Immunogenicity and Safety Study of a Booster Dose of GSK Biologicals' Meningococcal Vaccine 134612 Given at 12-15 Months of Age or at 15-18 Months of Age (Co-administered With Infanrix®) in Primed Healthy Toddlers.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,558
- 试验地点
- 57
- 主要终点
- Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 1 Group
研究概览
简要总结
The purpose of the study is to characterize the immunogenicity & safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and open-label for the booster phase.
详细描述
The purpose of this study is to evaluate the titer of antibody for serogroups A, C, Y and W-135 and the safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given to toddlers who were primed with GSK Biological's Hib-meningococcal vaccine 792014. In addition, this study will provide immunogenicity and safety data on the co-administration of Infanrix with meningococcal vaccine 134612 as compared to Infanrix administered alone.
Depending on the group the subject is assigned to, one or two blood samples will be taken out of the subject's arm during the study.
The protocol posting has been updated following a protocol amendment.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 6 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
- •A male or female between, and including, 6 and 12 weeks of age (+ 6 days) at the time of the first vaccination.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Born after 36 weeks gestation.
- •For inclusion in the booster phase, subjects must have received all three doses in the primary phase.
排除标准
- •Exclusion criteria for enrolment (primary phase)
- •Use of any investigational or non-registered product (drug or vaccine) 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s).
- •Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
- •History of Neisseria meningitidis, hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, polio or pertussis diseases.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, or by dry natural latex rubber.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures.
- •Acute disease at time of enrollment.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Concurrent participation 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 (pharmaceutical product or device).
- •Exclusion criteria for enrolment (booster phase)
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding entry into the booster phase (Visit 4), or planned use during the study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- •Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of entry into the booster phase (Visit 4) with the exception of Prevnar® and Hib (see the following three criteria) (Note; licensed influenza vaccine is allowed throughout the study)
- •Planned administration/administration of a fourth dose of Prevnar® within 30 days of a booster dose of Infanrix®
- •Previous administration of a booster dose of Hib prior to entry to the booster phase.
- •Previous administration of a primary dose of Hib vaccine that is not part of the study protocol.
- •Previous vaccination against Neisseria meningitidis that is not part of the study protocol.
- •Previous vaccination with diphtheria, tetanus and pertussis antigens outside of the primary phase of the study.
- •History of Neisseria meningitidis, Hib, diphtheria, tetanus or pertussis diseases.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, or by dry natural latex rubber.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures.
- •Acute disease at time of enrollment.
- •Administration of immunoglobulins and/or any blood products within the past 3 months or planned administration during the study period.
- •Concurrent participation 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 (pharmaceutical product or device).
结局指标
主要结局
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 1 Group
时间窗: One month post vaccination at 12-15 months of age (Month 11)
Antibody titers were expressed as Geometric mean titers (GMTs)
Number of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group
时间窗: One month post vaccination at 12-15 months of age (Month 11)
The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Menhibrix 2 Group
时间窗: One month post vaccination at 12-15 months of age (Month 11)
Antibody titers were expressed as Geometric mean titers (GMTs)
Number of Subjects With Anti-Diptheria (Anti-D) and Anti-Tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group and ActHIB- Infanrix Group
时间窗: One month post vaccination at 15-18 months of age (Month 14)
The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL).
Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Menhibrix 2 Group
时间窗: One month post vaccination at 12-15 months of age (Month 11)
The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group
时间窗: One month after vaccination at 15-18 months of age (Month 14)
Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)
Number of Subjects With hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group
时间窗: One month post vaccination at 15-18 months of age (Month 14)
The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group
时间窗: One month post vaccination at 15-18 months of age (Month 14)
Antibody titers were expressed as Geometric mean titers (GMTs)
次要结局
- Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value(One month after vaccination with Infanrix at 15-18 months of age (Month 14))
- Geometric Mean Antibody Concentrations for Anti-PT, Anti-FHA and Anti-PRN in Nimenrix 1 Group and Menhibrix 2 Group(One month after vaccination at 15-18 months of age (Month 14))
- Number of Subjects With Anti-D and Anti-T Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group and Menhibrix 2 Group(One month after vaccination at 15-18 months of age (Month 14))
- Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Vaccination With Infanrix Vaccine(During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase)
- Number of Subjects Reporting Any Unsolicited AEs in Nimenrix 1 Group and Menhibrix 2 Group After the Second Booster Phase Vaccination(During the 31-day follow-up period (Day 0-30))
- Anti-D and Anti-T Geometric Mean Antibody Concentrations(One month after vaccination with Infanrix at 15-18 months of age (Month 14))
- Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Following Each Dose With Nimenrix or Menhibrix Vaccine(During the 8-day follow-up period (Day 0-7) after vaccination in the booster phase)
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs in the Booster Phase(During the 8-day follow-up period (Day 0-7) after dose 4 and dose 5 vaccination)
- Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations Greater Than or Equal to Protocol Specified Cut-off Value(One month after vaccination with Infanrix at 15-18 months of age (Month 14))
- Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group(One month after vaccination at 15-18 months of age (Month 14))
- Number of Subjects Reporting Any New Onset of Chronic Illness (NOCI) and Any Emergency Room (ER) Visits(From the first primary study dose up to/excluding the first booster study dose (Month 0 up to Month 10-13))
- Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) After the First or Single Booster Phase Vaccination(During a 31-day follow-up period (Day 0-30))
- Number of Subjects With hSBA-MenA and hSBA MenW-135 Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group(One month after vaccination at 12-15 months of age (Month 11))
- Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group(Prior to vaccination at 15-18 months of age (Month 13))
- Number of Subjects Reporting Any Rash(From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22))
- Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group and Menhibrix 2 Group(One month after vaccination at 12-15 months of age (Month 11))
- Geometric Mean Antibody Titers for hSBA-MenA and hSBA MenW-135 in Nimenrix 1 Group(One month after vaccination at 12-15 months of age (Month 11))
- Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group(Prior to vaccination at 15-18 months of age (Month 13))
- Geometric Mean Antibody Titers for hSBA-MenA and hSBA-MenW-135 in Nimenrix 2 Group(One month after vaccination with Infanrix at 15-18 months of age (Month 14))
- Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)(From the first booster phase visit up to six months after the last vaccination (Month 10-13 up to Month 19-22))