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

GlaxoSmithKline1 site in 1 country433 target enrollmentNovember 2007

ConditionsInfections, Papillomavirus

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Infections, Papillomavirus
Sponsor: GlaxoSmithKline
Enrollment: 433
Locations: 1
Primary Endpoint: Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

September 2010

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

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-
•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.

Outcomes

Primary Outcomes

Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18

Time Frame: Up to year 9

Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type

Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and /or HPV-18

Time Frame: Up to year 7

Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type.

Secondary Outcomes

Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type(Up to year 8)
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type(Up to year 9)
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18(Up to year 7)
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection(Up to year 7)
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection(Up to year 7)
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection(Up to year 7)
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection(Up to year 7)
Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Types(Up to year 8)
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types(Up to year 7)
Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18(Up to year 7)
Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types(Up to year 9)
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types(Up to year 7)
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen(Up to year 8)
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen(Up to year 7)
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen(Up to year 7)
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen(Up to year 7)
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen(Up to year 7)
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen(Up to year 7)
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection(Up to year 7)
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection(Up to year 7)
Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 7(Up to year 7)
Number of Subjects With NOCD up to Year 8(Up to year 8)
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort(At Month 77 until year 9 (Month 113))
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset(At Month 77 until year 9 (Month 113))
Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 7(Up to year 7)
Number of Subjects With NOAD up to Year 8(Up to year 8)
Number of Subjects With Medically Significant Conditions up to Year 7(Up to year 7)
Number of Subjects With Medically Significant Conditions up to Year 8(up to year 8)
Number of Subjects With Serious Adverse Events (SAEs) up to Year 7(Up to year 7)
Number of Subjects With SAEs up to Year 8(up to year 8)
Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type.(Up to year 7)
Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type(Up to year 7)
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen(Up to year 7)
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection(Up to year 9)
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection(Up to year 9)
Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9(Up to year 9)
Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 9.(Up to year 9)
Number of Subjects With Medically Signifant Conditions up to Year 9(Up to year 9)
Number of Subjects With Serious Adverse Events (SAEs) up to Year 9.(up to year 9)
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type.(Up to year 7)
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection(Up to year 9)
Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Type(Up to year 7)