The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 5,800
- 试验地点
- 16
- 主要终点
- To evaluate the efficacy of ROTAVAC5D
研究概览
简要总结
This is a randomized, double-blind, phase 3 study to evaluate the Efficacy,Safety, and Immunogenicity of ROTAVAC 5D, a live attenuated rotavirus vaccine in healthy infants aged 6-8 weeks.
A total of 5800 healthy Chilean infants will be recruited in this study and randomized to receive either vaccine or placebo in 1:1 ratio. Among these participants 300 will be categorized to immunogenicity cohort, 150 from each group, and blood samples will be collected to assess the immune response.
详细描述
The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants.
This is a randomized, double-blind, phase 3 study to evaluate the Efficacy, Safety, and Immunogenicity of ROTAVAC 5D, a live attenuated rotavirus vaccine in healthy infants aged 6-8 weeks.
A total of 5800 healthy Chilean infants will be recruited in this study and randomized to receive either vaccine or placebo in 1:1 ratio. Among these participants 300 will be categorized to immunogenicity cohort, 150 from each group, and blood samples will be collected to assess the immune response. Inclusion At least one parent(s) or legally acceptable representative's consent for participation and are able to understand study procedures Subjects aged 6 to 8 weeks at recruitment No plans to move in the next 12 months Exclusion 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, chronic pulmonary disease, chronic renal disease, congenital heart 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) A known sensitivity or allergy to any components of the study vaccines. Major congenital or genetic defect. Has received any immunoglobulin therapy and/or blood products since birth. History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study, at the discretion of the principal investigator. Blood samples: In the "Immunogenicity Subset", 3 ml blood specimens will be collected at baseline and 28 (+) 5 days after the third dose of the Test Article/placebo to assess the anti rotavirus IgA antibody titer. Stool Specimens: The study team will attempt to collect a stool specimen for every GE episode, preferably within the first 2 days after episode onset. The stool specimen may be collected up to 7 days after the last day of diarrhea. The stool specimens will be sent to the laboratory. If the episode is a suspected intussusception or vaccine associated gastroenteritis that has occurred within four weeks after each dose of the Test Article/placebo, the specimen will be sent to the laboratory immediately for rotavirus testing and typing. For all ELISA RV positive samples, an aliquot of the stool specimen will be assessed for 20 enteropathogens by multiplex-PCR panel and to identify the genotype of the virus.
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 8 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 8 weeks at recruitment
- •No plans to move in the next 12 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, chronic pulmonary disease, chronic renal disease, congenital heart 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)
- •A known sensitivity or allergy to any components of the study vaccines.
- •Major congenital or genetic defect.
- •Has received any immunoglobulin therapy and/or blood products since birth.
- •History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study, at the discretion of the principal investigator.
研究组 & 干预措施
Rotavac 5D
Rotavirus Vaccine (ROTAVAC 5D), is a monovalent vaccine containing suspension of live attenuated rotavirus 116E prepared in Vero cells, containing NLT 10 power 5.0 FFU and administered as a three-dose regimen, 4 weeks apart.
干预措施: ROTAVAC 5D (Biological)
Placebo
Placebo administered as a three-dose regimen, 4 weeks apart.
干预措施: Placebo (Other)
结局指标
主要结局
To evaluate the efficacy of ROTAVAC5D
时间窗: 14 days following the 3rd dose till the age of 1 year (12 months) + up to 14 days].
Efficacy of ORV 116E in comparison to a placebo against moderate-severe rotavirus gastroenteritis defined as: episode of diarrhea (the passage of three or more loose or watery stools within a 24-hour period), with or without vomiting, that requires overnight hospitalization or rehydration therapy equivalent to World Health Organization (WHO) plan B (oral rehydration therapy) or plan C (intravenous rehydration therapy) in a medical facility such as a hospital, clinic, or supervised rural health care center
次要结局
- To assess the safety of ROTAVAC 5D for SAEs,especially intussusception events occurring during the study period in all subjects(from day of 1st dose till the age of 1 year (12 months) + up to 14 days)
- To evaluate the efficacy of a ROTAVAC 5D against any severity of rotavirusgastroenteritis(Till the age of 1 year (12 months) + up to 14 days)
- Efficacy of Severe rotavirus gastroenteritis (>11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus occurring at least 14 days following the third dose(Till the age of 12 months + up to 14 days)
- To evaluate the efficacy of ROTAVAC 5D against severe (>11 on the 20 point Vesikari scoring scale) gastroenteritis irrespective of etiology(From 14 days following the 3rd dose till the age of 1 year (12months) + up to 14 days)
- To evaluate the intent to treat efficacy of ROTAVAC 5D against severe rotavirus gastroenteritis(till the age of 1 year (12 months) + up to 14 days)
- To evaluate the efficacy of ROTAVAC 5D for rotavirus only gastroenteritis (absence of co-pathogens)(Throughout study period i.e.,30 months)
- To assess the safety of ROTAVAC 5D for adverse events in the 4-week period following administration of each of the three doses of the vaccine/placebo(day 0 to 28 following each dose)
- To evaluate the efficacy of a ROTAVAC 5D against any severity of gastroenteritis irrespective of etiology(till the age of 1 year (12 months) + up to 14 days)
- Safety of the subjects during study period To assess the safety of ROTAVAC 5D for immediate and seven day adverse events, after all the 3 doses(From the day of vaccine administration to 7 days for all the three doses.)
- Secondary Objectives (Immunogenicity)(Day 28 (+) 5 days after the third dose in comparison to baseline levels)