A Phase II, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety, Reactogenicity and Immunogenicity of Three Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Number of Subjects Reporting Grade "2" or Grade "3" Fever, Vomiting or Diarrhea
研究概览
简要总结
The aim of this study is to evaluate the reactogenicity, safety and immunogenicity of GSK Biologicals' human rotavirus (HRV) vaccine given concomitantly with routine vaccines including OPV in HIV positive infants. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
详细描述
HIV infected infants as determined prior to study entry (screening) and asymptomatic or mildly symptomatic (WHO stages I and II) of disease will be enrolled. The study will have two groups: Group HRV and Group Placebo. Three-dose immunisation will be administered at approximately 6, 10, and 14 weeks of age. Routine EPI (Expanded Program on Immunisation) vaccinations will be administered concomitantly with the study vaccines. At the time of first dose, subjects will be aged 6 to 10 weeks. This study will evaluate safety, reactogenicity and immunogenicity of the HRV vaccine 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)
盲法说明
The study was conducted in a double-blind manner. The parents/guardians of the subjects and the study personnel were unaware of the administered treatment (HRV vaccine or placebo).
入排标准
- 年龄范围
- 6 Weeks 至 10 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
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 and 10 weeks of age at the time of the first vaccination.
- •Written informed consent obtained from the parents or guardians of the subject
- •Documented HIV status of the subject as confirmed by PCR.
- •HIV asymptomatic and HIV mildly symptomatic; Stages I and II disease according to WHO's most recent classification for HIV stages in infants and children.
- •Born after a gestation period of 36 to 42 weeks.
排除标准
- •Use of any investigational or non-registered 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.
- •Previous routine vaccination except OPV, BCG and HBV vaccination at birth
- •Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
- •History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
- •Acute disease at time of enrolment.
- •Gastroenteritis within 7 days preceding the study vaccine administration.
- •Previous confirmed occurrence of RV gastroenteritis.
- •Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
- •HIV moderately and severely symptomatic: stages III and IV according to WHO's recent classification.
- •Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
研究组 & 干预措施
Rotarix Group
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
干预措施: Polio Sabin (Biological)
Rotarix Group
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
干预措施: Tritanrix-HB+Hib (Biological)
Placebo Group
Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
干预措施: Placebo (Biological)
Placebo Group
Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
干预措施: Tritanrix-HB+Hib (Biological)
Placebo Group
Subjects received 3 doses of placebo co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
干预措施: Polio Sabin (Biological)
Rotarix Group
Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix HepB Hib and Polio Sabin vaccines.
干预措施: Rotarix (Biological)
结局指标
主要结局
Number of Subjects Reporting Grade "2" or Grade "3" Fever, Vomiting or Diarrhea
时间窗: Within the 15-day solicited follow-up period after any dose
Symptoms reported in the table include: Fever: temperature (axillary route) \> 38.0 degree Celsius (°C); Diarrhea: ≥ 4 looser than normal stools/day; Vomiting: ≥ 2 episodes of vomiting/day.
次要结局
- The Number of Subjects With no Evidence of Immunosuppression and Moderate/ Severe Suppression, Based on CD4+ Absolute Cell Count and CD4+ Percent(At the screening visit and 2 months after dose 3 (Visit 4))
- Human Immunodeficiency Virus (HIV) Viral Load(At the screening visit and 2 months after dose 3)
- Number of Subjects Reporting Any Unsolicited Symptoms(Within 30 days after any dose)
- Number of Subjects With Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations More Than or Equal to the Cut-off Value(Two months after dose 3)
- Geometric Mean Concentration for Anti-HBs Antibodies(Two months after dose 3)
- Geometric Mean Concentration for Anti-PRP Antibodies(Two months after dose 3)
- Geometric Mean Concentration for Anti-diphtheria and Anti-tetanus Toxoids Antibodies(Two months after dose 3)
- Rotavirus in Diarrheal Stool Samples(From Dose 1 until 2 months after dose 3 or until end of RV shedding)
- Enteric Pathogens Identification(From Dose 1 until 2 months after dose 3 or until end of RV shedding)
- Number of Subjects With the RV in Stool Samples(From Dose 1 until post Dose 3)
- Number of Subjects Reporting Each Type of Solicited Symptom(Within the 15-day solicited follow-up period after each dose)
- Number of Subjects Who Seroconverted Against Rotavirus(Two months after dose 3)
- Serum Rotavirus Immunoglobulin A (IgA) Antibody Concentrations(Two months after dose 3)
- Number of Subjects With Anti-diphtheria and Anti-tetanus Toxoids Antibody Concentrations More Than or Equal to the Cut-off Value(Two months after dose 3)
- Number of Subjects With Anti-hepatitis B (HBs) Antibody Concentrations More Than or Equal to the Cut-off Value(Two months after dose 3)
- Number of Subjects With Anti-polio Types 1, 2 and 3 Antibody Titers More Than or Equal to the Cut-off Value(Two months after dose 3)
- Number of Subjects Reporting Any Serious Adverse Events(Until 2 months after dose 3 (for subjects RV negative at Day 42 post-dose 3) or until end of RV shedding (for subjects who shed RV at Day 42 post-dose 3))
- Number of Subjects With Vaccine Take(Two months after dose 3)
- Geometric Mean Titer for Anti-polio Types 1, 2 and 3 Antibodies.(Two months after dose 3)
- Number of Subjects With Anti-Bordetella Pertussis (BPT) Antibody Concentrations More Than or Equal to the Cut-off Value(Two months after dose 3)
- Geometric Mean Concentration for Anti-BPT Antibodies(Two months after dose 3)
- Rotavirus Antigen Excretion in Stool Samples(At day of each vaccination and at planned days following each vaccine dose until 2 months after dose 3 or until end of RV shedding)
- Rotavirus Vaccine Strain Identification(From dose 1 until 2 months after dose 3 or until end of RV shedding)