NCT00518336已完成2 期
Follow-up Study to Evaluate the Long-term Efficacy of a HPV Vaccine (580299) in Healthy Young Adult Women in Brazil
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 433
- 试验地点
- 5
- 主要终点
- Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Cervarix Group
Experimental
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.
干预措施: Blood sampling (Procedure)
Cervarix Group
Experimental
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.
干预措施: Collection of cervical specimen (Procedure)
Placebo Group
Placebo Comparator
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.
干预措施: Blood sampling (Procedure)
Placebo Group
Placebo Comparator
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.
干预措施: Collection of cervical specimen (Procedure)
Cervarix Group
Experimental
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.
干预措施: Cervarix (Biological)
结局指标
主要结局
Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18
时间窗: 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
时间窗: 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.
Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18
时间窗: Up to year 8
Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type.
次要结局
- 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 New Onset Chronic Diseases (NOCD) up to Year 7(Up to year 7)
- 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 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)
- 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 NOCD up to Year 8(Up to year 8)
- Number of Subjects With New Onset Autoimmune Disease (NOAD) 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)
- Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type(Up to year 8)
- Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18(Up to year 8)
- Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types(Up to year 8)
- Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18(Up to year 8)
- Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types(Up to year 8)
- Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types(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 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(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(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(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(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(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(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(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(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(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(Up to year 8)
- Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort(At Months 77-101)
- Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset(At Months 77-101)
- Number of Subjects Presenting Cervical Infections With Any Oncogenic 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 9)
- Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type(Up to year 9)
- Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types(Up to year 9)
- Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18(Up to year 9)
- Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types(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(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(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(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(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(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(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(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(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(Up to year 9)
研究者
研究点 (5)
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