Safety and Immunogenicity of an Inactivated Poliomyelitis Vaccine (IPOVAC) in Vietnamese Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Number of participants with treatment-related adverse events after each dose of vaccine
研究概览
简要总结
A dose escalating study with 3 different dosing regimens of the studied vaccine (IPOVAC- POLYVAC-Vietnam) and a licensed vaccine (IMOVAC-Sanofi Pasteur- France) is conducted in Vietnamese children, aged 2 months and above to assess the safety and immunogenicity. Two hundred and forty children are enrolled and placed randomly into 4 groups (60 children/group), each of which receive 3 doses of vaccine subcutaneously, at 4 week interval. Safety issues included immediate reaction at the site of injection and systemic reaction within 30 min of administration, within 7 days after each dose, unexpected event occur within 30 days of each dose, SAE (from start of dose 1 to 30 days after dose 3), blood cell count, urea, ALT,AST. Immunogenicity outcomes include seroconversion of neutralising antibodies for each of vaccine serotypes.
详细描述
The use of oral poliomyelitis vaccine (OPV) in Vietnam expanded immunisation program has resulted in successful eradication of polio in Vietnam. However due to the concern of OPV-related poliomyelitis cases occurred worldwide, WHO has recommended the countries to gradually change to inactivated polio vaccine (IPV). In Vietnam, POLYVAC has been approved and sponsored by the Ministry of Science and Technology to produce IPV under Japanese technology. The vaccine consisting of 3 serotypes (Serotype 1,2 and 3) has been proven safety in volunteer adults.
In this study, a dose escalating study with 3 different dosing regimens of the studied vaccine (IPOVAC) and a licensed vaccine (IMOVAC-Sanofi Pasteur- France) is conducted in Vietnamese children, aged 2 months and above to assess the safety and immunogenicity. Two hundred and forty children are enrolled and placed randomly into 4 groups (60 children/group), each of which receive 3 doses of vaccine subcutaneously, at 4 week interval. Safety issues evaluated include immediate reaction at the site of injection and systemic reaction within 30 min of administration, within 7 days after each dose, unexpected event occur within 30 days of each dose, SAE (from start of dose 1 to 30 days after dose 3), blood cell count, urea, ALT,AST. Seroconversion rates of neutralising antibodies for each of vaccine serotypes are to be assessed.
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
- Single (Participant)
入排标准
- 年龄范围
- 2 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children of both sexes, 2 months of ages
- •Full term babies (>=37 weeks)
- •Weight at birth (>=2500gr)
- •Have not been vaccinated with polio vaccine or vaccine containing poliovirus components
- •Not currently have acute infection (assessed via clinical check up and asking parents/care givers about health history before enrolment
- •Parents/legal guardians agree to participate their children in this study and sign the informed consent.
排除标准
- •Currently have chronic diseases (cardiovascular, liver and spleen related etc)
- •Use (orally or through infection) with corticoid containing drug (>1mg/kg dose)
- •Use of immunocompromised treatment within 4 weeks of enrolment
- •Being immunocompromised and autoimmune diseases (HIV, lupus)
- •the history of immunocompromised in the family
- •history of high fever
- •Allergic for any vaccine component
- •Fever (>38oC) within 3 days before vaccination or at enrolment
- •Malnourished (3rd level or above)
- •Blood disorder
- •use of vaccines which have not been licences 7 days before enrolment in this study
结局指标
主要结局
Number of participants with treatment-related adverse events after each dose of vaccine
时间窗: Upto 30 days after each dose
Number of participants with treatment-related adverse events after each dose of vaccine, immediately after vaccination (within 30 min), within 7 days and 30 days of vaccination, as assessed by CTCAE v.4.0
Number of participants with 4-fold or more increase in in antibody titers after 2 or 3 doses of vaccine (compared to pre-vaccination)
时间窗: Upto 30 days after the final dose
Seroconversion rate of each IPOVAC regimen and IMOVAC after 2 or 3 doses of vaccines
次要结局
- Number of participants with treatment-related SAE after each vaccination dose(Upto 30 days after vaccine dose)
- Number of participants with abnormal laboratory value(Upto 30 days after each vaccine dose)
研究者
Dang Duc Anh
General Director
National Institute of Hygiene and Epidemiology, Vietnam