NCT01381575已完成3 期
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV-16/18 L1 AS04 Vaccine When Administered According to Alternative 2-dose Schedules in 9 - 14 Year Old Females
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,447
- 试验地点
- 34
- 主要终点
- Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Month 7
研究概览
简要总结
This study has been designed to evaluate the immunogenicity and safety of GSK Biologicals' HPV-16/18 vaccine when administered according to alternative 2-dose schedules (0,6 months and 0,12 months) in healthy 9-14 year old females as compared to the standard 3-dose schedule (0,1,6 months) in 15-25 year old females.
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
- None
入排标准
- 年龄范围
- 9 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 can and will comply with the requirements of the protocol or/ and subjects who the investigator believes their parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol
- •A female between, and including, 9 and 25 years of age at the time of the first vaccination
- •Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject prior to enrolment in the study. In addition, subjects below the legal age of consent should sign and personally date a written informed assent form
- •Healthy subjects
- •Female subjects of non-childbearing potential may be enrolled in the study
- •Female subjects of childbearing potential may be enrolled in the study, if the subject:
- •has practiced adequate contraception for 30 days prior to vaccination, and
- •has a negative pregnancy test on the day of vaccination, and
- •has agreed to continue adequate contraception during the entire vaccination period and up to two months after the last study vaccine dose
排除标准
- •Pregnant or breastfeeding
- •A female planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the entire vaccination period and up to two months after the last study vaccine dose
- •Previous vaccination against HPV or planned administration of another HPV vaccine during the study
- •Child in care. A child in care is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian.
- •Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines
- •Cancer or autoimmune disease under treatment
- •Planned administration/administration of a vaccine/product not foreseen by the study protocol within 30 days before each dose of vaccine. Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
- •Previous administration of MPL or AS04 adjuvant.
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period
- •Any confirmed or suspected immunosuppressive or immunodeficient condition
- •Family history of congenital or hereditary immunodeficiency
- •Major congenital defects or serious chronic illness
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine
- •Acute disease and/or fever at the time of enrolment
结局指标
主要结局
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Month 7
时间窗: At Month 7 (i.e. one month after the last dose of study vaccine)
Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.
Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervarix 1 Group and Cervarix 2 Group at Month 7
时间窗: At Month 7 (i.e. one month after the last dose of study vaccine)
Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations greater than or equal to (≥) 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 concentrations ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with anti-HPV-16/18 antibody concentration lower than (\<) 8/7 EL.U/mL, respectively.
次要结局
- Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group(At Day 0 and at Months 13, 18, 24 and 36)
- Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group(At Day 0 and at Months 13, 18, 24 and 36)
- Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects(At Day 0 and at Months 7, 12, 24 and 36)
- Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects(At Day 0 and at Months 13, 18 and 36)
- Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group(At Day 0 and at Months 7, 12, 18, 24 and 36)
- Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects(At Day 0 and at Months 13, 18 and 36)
- Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects(At Day 0 and at Months 7, 12, 24 and 36)
- Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36(At Day 0 and at Months 7, 12, 18, 24 and 36)
- Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36(At Day 0 and at Months 7, 12, 18, 24 and 36)
- Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects(At Day 0 and at Months 13, 18 and 36)
- Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects(At Day 0 and at Months 13, 18 and 36)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(During the 30 day (Days 0-29) post-vaccination period)
- Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)(From Day 0 up to Month 13 (for Cervarix 1 Group and Cervarix 2 Group) and from Day 0 up to Month 18 (for Cervarix 3 Group))
- Number of Subjects With Medically Significant Conditions (MSCs)(From Day 0 up to Month 36 (throughout the study period))
- Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group(At Day 0 and at Months 13, 18, 24 and 36)
- Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects(At Day 0 and at Months 7, 12, 24 and 36)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 7-day period (Days 0-6) after each vaccine dose and across doses)
- Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects(At Day 0 and at Months 7, 12, 24 and 36)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 7-day period (Days 0-6) after each vaccine dose and across doses)
- Number of Subjects With Any, Related and Fatal Serious Adverse Events (SAEs)(From Day 0 up to Month 36 (throughout the study period))
- Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies(From Day 0 up to Month 36 (throughout the study period))
- Number of Subjects Completing the Vaccination Course(From Day 0 up to Month 13)
研究者
研究点 (34)
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