Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (PoliorixTM) in Healthy Chinese Toddlers
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 957
- 试验地点
- 2
- 主要终点
- Antibody Titers Against Poliovirus Type 1, 2 and 3.
研究概览
简要总结
This study aims to evaluate the persistence of anti-poliovirus antibodies in toddlers aged 18 months who were primed with oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in the primary study. The study will also assess the immunogenicity and reactogenicity of a booster dose of IPV in subjects primed with three doses of IPV.
详细描述
All subjects will also receive a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) at Day 0. This vaccine will be provided as part of the local standard of care and will not be associated with any study endpoint.
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
- 18 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- •Subjects who received the complete three-dose primary vaccination course in study NCT
- •Healthy male or female toddlers 18 to 24 months of age at the time of Visit 1 (Day 0).
- •Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
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 booster dose of study vaccine(s), or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to Visit 1 (Day 0).
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding Visit 1 (Day 0) or planned administration during the study period.
- •Administration of a vaccine not foreseen by the study protocol within 30 days of Visit 1 (Day 0) or planned administration during the study period.
- •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.
- •Evidence of previous booster vaccination against poliomyelitis or the disease since the conclusion visit of Study NCT
- •History of seizures or progressive neurological disease.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- •Major congenital defects or serious chronic illness.
- •Acute disease and/or fever at the time of enrolment.
研究组 & 干预措施
Group A
Subjects in this group will receive the GSK Biologicals' IPV vaccine at 18 months of age. Subjects will also receive a dose of DTPa/Hib (Infanrix+Hib) as part of the local standard of care.
干预措施: PoliorixTM (Biological)
Group A
Subjects in this group will receive the GSK Biologicals' IPV vaccine at 18 months of age. Subjects will also receive a dose of DTPa/Hib (Infanrix+Hib) as part of the local standard of care.
干预措施: Infanrix+Hib (Biological)
Group B
Subjects in this group will receive only a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) as part of the local standard of care and will not be associated with any study endpoint.
干预措施: Infanrix+Hib (Biological)
结局指标
主要结局
Antibody Titers Against Poliovirus Type 1, 2 and 3.
时间窗: Before booster vaccination.
Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs.
Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value
时间窗: Before booster vaccination.
A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 ED50.
Antibody Titers Against Poliovirus Type 1, 2 and 3
时间窗: One month after Poliorix™ booster vaccination.
Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals (CIs). This outcome measure concerns subjects in the Poliorix Group only.
次要结局
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.(Within 4-days (Days 0-3) post Poliorix™ booster vaccination.)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(Within 4-days (Days 0-3) post Poliorix™ booster vaccination.)
- Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)(Within the 31-day (Days 0-30) follow-up period after the Poliorix™ booster vaccination.)
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (Day 0 to Month 1).)