Meningitis
Conditions
Keywords
safety, immunogenicity, Meningococcal Polysaccharide Vaccine
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.
Interventions
BIOLOGICALGroup T
0.5ml, Intramuscular
BIOLOGICALGroup C
0.5ml, Intramuscular
Sponsors
Beijing Minhai Biotechnology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 30 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| to evaluate the adverse reactions after vaccination | within 28 days after vaccination |
Countries
China
Outcome results
None listed