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

August 25, 2016 updated by: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

A Single-center, Open, Phase I Clinical Trial to Evaluate Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangxi
      • Sanjiang, Guangxi, China, 545500
        • Recruiting
        • Sanjiang Center for Disease Control and Prevention
        • Contact:
        • Sub-Investigator:
          • Yang xu, Bachelor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High dose Group
Received Vaccine: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine,40μg/dose
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.
Other Names:
  • Menwaycon
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.
Other Names:
  • Menwaycon
Experimental: low dose Group
Received Vaccine: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine,20μg/dose
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.
Other Names:
  • Menwaycon
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.
Other Names:
  • Menwaycon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of adverse events during a 30 day follow-up period after each vaccination
Time Frame: 30 day after each vaccination
30 day after each vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Collaborators

Air Force Military Medical University, China
Guangxi Center for Disease Control and Prevention
Sanjiang Center for Disease Control and Prevention
National Institutes for Food and Drug Control, China
Simoon Record Pharma Information Consulting Co., Ltd.

Investigators

  • Study Chair: Du lin, master, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (Estimate)

August 25, 2016

Study Record Updates

Last Update Posted (Estimate)

August 26, 2016

Last Update Submitted That Met QC Criteria

August 25, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201518603

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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