CTRI/2018/06/014617已完成2 期
A Phase II/III, Multicenter, Randomized, Open Label, Active Controlled, Clinical Study to Assess the Immunogenicity and Safety of Tetanus Toxoid, Diphtheria Toxoid, and Acellular Pertussis (Tdap) Vaccine Manufactured by Serum Institute of India Pvt. Ltd (SIIPL) in Comparison with Boostrix�® Vaccine of GSK in Healthy Adults, Adolescents and Children in India.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,439
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 male or female subjects aged 4 years to 65 years on the day of enrollment
- •2 Healthy subjects as established by medical history, physical examination during screening and as per the clinical judgment of the Investigator
- •3 Sexually active participants to be using an effective method of contraception 30 days prior to the enrollment and throughout the study period
- •4 Subjects/ parent willing to provide assent or written informed consent
- •5 Subjects/ parent willingness and ability to comply with the requirements of the protocol
排除标准
- •1.History of previous vaccination against diphtheria, tetanus and pertussis with either the trial vaccine or another vaccine (except Tetanus-prone wound management for adults and/or for tetanus vaccination in pregnant women) in the past 5 yrs.
- •2.History of Tetanus, diphtheria or pertussis infection
- •3.History of administration of any vaccine within 30 days prior to administration of study vaccine or planned during the course of study participation.
- •4.History of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines.
- •5.History of anaphylactic shock.
- •6.History of any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, hematological functional abnormality, mental or physical disability or blood dyscrasias.
- •7.History of encephalopathy of unknown aetiology occurring within 7 days following a previous vaccination with a vaccine containing a pertussis component.
- •8.History of neurological complications following an earlier vaccination against diphtheria and/or tetanus.
- •9.Acute illness and/or fever at the time of vaccination or during the 7 days prior to the vaccination.
- •10.Receipt of any oral or injectable antibiotics 5 days before enrollment.
- •11.History of any cancer, HIV infection, organ transplant or any other immune system disorder.
- •12.Chronic administration of immunosuppressant or other immune modifying drugs during the period starting six months prior to the study vaccine dose.
- •13.History of receipt of a blood transfusion, other blood products, or immunoglobulins in 3 months prior to study vaccination.
- •14.Females who are pregnant, breastfeeding or planning to become pregnant.
- •15.Participant has any plans to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled.
研究者
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