Safety Evaluation of Meningococcal Group ACYW135 Conjugate Vaccine in 2-month to 55 Years Old Population.
Safety Evaluation of Meningococcal Group ACYW135 Conjugate Vaccine in 2-month to 55 Years Old Population.
A single-center and open-labeled Phase I study, designed to evaluate the safety by observing
 the occurrence of adverse events and change of hematology, liver and renal function after
 vaccination of a meningococcal group A, C, Y, and W135 conjugate vaccine in healthy
 population aged 2 months to 55 years old.
Inclusion Criteria:

 -  Healthy children, adolescents and adults (age range: 2 months to 55 years old) based
 on medical history, physical examination or judgement of the investigator

 -  Subjects aged ≥18 years old voluntarily agree to participate in this clinical study
 and sign the informed consent form; or for subjects aged <18 years old, the legal
 guardian voluntarily agrees that his/her child to participate in this clinical study,
 and sign the informed consent form. For juveniles aged ≥8 years old, both the subject
 and his/her legal guardians should voluntarily agree to participate in this clinical
 study and sign the informed consent form.

 -  The subject and his/her legal guardians as well as the family members are able to
 follow the request of clinical study protocol.

 -  Subjects aged 2 or 3 months should have no vaccination history of any meningococcal
 vaccine; subjects aged 7~23 months should have not received any other meningococcal
 vaccine except the meningococcal group A polysaccharide vaccine included in National
 Immunization Program, and the time since last vaccination of meningococcal group A
 polysaccharide vaccine should be >6 months; for subjects ≥2 years, the time since last
 vaccination of meningococcal vaccine should be >2 years.

 -  For subjects aged ≥2 years, there should be no clinically significant abnormal
 hematology, liver and renal function results judged by the investigator before
 immunization.

 -  Subjects should not receive any attenuated live vaccine 14 days, or inactivated
 vaccine 7 days before or after vaccination.

 -  Axillary temperature ≤37.0℃.

 Exclusion Criteria for First Dose:

 -  Subjects aged 2 or 3 months at enrollment with birth weight <2.5 kg.

 -  Subjects aged 2 or 3 months at enrollment had received blood products and immunoglobin
 after birth; subjects of other age groups had received blood products or immunoglobin
 in <3 months before vaccination.

 -  Subjects aged <12 months at enrollment are diagnosed as with pathological jaundice or
 have a history of pathological jaundice.

 -  Subjects aged <2 months at enrollment had abnormal labor (dystocia, assisted
 instrumental delivery) or with the history of asphyxia or nervous damage.

 -  Subjects aged ≥18 years who are planning pregnancy, or are pregnant, or are
 breastfeeding.

 -  Subjects aged ≥18 years with uncontrollable hypertension (during screening: systolic
 BP >140 mmHg or diastolic BP >90 mmHg).

 -  Subjects are known to be allergic to certain components contained in the
 investigational vaccine (mainly include: capsular polysaccharide of meningococcal
 group A, group C, group Y, or group W135, diphtheria toxoid or diphtheria antigen).

 -  Subjects with the history of serious allergy to any vaccine or drug. (including but
 not limited to: allergic shock, allergic laryngeal edema, allergic purpura,
 thrombocytopenic purpura, local allergic necrosis reaction [Arthus reaction]).

 -  Subjects with the history of meningitis.

 -  Subjects with moderate to severe fever (axillary temperature ≥38.0℃) in last 3 days.

 -  Subjects with the history or family history of convulsion, seizure, encephalopathy, or
 psychiatric disorders.

 -  Subjects with definite diagnosis of thrombocytopenia or other coagulation disorders.

 -  Subjects with primary or secondary immunological dysfunction, including HIV infection,
 disorder or resection of thyroid, pancreas, liver, spleen or kidney; or needed
 treatment due to thyroid disorders in last 12 months (time interval <12 months).

 -  Subjects have received immunosuppressive therapy, cytotoxic therapy, corticosteroid
 hormone (not include corticosteroid hormone spray for allergic rhinitis, epithelial
 corticosteroid hormone for acute and non-complicated dermatitis) in last 6 months
 (time interval <6 months).

 -  Subjects with known congenital malformation, developmental disabilities or clinically
 confirmed serious chronic diseases (e.g., Down syndrome, diabetes mellitus, sickle
 cell anemia or nervous disease, Guillain-Barre syndrome, etc.).

 -  Subjects with known or suspected diseases that are likely to affect the vaccination by
 investigators' judgement, such as: serious respiratory diseases, acute infection or
 the active period of chronic disease, serious cardiovascular diseases, liver and renal
 diseases, malignant tumors, serious infectious or allergic skin diseases.

 -  Subjects are participating or plan to participate in other clinical trials of
 investigational medications.

 -  Any other conditions that may influence the evaluation of clinical study by
 investigators' judgement.

 Exclusion Criteria for Second and Third Dose:

 -  New conditions that conforms with the exclusion criteria for first dose.

 -  Subjects that develop grade 4 adverse reactions after vaccination of investigational
 vaccine.

 -  Subjects that develop serious allergic reactions after vaccination of investigational
 vaccine.

 -  Any other conditions that may influence the evaluation of clinical study by
 investigators' judgement based on the exclusion criteria for first dose.