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Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 5 Months

NCT05252715 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2024-04-04

No results posted yet for this study

Summary

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

Conditions

  • Meningitis, Meningococcal

Interventions

BIOLOGICAL

Meningococcal ACYW135 Polysaccharide Conjugate Vaccine

Single intramuscular dose contains 5 µg each of Serogroup A, C, Y, and W135 meningococcal polysaccharide combined with tetanus toxoid.

BIOLOGICAL

Meningococcal A and C Polysaccharide Conjugate Vaccine

Single intramuscular dose contains 10 µg each of Serogroup A and C meningococcal polysaccharide combined with tetanus toxoid.

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
3 Months
Max Age
5 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-18
Primary Completion
2023-08-22
Completion
2024-09-18

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 NCT05252715 on ClinicalTrials.gov