MedDataX Logo

Follow-up Study to Evaluate the Long-term Efficacy of the HPV Vaccine (580299) in Healthy Young Adult Women in Brazil

NCT ID: NCT00518336

Last Updated: 2016-12-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

433 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IIb study is designed to evaluate the the long-term efficacy, safety and immunogenicity of the 580299 HPV vaccine (CervarixTM) in a Brazilian cohort of women vaccinated in the phase IIb, blinded, primary study 580299/001 (NCT00689741) and having participated in follow-up study 580299/007 (NCT00120848). Only subjects who participated in the primary \& follow-up study will be enrolled in this long-term follow-up study. Subjects were aged 15-25 years at the time of entry into the primary study.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this extension study, women who were vaccinated in the primary study, and participated in the follow-up study, will be followed with visits every 6 months.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infections, Papillomavirus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cervarix Group

Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.

Group Type EXPERIMENTAL

Blood sampling

Intervention Type PROCEDURE

Blood sampling at Visit 3, 5 and 7.

Collection of cervical specimen

Intervention Type PROCEDURE

Collection of cervical specimen at Visit2, 3, 4, 5, 6 and 7.

Cervarix

Intervention Type BIOLOGICAL

Three doses administered intramuscularly at 0, 1 and 6 months.

Placebo Group

Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.

Group Type PLACEBO_COMPARATOR

Blood sampling

Intervention Type PROCEDURE

Blood sampling at Visit 3, 5 and 7.

Collection of cervical specimen

Intervention Type PROCEDURE

Collection of cervical specimen at Visit2, 3, 4, 5, 6 and 7.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood sampling

Blood sampling at Visit 3, 5 and 7.

Intervention Type PROCEDURE

Collection of cervical specimen

Collection of cervical specimen at Visit2, 3, 4, 5, 6 and 7.

Intervention Type PROCEDURE

Cervarix

Three doses administered intramuscularly at 0, 1 and 6 months.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
* Subjects who participated in study 580299-007.
* Written informed consent obtained from the subject prior to enrollment.

Exclusion Criteria

* Use or planned use of any investigational or non-registered product other than the study vaccine.
* Decoding of the subject's 580299-001 treatment allocation to either the subject or the investigator.
* Administration or planned administration of any other HPV vaccine, other than the vaccine administered in study 580299-001.
Minimum Eligible Age

15 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Curitiba, Paraná, Brazil

Site Status

GSK Investigational Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

GSK Investigational Site

São Paulo, São Paulo, Brazil

Site Status

GSK Investigational Site

Campinas, , Brazil

Site Status

GSK Investigational Site

Fortaleza, , Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

Naud PS, Roteli-Martins CM, De Carvalho NS, Teixeira JC, de Borba PC, Sanchez N, Zahaf T, Catteau G, Geeraerts B, Descamps D. Sustained efficacy, immunogenicity, and safety of the HPV-16/18 AS04-adjuvanted vaccine: final analysis of a long-term follow-up study up to 9.4 years post-vaccination. Hum Vaccin Immunother. 2014;10(8):2147-62. doi: 10.4161/hv.29532.

Reference Type DERIVED
PMID: 25424918 (View on PubMed)

Roteli-Martins CM, Naud P, De Borba P, Teixeira JC, De Carvalho NS, Zahaf T, Sanchez N, Geeraerts B, Descamps D. Sustained immunogenicity and efficacy of the HPV-16/18 AS04-adjuvanted vaccine: up to 8.4 years of follow-up. Hum Vaccin Immunother. 2012 Mar;8(3):390-7. doi: 10.4161/hv.18865. Epub 2012 Feb 13.

Reference Type DERIVED
PMID: 22327492 (View on PubMed)

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Study Protocol

View Document

Document Type: Clinical Study Report

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Informed Consent Form

View Document

Document Type: Dataset Specification

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

109624

Identifier Type: OTHER

Identifier Source: secondary_id

109625

Identifier Type: OTHER

Identifier Source: secondary_id

109616 (Y7)

Identifier Type: -

Identifier Source: org_study_id