This vaccine is indicated for active immunization to prevent invasive meningococcal diseases caused by N. meningitidis serogroups A, C, Y and W135
Conditions
Interventions
study group(2-6 years old):Inoculate 1 dose of Groups ACYW135 Meningococcal Polysaccharide Conjugate Vaccine
control group(2-6 years old):Inoculate 1 dose of Groups ACYW135 Meningococcal Polysaccharide Vaccine
study group(7-17 years old):Inoculate 1 dose of Groups ACYW135 Meningococcal Polysaccharide Conjugate Vaccine
control group(7-17 years old):Inoculate 1 dose of Groups ACYW135 Meningococcal Polysaccharide Vaccine
study group(18-55 years old):Inoculate 1 dose of Groups ACYW135 Meningococcal Polysaccharide Conjugate Vaccine
control group(18-55 years old):Inoculate 1 dose of Groups ACYW135 Meningococcal Polysaccharide Vaccine
Sponsors
Shaanxi Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
2 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. People who meet the age (2-6 years, 7-17 years, 18-55 years) of this clinical trial; 2. Volunteers and/or their legal guardians voluntarily agree to participate in the study and sign the informed consent form (if the legal guardians go out, the entrusted person of the legal guardians can sign on their behalf on the premise of written entrustment); If you are 16-17 years old and have full civil capacity, you can provide bank statement, labor contract, income certificate issued by your employer, etc., and you can sign the informed consent; 3. Volunteers and/or their legal guardians/entrusted persons have the ability to participate in this trial according to the clinical trial protocol; 4.Volunteers aged 2 to 3 years old have not been vaccinated with other meningococcal vaccines except group A meningococcal polysaccharide vaccine, and the interval between vaccination and the latest group A meningococcal polysaccharide vaccine is more than 3 months; 5.If volunteers aged 4-6 years have received one dose of group A and group C meningococcal polysaccharide vaccine, the interval of vaccination is more than 3 years; And has not been inoculated with other meningococcal vaccines except group A meningococcal polysaccharide vaccine and group A C meningococcal polysaccharide vaccine; 6.Volunteers aged 7 to 55 years should not have been vaccinated with meningococcal vaccines in recent 3 years (including but not limited to: AC polysaccharide vaccine, AC conjugate vaccine, and ACYW135 polysaccharide vaccine).
Exclusion criteria
Exclusion criteria: 1. The volunteer is suffering from meningitis or has a history of meningitis; 2. It is known that volunteers are allergic to certain components of the vaccine used in this clinical trial (mainly including group A meningococcal polysaccharide, group C meningococcal polysaccharide, group Y meningococcal polysaccharide, group W135 meningococcal polysaccharide, diphtheria toxoid or diphtheria antigen, tetanus toxoid or tetanus antigen, lactose, sodium dihydrogen phosphate, disodium hydrogen phosphate), Or their immediate family members who have been vaccinated in the past are allergic to the above ingredients; 3. Volunteers or their immediate family members have a history of vaccination or severe drug allergy. (For example, but not limited to: anaphylactic shock, anaphylactic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthur reaction)); 4. The volunteer has a history of convulsion, epilepsy, encephalopathy and psychosis or a family history of the above diseases; 5. The volunteers are known or suspected to have diseases that have been judged by the researchers to affect vaccination, such as serious respiratory diseases, acute infections or chronic disease activity, serious cardiovascular diseases, serious liver and kidney diseases, malignant tumors, serious infectious or allergic skin diseases; 6. The volunteers are known or suspected to have abnormal immune function (such as HIV infection, thyroid, pancreas, liver, spleen, kidney disease history or removal history); Or in the past 12 months (interval<12 months) due to thyroid disease; 7. Volunteers have received immunosuppressive treatment, cytotoxic treatment, glucocorticoid drug treatment (excluding local treatment, surface treatment of acute non concurrent dermatitis, spray treatment of allergic rhinitis), etc. in the past 6 months (interval<6 months); 8. Female volunteers with potential pregnancy have a pregnancy plan in the last 6 months, or are known to be in pregnancy or lactation, or have a positive urine pregnancy test (women without potential pregnancy do not need to have a urine pregnancy test); 9. = 18 years old: volunteers with hypertension beyond the control of drugs (systolic blood pressure = 140mmHg or diastolic blood pressure = 90mmHg during screening measurement); 10. Volunteers have muscle contraindications such as thrombocytopenia, any coagulation dysfunction or being treated with anticoagulants that are clearly diagnosed; 11. Known volunteers have congenital malformations, developmental disorders or clinically diagnosed serious chronic diseases (such as Down's syndrome, severe thalassemia, sickle cell anemia or neurological disorders, Guillain Barre syndrome, etc.); 12. Volunteers have received blood products or immunoglobulins (except hepatitis B immunoglobulin) in the past 3 months (<3 months); 13. Volunteers plan to participate in or are participating in clinical trials of other drugs; 14. The investigator believes that the volunteers have any situation that may affect the clinical trial evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Group W135 meningococcal serum bactericidal activity (rsba) antibody;Group A meningococcal serum bactericidal activity (rsba) antibody;Group C meningococcal serum bactericidal activity (rsba) antibody;Group Y meningococcal serum bactericidal activity (rsba) antibody; | — |
Countries
China
Contacts
Public ContactWeijun Hu
Outcome results
None listed