A prospective, open-label, multicenter, phase IV clinical study to evaluate the long term persistence of immunological response after primary vaccination with Typhoid Vi Conjugate Vaccine and response to booster dose vaccination with Typhoid Vi Conjugate Vaccine of M/s Cadila Healthcare Limited in healthy subjects
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 236
- 试验地点
- 8
- 主要终点
- -Long-term persistence of anti-Vi IgG antibodies
研究概览
简要总结
This phase IV clinical trial is an extension of previously conducted phase II/III clinical trial (Protocol No. 15-03; CTRI Registration No. CTRI/2016/05/006975). A total of 236 subjects who were enrolled (aged 6 months to 45 years at the time of enrollment) and who had completed the previous clinical trial will be enrolled in the current study around 3 years after their primary vaccination. This study is planned to evaluate the long-term persistence of anti-Vi IgG antibodies in the subjects who were vaccinated with Typhoid Vi conjugate vaccine in the previous clinical trial and also to evaluate the immunogenicity and safety of booster dose vaccination with Typhoid Vi conjugate vaccine I.P. of M/s Cadila Healthcare Ltd. The anti-Vi antibody titres will be evaluated using VaccZyme ELISA kits. After booster dose vaccination, seroconversion rate (defined as ≥4-fold rise in antibody titre as compared to the baseline titre) and geometric mean titre of antibodies will be evaluated at day 10 & day 28. The safety of the vaccine will be assessed by recording the adverse events occurring to the vaccinated subjects .
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 6.00 Month(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who had participated and completed the previously conducted phase II/III clinical study (Project No. 15-03) and had received the study vaccine before 3 years ± 3 months
- •Informed consent from adult subjects or from parents of the pediatric subjects.
- •Additionally, assent from pediatric subjects of ≥7 years of age
- •Adult subjects or parents of pediatric subjects literate enough to fill the diary card.
排除标准
- •History of typhoid fever or vaccination against typhoid fever after previous study
- •Subjects administered blood, blood containing products or immunoglobulins during the past 3 months
- •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
- •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
-Long-term persistence of anti-Vi IgG antibodies
时间窗: Day 0 and Day 28
-Seroconversion rate 28 days post-vaccination
时间窗: Day 0 and Day 28
次要结局
- -Seroconversion rate 10 days post-vaccination(-Geometric mean titre of anti-Vi IgG antibodies 10 days and 28 days post-vaccination as compared to the baseline)