NCT02878291

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 26, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

August 22, 2016

Last Update Submit

August 25, 2016

Conditions

Meningitis, Meningococcal

Outcome Measures

Primary Outcomes (1)

  • Occurrence of adverse events during a 30 day follow-up period after each vaccination

    30 day after each vaccination

Study Arms (2)

High dose Group

EXPERIMENTAL

Received Vaccine: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine,40μg/dose

Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine

low dose Group

EXPERIMENTAL

Received Vaccine: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine,20μg/dose

Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine

Interventions

Meningococcal ACYW135 Polysaccharide Conjugate VaccineBIOLOGICAL

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.

Also known as: Menwaycon
High dose Group

Eligibility Criteria

Age3 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • months health infants who haven't immuned with Meningococcal A and C Conjugate Vaccine and population above 1 year old who have't given boost immunity.
  • Subject or legal representative who consent and has signed written informed consent.
  • Subject who did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
  • Subject and parent/guardian who is able to comply with all study procedures.
  • Axillary temperature ≤37.0 ℃.

You may not qualify if:

  • History of allergy，eclampsia, epilepsy, encephalopathy and mental disease or family disease.
  • Allergic history after vaccination.
  • History of meningitis infection disease.
  • Acute Febrile illness and Infectious Diseases.
  • Febrile illness (temperature ≥ 38°C) in the 3 days.
  • Immunodeficiency diseases patients who administered with immunosuppressive agents.
  • Children within 1 year old with abnormal labor, asphyxia rescue history,congenital malformations,genetic defects, eccyliosis or severe chronic disease.
  • Liver and kidney or cardiopulmonary disease，acute hypertension and diabetes.
  • In pregnancy or lactation or pregnant women.
  • Subject who plan to participate in or is in any other drug clinical trial.
  • Meningococcal vaccine contraindication.
  • Any condition that, in the judgment of investigator, may affect trial assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanjiang Center for Disease Control and Prevention

Sanjiang, Guangxi, 545500, China

RECRUITING

MeSH Terms

Conditions

Meningitis, Meningococcal

Condition Hierarchy (Ancestors)

Meningitis, BacterialCentral Nervous System Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsMeningococcal InfectionsNeisseriaceae InfectionsGram-Negative Bacterial InfectionsCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesMeningitisNeuroinflammatory Diseases

Study Officials

  • Du lin, Master

    Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 25, 2016

Study Start

June 1, 2016

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

August 26, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)