safety evaluation of meningococcal group acyw135 conjugate vaccine in 2-month to 55 years old population.

Conditions: Meningococcal Infections

Summary: 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.


Eligibility criteria:
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.

Keywords: meningitis, meningococcal, serogroup a meningitis, meningococcal, serogroup c meningitis, meningococcal, serogroup y meningitis, meningococcal, serogroup w135