NCT01047345 · OUTCOME

Percentage of Participants Who Experience a Systemic AE - 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 14 days after any vaccination - Base Study

What was measured

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

Analysis population: All participants who received at least 1 vaccination and had available follow-up 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

Group	Source count
9vHPV Vaccine - Base Study	608
Placebo - Base Study	305

Reported measurements

Source class 1

Values in Percentage of Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
9vHPV Vaccine - Base Study	59.7	Not reported	Not reported	Not reported	Not reported
Placebo - Base Study	55.7	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
-2.8
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
10.8
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Difference in Percentages
param Value
4.0
statistical Method
Miettinen & Nurminen

Complete source fields

analyses

ci Lower Limit
-2.8
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
10.8
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Difference in Percentages
param Value
4.0
statistical Method
Miettinen & Nurminen

classes

categories
measurements
group Id
OG000
value
59.7
group Id
OG001
value
55.7

denoms

counts
group Id
OG000
value
608
group Id
OG001
value
305
units
Participants

description

groups

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
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 follow-up data.

reporting Status

POSTED

time Frame

up to 14 days after any vaccination - Base Study

title

Percentage of Participants Who Experience a Systemic AE - Base Study

type

PRIMARY

unit Of Measure

Percentage of Participants

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

Preserved source evidence · Not medical advice