CTRI/2021/11/037996进行中（未招募）Unknown
An active post-marketing surveillance study to evaluate the safety and immunogenicity of ZyVac TCV of M/s. Cadila Healthcare Limited in healthy subjects
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 3,000
- 试验地点
- 13
- 主要终点
- Adverse events reported
研究概览
简要总结
This is an active post-marketing surveillance (PMS) study to evaluate the safety and immunogenicity of ZyVac TCV of M/s. Cadila Healthcare Limited in healthy subjects. A total of 3000 healthy subjects of 6 months to 45 years age group will be enrolled in this PMS study. The primary objective is to evaluate safety of the vaccine which will be assessed by recording adverse events throughout the study duration. The secondary objective is to evaluate the immunogenicity of the vaccine in a subset of overall population. For immunogenicity, seroconversion (at least 4-fold rise in anti-Vi IgG antibody titre 28 days after vaccination) and geometric mean titre of anti-Vi IgG antibodies at the baseline and at 28 days after vaccination will be evaluated.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 6.00 Month(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy subjects of either gender ≥6 months to ≤45 years of age at the time of enrollment
- •Subjects should be in a good health as determined by the medical history and physical examination based on clinical judgment of the investigator
- •No previous history of vaccination (oral or injectable) against typhoid fever
- •Informed consent from the adult subjects or from the parents of pediatric subjects.
- •Additionally, assent from pediatric subjects aged 7 years or more
- •Adult subjects or parents of pediatric subjects literate enough to fill the diary card
- •Adult subjects or, pediatric subjects and their parents intend to be available for follow-up for entire duration of the study.
排除标准
- •History of hypersensitivity reaction to any component of the vaccine
- •History of laboratory confirmed or suspected typhoid fever in the past 3 years
- •Subject who have had household contact with/ and/or intimate exposure to an individual with laboratory confirmed S.
- •Fever of any origin or infectious disorder of 3 days or more within the past month
- •Febrile illness (body temperature ≥ 37.5°C) at the time of enrollment
- •History of any vaccination within the past month
- •History of COVID-19 within the past 3 months
- •Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder
- •Confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy
- •Known case of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy
- •Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study
- •Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)
- •Subject participated in another clinical study in the past 3 months or subject intend to participate in another clinical study within 3 months following intended study vaccine administration
- •Subject with history of alcohol or drug abuse in the past one year
- •Any other reason for which the investigator feels that subject should not participate.
结局指标
主要结局
Adverse events reported
时间窗: Throughout the study duration
次要结局
- Seroconversion rate(28 days after vaccination)
- Geometric mean titre of anti-Vi IgG antibodies(Baseline (pre-vaccination) and 28 days after vaccination)
研究者
研究点 (13)
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