[Translation] A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial to evaluate the protective efficacy, immunogenicity and safety of quadrivalent recombinant norovirus vaccine (Pichia pastoris) in people aged 6 to 13 years
主要目的:评价四价重组诺如病毒疫苗对疫苗包含的 4 种基因型(GI.1、GII.3、GII.4、GII.17)引起的 AGE 的保护效力。
次要目的:
(1)评价四价重组诺如病毒疫苗对所有诺如病毒基因型引起的 AGE 的保护效力;
(2)评价四价重组诺如病毒疫苗对所有诺如病毒基因型引起的中重度 AGE 的保护效力;
(3)评价四价重组诺如病毒疫苗对疫苗包含的 4 种基因型(GI.1、GII.3、GII.4、GII.17)引起的中重度 AGE 的保护效力;
(4)评价四价重组诺如病毒疫苗的免疫原性;
(5)评价四价重组诺如病毒疫苗的安全性。
探索性目的:
(1)评价四价重组诺如病毒疫苗对重复感染(同一基因型别以及不同基因型别重复感染)的 AGE 保护效力;
(2)评价四价重组诺如病毒疫苗对交叉感染(GI.1、GII.3、GII.4、GII.17 以外型别)的AGE 保护效力;
[Translation] Primary objective: To evaluate the protective efficacy of the quadrivalent recombinant norovirus vaccine against AGE caused by the four genotypes (GI.1, GII.3, GII.4, and GII.17) included in the vaccine.
Secondary objectives:
(1) To evaluate the protective efficacy of the quadrivalent recombinant norovirus vaccine against AGE caused by all norovirus genotypes;
(2) To evaluate the protective efficacy of the quadrivalent recombinant norovirus vaccine against moderate to severe AGE caused by all norovirus genotypes;
(3) To evaluate the protective efficacy of the quadrivalent recombinant norovirus vaccine against moderate to severe AGE caused by the four genotypes (GI.1, GII.3, GII.4, and GII.17) included in the vaccine;
(4) To evaluate the immunogenicity of the quadrivalent recombinant norovirus vaccine;
(5) To evaluate the safety of the quadrivalent recombinant norovirus vaccine.
Exploratory objectives:
(1) To evaluate the AGE protective efficacy of the quadrivalent recombinant norovirus vaccine against repeated infection (same genotype and repeated infection of different genotypes);
(2) To evaluate the AGE protective efficacy of the quadrivalent recombinant norovirus vaccine against cross infection (types other than GI.1, GII.3, GII.4, and GII.17);