A Study of the ACYW135 Meningococcal Polysaccharide Conjugate Vaccine

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06337071
Study type	Interventional
Source	Aimei Vacin BioPharm (Zhejiang) Co., Ltd.
Contact	ZHENG Yan
Phone	+8687163627796
Email	yaqueer_zy@163.com
Status	Not yet recruiting
Phase	Phase 2
Start date	March 20, 2024
Completion date	June 2025

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See also
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