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 1(6-11 months):The investigational vaccine is to be administered at Months 0 and 1 as the primary series and 18 months of age as the booster dose
Control group(6-11 months):The comparator vaccine Group A and C Meningococcal conjugate vaccineis to be administered at Months 0 and 1 .
Study group 2(6-11 months):The investigational vaccine is to be administered at Months 0 and 3 as the primary series and 18 months of age as the booster dose
Study group 1 (12-23 months):The investigational vaccine is to be administered at Months 0 and 1 .
Control group (12-23 months):The comparator vaccine Group A and C Meningococcal conjugate vaccineis is to be administered at Months 0 and 1 .
Sponsors
Disease control and prevention center of Hunan Provincial
Eligibility
Sex/Gender
All
Age
0.6 Years to 2.3 Years
Inclusion criteria
Inclusion criteria: 1. Healthy infants (6-11 months old or 12-23 months old) who meet the age of enrollment in this clinical trial; 2. The legal guardian of the volunteer voluntarily agrees that his/her child will participate in the study and signs the informed consent form (if the legal guardian goes out, the trustee of the legal guardian can sign on behalf of him/her on the premise of written authorization); 3. Volunteers and their legal guardians/entrusted persons have the ability to participate in this trial according to the clinical trial plan; 4.6 Volunteers aged 1-11 months should not have been vaccinated with any meningococcal vaccine (including but not limited to group A polysaccharide vaccine and AC conjugate vaccine); 5. Volunteers aged from 12 to 23 months have not been vaccinated with any meningococcal vaccines (including but not limited to group A polysaccharide vaccine, AC conjugate vaccine) or have only been vaccinated with group A meningococcal polysaccharide vaccine, and the interval between vaccination and the last dose is more than 3 months.
Exclusion criteria
Exclusion criteria: Exclusion criteria for the first dose: 1. Preterm infants with gestational age42 weeks, or low birth weight infants with birth weight4000g; Or congenital malformations, developmental disorders, genetic defects, severe malnutrition, etc; 2. Volunteers were born with abnormal labor process (dystocia, assisted delivery with instruments) or had a history of asphyxia rescue, nervous organ damage, test tube infants or multiple births (triplets and above) (only applicable to infants aged 6-11 months); 3. The volunteers were diagnosed as suffering from or had suffered from pathological jaundice (lasting for 2 to 4 weeks and repeated) (only applicable to infants aged 6-11 months); 4. A certain component of the vaccine used in this clinical trial (mainly including group A meningococcal capsular polysaccharide, group C meningococcal capsular polysaccharide, group Y meningococcal capsular polysaccharide, group W135 meningococcal capsular polysaccharide, diphtheria toxoid or diphtheria antigen, tetanus toxoid or tetanus antigen, lactose, sodium dihydrogen phosphate, disodium hydrogen phosphate) Allergies or their immediate family members who have been vaccinated in the past are allergic to the above ingredients; 5. Volunteers 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)); 6. The volunteer has a history of convulsion, epilepsy, encephalopathy and psychosis or a family history of the above diseases; 7. The volunteers have contraindications to intramuscular injection such as thrombocytopenia, any coagulation dysfunction or being treated with anticoagulants; 8. Volunteers who are known or suspected to have abnormal immunological functions (such as HIV infection, history of thyroid, pancreas, liver, spleen, kidney disease or resection), have received or are receiving immunosuppressive therapy, cytotoxic therapy, and systemic glucocorticoid therapy within 3 months before enrollment (any route of medication, = 2mg/kg/day, = 7 days); 9. The volunteer is suffering from meningitis or has a history of meningitis; 10. Known volunteers have congenital malformations, developmental disorders or clinically diagnosed serious chronic diseases (such as Down's syndrome, thalassemia, sickle cell anemia or neurological disorders, Guillain Barre syndrome, etc.); 11. The volunteers are known or suspected to have diseases that have been judged by the researchers to affect vaccination, such as severe respiratory diseases, acute infection or chronic disease activity, severe cardiovascular diseases, liver and kidney diseases, malignant tumors, serious infectious or allergic skin diseases; 12. Volunteers have received blood products or immunoglobulins (except hepatitis B immunoglobulin) within 3 months (<3 months); 13. Volunteers are participating in or planning to participate in clinical trials of other drugs and medical devices during the phase III clinical trial. 14. The investigator believes that the volunteers have any situation that may affect the clinical trial evaluation. Exclusion criteria for follow-up agents: 1. Serious acute allergic reaction occurred after the previous vaccination; 2. Occurrence of serious adverse events related to the previous vaccination; 3. Those newly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Group A meningococcal serum bactericidal activity (rsba) antibody;Group C meningococcal serum bactericidal activity (rsba) antibody;Group Y meningococcal serum bactericidal activity (rsba) antibody;Group W135 meningococcal serum bactericidal activity (rsba) antibody; | — |
Countries
China
Contacts
Public ContactHuang Tao
Outcome results
None listed