[Translation] A randomized, blinded, similar vaccine-controlled phase III clinical trial to evaluate the immunogenicity and safety of freeze-dried ACYW135 group meningococcal conjugate vaccine in healthy infants aged 3 months to 6 years
主要目的:
(1)评价3月龄受试者完成3剂基础免疫、1剂加强免疫后的免疫原性和安全性。
(2)评价6-11月龄和12-23月龄(2剂组)受试者完成2剂基础免疫、2-6周岁受试者完成1剂基础免疫后的免疫原性和安全性。
次要目的:
(1)评价6-11月龄试验组受试者加强免疫1剂后的免疫原性和安全性。
探索性目的:
(1)评价12-23月龄(1剂组)受试者完成1剂基础免疫后的免疫原性和安全性。
(2)评价3月龄试验组受试者完成1剂加强免疫后12个月和24个月的免疫持久性。
(3)评价6-11月龄试验组受试者完成加强免疫后12个月和18个月的免疫持久性。
(4)评价12-23月龄试验组受试者完成基础免疫后12个月的免疫持久性。
(5)评价2-6周岁受试者完成基础免疫后12个月、24个月和36个月的免疫持久性。
[Translation] Main objectives:
(1) To evaluate the immunogenicity and safety of 3-month-old subjects after completing 3 doses of primary immunization and 1 dose of booster immunization.
(2) To evaluate the immunogenicity and safety of 6-11-month-old and 12-23-month-old (2-dose group) subjects after completing 2 doses of primary immunization and 2-6-year-old subjects after completing 1 dose of primary immunization.
Secondary objectives:
(1) To evaluate the immunogenicity and safety of 6-11-month-old subjects after 1 dose of booster immunization.
Exploratory objectives:
(1) To evaluate the immunogenicity and safety of 12-23-month-old (1-dose group) subjects after completing 1 dose of primary immunization.
(2) To evaluate the immune persistence of 3-month-old subjects 12 months and 24 months after completing 1 dose of booster immunization.
(3) To evaluate the immune persistence of 6-11-month-old subjects 12 months and 18 months after completing booster immunization.
(4) To evaluate the immune persistence of 12-23-month-old subjects 12 months after completing primary immunization.
(5) Evaluate the persistence of immunity in subjects aged 2-6 years at 12 months, 24 months and 36 months after completion of basic immunization.