A prospective, randomized, parallel, three-arm, open-label, multicenter, phase IV clinical trial to evaluate the immunological non-interference of Typhoid Vi conjugate vaccine with Yellow fever vaccine administered to healthy subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 714
- 试验地点
- 9
- 主要终点
- Non-inferiority for seroconversion for anti-Vi and anti-YF IgG antibodies at 28 days after vaccination
研究概览
简要总结
This is a prospective, randomized, parallel, three-arm, open-label, multicenter, phase IV clinical trial to evaluate the immunological non-interference of Typhoid Vi conjugate vaccine with Yellow fever vaccine administered to healthy subjects. A total of 714 healthy subjects will be enrolled in the study with 1:1:1 allocation in the study groups (Test – 238; Reference 1 – 238; Reference 2 – 238).
The subjects will be enrolled in 4 age cohorts as follows: 9 months to <5 years; ≥5 to <12 years; ≥12 to <18 years and ≥18 to 65 years. A minimum of 40 subjects will be enrolled in each of the 4 age cohorts in each of the 3 study groups.
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TCV+YF: Test Group: TCV and YF vaccine administered concomitantly after randomization of the subjects into the study at day 0.
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TCV: Reference Group 1: TCV vaccine administered after randomization of the subjects into the study at day 0.
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YF: Reference Group 2: YF vaccine administered after randomization of the subjects into the study at day 0.
Outcome of the study are; 1. Non-inferiority for seroconversion for anti-Vi and anti-YF IgG antibodies at 28 days after vaccination. 2. Immune response; Geometric mean titre of anti-Vi and anti-YF IgG antibodies at 28 days after vaccination. 3. Safety; Solicited local and systemic adverse events & Unsolicited adverse events reported during the study. 4. Safety: Serious adverse events reported during the study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 9.00 Month(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of either gender of 9 months to 65 years of age (both inclusive)
- •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 or yellow fever
- •Informed consent from the adult subjects or from the parents of pediatric subjects.
- •Additionally, assent from pediatric subjects aged 7 to <18 years
- •Adult subjects or parents of pediatric subjects literate enough to fill the diary card.
排除标准
- •History of hypersensitivity reaction to any component of the study vaccines including egg and chicken proteins
- •History of laboratory confirmed or suspected typhoid fever in the past 3 years
- •History of laboratory confirmed or suspected yellow fever in the past
- •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
- •Subjects positive for serological markers against Dengue infection(NS1 antigen, IgM and IgG antibodies)
- •History of any vaccination within the past month
- •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
- •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
Non-inferiority for seroconversion for anti-Vi and anti-YF IgG antibodies at 28 days after vaccination
时间窗: At 28 days after respective vaccination
次要结局
- Immunogenicity-Geometric mean titre of anti-Vi and anti-YF IgG antibodies at 28 days after vaccination(At 28 days after respective vaccination)
- Safety- Solicited local and systemic adverse events & Unsolicited adverse events reported during the study(Throughout the study duration)
- Safety-Serious adverse events reported during the study(Throughout the study duration)
研究者
Dr Ravindra Mittal
Zydus Lifesciences Limited