[Translation] A randomized, double-blind, controlled phase I/II clinical trial to evaluate the safety, dosage, and schedule of the nine-valent recombinant human papillomavirus vaccine (Pichia pastoris) in people aged 18-45 years
I期研究阶段 主要目的 评价不同剂量佐剂试验疫苗接种于18-45岁人群中的安全性。次要目的 初步探索不同剂量佐剂试验疫苗接种于18-45 岁人群中的免疫原性。 II期研究目的 评价18-45 岁女性人群按0,2 月或0,6月两种免疫程序接种不同剂量佐剂试验疫苗的免疫原性和安全性,探索最佳配比佐剂剂量和免疫程序。
[Translation] Phase I study: The main purpose is to evaluate the safety of different doses of adjuvanted test vaccine inoculated in the population aged 18-45 years. The secondary purpose is to preliminarily explore the immunogenicity of different doses of adjuvanted test vaccine inoculated in the population aged 18-45 years. The purpose of Phase II study: To evaluate the immunogenicity and safety of different doses of adjuvanted test vaccine inoculated in female population aged 18-45 years according to two immunization schedules of 0, 2 months or 0, 6 months, and to explore the optimal ratio of adjuvant dose and immunization schedule.