A multicentre follow-up study to assess the immunological persistence of anti-Vi IgG antibodies at 12, 24 and 36 months post primary dose and to evaluate the immune response to a single booster dose of typhoid Vi conjugate vaccine administered at 36 months post primary dose to 6 months to 45-year-old subjects in both treatment arms who participated in the BECT053 study. - None

Biological ELimited0 个研究点目标入组 233 人开始时间: 待定最近更新: 2024年7月22日

试验速览

暂无简介。

•1. Healthy primed children, adolescents and adults of either gender between 6 months to 45 years (both inclusive) of age, who participated in a previous phase-II/III study bearing No.BECT053.
•2. Subjects who are willing to participate and who would be expected to comply with the requirements of the protocol.
•3. Written voluntarily given informed consent given by the subject or subject’s parent / legally acceptable representative prospectively.

•1. Subjects who did not receive a single dose of Typhoid conjugate vaccine in previous study bearing No. BECT053.
•2. Subjects for whom blood samples could not be collected either at baseline or at post vaccination period in the previous study bearing No. BECT053.
•3. Female subjects with UPT (Urine Pregnancy Test) positive at Visit 3 (pre-booster at Day 730).
•4. History of documented hypersensitivity to any component of the vaccine.
•5. History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
•6. Receipt of any other investigational intervention or blood products in the last 3 months or anticipated during the course of the study.
•7. Any confirmed or suspected immunosuppressive or immune-deficient condition or receipt of systemic immunosuppressant or systemic corticosteroids in the last 3 months based on medical history and physical examination;
•8. Known history of diabetes, tuberculosis, cancer, chronic kidney, heart, or liver disease, progressive neurological disorders, poorly controlled seizures, or terminal illness.
•9. Any condition determined by the investigator likely to interfere with evaluation of the vaccine or to be a significant potential health risk to the child or make it unlikely that the child would complete the study.

发起方

Biological ELimited