A Phase III, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Protective Efficacy of Three Doses of Oral Rotavirus Vaccine (ORV) 116E, Against Severe Rotavirus Gastroenteritis in Infants
试验速览
- 阶段
- 3 期
- 入组人数
- 6,800
- 试验地点
- 6
- 主要终点
- Efficacy against severe rotavirus gastroenteritis (>=11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus
研究概览
简要总结
The trial is a phase III randomized, double-blind, placebo-controlled trial with the primary objective of evaluating the efficacy of three doses of ORV 116E, 10^5.0 FFU, against severe rotavirus gastroenteritis, in comparison with a placebo in India.
详细描述
The trial is a phase III randomized, double-blind, placebo-controlled trial with the primary objective of evaluating the efficacy of three doses of ORV 116E, 10^5.0 FFU, against severe rotavirus gastroenteritis, in comparison with a placebo in India. The clinical trial is not a global trial. Three administrations of ORV 116E will be co-administered with childhood vaccines (which will include vaccines against diphtheria, pertussis, tetanus, Haemophilus influenzae B and Hepatitis B and OPV) at 6 to 7 weeks, greater than or equal to 10 weeks and greater than or equal to 14 weeks of age. 6800 subjects will be enrolled in three sites - Delhi, Pune (Maharashtra) and Vellore (Tamil Nadu) and followed up till the age of 2 years (24 months + up to 14 days). Multiple trial sites are included to ensure greater demographic distribution to obtain evidence of cross immunity and quicker recruitment of the necessary number of subjects. The subjects to be included from these sites would be representative of the population of India.
The protocol has been reviewed by the institutional review boards of the Society for Applied Studies (New Delhi), KEM Hospital Research Centre (Pune), Christian Medical College (Vellore). Ethics clearance has also been obtained from the Department of Biotechnology, Government of India and Western Institutional Review Board.
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 7 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least one parent(s) or legally acceptable representative's consent for participation and are able to understand study procedures
- •Subjects aged 6 to 7 weeks at recruitment
- •No plans to move in the next 24 months
排除标准
- •Administration of rotavirus vaccine in the past
- •Presence of any illness requiring hospital referral (temporary exclusion)
- •Known case of immunodeficiency disease, known HIV positive
- •Known case of chronic gastroenteritis disease
- •Any other conditions which in the judgment of the investigator warrant exclusion (e.g. no exclusion criteria but seems "ill", investigators suspects neglect)
- •Diarrhea on the day of enrollment (temporary exclusion)
研究组 & 干预措施
Oral Rotavirus Vaccine 116E (ORV 116E)
Oral Rotavirus Vaccine 116E (ORV 116E), 10^5.0 FFU of Bharat Biotech International Limited, 3 doses of 0.5 mL at 4 week intervals
干预措施: ORV 116E (Biological)
Placebo
3 doses of 0.5 mL at 4 week intervals
干预措施: Placebo (Biological)
结局指标
主要结局
Efficacy against severe rotavirus gastroenteritis (>=11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus
时间窗: Up to 2 years of age
Efficacy of ORV 116E will be assessed in comparison to a placebo against severe rotavirus gastroenteritis (\>=11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus in all subjects from 14 days following the 3rd dose till the age of 2 years (24 months) + up to 14 days.
次要结局
- Efficacy against any severity of gastroenteritis caused by a non vaccine rotavirus(Up to 2 years of age)
- Efficacy against any severity of gastroenteritis irrespective of etiology(Up to 2 years of Age)
- Efficacy against severe (>=11 on the 20 point Vesikari scoring scale) gastroenteritis irrespective of etiology(Up to 2 years of age)
- Efficacy to prevent hospitalization and/or supervised rehydration therapy (equivalent to WHO plan B or C) in a treatment facility/hospital for gastroenteritis caused by non vaccine rotavirus(Up to 2 years of age)
- Efficacy to prevent hospitalization and/or supervised rehydration therapy (equivalent to WHO plan B or C) in a treatment facility/hospital for gastroenteritis of any etiology(Up to 2 years of age)
- Efficacy to prevent hospitalization and/or supervised re-hydration therapy (equivalent to WHO plan B or C) in a treatment facility/hospital for severe gastroenteritis of any etiology(Up to 2 years of age)
- Efficacy against severe rotavirus gastroenteritis (>=11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus(From the age of 12 months till the age of 2 years of age)
- Efficacy against severe rotavirus gastroenteritis (>=11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus in intent-to-treat population(Up to 2 years of age)
- Efficacy to prevent hospitalization and/or supervised re-hydration therapy (equivalent to WHO plan B or C) in a treatment facility/hospital for severe gastroenteritis caused by non vaccine rotavirus(Up to 2 years of age)
- Efficacy against very severe rotavirus gastroenteritis (≥16 on the 20-point Vesikari scoring system) caused by non vaccine rotavirus(Up to 2 years of age)
- Safety of ORV 116E for immediate adverse events and serious adverse events in comparison to a placebo(Up to 2 years of age)
- Safety of ORV 116E for adverse events in a subset(2 weeks period following each administration)
- Safety of ORV 116E for intussusception events(Up to 2 years of age)
- Immunogenicity rates to three doses of the ORV 116E and vaccine virus shedding rates after each of the three doses of the ORV 116E in a subset(28 days after administration of third dose)