AN EXTENSION OF BBIL/CTP/04/2010 PHASE 3 CLINICAL TRIAL OF TYPBAR TCV®: To DETERMINE THE LEVEL OF ANTI-SALMONELLA TYPHI VI POLYSACCHARIDE IGG ANTIBODIES AT THE END OF APPROXIMATELY 7 YEARS AND FOLLOW UP OF A BOOSTER DOSE OF TYPBAR TCV® DOSE IN THOSE WHO HAVE LOWER LEVEL OF ANTIBODIES (BELOW CORRELATE OF PROTECTION) IN HEALTHY PRIMED AND BOOSTER DOSE RECEIVED CHILDREN AND ADULTS
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 981
- 试验地点
- 6
- 主要终点
- To determine the long term persistence of immune response of Typbar TCV®
研究概览
简要总结
The present study is an extension of BBIL/CTP/04/2010 phase 3 clinical trial, which was approved by CDSCO on 9 August 2011. This study compared Typbar TCV®with reference Typbar® in 981 subjects aged between 6 months and 45 years across 8 sites in India*.* An addendum was approved by CDSCO on 22 November 2013 wherein a booster dose for Typbar TCV® was administered to 376 subjects.
An extension of BBIL/CTP/04/2010 phase 3, randomized, multicentric study to evaluate the immunogenicity and safety of booster dose of typhoid Vi capsular polysaccharide-tetanus toxoid protein conjugate vaccine (Typbar TCV®) administered in healthy children and adults primed with Typbar® and Typbar TCV®.
Prior to administration of booster dose of Typbar TCV®, all the primedand boosteredsubjects will be evaluated for anti-salmonella Vi-polysaccharide IgG. Only those subjects found not to be having the protective level of antibody titer(≤2µg/mL as measured byShousun C. Szu et al method), will be given a booster dose and will be assessed for boosting effect of Typbar TCV® by measuring the immunogenicity after a period of 28 days.
CTRI/2011/08/001957 - CTRI number for the first stuy
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
- 7.50 Year(s) 至 52.50 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy primed children and adults who participated in BBIL/CTP/04/2010 phase 3 and its addendum (initiated: August 2011) follow-on extension clinical trial 2.Adults and for minor subjects whose parent or guardian is able to understand planned study procedures comprehend and will comply with the requirements of the protocol procedures.
- •3.Written informed consent obtained from adult subject or subjects parent or guardian (if minor) prior to performance of any study specific procedure.
- •4.Generally healthy subjects without acute or chronic clinically significant pulmonary, cardiovascular hepatic or renal functional abnormality as determined by physical examination.
排除标准
- •1.Primed and boostered subjects whose anti-salmonella Vi-polysaccharide IgG titer are found to be >2µg/mL 2.Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines or vaccines as per UIP schedule during the study period 3.Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product for typhoid).
- •4.Administration of long-acting immune-modifying drugs (e.g. infliximab, rituximab) at any time during the study period.
- •5.Any confirmed or suspected immunosuppressive or immune-deficient condition, based on medical history and physical examination (e.g. Severe Combined Immunodeficiency Disease).
- •6.Subject with history of hypersensitivity to the vaccine or any of its composition or a present or past history of allergic reactions.
- •7.Subjects suffering from acute or chronic infections or any other serious liver, renal, cardiac, respiratory or metabolic disease.
- •8.Subjects with uncontrolled epilepsy or other progressive diseases of nervous system.
- •9.Subjects unwilling to comply with the study procedures.
- •10.Infection with Human Immunodeficiency Virus (HIV) regardless of clinical stage of immunodeficiency or current autoimmune disease.
- •11.Have signs or symptoms that could confound or confuse assessment of study vaccine reactogenicity.
结局指标
主要结局
To determine the long term persistence of immune response of Typbar TCV®
时间窗: Day -60 to -1 | Day 0 | Day 28
次要结局
- To evaluate the safety and tolerability of booster dose of Typbar TCV®(a)Proportion of participants with local and systemic adverse events)