[Translation] Phase I/II clinical trial of randomized, double-blind, controlled design to evaluate the safety, dosage and procedure of nine-valent recombinant human papillomavirus vaccine (Pichia pastoris) inoculated in people aged 18-45
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 stage Main purpose To evaluate the safety of different doses of adjuvant test vaccine inoculated in the population aged 18-45. Secondary objective To preliminarily explore the immunogenicity of different doses of adjuvant trial vaccine inoculated in the 18-45 year old population. The purpose of the Phase II study is to evaluate the immunogenicity and safety of the 18-45-year-old female population inoculated with different doses of adjuvant experimental vaccines 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 .