NCT01198769已完成4 期
Immunogenicity, Reactogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Taiwanese Infants Who Received Hepatitis B Immunoglobulin After Birth.
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody.
研究概览
简要总结
The purpose of this study is to assess immunogenicity and safety of Rotarix TM when administered in healthy Taiwanese infants (aged 6 to 12 weeks at the time of first vaccination) who received Hepatitis B immunoglobulin after birth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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 who the investigator believes that parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
- •A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- •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.
- •Infants who have received a previous dose of hepatitis B immunoglobulin after birth.
排除标准
- •Child in care.
- •Use of any investigational or non-registered product other than the study vaccine 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 with the exception of Hepatitis B immunoglobulin since birth. Child is unlikely to remain in the study area for the duration of the study.
- •Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine.
- •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.
- •Previous vaccination against rotavirus.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Family history of congenital or hereditary immunodeficiency.
- •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.
- •Administration of immunoglobulins (with the exception of HBIG) and/or any blood products since birth or planned administration during the study period.
- •Gastroenteritis within 7 days preceding the study vaccine administration.
- •Previous confirmed occurrence of Rotavirus gastroenteritis.
研究组 & 干预措施
Rotarix Group
Experimental
subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
干预措施: Rotarix TM (Biological)
结局指标
主要结局
Number of Seroconverted Subjects for Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody.
时间窗: 2 months post-Dose 2 (at study Month 4)
Seroconversion is defined as the appearance of IgA antibody concentration equal to or above (≥) 20 Units per millilitre (U/mL) in the serum of subjects who were seronegative before vaccination. A seronegative subject is a subject with anti-rotavirus IgA antibody concentration below (\<) 20 U/mL.
次要结局
- Number of Subjects Reporting Unsolicited Adverse Events (AEs).(Within the 31-day (Days 0-30) follow-up period after vaccination)
- Number of Subjects Reporting Solicited General Symptoms.(During the 8-day (Days 0-7) post-vaccination period)
- Number of Subjects With Rotavirus (RV) Present in the Gastroenteritis (GE) Stool Sample.(From Day 0 (first vaccine dose) to study Month 4 (2 months post-Dose 2))
- Serum Anti-rotavirus IgA Antibody Concentrations.(2 months post-Dose 2 (at study Month 4))
- Number of Subjects Reporting Serious Adverse Events (SAEs).(During the entire study period (from Dose 1 at Day 0 up to Month 4))
研究者
研究点 (2)
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