Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine 134612 With or Without Co-administration of Cervarix and Boostrix in Female Adolescents and Young Adults at 9-25 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,300
- 试验地点
- 4
- 主要终点
- Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Concentrations Equal to or Above (≥) 1.0 IU/mL
研究概览
简要总结
The purpose of this study is to evaluate safety and immunogenicity of GSK Biologicals' meningococcal vaccine GSK134612 (MenACWY-TT) co-administered with Cervarix as compared to MenACWY-TT and Cervarix administered alone and the co-administration of MenACWY-TT with Cervarix and Boostrix as compared to MenACWY-TT administered alone and Cervarix co-administered with Boostrix.
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 and subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, 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 parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than legal age, or written informed consent obtained from the subject if the subject has achieved legal age. The legal age will be determined according to local regulations in each participating country.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- •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 treatment period and for 2 months after completion of the vaccination series.
排除标准
- •Child in care.
- •Use of any investigational or non-registered product other than the study vaccine(s) 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. For corticosteroids, this will be ≥10 mg/day prednisone or equivalent. Inhaled and topical steroids are allowed.
- •Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after each study dose of vaccine(s), with the exception of licensed inactivated influenza vaccine.
- •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 product or a non-investigational vaccine/product.
- •Previous vaccination with a meningococcal polysaccharide or conjugate vaccine within the last 10 years.
- •History of meningococcal disease since birth.
- •History of serious allergic reaction following any other DTP-containing vaccine or any component of the study vaccines.
- •History of encephalopathy within seven days of administration of a previous pertussis antigen-containing vaccine that is not attributable to another identifiable cause.
- •Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of tetanus-toxoid containing vaccine should not receive Boostrix unless at least 10 years have elapsed since the last dose of tetanus-toxoid containing vaccine.
- •Previous vaccination with a tetanus-toxoid containing vaccine within the previous five years.
- •Temperature of ≥ 40.5°C (105°F) within 48 hours of receipt of a previous dose of DTP vaccine (diphtheria-tetanus-whole cell pertussis [DTPw] and/or diphtheria-tetanus-acellular pertussis [DTaP]), not due to another identifiable cause.
- •Collapse or shock-like state within 48 hours of receipt of a previous dose of DTP vaccine.
- •Seizures with or without fever within three days of a previous dose of DTP vaccine.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and history directed physical examination.
- •A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
- •History of any allergic disease/reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- •Progressive neurologic disorder, unstable neurologic conditions, uncontrolled epilepsy or progressive encephalopathy.
- •History of any neurologic disorders or seizures. A history of ADHD or depression or a history of a single, simple febrile seizure does not exclude a subject.
- •Major congenital defects or serious chronic illness.
- •Previous history of Guillain-Barré Syndrome.
- •Bleeding disorders, such as hemophilia or thrombocytopenia, or subjects on anti-coagulant therapy.
- •Acute disease and/or fever at the time of enrolment.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- •Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
- •Previous administration of MPL or AS04 adjuvant.
- •History of chronic alcohol consumption and/or drug abuse.
- •Pregnant or lactating female.
- •A subject planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose.
- •Subjects must be at least three months post-pregnancy and not breastfeeding to enter the study.
研究组 & 干预措施
Nimenrix+Cervarix (0,1,6-Month) Group
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
干预措施: Cervarix® (Biological)
Nimenrix+Cervarix (1,2,7-Month) Group
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
干预措施: Meningococcal vaccine GSK134612 (Biological)
Nimenrix+Cervarix (1,2,7-Month) Group
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
干预措施: Cervarix® (Biological)
Nimenrix+Cervarix (0,1,6-Month) Group
Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
干预措施: Meningococcal vaccine GSK134612 (Biological)
Cervarix Group
Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm.
干预措施: Cervarix® (Biological)
Nimenrix+Cervarix+Boostrix Group
Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
干预措施: Meningococcal vaccine GSK134612 (Biological)
Nimenrix+Cervarix+Boostrix Group
Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
干预措施: Cervarix® (Biological)
Boostrix+Cervarix Group
Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
干预措施: Cervarix® (Biological)
Boostrix+Cervarix Group
Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
干预措施: Boostrix® (Biological)
Nimenrix+Cervarix+Boostrix Group
Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm.
干预措施: Boostrix® (Biological)
结局指标
主要结局
Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Concentrations Equal to or Above (≥) 1.0 IU/mL
时间窗: At one month after Boostrix vaccination (Month 1)
The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as International Units per milliliter (IU/mL). This analysis was only performed on the groups receiving Boostrix vaccine.
Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA)
时间窗: At one month after vaccination with Nimenrix (Month 1)
The analysis was performed for the serogroups -MenA, -MenC -MenW-135 and -MenY. Antibody titers, tabulated as geometric mean titers (GMTs), were obtained by serum bactericidal assay using rabbit complement. This analysis was only performed on groups receiving Nimenrix vaccine.
Anti-HPV-16 and Anti-HPV-18 Concentrations
时间窗: At one month after vaccination with Cervarix (Month 7)
The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL).
Anti-Pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
时间窗: At one month after Boostrix vaccination (Month 1)
The antibody concentrations were tabulated as GMCs and expressed as IU/mL. GMCs were only analyzed in subjects receiving Boostrix vaccination.
次要结局
- Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128(Prior to and one month after vaccination with Nimenrix (Months 0 and 1))
- Anti-T Antibody Concentrations(Prior to and one month after vaccination with Nimenrix (Months 0 and 1))
- Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL(Prior to the first dose and one month after the third dose of Cervarix [Month 0 and Month 7/Month 8 in Nimenrix+Cervarix (1,2,7-Month) Group])
- rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response(At one month after Nimenrix vaccination (Month 1))
- Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies(Prior to and one month after the third dose of Cervarix (Month 0 and Month 7/Month 8))
- Number of Subjects With Serious Adverse Events SAE(s)(During the entire study period (from Month 0 to Month 8))
- Number of Subjects With New Onset Chronic Illnesses (NOCIs)(During the entire study period (from Month 0 to Month 8))
- Anti-HPV-16 and Anti-HPV-18 Concentrations(Prior to and one month after the third dose of Cervarix (Months 0 and 8))
- Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL(Prior to and one month after Boostrix vaccination (Month 0 and Month 1))
- Number of Subjects Reporting Solicited General Symptoms(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Number of Subjects With Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥ 1.0 IU/mL(Prior to and one month after vaccination with Nimenrix (Months 0 and 1))
- Anti-D and Anti-T Antibody Concentrations(Prior to and one month after Boostrix vaccination (Months 0 and 1))
- Number of Subjects With Unsolicited Adverse Events AE(s)(During the 31-day (Days 0-30) period following vaccination with Nimenrix, Boostrix or the first dose of Cervarix)
- Number of Subjects With Potential Immune-mediated Diseases (pIMDs)(During the entire study period (from Month 0 to Month 8))
- Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Antibodies(At one month after Boostrix vaccination (Month 1))
- Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value(Prior to and one month after Boostrix vaccination (Months 0 and 1))
- Number of Subjects Reporting Solicited Local Symptoms(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)