A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of Live Attenuated Varicella Vaccine in Healthy People
Status: Active_not_recruiting
Location: See all (13) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The goal of this clinical trial is to evaluate the efficacy, safety and immunogenicity of a live attenuated varicella vaccine manufactured by Beijing Institute of Biological Products Co., Ltd in healthy children.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 59
Healthy Volunteers: t
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• Healthy volunteer between 13 - 59 years old for Stage 1, 1-12 years old for Stage 2, and be able to provide legal identification ;
• Subject and/or guardian has the ability to understand study requirements and processes, consent to participate in clinical trials, and sign informed consent forms;
• Consent to use effective contraception during study participation, no pregnancy and no family planning (for women of childbearing potential or their spouses);
• Axillary temperature ≤ 37.0 °C on the day of enrollment;
Locations
Other Locations
China
Qi County Center for Disease Control and Prevention
Hebi
Wuzhi County Center for Disease Control and Prevention
Jiaozuo
Wuyang County Center for Disease Control and Prevention
Luohe
Mianyang Anzhou District Center for Disease Control and Prevention
Mianyang
Southern County Center for Disease Control and Prevention
Nanchong
Neijiang City Center for Disease Control and Prevention
Neijiang
Lancang Lahu Autonomous County Center for Disease Control and Prevention
Pu'er
Sinan County Center for Disease Control and Prevention
Tongren
Songtao Miao Autonomous County Center for Disease Control and Prevention
Tongren
Yuping Dong Autonomous County Center for Disease Control and Prevention
Tongren
Yanshan County Center for Disease Control and Prevention
Wenshan
Huaiyin District Center for Disease Control and Prevention
Xuzhou
Pei County Center for Disease Control and Prevention
Xuzhou
Time Frame
Start Date: 2022-12-26
Completion Date: 2026-09-14
Participants
Target number of participants: 12440
Treatments
Experimental: Experimental Group
Single subcutaneous injection of the investigational vaccine (0.5 ml)
Placebo_comparator: Placebo Group
Single subcutaneous injection of the investigational placebo (0.5 ml)
Related Therapeutic Areas
Sponsors
Collaborators: Jiangsu Province Center for Disease Control and Prevention, Beijing Institute of Biological Products Co Ltd.
Leads: China National Biotec Group Company Limited