NCT01021293已完成3 期
Immunogenicity and Safety of GSK Biologicals' IPV (Poliorix™) in Infants
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,101
- 试验地点
- 1
- 主要终点
- Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
研究概览
简要总结
The purpose of the study is to evaluate the immunogenicity and safety of Poliorix™ when administered to healthy Chinese infants at 2, 3 and 4 months of age.
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
- 60 Days 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female infant between, and including, 60 and 90 days of age at the time of the first vaccination.
- •Born after a gestation period of 36 to 42 weeks inclusive.
- •Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (LAR) (s) can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
排除标准
- •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 since birth.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with exception of DTP, Hib and/or hepatitis B vaccine(s).
- •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 or intercurrent poliomyelitis disease or vaccination.
- •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(s).
- •Major congenital defects or serious chronic illness.
- •Child in care.
- •The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved and if no other exclusion criteria are met:
- •Current febrile illness or axillary temperature > 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
研究组 & 干预措施
Poliorix Group
Experimental
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
干预措施: Poliorix™ (Biological)
Control Group
Active Comparator
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
干预措施: Oral Poliovirus vaccine (Biological)
结局指标
主要结局
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
时间窗: At Month 3, one month after the third vaccine dose
A seroprotected subject was defined as a vaccinated subject with anti-polio types 1, 2 and 3 titers greater than or equal to (≥) 8 effective dose 50 (ED50).
次要结局
- Anti-poliovirus Types 1, 2 and 3 Antibody Titers(Prior to the first vaccine dose (Day 0) and one month after the third vaccine dose (Month 3))
- Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3(At Day 0, prior to the first vaccine dose)
- Number of Subjects With Any Unsolicited Adverse Events (AEs)(Within the 31-day (Days 0-30) post-vaccination period)
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Day 0 to Month 3))
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses)
研究者
研究点 (1)
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