Last updated: 03/07/2019 11:50:19
Follow-up study to evaluate the long-term efficacy of the HPV vaccine (580299) in healthy young adult women in Brazil
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Follow-up study to evaluate the long-term efficacy of a HPV vaccine (580299) in healthy young adult women in Brazil
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of subjects presenting cervical infections with human papillomavirus (HPV) -16 and/or HPV-18
Timeframe: Up to year 8
Number of subjects presenting cervical infections with human papillomavirus (HPV) -16 and/or HPV-18
Timeframe: Up to year 9
Number of subjects presenting cervical infections with human papillomavirus (HPV) -16 and /or HPV-18
Timeframe: Up to year 7
Secondary outcomes:
Number of Subjects Presenting Cervical Infections With Any oncogenic HPV type
Timeframe: Up to year 8
Number of Subjects Presenting Cervical Infections With Individual oncogenic non-vaccine HPV type
Timeframe: Up to year 8
Number of subjects with persistent infection (6-month definition) with HPV-16 and/or HPV-18
Timeframe: Up to year 8
Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Types
Timeframe: Up to year 8
Number of Subjects With Persistent Infection (6-month Definition) With individual Oncogenic non-vaccine HPV Types
Timeframe: Up to year 8
Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18
Timeframe: Up to year 8
Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types
Timeframe: Up to year 8
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
Timeframe: Up to year 8
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
Timeframe: 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
Timeframe: Up to year 8
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
Timeframe: Up to year 8
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
Timeframe: Up to year 8
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
Timeframe: Up to year 8
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
Timeframe: Up to year 8
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
Timeframe: Up to year 8
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
Timeframe: Up to year 8
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
Timeframe: Up to year 8
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
Timeframe: Up to year 8
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection
Timeframe: Up to year 8
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
Timeframe: Up to year 8
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Timeframe: At Months 77-101
Anti-HPV-16 and Anti-HPV-18 pseudovirion-based neutralization assay (PBNA) Titers in the Immunogenicity Subset
Timeframe: At Months 77-101
Number of Subjects with New Onset Chronic Diseases (NOCD) up to Year 7
Timeframe: Up to year 7
Number of Subjects With NOCD up to Year 8
Timeframe: Up to year 8
Number of subjects with New Onset Autoimmune Disease (NOAD) up to Year 7
Timeframe: Up to year 7
Number of subjects with NOAD up to year 8
Timeframe: Up to year 8
Number of subjects with medically significant conditions up to Year 7
Timeframe: Up to year 7
Number of Subjects with medically significant conditions up to year 8
Timeframe: up to year 8
Number of Subjects with serious adverse events (SAEs) up to year 7
Timeframe: Up to year 7
Number of subjects with SAEs up to year 8
Timeframe: up to year 8
Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type.
Timeframe: Up to year 9
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
Timeframe: Up to year 9
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18
Timeframe: Up to year 9
Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type
Timeframe: Up to year 9
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
Timeframe: Up to year 9
Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18
Timeframe: Up to year 9
Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types
Timeframe: Up to year 9
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
Timeframe: Up to year 9
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
Timeframe: Up to year 9
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
Timeframe: Up to year 9
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
Timeframe: Up to year 9
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
Timeframe: Up to year 9
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
Timeframe: Up to year 9
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
Timeframe: 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 an HPV 16 and/or HPV-18 Cervical Infection
Timeframe: 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
Timeframe: 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 Individual Oncogenic Non-vaccine HPV Types Cervical Infection
Timeframe: Up to year 9
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
Timeframe: Up to year 9
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection
Timeframe: Up to year 9
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
Timeframe: Up to year 9
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Timeframe: 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
Timeframe: At Month 77 until year 9 (Month 113)
Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9
Timeframe: Up to year 9
Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 9.
Timeframe: Up to year 9
Number of Subjects With Medically Signifant Conditions up to Year 9
Timeframe: Up to year 9
Number of Subjects With Serious Adverse Events (SAEs) up to Year 9.
Timeframe: up to year 9
Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type.
Timeframe: Up to year 7
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type.
Timeframe: Up to year 7
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18
Timeframe: Up to year 7
Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type
Timeframe: Up to year 7
Number of Subjects With Persistent Infection (6-month Definition) With individual Oncogenic non-vaccine HPV Types
Timeframe: Up to year 7
Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18
Timeframe: Up to year 7
Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Type
Timeframe: Up to year 7
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
Timeframe: 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
Timeframe: Up to year 7
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Up to year 7
Interventions:
Procedure/surgery: Blood sampling
Procedure/surgery: Collection of cervical specimen
Biological/vaccine: Cervarix
Enrollment:
433
Observational study model:
Not applicable
Primary completion date:
2008-11-07
Time perspective:
Not applicable
Clinical publications:
Carvalho De N et al. (2010) Sustained efficacy and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine up to 7.3 years in young adult women. Vaccine. 28(38):6247-6255.
Naud PS et al. (2014) 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.10(8):2147-2162.
Roteli-Martins CM et al. (2012) Sustained immunogenicity and efficacy of the HPV-16/18 AS04-adjuvanted vaccine: up to 8.4 years of follow-up. Hum Vaccin Immunother. 8(3):390-397.
Teixeira CSC et al. (2017) Detection of High-Risk Human Papillomavirus in Cervix Sample in an 11.3-year Follow-Up after Vaccination against HPV 16/18. Rev Bras Ginecol Obstet. 39(8):408-414.
Medical condition
Infections, Papillomavirus
Product
SB580299
Collaborators
Not applicable
Study date(s)
November 2007 to July 2008
Type
Interventional
Phase
2/3
Participation criteria
Sex
Female
Age
15 - 25 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion 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 580299-007.
- 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.
Trial location(s)
Location
GSK Investigational Site
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 03015000
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2008-11-07
Actual study completion date
2008-11-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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