A Multicenter Randomized, Blinded, Placebo-controlled Phase III Clinical Trial Evaluating the Protective Efficacy, Safety and Immunogenicity of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years
A total of 13500 Chinese women aged 18-45 years old were divided into three age groups: 18-26 years old, 27-35 years old, and 35-45 years old. The experimental group and the placebo group were randomly assigned in a ratio of 1:1. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or placebo according to the 0, 2, and 6 months immunization program.
A Randomized, Blind, and Positive Control Design to Evaluate the Immunization Efficacy of 11 Valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 18-26 Years
A total of 480 Chinese women aged 18-26 years old were enrolle,experimental group and the control group were randomly assigned in a ratio of 3:1. 360 Chinese women in the experimental group and 120 in the control group. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or control vaccine according to the 0, 2, and 6 months immunization program.
A Randomized, Blinded, Placebo-controlled Phase I Clinical Trial Evaluating the Safety and Preliminary Immunogenicity of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years
A total of 90 Chinese women aged 9-45 years old were divided into three age groups: 27-45 years old, 18-26 years old, and 9-17 years old. The experimental group and the placebo group were randomly assigned in a ratio of 2:1. Sixty patients had a placebo group of 30 patients. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or placebo according to the 0, 2, and 6 months immunization program.
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