A prospective, randomized, two-arm, parallel, single-blind, active-controlled, multicentre, non-inferiority clinical study to evaluate the immunogenicity and safety of Typhoid ViCapsular Polysaccharide Tetanus Toxoid Conjugate Vaccine of M/s Cadila HealthcareLimited compared to Typhoid Vi Capsular Polysaccharide Tetanus Toxoid ConjugateVaccine of M/s Bharat Biotech International Limited in healthy subjects
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 8
- 主要终点
- Sero-conversion rate i.e., Proportion of subjects with ≥ 4 fold rise in anti-Vi IgG antibodies 42 days post-vaccination as compared to baseline
研究概览
简要总结
This is a randomized, parallel group, multicentre, non-inferiority phase II/III clinical trial to evaluate the immunogenicity and safety of Typhoid Vi capsular polysaccharide tetanus toxoid conjugate vaccine of M/s. Cadila Healthcare Ltd. (Test vaccine) as compared to Typhoid Vi capsular polysaccharide tetanus toxoid conjugate vaccine of M/s. Bharat Biotech International Ltd. (Reference vaccine) in healthy subjects of 6 months to 45 years of age. There will be two age cohorts in this study; Adult cohort & Pediatric cohort. The enrollment in this study will be sequential in nature wherein the adult subjects (18 to 45 years) will be enrolled prior to the enrollment of pediatric subjects (6 months to 17 years). A minimum of 238 subjects will be enrolled in this study and will receive either study vaccine as per the central computer generated randomization plan. Two blood samples will be collected; once pre-vaccination (on day 0) & another post-vaccination (on day 42) to determine anti-Vi IgG antibody titre through ELISA method. The primary efficacy/immunogenicity endpoint of this study is to demonstrate the non-inferiority of test vaccine to the reference vaccine for the proportion of subjects with seroconversion (≥ 4 fold rise) for anti-Vi IgG antibodies post-vaccination. In addition, geometric mean titre of anti-Vi IgG antibodies at the baseline and at the end of study will also be calculated for both the study groups. 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
- Participant Blinded
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 between 6 months to 45 years of age
- •Informed consent from adult subjects or from subject’s legally acceptable representative for non-adult subjects.
- •Additionally, assent from non-adult subjects of more than 7 years of age
- •Adult subject or legally acceptable representative of non-adult subject literate enough to fill the diary card.
排除标准
- •History of hypersensitivity reaction to any component of the study vaccines
- •History of typhoid fever or vaccination against typhoid fever within the last three years
- •History of any vaccination within the past 7 days
- •Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological or immunological disorder
- •Subjects with 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)
- •Participation in another clinical trial in the past 3 months
- •Subjects with history of alcohol or drug abuse in the past one year.
结局指标
主要结局
Sero-conversion rate i.e., Proportion of subjects with ≥ 4 fold rise in anti-Vi IgG antibodies 42 days post-vaccination as compared to baseline
时间窗: 42 days post-vaccination
次要结局
- Geometric mean titre of anti-Vi IgG antibodies at baseline and 42 days post-vaccination(42 days post-vaccination)
- Sero-conversion rate in anti-Vi IgG antibodies 42 days post-vaccination as compared to baseline in both age groups(42 days post-vaccination)
- Geometric mean titre of anti-Vi IgG antibodies at baseline and 42 days post-vaccination in subjects in both age groups(42 days post-vaccination)