CTRI/2024/08/072503尚未招募1 期
An Open-label, Single-treatment, Single-period, Single dose, clinical phase 1 study to assess the safety and tolerability of bivalent typhoid and paratyphoid a conjugate vaccine (btpt) of M/s Zydus Lifesciences ltd., India in healthy, adult human subjects - NI
Zydus Lifesciences 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
- 1 期
- 状态
- 尚未招募
- 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.Male and non-pregnant, non-lactating female subjects aged between 18 and 50 years (Both inclusive).
- •2.Ability to communicate effectively with study personnel.
- •3.Willingness to adhere to the protocol requirements.
- •4.Be able to give written informed consent for participation in the trial.
- •5.Normal health as determined by personal medical/surgical history, vital signs, physical examination, Chest X-ray PA view (only if clinically indicated), ECG and laboratory assessment data during screening (within the clinically acceptable range).
- •6.Male subjects and female subjects of childbearing potential must agree to use effective contraception till study completion.
- •7.Subject should be literate to understand study requirement.
排除标准
- •1.Any hypersensitivity reaction or History of anaphylaxis or serious adverse event with previous receipt of tetanus and/or diphtheria toxoid containing vaccines.
- •2.Subjects with known hypersensitivity to any component of the study vaccine.
- •3.Household contact with known exposure to an individual with laboratory confirmed S. Typhi or S. Paratyphi A.
- •4.Subjects who are taking immunostimulant therapy (e.g., interferons) or immunosuppressant medications (e.g., corticosteroids, cytotoxic drugs or antimetabolites, etc.).
- •5.Subjects who are known to be suffering from diseases which can affect immune competence e.g., diabetes, immunodeficiency disorders or known to be HIV positive.
- •6.Subjects who have received immunoglobulins parenterally during the preceding 3 months.
- •7.Subjects who have received any type of typhoid vaccine in last 3 years.
- •8.Subjects who have received any vaccine in preceding one month of dosing and who are planning to take vaccine during study period.
- •9.History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease, gynaecological or any other body system involvement which interferes with safety assessment as per investigator discretion.
- •10.History or presence of alcoholism or drug abuse within the past one-year.
- •11.History or presence of significant smoking (more than 10 cigarettes per day)
- •12.Blood pressure less than 100/60 (Systolic/diastolic) mm Hg or more than 140/90 (Systolic/diastolic) mm Hg.
- •13.Pulse less than 60/minute or more than 100/minute.
- •14.History of fever or any other infection in last 2 weeks of enrollment
- •15.Any clinically significant ECG abnormalities at screening.
- •16.Any clinically significant abnormal laboratory values during screening.
- •17.Subjects who have participated in clinical research studies within past 3 months.
- •18.A positive urine drugs of abuse test or positive alcohol test at check-in.
- •19.For female subjects, positive serum ß-hCG level or urine pregnancy test at the screening or check-in visit.
- •20.Female subjects with history of pregnancy or lactation in the past 3 months.
- •21.Female subjects with history of less than 1 year of menopause and not using adequate anti-fertility measures.
研究者
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