July 20, 2023 Source: drugdu 146
Recently, Zhejiang Pukang Biotechnology Co., Ltd. has completed the Phase IV clinical trial titled "Single-Arm, Multi-Center Evaluation of the Safety and Immunogenicity of Freeze-Dried Live Attenuated Hepatitis A Vaccine in Chinese Children Aged 18-24 Months" and received the final report. This Phase IV clinical study, involving a large sample size of 10,000 cases across multiple centers, aimed to observe the safety and immunogenicity of the freeze-dried live attenuated Hepatitis A vaccine in the real world. The study results show that after a single dose of the vaccine, the AEFI incidence rate in the 18-24 month-old children was 0.34%, with no serious AEFI reported, and an antibody seroconversion rate of 98.91%. This confirms the vaccine's good safety and immunogenicity profile, providing richer data support for its widespread application.
The freeze-dried live attenuated Hepatitis A vaccine (H2 strain), developed and produced by Zhejiang Pukang Biotechnology Co., Ltd., simulates the virus's natural infection mechanism. It not only stimulates the body's humoral immune response but also effectively induces cellular immunity. A single dose is sufficient to achieve a nearly 100% antibody seroconversion rate and provides lasting and effective protection.
As the first domestically marketed freeze-dried live attenuated Hepatitis A vaccine, Zhejiang Pukang Biotechnology Co., Ltd. has produced about 200 million doses since 1992, benefiting populations nationwide and making a significant contribution to controlling the spread of Hepatitis A. Pukang will continue to uphold its scientific and rigorous approach, constantly improving its research, production, and quality management levels, to provide safer and more effective vaccines for the prevention and control of human diseases.
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