AN EXTENSION OF BBIL/CTP/04/2010 PHASE 3 CLINICAL TRIAL OF TYPBAR TCVÂ®: 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 TCVÂ® DOSE IN THOSE WHO HAVE LOWER LEVEL OF ANTIBODIES (BELOW CORRELATE OF PROTECTION) IN HEALTHY PRIMED AND BOOSTER DOSE RECEIVED CHILDREN AND ADULTS - Typbar TCVÂ® 7 years followup study

Bharat Biotech International Ltd0 个研究点目标入组 318 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•1.Primed and boostered subjects whose anti-salmonella Vi-polysaccharide IgG titer are found to be >2Âµg/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

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