CTRI/2025/11/097033招募中2 期
A prospective, randomized, parallel, single-blind, two-arm, active-controlled, multicentre, age de-escalation, phase II clinical trial to evaluate the immunogenicity and safety of Bivalent Typhoid and Paratyphoid A Conjugate Vaccine of M/s. Zydus Lifesciences Ltd. as compared to Typhoid Vi Conjugate Vaccine of M/s. Zydus Lifesciences Ltd. in healthy participants.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 7
- 主要终点
- and anti-LPS IgG antibodies
研究概览
简要总结
The safety and immunogenicity of Bivalent Typhoid and Paratyphoid A Conjugate Vaccine of M/s. Zydus Lifesciences Ltd. (BTPTCV) was evaluated in a phase I clinical trial. In that study, the vaccine was found to be well tolerated
and immunogenic when administered as single dose intramuscularly to healthy adults. The current phase II clinical trial is planned to evaluate the immunogenicity and safety of BTPTCV in the intended population including
adults, children, toddlers and infants. The participants to be enrolled in the study will be aged 6 months to 65 years. The comparator vaccine, Typhoid Vi Conjugate Vaccine of M/s. Zydus Lifesciences Ltd. (TCV), is already
approved for use in this age group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 6.00 Month(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of either gender of 6 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 3)No previous history of vaccination (oral or injectable) against typhoid or paratyphoid fever 4)Informed consent from the adult subjects or from the parents of pediatric subjects.Additionally,assent from pediatric subjects aged 7 to less than 18 years.
- •Adult subjects or parents of pediatric subject should be literate enough to fill the diary card.
- •Men and women of childbearing potential must agree to use adequate birth control measures during the study.
- •Acceptable methods of birth control in this study include surgical sterilization,intrauterine device, oral contraceptive, contraceptive patch, long-acting injectable contraceptive, male partner’s vasectomy, double-barrier method (condom or diaphragm with spermicide) or abstinence for at least 4 weeks prior to vaccine administration, during study participation and for 30 days after vaccine administration.
排除标准
- •History of hypersensitivity reaction or serious adverse event to any component of the vaccine
- •Household contact with known exposure to an individual with laboratory confirmed or clinical diagnosis of typhoid or paratyphoid fever
- •Fever of any origin or infectious disorder of 3 days or more within the past month
- •Febrile illness (body temperature less than equal to 37.5°C) at the time of enrolment
- •History of any vaccination within the past month
- •Significant acute or chronic infection requiring systemic antibiotic treatment within the past month
- •Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder
- •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
- •Female participants who are pregnant, currently breastfeeding, or attempting to conceive.
结局指标
主要结局
and anti-LPS IgG antibodies
时间窗: Day 0 to Day 28
Seroconversion rate of anti-Vi IgG antibodies
时间窗: Day 0 to Day 28
次要结局
- Geometric mean titre of anti-Vi IgG antibodies(and anti-LPS IgG antibodies)
- Solicited local and systemic adverse(events)
- Unsolicited adverse events(Day 0 to Day 28)
- Serious adverse events(Day 0 to Day 28)
研究者
Dr Deven Parmar
Zydus Lifesciences Ltd
研究点 (7)
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