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Safety Study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months

NCT02878291 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-08-26

No results posted yet for this study

Summary

The purpose of this study is to evaluate safety of meningococcal ACYW135 polysaccharide conjugate vaccine in healthy volunteers aged above 3 Months

Conditions

  • Meningitis, Meningococcal

Interventions

BIOLOGICAL

Meningococcal ACYW135 Polysaccharide Conjugate Vaccine

Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg each of Serogroup A, C, Y, and W135 polysaccharide conjugated to Tetanus Toxoids.

BIOLOGICAL

Meningococcal ACYW135 Polysaccharide Conjugate Vaccine

Group 2:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 5 µg each of Serogroup A, C, Y, and W135 polysaccharide conjugated to Tetanus Toxoids.

Sponsors & Collaborators

  • Guangxi Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Sanjiang Center for Disease Control and Prevention

    collaborator UNKNOWN

  • National Institutes for Food and Drug Control, China

    collaborator OTHER

  • Air Force Military Medical University, China

    collaborator OTHER

  • Simoon Record Pharma Information Consulting Co., Ltd.

    collaborator INDUSTRY

  • Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Du lin, Master · Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-11-30
Completion
2016-12-31

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 NCT02878291 on ClinicalTrials.gov