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

Primary Purpose

Meningitis, Meningococcal

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Meningococcal ACYW135 Polysaccharide Conjugate Vaccine
Meningococcal ACYW135 Polysaccharide Conjugate Vaccine
Sponsored by
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meningitis, Meningococcal

Eligibility Criteria

3 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 3-11 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 ℃.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Sanjiang Center for Disease Control and PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High dose Group

low dose Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 22, 2016
Last Updated
August 25, 2016
Sponsor
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Collaborators
Guangxi Center for Disease Control and Prevention, Sanjiang Center for Disease Control and Prevention, National Institutes for Food and Drug Control, China, Air Force Military Medical University, China, Simoon Record Pharma Information Consulting Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02878291
Brief Title
Safety Study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months
Official Title
A Single-center, Open, Phase I Clinical Trial to Evaluate Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Collaborators
Guangxi Center for Disease Control and Prevention, Sanjiang Center for Disease Control and Prevention, National Institutes for Food and Drug Control, China, Air Force Military Medical University, China, Simoon Record Pharma Information Consulting Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis, Meningococcal

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High dose Group
Arm Type
Experimental
Arm Description
Received Vaccine: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine,40μg/dose
Arm Title
low dose Group
Arm Type
Experimental
Arm Description
Received Vaccine: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine,20μg/dose
Intervention Type
Biological
Intervention Name(s)
Meningococcal ACYW135 Polysaccharide Conjugate Vaccine
Other Intervention Name(s)
Menwaycon
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Meningococcal ACYW135 Polysaccharide Conjugate Vaccine
Other Intervention Name(s)
Menwaycon
Intervention Description
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.
Primary Outcome Measure Information:
Title
Occurrence of adverse events during a 30 day follow-up period after each vaccination
Time Frame
30 day after each vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 3-11 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 ℃. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Du lin, Master
Organizational Affiliation
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Official's Role
Study Chair
Facility Information:
Facility Name
Sanjiang Center for Disease Control and Prevention
City
Sanjiang
State/Province
Guangxi
ZIP/Postal Code
545500
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wu yimei, Bachelor
Phone
86-772-6636680
Email
sjcdcwuyimei@126.com
First Name & Middle Initial & Last Name & Degree
Yang xu, Bachelor

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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