NCT00092521 · OUTCOME

Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer]

Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED) · Source last updated 2015-09-25

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

Measure: NUMBER
Unit: incidence rate per 100 person-years
Interval / dispersion: Not reported
Time frame: Follow-up through end of study (4 years)

Analysis population: Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide follow-up data. Group 2 Base Study Monovalent HPV (Type 16) Vaccine was not part of the pre-specified efficacy analysis population.

Groups in this outcome

Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.

Group 3 - Base Study Placebo

The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the 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
Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine	2261
Group 3 - Base Study Placebo	2279

Reported measurements

Source class 1

Values in incidence rate per 100 person-years · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine	0	Not reported	Not reported	Not reported	Not reported
Group 3 - Base Study Placebo	1.1	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
94.9
ci Pct Value
95
ci Upper Limit
100
estimate Comment
CI based on binomial tail probabilities and not from a dispersion parameter
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Percent relative risk reduction
param Value
100
tested Non Inferiority
false

Complete source fields

analyses

ci Lower Limit
94.9
ci Pct Value
95
ci Upper Limit
100
estimate Comment
CI based on binomial tail probabilities and not from a dispersion parameter
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Percent relative risk reduction
param Value
100
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1.1

denoms

counts
group Id
OG000
value
2261
group Id
OG001
value
2279
units
Participants

groups

description
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
id
OG000
title
Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine
description
The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
id
OG001
title
Group 3 - Base Study Placebo

param Type

NUMBER

population Description

Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide follow-up data. Group 2 Base Study Monovalent HPV (Type 16) Vaccine was not part of the pre-specified efficacy analysis population.

reporting Status

POSTED

time Frame

Follow-up through end of study (4 years)

title

Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer]

type

PRIMARY

unit Of Measure

incidence rate per 100 person-years

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

Preserved source evidence · Not medical advice