For prevention of infectious diseases caused by group A and C meningococci Polysaccharide Conjugate Vaccine
Conditions
Interventions
experimental group of 6~11months:2 dose of group A and C meningococcal polysaccharide conjugate vaccine produced by Yuxi Walvax Biotechnology Co., Ltd.and one dose was strengthened at 18 months
control group of 6~11 months:2 dose of group A and C meningococcal polysaccharide conjugate vaccine produced by Wuxi Luoyi Biotechnology Co., Ltd.
experimental group of 12~23 months:2 dose of group A and C meningococcal polysaccharide conjugate vaccine produced by Yuxi Walvax Biotechnology Co., Ltd.
control group of 12~23 months: 2 dose of group A and C meningococcal polysaccharide conjugate vaccine produced by Wuxi Luoyi Biotechnology Co., Ltd.
Sponsors
Shanxi Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
0.5 Years to 2 Years
Inclusion criteria
Inclusion criteria: (1) Healthy children aged 6~11 months or 12~23 months 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) For 6-11 months of age, subjects had not been vaccinated with any meningococcal vaccine (including but not limited to: AC conjugate vaccine, AC polysaccharide vaccine, group a polysaccharide vaccine, and acyw135 polysaccharide vaccine); for 12-23 months old, subjects had not received any meningococcal vaccine (including but not limited to: AC conjugate vaccine, AC polysaccharide vaccine, group a polysaccharide vaccine, acyw135 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: Exclusion criteria for the first dose of inoculation: Subjects with any of the following conditions could not be included in the study: 1. For the age of 6-11 months: the subjects were preterm infants (mothers with gestation of 28 weeks to less than 37 weeks) or low birth weight (birth weight: Girls < 2300G, boys < 2500g), or congenital malformations, developmental disorders, genetic defects, severe malnutrition, etc. 2. For the age of 6-11 months: the subjects were born with abnormal labor process (dystocia, instrumental delivery), asphyxia rescue history and nerve organ damage history. 3. For the age of 6-11 months: the subjects were diagnosed with or had pathological jaundice (lasting for 2-4 weeks, repeated). 4. Subjects known to be allergic to certain components of the vaccine used in this clinical study (including: group A and group C meningococcal capsular polysaccharide, lactose, tetanus toxoid). 5. The subjects had a history of vaccination or severe drug allergy (e.g., but not limited to: anaphylactic shock, anaphylactic laryngeal edema, allergic purpura, thrombocytopenic purpura, and local allergic necrosis reaction (Arthus reaction)). 6. Subjects had history of convulsion, epilepsy, encephalopathy and mental or family history. 7. Subjects had a history of thrombocytopenia or other coagulation disorders. 8. The subjects were 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. 9. Subjects had a history of meningitis. 10. Subjects were known to have congenital malformations, developmental disorders or clinically diagnosed serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or thalassemia, neurological disorders, Guillain Barre syndrome, etc.). 11. Subjects' known or suspected diseases include: severe respiratory disease, acute infection or active chronic disease, severe cardiovascular and cerebrovascular disease, liver and kidney disease, malignant tumor, serious skin disease, active tuberculosis. 12. Subjects had received blood products or globulin therapy (except hepatitis B immunoglobulin) in the past 3 months (< 3 months). 13. Subjects are participating in or planning other drug clinical studies. 14. Any situation considered by the investigator to be likely to affect the evaluation of the clinical study. The exclusion criteria of subsequent dose vaccination were as follows: If any of the following conditions occurs during the study safety observation period, the subjects can not continue to be vaccinated, but other research steps can be continued according to the judgment of the researcher. 1. Severe allergic reaction at the time of vaccination of the previous dose of vaccine; 2. Serious adverse events that have causal relationship with the previous dose of vaccine inoculation occur; 3. Those who meet the first dose exclusion criteria after the previous vaccination; 4. Any situation that the researcher believes may affect the assessment.
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