NCT00241644已完成3 期
Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,089
- 试验地点
- 13
- 主要终点
- Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain
研究概览
简要总结
The primary objective of this study is to determine if the GSK Biologicals' human rotavirus (HRV) vaccine (pooled HRV groups) given concomitantly with routine expanded program on immunisation (EPI) vaccinations can prevent severe rotavirus gastroenteritis (≥11 on the 20-point Vesikari scoring system [Ruuska, 1990]) caused by the circulating wild-type RV strains during the period from 2 weeks after the last dose of HRV vaccine or placebo until Visit 5.
The primary objective will be reached if the lower limit of the 95% confidence interval (CI) on vaccine efficacy is >0%.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
The study will have three groups: Rotarix 3-Dose Group, Rotarix 2-Dose Group and Placebo Group. Three-dose immunisation will be administered in healthy infants at approximately 6, 10, and 14 weeks of age. Routine EPI vaccinations will be administered concomitantly with the study vaccines. This study will also evaluate immunogenicity and safety relative to the placebo.
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
- 5 Weeks 至 10 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 child between, and including, 5 and 10 weeks of age at the time of the first study vaccination.
- •Written informed consent obtained from the parent or guardian of the subject who is of legal age
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •In South Africa, birth weight > 2000 grams or if weight unknown, gestation period > 36 weeks.
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 first dose of study vaccine, or planned use 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
- •Planned administration of a vaccine not foreseen by the study protocol within 14 days before each dose of study vaccine(s) and ending 14 days after.
- •Chronic administration (defined as more than 14 days) of immunosuppressants since birth.
- •History of use of experimental rotavirus vaccine.
- •Previous routine vaccination except Bacille Calmette-Guérin (BCG), hepatitis B virus (HBV) and oral poliovirus (OPV) vaccination at birth
- •Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception or other medical condition determined to be serious by the investigator.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
- •History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
- •Acute disease at the time of enrolment.
- •Gastroenteritis within 7 days preceding the first study vaccine administration
- •Previous confirmed occurrence of rotavirus gastroenteritis (RV GE).
- •A family history of congenital or hereditary immunodeficiency.
- •Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
- •History of any neurologic disorders or seizures.
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
结局指标
主要结局
Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain
时间窗: From 2 weeks after the last vaccine or placebo dose up to 1 year of age
Number of subjects presenting with three or more looser than normal stools or watery stools within a day, occurring after administration of dose 1 of study vaccine in which rotavirus other than vaccine strain was identified in a stool sample with a score ≥ 11 on the 20-point Vesikari scoring system.
次要结局
- Number of Seroconverted Subjects(One month after the last vaccine or placebo dose)
- Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies in Initially Seronegative Subjects(One month after the last vaccine dose)
- Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain, Classified by Rotavirus Type(From 2 weeks after the last vaccine or placebo dose up to 1 year of age)
- Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies(One month after the last vaccine or placebo dose)
- Number of Subjects Reporting Any Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain(From 2 weeks after the last vaccine or placebo dose up to 1 year of age)
- Number of Subjects Reporting Severe Gastroenteritis of Any Cause(From 2 weeks after the last vaccine or placebo dose up to 1 year of age)
- Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain(From 2 weeks after the last vaccine or placebo dose up to 1 year of age)
- Number of Seropositive Subjects(One month after the last vaccine or placebo dose)
- Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain(From the first vaccine or placebo dose up to 1 year of age)
- In South Africa, Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain(From 2 weeks after the third dose of vaccine or placebo up to 1 year of age)
- For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains(During the period from 1 year of age to study end)
- For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Episode Caused by the Circulating Wild-type RV Strains(During the period from 1 year of age to study end)
- For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strains, Classified by Rotavirus Type(During the period from 1 year of age to study end)
- Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Drop Out(From the first dose of vaccine or placebo up to end of the study)
- Number of Subjects Reporting Serious Adverse Events (SAEs)(From the first dose of vaccine or placebo up to end of the study)
研究者
研究点 (13)
Loading locations...
相似试验
已完成
3 期
To Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants in Co-administration With Specific Childhood VaccinesInfections, RotavirusNCT00140686GlaxoSmithKline3,994
已完成
3 期
Study of 2 Doses of HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy InfantsInfections, RotavirusNCT00139347GlaxoSmithKline6,360
已完成
2 期
A Study to Test 2 Doses of the HRV Vaccine Given With or Without OPV in Healthy Infants in BangladeshInfections, RotavirusNCT00139334GlaxoSmithKline300
已完成
不适用
A Cohort Study in Korean Patients With Chronic Hepatitis B (CHB) Receiving Pegylated InterferonChronic Hepatitis BNCT01531166Yonsei University500
已完成
3 期
A Study to Test 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy InfantsInfections, RotavirusNCT00197210GlaxoSmithKline10,708