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Complementary Testing to Evaluate Immunogenicity of Human Papillomavirus (HPV) Vaccine (580299) in Healthy Female Subjects Aged >/= 26 Years

NCT ID: NCT00456807

Last Updated: 2016-12-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-01-31

Brief Summary

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Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. This study will supplement an ongoing study evaluating the safety, efficacy and immunogenicity of the vaccine in women aged 26 years and above. This study will therefore assess additional immunogenicity parameters of the vaccine in women from selected investigative sites.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed Description

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Conditions

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Infections, Papillomavirus

Keywords

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Human Papillomavirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cervarix Group

Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).

Group Type EXPERIMENTAL

Cervarix TM

Intervention Type BIOLOGICAL

Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.

Placebo Group

Subjects who received 3 doses of placebo during the primary study (NCT00294047).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.

Interventions

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Placebo

Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.

Intervention Type BIOLOGICAL

Cervarix TM

Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.

Intervention Type BIOLOGICAL

Other Intervention Names

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GSK Biologicals' HPV-16/18 VLP/AS04 vaccine

Eligibility Criteria

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Inclusion Criteria

* A female enrolled in study 104820 and who received three doses of study vaccine/control.
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
* Written informed consent obtained from the subject prior to enrolment in this ancillary study.

Exclusion Criteria

* Pregnancy.
* Administration of any HPV vaccine other than that foreseen by the study protocol.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine since study start.
* Chronic administration of immunosuppressants or other immune-modifying drugs since study start.
* Administration of immunoglobulins and/or any blood products within 90 days preceding a blood sampling.
Minimum Eligible Age

26 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Amsterdam, , Netherlands

Site Status

GSK Investigational Site

Delft, , Netherlands

Site Status

Countries

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Netherlands

Study Documents

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Document Type: Individual Participant Data Set

View Document

Document Type: Clinical Study Report

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Dataset Specification

View Document

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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109801

Identifier Type: -

Identifier Source: org_study_id