NCT00432380已完成2 期
Immunogenicity and Safety of Two Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Liquid Vaccine (GSK 357941A) in Healthy Infants.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody
研究概览
简要总结
This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid vaccine when given along with the routine infant immunizations in Philippines.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 5 Weeks 至 10 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants between, and including, 5-10 weeks of age at the time of the first dose of HRV liquid vaccine or placebo.
- •Birth weight of the subject should be > 2000 grams.
- •Written informed consent obtained from the parent or guardian of the subject.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) 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 within six months prior to the first vaccine dose.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol except for DTPw, HBV and OPV vaccines within 14 days before each dose of HRV liquid vaccine or placebo and ending 14 days after. BCG is administered at birth according to the local EPI.
- •Concurrently participating in another clinical study, at any time during the study period.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •History of allergic disease or reactions likely to be exacerbated by any component of the HRV liquid vaccine or placebo.
- •Acute disease at the time of enrolment.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
结局指标
主要结局
Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody
时间窗: At Month 3
Seroconversion was defined as the appearance of anti-RV IgA antibody concentrations greater than or equal to (≥) 20 units per milliliter (U/mL) in subjects initially (i.e. prior to the first dose of Rotarix™ vaccine or placebo) seronegative, when administered concomitantly with the second and third routine EPI immunization. This outcome measure only concerns subjects in the Placebo-Rotarix-Rotarix Group.
次要结局
- Number of Seroconverted Subjects for Anti-RV IgA Antibody(At Month 3)
- Serum IgA Antibody Concentrations Against Rotavirus(At Month 3)
- Number of Subjects Reporting Grade 2 or Grade 3 Fever, Vomiting or Diarrhea(During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses)
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms(During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses)
- Number of Subjects Reporting RV in Gastroenteritis (GE) Episodes(From Dose 1 of study vaccine or placebo (at Day 0) up to Month 3)
- Number of Subjects Reporting Any Unsolicited Adverse Event (AE)(During the 31-day (Days 0-30) period following any study vaccine dose or placebo)
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Day 0 to Month 3))
研究者
研究点 (1)
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