Immunogenicity and Safety of Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine

Study Overview
=================
Brief Summary
-----------------
The purpose of this double-blind study is to evaluate the safety, reactogenicity and immunogenicity of Group A,C,Y and W135 Meningococcal Polysaccharide Vaccine in 2 to 30 years-old Children and Adults. All subjects will receive 1 dose of Group A,C,Y and W135 Meningococcal Polysaccharide Vaccine.

Official Title
-----------------
Immunogenicity and Safety of Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine in More Than 2 Years Old Children and Adults

Conditions
-----------------
Meningitis

Intervention / Treatment
-----------------
* Biological: Group T
* Biological: Group C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study. Healthy permanent residence 2-30 years old. Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures. Axillary temperature ≤37.0 ℃. Exclusion Criteria: History of meningitis infection or vaccination of meningococcal vaccine within the past 6 months. Allergic history or any SAE after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia. Patients administered with immunosuppressive agents, cytotoxicity factor or corticosteroids in the 6 months preceding the vaccine trial. Receipt of blood or blood-derived products in the 3 months preceding vaccination. Participation in another clinical study investigating a vaccine, drug in the 30 days preceding vaccination. Receipt of any live virus vaccine in the 15 days preceding vaccination. Receipt of any subunit vaccine and inactivated vaccine in the 7 days before vaccination. Febrile illness (temperature ≥ 38°C) in the 3 days or any acute illness/infection in the 7 days preceding vaccination. Thrombocytopenia. History of thyroid gland excision or treatment for thyroid gland disease in last 12 months. Functional or anatomic asplenia. History of eclampsia, epilepsy, encephalopathy and mental disease or family disease. Chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease, Guillain-Barre Syndrome). Known or suspected diseases, including: respiratory system disease, acute infection or active stage of chronic disease, HIV infection of children or mothers, cardiovascular disease, acute hypertension, cancer treatment, skin disease, etc. In pregnancy or lactation or pregnant women during the test plan Any condition that, in the judgment of investigator, may affect trial assessment.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 30 Years

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group T<br>Participants of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine. | Biological: Group T<br>* 0.5ml, Intramuscular<br>* Other names: vaccine made by Beijing Minhai Biotechnology Co., Ltd;|
| Active Comparator: Group C<br>Participants of enrollment will receive 1 dose on Group A, C, Y and W135 Meningococcal Polysaccharide Vaccine. | Biological: Group C<br>* 0.5ml, Intramuscular<br>* Other names: vaccine made by Hualan Biological Engineering, INC;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects exhibiting a >=4 fold increase in rSBA titers level from pre-vaccination to post-vaccination |  | 28 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the adverse reactions after vaccination |  | within 28 days after vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
safety, immunogenicity, Meningococcal Polysaccharide Vaccine