NCT03158220 · OUTCOME

Percentage of Participants With Elevated Temperature (Fever)

Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004) · Source last updated 2019-11-21

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 post any vaccination

What was measured

Participants were asked to record oral body temperature in the Vaccination Report Card. The percentage of participants with elevated temperature (≥37.8°C or 100.0°F) was assessed.

Analysis population: All participants that received at least 1 vaccination and had available data for endpoint.

Groups in this outcome

Women 16-26 Years of Age

Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.

Women 27-45 Years of Age

Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on 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

Group	Source count
Women 16-26 Years of Age	570
Women 27-45 Years of Age	640

Reported measurements

Source class 1

Values in Percentage of Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Women 16-26 Years of Age	3.5	Not reported	Not reported	Not reported	Not reported
Women 27-45 Years of Age	2.5	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
-3.1
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.9
estimate Comment
Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
0.300
param Type
Difference in Percentages
param Value
-1.0
statistical Method
Miettinen & Nurminen

Complete source fields

analyses

ci Lower Limit
-3.1
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.9
estimate Comment
Difference in percentages calculated as % Women 27-45 Years of Age minus % Women 16-26 Years of Age.
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
0.300
param Type
Difference in Percentages
param Value
-1.0
statistical Method
Miettinen & Nurminen

classes

categories
measurements
group Id
OG000
value
3.5
group Id
OG001
value
2.5

denoms

counts
group Id
OG000
value
570
group Id
OG001
value
640
units
Participants

description

Participants were asked to record oral body temperature in the Vaccination Report Card. The percentage of participants with elevated temperature (≥37.8°C or 100.0°F) was assessed.

groups

description
Young adult women 16- to 26-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
id
OG000
title
Women 16-26 Years of Age
description
Adult women 27- to 45-years old received V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6.
id
OG001
title
Women 27-45 Years of Age

param Type

NUMBER

population Description

All participants that received at least 1 vaccination and had available data for endpoint.

reporting Status

POSTED

time Frame

Up to 5 days post any vaccination

title

Percentage of Participants With Elevated Temperature (Fever)

type

SECONDARY

unit Of Measure

Percentage of Participants

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

Preserved source evidence · Not medical advice