ISRCTN37623829已完成未知
A Phase IV, open-label, controlled study to evaluate the up-to-four-year antibody persistence among Malian children who previously received different doses and schedules of meningococcal conjugate group A vaccine (PsA-TT 5µg or 10µg) between 9 and 18 months of age and to assess the boosting effect following a catch-up campaign dose of MenAfriVac® (PsA-TT 10µg)
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- PATH
- 入组人数
- 825
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •Former Study PsA-TT-007 participants:
- •1. Received study vaccine (PsA-TT 5µg or 10µg)
- •2. Final evaluable blood collection must have been completed within 3 months after the second vaccination
- •3. Younger than 6 years of age as of March 1st, 2017
- •4. Written informed consent obtained from the participants’ parent(s) or guardian following international ethical guidelines for epidemiological studies and applicable local ethical guidance and requirements (added 27/02/2017)
- •Control participants:
- •1. Born between March 2011 and March 2012
- •2. No evidence of chronic disease
- •3. Younger than 6 years of age as of March 1st, 2017
- •4. Written informed consent obtained from the participants’ parent(s) or guardian following international ethical guidelines for epidemiological studies and applicable local ethical guidance and requirements (added 27/02/2017)
排除标准
- •Exclusion criteria as of 27/02/2017:
- •1. Received meningococcal vaccination outside the PsA-TT-007 study (all participants, conjugate or polysaccharide)
- •2. Any chronic condition or medical/hereditary history suggesting participant would be immunocompromised (i.e. primary immunodeficiency, HIV, autoimmune disease)
- •3. Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying agents within the past three months (including systemic or inhaled corticosteroids, this means prednisone or equivalent, =0.5 mg/kg/day; topical steroids are allowed)
- •4. Administration of immunoglobulins and/or any blood products within the last 90 days.
- •5. Residence outside the study area for any prolonged period since birth (at the discretion of the PI) such that the potential for exposure to circulating N. meningitidis serogroup A may differ from the rest of the population (control participants only)
- •6. Intent to move out of the study population within the period of study conduct
- •7. Any condition or criteria that in the opinion of the investigator might compromise the well-being of the participant or compliance with study procedures or interfere with the outcome of the study
- •Original exclusion criteria:
- •Former Study PsA-TT-007 participants:
- •1. Received meningococcal vaccination outside the PsA-TT-007 study (all participants, conjugate or polysaccharide)
- •2. Any chronic condition or medical/hereditary history suggesting participant would be immunocompromised (i.e. primary immunodeficiency, HIV, autoimmune disease)
- •3. Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying agents within the past three months (including systemic or inhaled corticosteroids, this means prednisone or equivalent, =0.5 mg/kg/day; topical steroids are allowed)
- •4. Administration of immunoglobulins and/or any blood products within the last 90 days.
- •Control participants:
- •1. Residence outside the study area for any prolonged period since birth (at the discretion of the PI) such that the potential for exposure to circulating N. meningitidis serogroup A may differ from the rest of the population
- •2. Intent to move out of the study population within the period of study conduct
- •3. Any condition or criteria that in the opinion of the investigator might compromise the well-being of the participant or compliance with study procedures or interfere with the outcome of the study
研究者
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