CTRI/2020/04/024843进行中（未招募）3 期
Immunogenicity and Safety of SHAN6® vaccine when administered as booster in healthy toddlers in India - NI
Sanofi Healthcare India Pvt Ltd formerly known as Shantha Biotechnics Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
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) Subjects, who have received 3 doses of the same study vaccine and provided the Pre and post dose blood sample, by virtue of their participation in the Phase III study (Study code: SH600003)
- •2) Subjects (now toddler) between 12-24 months of age whose parents/ Legally Acceptable Representative (LAR), has signed the written informed consent.
- •3) Toddlers with good general health.
- •4) Toddlers who have not received any vaccine containing Diphtheria(D), Tetanus(T), whole cell Pertussis(wP), acellular pertussis (aP), Hepatitis B (Hep B), Haemophilus influenzae type b (Hib), Inactivated polio vaccine (IPV) vaccine in second year of life.
- •5) Toddlers who have received their first dose of Measles/ Measles containing vaccines at least 4 weeks before the enrollment in the study
- •6) Subjects and Parents/LAR are able to attend all scheduled visits and to comply with all study procedures.
排除标准
- •1) Participation in another clinical trial in the 4 weeks preceding the trial inclusion
- •2) Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine during the trial participation period.
- •3) Receipt of 2 doses of Measles/ Measles containing vaccines before enrollment in the study.
- •4) Known systemic hypersensitivity to any of the vaccine components
- •5) Chronic illness at a stage that could interfere with trial conduct
- •6) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, within preceding 6 months or long-term systemic corticosteroids therapy within the past 3 months.
- •7) Blood or blood-derived products received in the 30 days
- •8) Documented history of diphtheria, pertussis, tetanus, Haemophilus influenzae type b, Hepatitis B, poliomyelitis, measles, mumps or rubella infection(s)
- •9) Known personal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity.
- •10) Known thrombocytopenia,
- •11) Bleeding disorder or receipt of anticoagulants in the 3
- •12) Moderate or severe acute illness/infection or febrile illness on the day of inclusion
- •13) Identified as a natural or adopted child of the Investigator, relatives or employee.
- •14) Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
- •15) Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
- •16) Known precautions to further vaccination with pertussis vaccine
研究者
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