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Immunogenicity and Safety of Bivalent Meningococcal Serogroups A and C Tetanus Toxoid Conjugate Vaccine in Chinese

NCT03714737 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1950

Last updated 2018-10-22

No results posted yet for this study

Summary

Invasive meningococcal disease and meningococcal meningitis caused by Neisseria meningitidis have their highest incidence in children, with a second peak in adolescents and young adults. The most important disease-causing serogroups are meningococcal serogroups A (MenA) and MenC in Asia, such as China. The specific vaccine use in each country depends on the predominant serogroups, cost, and availability. conjugate vaccines are preferred to polysaccharide vaccines due to their impact on decreasing nasopharyngeal carriage of N. meningitidis and their overall increased immunogenicity in children. This clinical trial is planning to evaluate the immunogenicity and safety of bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine in Chinese healthy children aged 3 months to 5 years.

Conditions

  • Vaccine

Interventions

BIOLOGICAL

experimental vaccine

bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(OLYMVAX Biological Co., LTD)

BIOLOGICAL

Positive control vaccine 1

bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(WALVAX Biological Co., LTD)

BIOLOGICAL

Positive control vaccine 2

bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(Royal (Wuxi) Biological Co., LTD)

Sponsors & Collaborators

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-05-12
Primary Completion
2017-09-11
Completion
2018-09-06

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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 NCT03714737 on ClinicalTrials.gov