A randomized, open label, multi-center study to compare the safety and immunogenicity of BBILâ??s Typbar-TCVâ?¢ to Sanofi Pasteurâ??s Typhim ViÂ®, administered intramuscularly to subjects aged 2 to 15 years - Typbar-TCV

Bharat Biotech International Ltd0 个研究点目标入组 340 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Healthy subjects aged between 2 to 15 years at the time of enrollment.
•2. Subject has not previously been documented to have received a typhoid vaccine.
•3. Subjects are not currently participating in any other clinical trial or are in receipt of any
•other investigational product in the last 06 months
•4. Subject parents or legally acceptable representative (LAR) is willing and able to provide,
•audio-video recorded and signed, informed consent.
•5. Subject parents or family and the subject intend to remain in the area during the study period
•and be available for follow up.

•1.Acute medical illness with or without fever within the last 72 hours or an axillary temperature >=37.5Â°C at the time of enrolment [temporary exclusion, till a febrile].
•2.Known or suspected impairment of immunologic function.
•3.In receipt of systemic immunosuppressant or systemic cortico-steroids. Individuals on a tapering dose schedule of oral steroids lasting <7 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrolment. Prior or anticipated receipt of immune globulin or other blood products, or other immune modulator therapy except routine vaccines within 6 weeks of administration of the study vaccines.
•4.Suspected or known hypersensitivity to any of the investigational or marketed vaccine components.
•5.Any condition that, in the opinion of the investigator, would pose a health risk to the participant, or interfere with the evaluation of the study objectives.

发起方