Safety Study of ACYW135 Meningococcal Polysaccharide Vaccine Aged 2-50 Years Old
Safety Study of ACYW135 Meningococcal Polysaccharide Vaccine Aged 2-50 Years Old
This phase I clinical study evaluates the safety of ACYW135 meningococcal polysaccharide
 vaccine in population aged 2-6, 7-17, 18-50 years old by the method of both passive and
 active surveillance.
Inclusion Criteria:

 -  With the subject (or his guardian's) informed consent and signed the informed consent;

 -  The history, physical examination and clinical judgement were determined to be healthy
 and in accordance with the vaccination age of the product;

 -  The Subject or his guardian could comply with the clinical study protocol;

 -  Have not been inoculated with Meningococcal vaccine in the past six months and A + C
 meningococcal polysaccharide vaccine in the past two years;

 -  Have not been inoculated with other preventive biological products;

 -  Axillary temperature≤37.0 ℃.

 Exclusion Criteria:

 -  Children with the history of Neisseria meningitis;

 -  Had allergies or serious adverse reactions of previous vaccination, such as allergies,
 urticaria, dyspnea, edema, abdominal pain, etc;

 -  Had immune inhibitor therapy and cytotoxic therapy, inhaled corticosteroids in the
 past 6 months (not including allergic rhinitis corticosteroid aerosol therapy,
 patients with acute non concurrent dermatitis surface corticosteroid therapy);

 -  Have been accepted blood products in the past 3 months;

 -  Have been inoculated with other research drugs or vaccines in the past month;

 -  Have been inoculated with attenuated live vaccine in the past 14 days;

 -  Have been inoculated with subunit or inactivated vaccine in the past 7 days;

 -  Had any acute illness, the need for systemic application of antibiotics or antiviral
 treatment in the past 7 days;

 -  Had fever in the past 3 days (axillary temperature≥38.0℃) ;

 -  Have been diagnosed with abnormal coagulation function (such as the lack of
 coagulation factors, coagulation disorders and abnormal blood platelet), obvious
 bruises or coagulation disorders by physician diagnosis;

 -  Had the history of thyroid resection or the need for treatment of thyroid diseases in
 the past 12 months;

 -  Asplenia, functional asplenia and asplenia or splenectomy of any situation;

 -  Had epilepsy, convulsions, encephalopathy, mental illness or family history;

 -  Suffering from serious chronic diseases (such as Down's syndrome, diabetes, sickle
 cell anemia, neurological disorders or Guillain-Barre syndrome);

 -  Suffering from known or suspected concurrent diseases including: respiratory diseases,
 acute or chronic infection of the activities, children's mother or the subject had HIV
 infection, cardiovascular disease, high blood pressure, during cancer treatment
 period, skin diseases;

 -  The female during her pregnant and lactation period or who plan to become pregnant
 during the trial.

 -  The subject of any other factors that are not suitable to participate in clinical
 trials according to the researcher's judgment.