NCT01502969已完成2 期
A Phase 2b Study of Rotavin-M1 Vaccine in Vietnamese Children
National Institute of Hygiene and Epidemiology, Vietnam4 个研究点 分布在 1 个国家目标入组 799 人开始时间: 2010年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 799
- 试验地点
- 4
- 主要终点
- Anti-rotavirus IgA antibody responses 1 month after vaccination
研究概览
简要总结
This is a multiple-site phase 2b, randomized, placebo control study to evaluate the safety and immunogenicity of Rotavin-M1, produced by the Center for Research and Production of Vaccines and Biologicals, Vietnam.
详细描述
The investigators evaluate the vaccine schedule consisting of 2 doses of Rotavin-M1, 10e6.3ffu/dose at 2 month interval in children in two study sites, Thanh Son- Phu Tho and Thai Binh city-Thai Binh provinces.
This vaccine dose and schedule was chosen based on results from the previous dose-escalating study (NCT01377571).
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
- Triple (Participant, Care Provider, 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
- •At study entry
- •A healthy male or female, 6 to 12 weeks of age (42 days to 84 days of age).
- •Full term gestation (>=37 weeks).
- •Birth weight of the subject should be >=2.5 kg.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Did not use any dose of Rota virus vaccine.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Received dose
- •Oral informed consent obtained from the parent or guardian of the subject for continuing participate the study.
排除标准
- •At study entry
- •Has a chronic disease (cardiovascular, liver, kidney disease).
- •Acute disease at the time of enrolment.
- •Administering corticosteroids (> 1mg/kg/day).
- •Received any immunosuppressive therapy within 4 week before vaccination (Administration of immunoglobulins and/or any blood product or corticosteroids for >2 weeks).
- •Immunosuppressive or immunodeficient condition.
- •Family has immunosuppressive or immunodeficient condition medical history.
- •History of high fever convulsion.
- •Allergic or reaction with any component of vaccine, includes anaphylactic shock with any antibiotic.
- •Preterm of gestation delivery (gestation period < 37 weeks).
- •Low birth weight (<2.5 kg).
- •Fever (axillary temperature >38oC) within 3 days before or on the day of vaccination.
- •Malnutrition.
- •Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.
- •Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Acute disease at the time of 2nd dose.
- •Administering corticosteroids (> 1mg/kg/day).
- •Received any immunosuppressive therapy within 4 week before vaccination (Administration of immunoglobulins and/or any blood product or corticosteroids for >2 weeks).
- •History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
- •Fever (axillary temperature >38oC) within 3 days before or on the day of vaccination.
- •Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.
- •Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine during the study period.
研究组 & 干预措施
Placebo
Placebo Comparator
Children receiving placebo (cell culture medium in absence of virus)
干预措施: cell culture medium in absence of virus (Biological)
结局指标
主要结局
Anti-rotavirus IgA antibody responses 1 month after vaccination
时间窗: 12 months
To assess IgA antibody responses 1 month after completing 2 doses of Rotavin-M1, 10e6.3ffu/dose
次要结局
- RV-IgA antibody responses to Rotavin-M1 one year after 1st dose(12 year)
- anti-RV IgG antibody responses 1 year after the 1st dose(12 month)
- Anti-rotavirus IgG antibody responses 1 month after vaccination with Rotavin-M1(12 months)
- safety and reactogenicity of each doses of Rotavin-M1, 10e6.3ffu/dose(12 months)
研究者
Dang Duc Anh
Deputy Director
National Institute of Hygiene and Epidemiology, Vietnam
研究点 (4)
Loading locations...
相似试验
已完成
2 期
A Dose-escalating Study to Evaluate the Immunogenicity and Safety of Rotavin-M1 Vaccine in Healthy InfantsDiarrheaFeverNauseaVomitIrritabilityNCT01377571National Institute of Hygiene and Epidemiology, Vietnam200
已完成
1 期
Recombinant, Bivalent, Norovirus Vaccine StudyNorovirusNCT05508178Icon Genetics GmbH60
已完成
2 期
A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMENRespiratory Tract InfectionNCT04032093Pfizer1,153
已完成
2 期
A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Elderly AdultsCovid19 VaccineNCT04822025Medigen Vaccine Biologics Corp.420
已完成
2 期
A STUDY OF A RSV VACCINE WHEN GIVEN TOGETHER WITH TDAP IN HEALTHY NONPREGNANT WOMEN AGED BETWEEN 18 TO 49 YEARSRespiratory Tract InfectionNCT04071158Pfizer713