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ACTIVE NOT RECRUITING
NCT05935176
PHASE4

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

Sponsor: CanSino Biologics Inc.

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

MCV4

2 dose of MCV4 on Day 0 and Month 1

BIOLOGICAL

MCV4

2 dose of MCV4 on Day 0 and Month 3

BIOLOGICAL

MCV4

1 booster dose of MCV4 at 3 years old

Locations (1)

Wuzhi County Center for Disease Control and Prevention

Jiaozuo, Henan, China