[Translation] A randomized, double-blind, positive-controlled phase Ib clinical trial to evaluate the safety and immunogenicity of 13-valent pneumococcal polysaccharide conjugate vaccine in healthy infants aged 2 months (minimum 6 weeks) and healthy children aged 2 to 5 years (before the 6th birthday)
主要目的:评价各年龄组受试者接种试验疫苗后的安全性。
次要目的:(1)评价各年龄组受试者接种试验疫苗后的安全性;(2)评价2月龄(最小6周龄)受试者接种试验疫苗基础免疫后30天针对所有血清型诱导的免疫反应;(3)评价2月龄(最小6周龄)受试者接种试验疫苗加强免疫后30天针对所有血清型诱导的免疫反应;(4)评价2~5岁(6岁生日前)受试者接种试验疫苗后30天针对所有血清型诱导的免疫反应。
[Translation] Primary objective: To evaluate the safety of the test vaccine in subjects of each age group.
Secondary objectives: (1) To evaluate the safety of the test vaccine in subjects of each age group; (2) To evaluate the immune response induced against all serotypes in subjects aged 2 months (minimum 6 weeks) 30 days after primary immunization with the test vaccine; (3) To evaluate the immune response induced against all serotypes in subjects aged 2 months (minimum 6 weeks) 30 days after booster immunization with the test vaccine; (4) To evaluate the immune response induced against all serotypes in subjects aged 2 to 5 years (before the 6th birthday) 30 days after immunization with the test vaccine.