The Vaccine Response and Long-term Antibody Persistence of GSK Biologicals' MenACWY-TT Vaccine (GSK134612) Administered as One Dose at 6 Years Post-MenC Primary Vaccination in Healthy Subjects Aged 12-18 Months at Primary Vaccination
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 9
- 主要终点
- Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroup A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY)
研究概览
简要总结
The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' MenACWY-TT vaccine administered at 6 years post-primary vaccination with either GSK Biologicals' Hib-MenC-TT vaccine (Menitorix™) or Hiberix™ and Meningitec™, in healthy subjects aged 12-18 months at primary vaccination and to evaluate the long-term antibody persistence at 2 years after MenACWY-TT booster vaccination.
This is an extension study of the Hib-MenC-TT-016 study (NCT number: NCT00326118).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 84 Months 至 95 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects' parent(s)/Legally Acceptable Representative(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
- •A male or female between, and including, 84 and 95 months of age at the time of the booster vaccination.
- •Written informed consent obtained from the parent(s)/LAR(s) of the subject and written informed assent obtained from the subject in accordance with local laws and regulations.
- •Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
- •Having completed the vaccination in the study [Hib-MenC-TT-016 (106445)] as per protocol.
排除标准
- •Child in care.
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the 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 vaccine dose. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- •Administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the study vaccine dose, with the exception of a licensed inactivated influenza vaccine which can be administered at any time during the study according to the local recommendations.
- •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 vaccine/product.
- •Previous vaccination with meningococcal vaccine except the meningococcal vaccination received in the Hib-MenC-TT-016 study.
- •History of meningococcal disease.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including Human Immunodeficiency Virus (HIV)infection, based on medical history and physical examination (no laboratory testing required).
- •Family history of congenital or hereditary immunodeficiency.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, and history of serious allergic reaction (anaphylaxis) following the administration of vaccine(s).
- •Major congenital defects or serious chronic illness.
- •History of any neurological disorders or seizures, including GBS. History of a simple, single febrile seizure is permitted.
- •Acute disease and/or fever at the time of enrollment.
- •Fever is defined as temperature ≥ 37.5°C for oral, axillary or tympanic route, or ≥ 38.0°C for rectal route. The preferred route for recording temperature in this study will be oral.
- •Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding the study vaccination or planned administration during the booster vaccination phase of the study (i.e. between Visit 1 and Visit 2) and within 3 months preceding the blood sampling at Visit
- •The following criteria should be checked for the long-term persistence phase at two years after booster vaccination (Visit 3):
- •In case an exclusion criterion becomes applicable, the subject will not enter the long-term follow-up and the reason will be documented.
- •Previous administration of a meningococcal vaccine with the exception of the meningococcal vaccination given in the primary study and the booster vaccination in this particular study.
- •History of meningococcal disease.
研究组 & 干预措施
Menitorix Group
Subjects who were primed with Menitorix™ (Hib-MenC-TT) + Priorix™ (MMR) vaccines in the primary study HIB-MENC-TT-016 (NCT00326118) received one dose of Nimenrix™ (MenACWY-TT) booster vaccine at Month 72 post primary vaccination (booster visit 1).
The MenACWY-TT vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
干预措施: Meningococcal conjugate vaccine GSK134612 (Biological)
Meningitec + Hiberix Group
Subjects who were primed with Meningitec™ (MCC) + Hiberix™ (Hib) + Priorix™ (MMR) vaccine in the primary study HIB-MENC-TT-016 (NCT00326118) received one dose of Nimenrix™ (MenACWY-TT) booster vaccine at Month 72 post primary vaccination (booster visit 1).
The MenACWY-TT vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
干预措施: Meningococcal conjugate vaccine GSK134612 (Biological)
结局指标
主要结局
Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroup A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY)
时间窗: At Month 73, one month post-booster vaccination
Vaccine response was defined as: For initially seronegative subjects (pre-vaccination rSBA titer below 1:8), antibody titer greater than or equal to (≥) 1:32 at post-vaccination; for initially seropositive subjects, antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer.
次要结局
- Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values(At Month 96, 24 months post-booster vaccination)
- Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY(At Month 73, one month post-booster vaccination)
- Number of Subjects With Anti-tetanus (Anti-T) Concentrations ≥ the Predefined Cut-off Values(At Month 73, one month post-booster vaccination)
- Antibody Concentrations Against Tetanus (Anti-T) Antigen(At Month 73, one month post-booster vaccination)
- Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY(At Month 96, 24 months post-booster vaccination)
- Number of Subjects With Any Solicited Local Symptoms(During the 4-day (Days 0-3) post-booster vaccination period at Month 72)
- Number of Subjects With Any Solicited General Symptoms(During the 4-day (Days 0-3) post-booster vaccination period at Month 72)
- Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)(During the 31-day (Days 0-30) post-booster vaccination period at Month 72)
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(During the 31-day (Days 0-30) post-booster vaccination period at Month 72)
- Number of Subjects With Serious Adverse Events (SAEs)(From Month 72 up to study end, at Month 96)