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Phase IV Clinical Study of Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector)
Sponsor: CanSino Biologics Inc.
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).
Official title: Phase IV Clinical Trial of Immunogenicity of ACYW135 Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in a Population Aged 6 to 23 Months
Key Details
Gender
All
Age Range
6 Months - 23 Months
Study Type
INTERVENTIONAL
Enrollment
660
Start Date
2023-09-20
Completion Date
2026-07-15
Last Updated
2026-03-04
Healthy Volunteers
Yes
Conditions
Interventions
MCV4
2 dose of MCV4 on Day 0 and Month 1
MCV4
2 dose of MCV4 on Day 0 and Month 3
MCV4
1 booster dose of MCV4 at 3 years old
Locations (1)
Wuzhi County Center for Disease Control and Prevention
Jiaozuo, Henan, China