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

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate safety 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

Conditions
-----------------
Meningitis, Meningococcal

Intervention / Treatment
-----------------
* Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine
* Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 3 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose Group<br>Received Vaccine: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine,40μg/dose | Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine<br>* 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.<br>* Other names: Menwaycon;|
| Experimental: low dose Group<br>Received Vaccine: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine,20μg/dose | Biological: Meningococcal ACYW135 Polysaccharide Conjugate Vaccine<br>* 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.<br>* Other names: Menwaycon;|

What is the study measuring?
-----------------
Primary Outcome Measures

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