NCT00969228已完成4 期
Immunogenicity, Reactogenicity and Safety Study to Evaluate Two Doses of the Lyophilised Formulation of the Human Rotavirus (HRV) Vaccine When Administered to Healthy Korean Infants Previously Uninfected With HRV
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 684
- 试验地点
- 18
- 主要终点
- Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A
研究概览
简要总结
The aim of this study is to assess the immunogenicity, reactogenicity and safety of the human rotavirus (HRV) Rotarix ™ vaccine when administered in healthy infants aged approximately 6-12 weeks at the time of first vaccination.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- •A male or female between, and including, 6 to 12 weeks of age at the time of the first dose of the vaccination.
- •Written informed consent obtained from the parents or guardians of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Born after a normal gestation period of between 37 and 41 weeks + 6 days inclusive.
- •Subjects for whom the vaccination history is available from vaccination diary cards or medical charts.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine with the exception of the routine infant vaccines.
- •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.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •Acute disease at the time of enrolment.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Gastroenteritis (GE) within 7 days preceding the study vaccine administration.
- •Previous confirmed occurrence of RV GE.
- •Previous vaccination with rotavirus vaccine or planned use during the study period.
研究组 & 干预措施
Rotarix Group
Experimental
Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
干预措施: Rotarix ™ (Biological)
Placebo Group
Placebo Comparator
Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
干预措施: Placebo (Biological)
结局指标
主要结局
Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A
时间窗: One month after the second vaccine dose
Seroconversion is defined as the appearance of antibodies with concentrations greater than or equal to 20 units per milliliter (U/mL) in the serum of subjects seronegative before vaccination.
次要结局
- Number of Subjects Reporting Solicited Symptoms(During the 8-day (Day 0 - Day 7) follow-up period after each vaccine dose.)
- Number of Subjects Reporting Unsolicited Adverse Events (AEs)(During the 31-day (Day 0 - Day 30) follow-up period after each vaccine dose)
- Number of Subjects Reporting Rotavirus Gastroenteritis Episode(s)(From Dose 1 up to 1 month after Dose 2.)
- Serum Anti-rotavirus Immunoglobulin A Antibody Concentrations(One month after the second vaccine dose)
- Number of Subjects Reporting Serious Adverse Events (SAEs)(Throughout the study period (2-3 months).)
研究者
研究点 (18)
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