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A Study of the ACYW135 Meningococcal Polysaccharide Conjugate Vaccine

NCT06337071 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2024-03-29

No results posted yet for this study

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.

Conditions

  • Meningococcal Meningitis

Interventions

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.

Sponsors & Collaborators

  • Aimei Vacin BioPharm (Zhejiang) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • ZHENG Yan · YUNNAN CENTER FOR DISEASE CONROL AND PREVENTION

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-20
Primary Completion
2024-06-30
Completion
2025-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06337071 on ClinicalTrials.gov