUTCOME

Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) - 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

Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded.

Analysis population: All participants who received at least 1 vaccination and had available temperature 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 Study604
Placebo - Base Study304

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
9vHPV Vaccine - Base Study6.5Not reportedNot reportedNot reportedNot reported
Placebo - Base Study3.0Not 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
    0.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.2
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.026
    param Type
    Difference in Percentages
    param Value
    3.5
    statistical Method
    Miettinen & Nurminen
Complete source fields
analyses
  1. ci Lower Limit
    0.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.2
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.026
    param Type
    Difference in Percentages
    param Value
    3.5
    statistical Method
    Miettinen & Nurminen
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6.5
      2. group Id
        OG001
        value
        3.0
denoms
  1. counts
    1. group Id
      OG000
      value
      604
    2. group Id
      OG001
      value
      304
    units
    Participants
description
Participants collected their oral body temperature in the evening of their vaccination day and at the same time each day thereafter for 4 days. The maximum body temperature obtained within 5 days of any of the 3 vaccinations was recorded.
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 temperature data.
reporting Status
POSTED
time Frame
up to 5 days after any vaccination - Base Study
title
Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) - Base Study
type
PRIMARY
unit Of Measure
Percentage of Participants

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Preserved source evidence · Not medical advice