NCT06337071

A Study of the ACYW135 Meningococcal Polysaccharide Conjugate Vaccine

A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of the ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in People Aged 3 Months to 15 Years Old in a Randomized, Double-blind, Parallel Controlled Design

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Aimei Vacin BioPharm (Zhejiang) Co., Ltd. · Industry
• Sex: All
• Age: 3 Months – 15 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to explore the safety and immunogenicity of the experimental vaccine compared with the control vaccines. It is planed to enroll a total of 1,200 subjects, including 300 subjects in each of the 3-5 months old, 6-11 months old, 12-23 months old and 2-15 years old groups, who will be randomly assigned to the trial in a 1:1 ratio to study group or control group. The 3-5 month-old group will have three doses vaccination at 0, 1 and 2 month, and a booster dose at 12 months of age; the 6-11month-old and 12-23 month-old groups will each have total two doses vaccination; the 2-15 year-old group will have one dose vaccination.

Detailed description

The purpose of this study was to evaluate the safety and immunogenicity of the experimental vaccine(ACYW135 Meningococcal Polysaccharide Conjugate Vaccine) compared with the control vaccines(ACYW135 Meningococcal Polysaccharide Conjugate Vaccine and ACYW135 Meningococcal Polysaccharide Vaccine). It is planed to enroll a total of 1,200 subjects, including 300 subjects in each of the 3-5 months old, 6-11 months old, 12-23 months old and 2-15 years old groups, who will be randomly assigned to the trial in a 1:1 ratio to study group or control group. The 3-5 month-old group will have three doses vaccination at 0, 1 and 2 month, and a booster dose at 12 months of age; the 6-11month-old and 12-23 month-old groups will each have total two doses vaccination(at month 0, 1 or at month 0, 3); the 2-15 year-old group will have one dose vaccination. The immunogenicity and immune persistence will be evaluated by rabbit complement serum bactericidal assay.

Conditions

• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	ACYW135 Meningococcal Polysaccharide Conjugate Vaccine	ACYW135 Meningococcal Polysaccharide Conjugate Vaccine was produced by meningococcal polysaccharide from group A, C, Y, W135 and conjugated protein CRM197.
BIOLOGICAL	ACYW135 Meningococcal Polysaccharide Vaccine	ACYW135 Meningococcal Polysaccharide Vaccine was produced by meningococcal polysaccharide from group A, C, Y, W135.

Timeline

• Start date: 2024-03-20
• Primary completion: 2024-06-01
• Completion: 2025-06-01
• First posted: 2024-03-29
• Last updated: 2024-03-29

Locations

1 site across 1 country: China