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 Measles and Rubella vaccine administered to healthy infants
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 12
- 主要终点
- Non-inferiority for seroconversion for anti-Vi, anti-measles and anti-rubella IgG
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 (TCV) with Measles and Rubella (MR) vaccine administered to healthy infants. A total of 900 healthy infants of 9 to 10 months age will be enrolled in this study. The primary objective is to evaluate the immunological non-interference of co-administration of TCV with MR vaccine. To evaluate the possible effect of co-administration of the vaccines on the immune response, both TCV with MR vaccine will be administered concomitantly in one set of subjects (test group) while in other set of subjects, these vaccines will be administered sequentially (reference groups). The study subjects will be allocated to one of the three study groups as mentioned below in 1:1:1 allocation ratio based on the central computer generated randomization plan.
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Test group (TCV+MR): TCV and MR vaccine administered concomitantly at day 0
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Reference group 1 (MR/TCV): MR vaccine administered at day 0 followed by TCV at day 28
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Reference group 2 (TCV/MR): TCV administered at day 0 followed by MR vaccine at day 28
The immune response (seroconversion and geometric mean titre of antibodies) in the subjects who have been administered TCV and MR vaccine concomitantly will be compared with the immune response in the subjects who have been administered TCV and MR vaccine sequentially. The subjects will be followed up for 6 months after concomitant / last vaccination. The safety of the study vaccines will be assessed by recording the adverse events occurring during the entire course of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 9.00 Month(s) 至 10.00 Month(s)（—）
- 性别
- All
入选标准
- •Healthy infant subject of either gender aged (Age calculated as per completed months) 9 to 10 months at the time of enrollment
- •Subjects should be in good health as determined by medical history and physical examination based on clinical judgment of the investigator
- •No history of vaccination against typhoid fever, measles and rubella
- •Written informed consent from the subject’s parent (mother/father)
- •Subject’s parent literate enough to fill the diary card.
排除标准
- •History of hypersensitivity reaction to any component of the vaccines
- •History of laboratory confirmed or suspected measles, rubella or typhoid fever in past
- •History of any vaccination against typhoid fever, measles or rubella in past
- •Subject exposed (Close contact (family member or neighbour) with laboratory confirmed or clinical diagnosis of measles / rubella / typhoid fever) to measles virus, rubella virus or Salmonella typhi within the past 30 days
- •Fever of any origin or infectious disorder of 3 days or more within the past 30 days
- •Febrile illness (axillary temperature ≥ 37.5°C) at the time of enrollment
- •History of any vaccination within the past 30 days
- •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
- •Subject participated in another clinical study in the past 3 months
- •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, anti-measles and anti-rubella IgG
时间窗: At 28 days after respective vaccination
antibodies
时间窗: At 28 days after respective vaccination
次要结局
- Geometric mean titre of anti-Vi, anti-measles and anti-rubella IgG antibodies(At 28 days after respective vaccination)
- Seroconversion rate and geometric mean titre of anti-Vi, anti-measles and antirubella(IgG antibodies)
- Adverse events reported(Throughout the study duration)