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Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.

2019年11月25日 更新者：GlaxoSmithKline

A Dose-range Study to Assess the Safety and Immunogenicity of a Novel HPV Vaccine When Administered Intramuscularly According to a 3-dose Schedule (0,1,6-month) in Healthy Adult Females (18-25 Years of Age)

Human Papilloma viruses (HPV) are viruses that cause infections of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection, if it persists, can lead over a long period of time to cancer of the cervix in women. In collaboration with MedImmune Inc., GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the adjuvant AS04. GSK Biologicals is also evaluating novel HPV vaccine formulations.This study will evaluate the immunogenicity and safety of a novel GSK Biologicals HPV vaccine in women 18-25 years of age at study start. Approximately 376 study subjects will receive the novel HPV vaccine or the control vaccine administered intramuscularly according to a 0-1-6 month schedule.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

383

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 比利时
      • Bruxelles、比利时、1070
        • GSK Investigational Site
      • Gent、比利时、9000
        • GSK Investigational Site
      • Leuven、比利时、3000
        • GSK Investigational Site
      • Liège、比利时、4000
        • GSK Investigational Site
      • Roeselare、比利时、8800
        • GSK Investigational Site
      • Wilrijk、比利时、2610
        • GSK Investigational Site
  • 美国
    • Colorado
      • Aurora、Colorado、美国、80045
        • GSK Investigational Site
      • Golden、Colorado、美国、80401
        • GSK Investigational Site
    • Rhode Island
      • Kingston、Rhode Island、美国、02881
        • GSK Investigational Site
    • Utah
      • Salt Lake City、Utah、美国、84109
        • GSK Investigational Site
      • Salt Lake City、Utah、美国、84121
        • GSK Investigational Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 25年 (成人)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • A woman between, and including, 18 and 25 years of age at the time of the first vaccination
  • Written informed consent from the subject prior to enrolment
  • Subject must be free of obvious health problems
  • Subject must be of non-childbearing potential and have had no more than 6 lifetime sexual partners

Exclusion Criteria:

  • Pregnant or breastfeeding
  • A woman planning to become pregnant or planning to discontinue contraceptive precautions during approximately the first nine months of the study (Month 0-8)
  • Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality
  • History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease
  • Previous vaccination against human papillomavirus (HPV)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器：HPV-16/18 Group
Female subjects who received 3 doses of the HPV-16/18 L1 AS04 vaccine intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
生物：HPV 16/18 L1 AS04
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
实验性的：HPV-TETRA A Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 1 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
生物：HPV-16/18/31/45 L1 AS04 Formulation 1
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
实验性的：HPV-TETRA B Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 2 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
生物：HPV-16/18/31/45 L1 AS04 Formulation 2
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
实验性的：HPV-TETRA C Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 3 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
生物：HPV-16/18/31/45 L1 AS04 Formulation 3
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
实验性的：HPV-TETRA D Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 4 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
生物：HPV-16/18/31/45 L1 AS04 Formulation 4
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
实验性的：HPV-TETRA E Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 5 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
生物：HPV-16/18/31/45 L1 AS04 Formulation 5
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
实验性的：HPV-TETRA F Group
Female subjects who received 3 doses of the HPV-16/18/31/45 L1/AS04 vaccine, formulation 6 intramuscularly, into the deltoid of the non-dominant arm according to a 3-dose 0, 1, 6-month vaccination schedule.
生物：HPV-16/18/31/45 L1 AS04 Formulation 6
3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Seroconverted Subjects for Anti-Human Papillomavirus (Anti-HPV)-16 at Month 7
大体时间：At Month 7
Seroconversion was defined as the appearance of anti-HPV-16 antibodies [i.e. antibody titer greater than or equal to (≥) the cut-off value] in the serum of subjects seronegative before vaccination. The cut-off value was 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
At Month 7
Number of Seroconverted Subjects for Anti-HPV-18 at Month 7
大体时间：At Month 7
Seroconversion was defined as the appearance of anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL.
At Month 7
Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 7
大体时间：At Month 7
Anti-HPV-16 antibody titers were presented as Geometric Mean Titers (GMT) and expressed in EL.U/mL.
At Month 7
Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 7
大体时间：At Month 7
Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
At Month 7

次要结果测量

结果测量
措施说明
大体时间
Number of Seroconverted Subjects for Anti-HPV-16 at Month 2
大体时间：At Month 2
Seroconversion was defined as the appearance of anti-HPV-16 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 8 EL.U/mL.
At Month 2
Number of Seroconverted Subjects for Anti-HPV-18 at Month 2
大体时间：At Month 2
Seroconversion was defined as the appearance of anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 7 EL.U/mL.
At Month 2
Anti-HPV-16 Antibody Titers Assessed by ELISA at Month 2
大体时间：At Month 2
Anti-HPV-16 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
At Month 2
Anti-HPV-18 Antibody Titers Assessed by ELISA at Month 2
大体时间：At Month 2
Anti-HPV-18 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
At Month 2
Number of Seroconverted Subjects for Anti-HPV-31 at Months 2 and 7
大体时间：At Month 2 and Month 7
Seroconversion was defined as the appearance of anti-HPV-31 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 59 EL.U/mL.
At Month 2 and Month 7
Number of Seroconverted Subjects for Anti-HPV-45 at Months 2 and 7
大体时间：At Month 2 and Month 7
Seroconversion was defined as the appearance of anti-HPV-45 antibodies (i.e. antibody titer ≥ cut-off value) in the serum of subjects seronegative before vaccination. The cut-off value was 59 EL.U/mL.
At Month 2 and Month 7
Anti-HPV-31 Antibody Titers Assessed by ELISA at Months 2 and 7
大体时间：At Month 2 and Month 7
Anti-HPV-31 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
At Month 2 and Month 7
Anti-HPV-45 Antibody Titers Assessed by ELISA at Months 2 and 7
大体时间：At Month 2 and Month 7
Anti-HPV-45 antibody titers were presented as Geometric Mean Titers and expressed in EL.U/mL.
At Month 2 and Month 7
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
大体时间：During the 7 day post-vaccination period following each dose and across doses
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activity. Grade 3 redness/swelling = redness/swelling above 50 millimeters (mm). All the reported local symptoms are considered related to the vaccination in the study.
During the 7 day post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
大体时间：During the 7 day post-vaccination period following each dose and across doses
Assessed solicited general symptoms were arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Any Fever = axillary temperature greater than or equal to (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever greater than (>) 39.0°C. Related = general symptom assessed by the investigator as causally related to the vaccination.
During the 7 day post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
大体时间：During the 30-day post-vaccination period
An unsolicited adverse event (AE) was defined as any AE reported in addition to those solicited during the clinical study. Also, any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Any is defined as the occurrence of any unsolicited AE irrespective of its intensity grade and relationship to vaccination. Grade 3 unsolicited AE = an AE that prevented normal, everyday activities. Related AE = an AE assessed by the investigator as causally related to the study vaccination.
During the 30-day post-vaccination period
Number of Subjects With Any Serious Adverse Events (SAEs)
大体时间：From Day 0 to Month 7
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.
From Day 0 to Month 7
Number of Subjects With Any SAEs During the Extended Safety Follow-up
大体时间：From Day 0 to Month 12
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.
From Day 0 to Month 12
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
大体时间：From Day 0 to Month 12
Outcomes of reported pregnancies were: Healthy baby, Spontaneous abortion, Elective abortion.
From Day 0 to Month 12
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)
大体时间：From Day 0 up to Month 12
NOCDs assessed include chronic diseases such as autoimmune disorders, diabetes, allergies also asthma and pathognomic signs/symptoms of these diseases.
From Day 0 up to Month 12
Number of Subjects Reporting Medically Significant Conditions
大体时间：From Day 0 up to Month 12
Medically significant conditions are AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or SAEs that were not related to common diseases.
From Day 0 up to Month 12
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
大体时间：At Month 2 and Month 7
The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, blood urea nitrogen = BUN) and haematological [basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin = HGB, leukocytes (white blood cells) = WBC, lymphocytes = LYM, monocytes = MONO, neutrophils = NEU and platelets = PLA]. Abnormal values of a parameter at Months 2 and 7 are defined as below and above the normal ranges, as compared to the baseline status of the same parameter.
At Month 2 and Month 7

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

GlaxoSmithKline

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2005年3月4日

初级完成 (实际的)

2006年3月27日

研究完成 (实际的)

2006年3月27日

研究注册日期

首次提交

2005年10月3日

首先提交符合 QC 标准的

2005年10月3日

首次发布 (估计)

2005年10月4日

研究记录更新

最后更新发布 (实际的)

2019年12月12日

上次提交的符合 QC 标准的更新

2019年11月25日

最后验证

2019年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • 102115
  • 2004-003766-14 (EudraCT编号)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

IPD is available via the Clinical Study Data Request site (click on the link provided below).

IPD 共享时间框架

IPD is available via the Clinical Study Data Request site (click on the link provided below).

IPD 共享访问标准

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

研究数据/文件

  1. 数据集规范
    信息标识符：102115
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  2. 统计分析计划
    信息标识符：102115
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  3. 研究协议
    信息标识符：102115
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  4. 个人参与者数据集
    信息标识符：102115
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 102115 are summarised with studies 107919 and 108052 on the GSK Clinical Study Register.
  5. 知情同意书
    信息标识符：102115
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  6. 临床研究报告
    信息标识符：102115
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

HPV 16/18 L1 AS04的临床试验

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赞助者和合作者

医疗条件

药物干预

CROs by country

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

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