CTRI/2022/05/042363进行中（未招募）2 期
A Phase II/III study, Multicenter, Double-Blind, Randomized, Active ControlledStudy to evaluate Safety and Immunogenicity of SII Inactivated Salk PolioVaccine (Adsorbed) in comparison with Sii Licensed Inactivated PoliovirusVaccine (IPV)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Healthy infants as established by medical history and clinical examination before entering the study
- •2. Age: 6-8 weeks at the time of enrollment
- •3. Parental ability and willingness to provide informed consent
- •4. Parent who intends to reside in the area with the child during the study period
- •5. Receipt of birth dose of OPV (within 14 days of birth)
排除标准
- •1. Presence of fever on the day of enrollment [Temporary exclusion criteria].
- •2. Acute disease at the time of enrollment [Temporary exclusion criteria].
- •3. Prior receipt or intent to receive OPV/IPV/IPV containing vaccines
- •during the study period. (except birth dose of OPV and on national/subnational immunization days)
- •4. Presence of significant malnutrition (weight-for-height z-score < -3SD median)
- •5. Known or suspected impairment of immunological function based on medical history and physical examination.
- •6. Receipt of immunoglobulin therapy and / or blood products since birth or planned administration during the study period
- •7. Planned concurrent participation in another clinical study at any point throughout the entire study period
- •8. Any clinically significant congenital malformation or genetic defect which may interfere with the evaluation of safety or immunogenicity of
研究者
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