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Immunogenicity and Safety of MCV4 in Volunteers Aged 6 Months-5 Years

NCT06314685 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2450

Last updated 2024-04-03

No results posted yet for this study

Summary

The purpose of this study is to evaluate the immunogenicity and safety of Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old.

Conditions

  • Healthy Population

Interventions

BIOLOGICAL

Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine

As a experimental vaccine for 6 months to 5 years old.

BIOLOGICAL

Group A and C Meningococcal Polysaccharide Vaccine

As a control vaccine for ages 6-11 months and 12-23 months.

BIOLOGICAL

Group ACYW135 Meningococcal Polysaccharide Vaccine

As a control vaccine for ages 2-5 years.

Sponsors & Collaborators

  • Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Lin Du · Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-10
Primary Completion
2024-08-30
Completion
2024-08-30

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 NCT06314685 on ClinicalTrials.gov