Safety Study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months
NCT ID: NCT02878291
Last Updated: 2016-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
200 participants
INTERVENTIONAL
2016-06-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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High dose Group
Received Vaccine: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine,40μg/dose
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.
low dose Group
Received Vaccine: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine,20μg/dose
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
3 Months
ALL
Yes
Sponsors
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Guangxi Center for Disease Control and Prevention
OTHER_GOV
Sanjiang Center for Disease Control and Prevention
UNKNOWN
National Institutes for Food and Drug Control, China
OTHER
Air Force Military Medical University, China
OTHER
Simoon Record Pharma Information Consulting Co., Ltd.
INDUSTRY
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Du lin, Master
Role: STUDY_CHAIR
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Locations
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Sanjiang Center for Disease Control and Prevention
Sanjiang, Guangxi, China
Countries
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Facility Contacts
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Other Identifiers
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201518603
Identifier Type: -
Identifier Source: org_study_id
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