预防性疫苗Ⅳ期临床试验考虑要点

A Few Important Considerations for Phase ⅣClinical Trials of Preventive Vaccines

目的为预防性疫苗Ⅳ期临床试验提供参考。方法结合相关资料及经验,提出预防性疫苗进行Ⅳ期临床试验时需考虑的要点。结果与结论进行预防性疫苗的Ⅳ期临床试验时,需依据有关的法规认真设计和实施,科学评估疫苗的质量,保证疫苗的安全和有效。

Objective To provide some reference for phase IV clinical trials of preventive vaccines. Methods A few important considerations for phase IV clinical trials of preventive vaccines were put forward based on the relevant data and experience. Results and Conclusion In the phase IV clinical trials of preventive vaccines, we should design and implement the trials according to the relevant laws and regulations, evaluate the quality of the vaccines scientifically and ensure the safety and efficacy of the vaccines.