NCT00994695已完成2 期
A Phase II Open and Parallel Safety, Immunogenicity and Reactogenicity Trial of Mencevax ACW135 Polysaccharide Vaccine Comparing Three Groups: 2 - 4 Year, 5 - 14 Year and 15 - 29 Year Old Ethiopians
Armauer Hansen Research Institute, Ethiopia2 个研究点 分布在 1 个国家目标入组 412 人开始时间: 2005年11月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 412
- 试验地点
- 2
- 主要终点
- To evaluate point estimates and trends in immunogenicity after not less than 28 days (+6 days) among children 2 - 4 years as compared to children 5 - 14 years and adolescents/adults 15 - 29 years (all ages inclusive)
研究概览
简要总结
Primary objective:
To assess the immunogenicity of the Mencevax ACW135 polysaccharide vaccine at 28 days (+6days) post vaccination in 2-4, 5-14, 15-29 year age groups and compare the immunogenicity between these age groups.
Secondary Objectives:
- To estimate the incidence of common adverse events following immunization (AEFI) of GSK Nm ACW135 polysaccharide vaccine at 1h, 1d, 2d, 3d, 7d and 28 days post-vaccination
- To assess the persistence of antibody against meningitis A, C and W135 at 11 and 23 months post vaccination in 2-4, 5-14, 15-29 year age groups
Study site:Two rural communities (Kebele) in Butajira district, Ethiopia.
Methods:
- Phase II, open and parallel safety and immunogenicity trial.
- 234 younger children (2-4 years), 145 older children (5-14 years) and 33 adults (15-29 years of age) were randomly selected from the demographic surveillance database and enrolled after screening and consenting.
- Study participant received Mencevax ACW polysaccharide vaccine 50 mg in 0.5ml subcutaneously.
- Blood samples for measuring SBA titres were collected at pre vaccination and on day 28 (+6 days) post vaccination.
- Active follow up for AEFI on post vaccination day 0, 1, 2, 3, 7, & 28.
- Primary end point was vaccine response defined as sero-conversion (in subjects initially seronegative) or a 4 fold increase (in subjects initially seropositive) in serum bactericidal antibodies (SBA) against serogroups Men A, C and W135) on post vaccination day 28. In addition seroconversion was assessed by ELISA Men A IgG on day 0 and day 28 post vaccination.
- Secondary endpoints were incidence of general and local symptoms and other adverse events following immunisation during the post vaccination period day 0 to 28 and immune persistence on post vaccination month-11 and month-23.
Results:
- No significant difference in the incidence of general or local AEFI was observed between the age groups
- The statistical analysis for the Immunogenicity data is in progress
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 2-29 years, both sexes, living in the selected villages of Butajira area
- •A written informed consent signed by the individual (>=18y) or caretaker/guardian (2 to 17 years of age) as 18 is the legal age of maturity in Ethiopia. Assent from children/adolescents aged 12-17 years old.
- •Free of obvious health problems ascertained by medical history and clinical examination on the day of enrolment
排除标准
- •Those who are unlikely to complete the follow up at 4-weeks post-vaccination.
- •Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Administration of blood transfusion within 2 years prior to enrolment or planned use during the study period.
- •Verbal report of previous vaccination with meningococcal serogroup A, C, Y or W135 vaccines since
- •Confirmed or suspected immunosuppressive or immunodeficient condition including HIV infection.
- •A family history of congenital or hereditary immunodeficiency.
- •History of allergic reaction to any component of the vaccine
- •Presence of any fever (defined as axillary temperature of 37.5 degree centigrade or more) and/or severe illness on the day of enrolment/ vaccination.
结局指标
主要结局
To evaluate point estimates and trends in immunogenicity after not less than 28 days (+6 days) among children 2 - 4 years as compared to children 5 - 14 years and adolescents/adults 15 - 29 years (all ages inclusive)
时间窗: 28 days
次要结局
- To assess the incidence of adverse events following vaccination at 1h, 1d, 2d, 3d, 7d and 28 days post-vaccination.(28days)
- To assess the immunogenicity at 11 months and 23 months (inclusive) postvaccination.(23 month)
研究者
研究点 (2)
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