For prevention of infectious diseases caused by group A and C meningococci
Conditions
Interventions
study group1:1 dose of group A and C meningococcal polysaccharide conjugate vaccine (lot 1) produced by Yuxi Walvax Biotechnology Co., Ltd.
study group2:1 dose of group A and C meningococcal polysaccharide conjugate vaccine (lot 2) produced by Yuxi Walvax Biotechnology Co., Ltd.
study group3:1 dose of group A and C meningococcal polysaccharide conjugate vaccine (lot 3) produced by Yuxi Walvax Biotechnology Co., Ltd.
reference group:1 dose of freeze-dried group A and group C meningococcal conjugate vaccine produced by ROYAL (WUXI) BIO-PHARMACEUTICAL CO., LTD.
Sponsors
Shaanxi Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
2 Years to 5 Years
Inclusion criteria
Inclusion criteria: (1) Healthy children aged 2-5 years who are in line with the observation conditions of this clinical study. (2) The legal guardians of the subjects voluntarily agree to their children's participation in the study and sign the informed consent form (if the legal guardian cannot be present, the legal guardian's client can sign on behalf of the legal guardian under the premise of written entrustment). (3) Subjects and their legal guardians are capable of participating in the study according to the clinical study protocol. (4) Subjects have completed 2 doses of group A meningococcal polysaccharide vaccine in accordance with the requirements of the national immunization program, but have not received any meningococcal polysaccharide or conjugate vaccine except for group A meningococcal polysaccharide vaccine. (5) The time interval between the administration of the study vaccine and the administration of other subunit vaccines or inactivated vaccines should be no less than 7 days, and that with other live-attenuated vaccines should be no less than 14 days. (6) Subjects have no records of axillary body temperature >= 38.0 degrees C in the past 3 days. (7) The axillary temperature of the subjects on the day of administration is <= 37.0 degrees C.
Exclusion criteria
Exclusion criteria: (1) Subjects are known to be allergic to certain components of the vaccine used in this clinical study (mainly include: group A meningococcal capsular polysaccharide, group C meningococcal capsular polysaccharide, tetanus toxoid and lactose). (2) Subjects have a history of severe allergy to vaccination or drug (including but not limited to: anaphylactic shock, anaphylactic laryngeal edema, allergic purpura, thrombocytopenic purpura, and local allergic necrosis reaction/Arthus reaction). (3) Subjects are suffering from meningitis or have a history of meningitis. (4) Subjects have history or family history of convulsion, epilepsy, encephalopathy and mental diseases. (5) Subjects have a history of thrombocytopenia or other coagulation disorders. (6) Subjects are known or suspected to have immunodeficiency, including being treated with immunosuppressive agents (such as radiotherapy, chemotherapy, corticosteroids, antimetabolic drugs, cytotoxic drugs, etc.) and HIV infection. (7) Subjects are known to have congenital malformations, developmental disorders or clinically diagnosed severe chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or thalassemia, neurological disorders, Guillain Barre syndrome, etc.). (8) Subjects are known or suspected to have the following diseases: severe respiratory disease, acute infection or active chronic disease, severe cardiovascular disease, liver and kidney disease, malignant tumor, serious skin disease and active tuberculosis. (9) Subjects have received blood products or globulin treatment within 3 months (< 3 months) (except for hepatitis B immunoglobulin). (10) Subjects are participating in or planning to participate in other drug clinical studies. (11) Any situation that the researchers believe may affect the evaluation of the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection of serum bactericidal activity (rSBA) by antibody titer before/after immunization; | — |
Countries
China
Contacts
Public ContactZhen Huang
Outcome results
None listed