NCT05935176

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

Phase IV Clinical Trial of Immunogenicity of ACYW135 Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in a Population Aged 6 to 23 Months

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 660 (actual)
• Sponsor: CanSino Biologics Inc. · Industry
• Sex: All
• Age: 6 Months – 23 Months
• Healthy volunteers: Accepted

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).

Detailed description

Meningococci are divided into 12 serogroups, and 95% of meningococcal cases are caused by serogroups A, B, C, X, W, and Y. Meningococcal epidemic flora can change, and the reasons are related to various factors such as meningococcal strain variation, human mobility transmission, and vaccination against different serogroups of meningococci, etc. The emergence of new serogroups of meningococci can cause the original vaccine to lose its immune protective efficacy and require a new vaccine immunization prevention strategy. the ACYW135 group meningococcal polysaccharide conjugate vaccine was approved in 2016 for a whole population The vaccine has been approved by the State Drug Administration for the prevention of epidemic meningoencephalitis caused by meningococci of groups A, C, W135 and Y in children from 3 months to 3 years of age (47 months of age).

Conditions

• Epidemic Meningitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-09-20
• Primary completion: 2026-05-15
• Completion: 2026-07-15
• First posted: 2023-07-07
• Last updated: 2026-03-04

Locations

1 site across 1 country: China