Booster Vaccination Study to Assess Safety & Reactogenicity of a Dose of DTPw-HBV/Hib Vaccine and to Assess the Immunogenicity, Safety & Reactogenicity of a Dose of Mencevax™ ACW in Subjects Primed in Study 759346/007
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 4
- 主要终点
- Number of Subjects With Serum Bactericidal Assay Against N. Meningitidis Serogroups A, C Using Rabbit Complement (rSBA-MenA,C) Antibodies
研究概览
简要总结
The purpose of this study is to assess the safety and reactogenicity of a booster dose of diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the immunogenicity, safety, and reactogenicity of a dose of Mencevax™ Group A, C and W135 polysaccharide meningococcal vaccine (ACW) at 24 to 30 m in primed subjects.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
This open study will have two parallel groups based on the vaccination received in the primary study: AC primed Group: primed with Tritanrix™-HepB/Hib-MenAC vaccine and AC unprimed Group (control): primed with Tritanrix™-HepB/Hiberix™ vaccine. All subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™ vaccine at 15 to 18 months of age with GSK Biological's OPV vaccine given concomitantly and a dose of Mencevax™ ACW vaccine at 24 to 30 months of age. Blood sampling will be done prior to (pre) and one month after (post) the Mencevax™ ACW vaccine administration for immunogenicity analyses. The study will last minimum 7 to maximum 16 months per subject.
Mencevax™ ACWY was changed to Mencevax™ ACW throughout the posting to correct an inconsistency in the earlier version of the protocol posting and to reflect the actual situation.
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
- 15 Months 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- •A male or female between, and including, 15 and 18 months of age at the time of 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.
- •Having participated in the primary vaccination study (CPMS N° 759346/007).
- •Exclusion criteria:
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of vaccination.
- •Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A, C or W disease, after the date of the study conclusion visit of the primary vaccination study (CPMS N° 759346/007).
- •History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease.
- •Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A, C or W disease.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •A family history of congenital or hereditary immunodeficiency.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines administered in the study.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures including febrile seizures in infancy.
- •Acute disease at the time of enrolment.
- •Axillary temperature ≥ 37.5°C at the time of vaccination.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the vaccination or planned administration during the study period.
- •Anaphylactic reaction following the administration of vaccine in the primary vaccination study.
- •Known hypersensitivity to any component of the vaccine, or subjects having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B, Hib or meningococcal vaccines.
排除标准
- 未提供
结局指标
主要结局
Number of Subjects With Serum Bactericidal Assay Against N. Meningitidis Serogroups A, C Using Rabbit Complement (rSBA-MenA,C) Antibodies
时间窗: At one month post vaccination with Mencevax™ ACW vaccine (Month 25-31)
Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:128.
次要结局
- Number of Subjects With rSBA-MenA,C, W-135 Antibody Titers ≥ Predefined Cut-offs(Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31))
- Number of Subjects With Anti-polysaccharide A (Anti-PSA) and C (Anti-PSC) Antibody Concentrations Above Predefined Cut-off Values(Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31))
- Number of Subjects With Anti- Polysaccharide W (Anti-PSW) Antibody Concentrations ≥ Predefined Cut-off Values(Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31))
- Anti-PSW Antibody Concentrations(Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31))
- Number of Subjects With Solicited Local Symtoms(During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine)
- Anti-rSBA-MenA, C, W-135 Antibody Titers(Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31))
- Anti-PSA and Anti-PSC Antibody Concentrations(Prior to (Months 24-30) & one month after the administration of the Mencevax™ ACW vaccine (Months 25-31)
- Number of Subjects With Vaccine Response for rSBA-Men A, C and W-135(At one month after the administration of the Mencevax™ ACW vaccine (Months 25-31))
- Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations ≥ Predefined Cut-off Values(Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine)
- Number of Subjects With Solicited General Symptoms(During the 4-Day (Days 0-3) after the administration of the Mencevax™ ACW vaccine)
- Number of Subjects With Unsolicited Adverse Events (AEs)(During the 31-Day (Days 0-30) after the administration of the Mencevax™ ACW vaccine)
- Anti-HBs Antibody Concentrations(Prior to (Months 24-30) the administration of the Mencevax™ ACW vaccine)
- Number of Subjects With Fever(During the 4-day (Days 0-3) after the administration of the Tritanrix™-HepB/Hiberix™ vaccine)
- Number of Subjects With Serious Adverse Events (SAEs)(From Months 15-18 and up to Months 25-31 post vaccination)