A Study to Evaluate Safety, Immunogenicity and Efficacy of GSK Biologicals HPV-16/18 L1/AS04 Vaccine Administered Intramuscularly According to a Three-dose Schedule (0, 1, 6 Month) in Healthy Adult Female Subjects Aged 26 Years and Above
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5,752
- 试验地点
- 76
- 主要终点
- Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
研究概览
简要总结
This is a multicentre study in which women were planned to receive either the Human Papillomavirus Vaccine (HPV) vaccine or control. Under Protocol Amendment 3, study participation will last approximately 48 months and involves a total of eleven scheduled visits. Under Protocol Amendment 4, study participation will last up to 84 months and involves a maximum of seventeen scheduled visits.
详细描述
The Protocol Posting has been updated due to protocol amendment 5 and in order to comply with the FDA Amendment Act, Sep 2007.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 26 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
时间窗: Up to Month 84
CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
时间窗: Up to Month 84
CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) - Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus
次要结局
- Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.(At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84)
- Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.(At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84)
- Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.(At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84)
- Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.(At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84)
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.(Within 7 days (Days 0-6) after vaccination)
- Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18(Up to Month 84)
- Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen(Up to Month 84)
- Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.(Up to Month 84)
- Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status(Up to Month 84)
- Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection(Up to Month 84)
- Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).(Up to Month 84)
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.(Within 7 days (Days 0-6) after vaccination)
- Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).(Up to Month 48 and up to Month 84)
- Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18(Up to Month 84)
- Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.(Up to Month 84)
- Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy(Up to Month 84)
- Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection(Up to Month 84)
- Number of Subjects With First Colposcopy(Up to Month 84)
- Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.(Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.)
- Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.(Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.)
- Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).(Within 30 days (Days 0 - 29) post-vaccination period.)
- Number of Subjects Reporting New Onset of Autoimmune Disease (NOADs).(Up to Month 48)
- Number of Subjects Reporting Medically Significant Conditions (MAEs).(Up to Month 48)
- Number of Subjects Reporting Related or Fatal Serious Adverse Event.(Up to Month 84)
- Number of Subjects Reporting New Onset of Chronic Disease (NOCDs).(Up to Month 48)
- Number of Subjects With Pregnancies and Their Outcomes.(Up to Month 48)
- Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the Type Assignment Algorithm (TAA)(Up to Month 48)
- Number of Subjects Reporting Any AE/SAE Leading to Premature Discontinuation of the Study.(Up to Month 84)
- Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen(Up to Month 84)
- Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations(Up to Month 48)