PACTR202405741158761尚未招募3 期
A Phase III, Multi-Center, Randomized, Observer-Blind, Active Controlled Non-Inferiority Study to Evaluate the Immunogenicity and Safety of Shanghai Institute of Biological Products Co., Ltd.’s Measles, Mumps and Rubella (MMR) Vaccine Compared to a Licensed and WHO Prequalified GSK MMR Vaccine in Healthy African Children, 9- 11 Months of Age.
Shanghai Institute of Biological Products Co. Ltd SIBP0 个研究点目标入组 1,200 人开始时间: 2024年4月22日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,200
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
- 年龄范围
- 1 Month(s) 至 23 Month(s)（—）
- 性别
- All
入选标准
- •1. Healthy male and female child as established by medical history and clinical examination at enrollment.
- •2. Age: 9-11 months (inclusive) at the time of enrollment
- •3. Parent’s/legally acceptable representative’s (LAR) ability to read and willingness to provide written informed consent as per the
- •ethical and regulatory requirements of the site.
- •4. Parent confirms intention to stay in the study area for the study duration, bring their child in for the required study visits or to accept a home visit by the study staff.
排除标准
- •1. Presence of fever (defined as axillary temperature = 37.5°C) (temporary exclusion until recovery)
- •2. Acute disease of moderate to severe intensity at the time of enrollment (temporary exclusion until recovery)
- •3. Use of antipyretics within the last 72 hours prior to enrolment (temporary exclusion until recovery)
- •4. Prior (within 6 months) or concurrent participation in another interventional clinical trial during the study
- •5. Presence of severe malnutrition (weight-for-height z-score < -3SD median)
- •6. Positive test for any of the following: HIV, hepatitis B, hepatitis C and syphilis
- •7. Presence of any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological (including severe anemia), endocrine, immunological, dermatological, neurological, cancer, or autoimmune disease) as determined by medical history and / or physical examination which would compromise the participant’s health or is likely to result in nonconformance to the protocol.
- •8. Known or suspected impairment of immunological function based on medical history and physical examination.
- •9. Prior receipt or intent to receive measles, mumps, rubella, or yellowfever-containing vaccine during the study vaccination and follow up period up to Day 85 outside the study center.
- •10. Receipt of any vaccine (except OPV and inactivated influenza) within 4 weeks of the day of study vaccination or intent to receive any within 6 weeks after study vaccination. 11. Receipt of immunoglobulin therapy and / or blood products in the past 9 months or planned administration during the study period
- •12. Receipt of any immune-modifying or immunosuppressant drugs prior to the first study vaccine dose or planned use during the study. A chronic oral or parenteral use (defined as more than 14 days) of high dose corticosteroids (defined as =2 mg/kg of body weight or =20 mg/day of prednisone or equivalent for persons who weigh >10 kg) will be exclusionary for the study. Children o
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