Phase IV Clinical Study of Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector)

Summary

The purpose of this clinical study is to evaluate the immunogenicity and immunopersistence of the ACYW135 meningococcal polysaccharide conjugate vaccine (CRM197 vector).The protocol consists of two parts: Part 1 enrolled 660 eligible participants aged 6 to 23 months, which has now been completed. Part 2 : Open Clinical Researchplans to enroll approximately 100 eligible participants from Part 1 who have completed immunopreservance blood sampling. Participants will receive a single booster dose of the ACYW135 group meningococcal polysaccharide conjugate vaccine (CRM197 vector) at age 3 years (but not yet 4 years).

Timeline

Start

2023-09-20

Primary completion

2026-05-15

Completion

2026-07-15

Drugs

Indications