For the prevention of meningococcal meningitis caused by group A, group C, group Y and group W135 meningococci
Conditions
Interventions
study group 1:1 dose of group ACYW135 meningococcal polysaccharide conjugate vaccine at Month 0, 1 and 2 respectively
1 booster dose of group ACYW135 meningococcal polysaccharide conjugate vaccine at 12-18 months of age
control group:1 dose of group ACYW135 meningococcal polysaccharide conjugate vaccine at Month 0, 1 and 2 respectively
study group 2:1 dose of group ACYW135 meningococcal polysaccharide conjugate vaccine at Month 0, 1 and 2 respectively
Sponsors
Guangxi Center for Disease Prevention and Control
Eligibility
Sex/Gender
All
Age
0.2 Years to 0.3 Years
Inclusion criteria
Inclusion criteria: Volunteers must meet all of the following inclusion criteria: 1. Healthy infants in accordance with the age of this clinical trial (3 months old, 2 months old (minimum 6 weeks old)). 2. The legal guardian of the volunteer voluntarily agreed that the child would participate in the study and signed the informed consent. 3. Volunteers and their legal guardians have the ability to participate in the trial according to the clinical trial plan. 4. Volunteers should not have received any meningococcal vaccine (including but not limited to: AC conjugate vaccine). 5. The interval between the day of vaccination and other subunit vaccines and inactivated vaccines should be more than 7 days, and the interval between the day of vaccination and other live attenuated vaccines should be more than 14 days. 6. In the past 3 days, there were no subjects with axillary temperature >= 38.0 degrees C. 7. Subjects with axillary temperature <= 37.3 degrees C on the day of enrollment.
Exclusion criteria
Exclusion criteria: Exclusion criteria for the first dose of vaccination: Volunteers with any of the following conditions could not be included in the study: 1. The volunteers are suffering from meningitis or have a history of meningitis. two Known volunteers are allergic to certain components 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), or His immediate family members had been vaccinated with meningococcal vaccine and were allergic to the above ingredients. 3. The volunteers or their immediate family members had a history of vaccination or severe drug allergy. (for example, but not limited to: anaphylactic shock, anaphylactic laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, local anaphylactic necrosis reaction (Arthus reaction)). 4. Volunteers with birth weight less than 2.5kg or more than 4.0KG, gestational age less than 37 weeks or more than 42 weeks, abnormal labor process (dystocia at birth, instrumental Midwifery) or history of asphyxia and nervous organ damage were test tube infants or multiple births (triplets and above), and were suffering from or had been suffering from rational jaundice (lasting for 2-4 weeks and repeated). 5. The volunteers had a history of convulsion, epilepsy, encephalopathy and psychosis or a family history of the above diseases. 6. It is known that the volunteers have severe congenital malformations, developmental disorders or severe chronic diseases with clinical diagnosis (such as Down's syndrome, severe thalassemia, sickle cell anemia or neurological diseases, Guillain Barre syndrome, vitamin B6 dependence syndrome, etc.) that may interfere with the study. 7. It is known or suspected that the volunteers have diseases determined by the researchers to affect the vaccination, such as severe respiratory diseases, acute infection or chronic disease activity, severe cardiovascular diseases, liver and kidney diseases, malignant tumors, severe infectious or allergic skin diseases. eight It is known or suspected that the volunteers have immunological dysfunction (such as HIV infection, history of thyroid, pancreas, liver, spleen, kidney or resection, autoimmune disease (recurrent perianal abscess), or are receiving immunosuppressive therapy, cytotoxic therapy, corticosteroids (excluding topical corticosteroid therapy, acute non concurrent dermatitis) Steroid therapy, etc. 9. The volunteers had a history of thrombocytopenia or other coagulation disorders. 10. Volunteers received blood products or immunoglobulin after birth (hepatitis B immunoglobulin is acceptable). 11. Volunteers plan to participate in or are participating in other drug clinical trials. 12. The researchers believe that volunteers have any situation that may affect the evaluation of clinical trials. Exclusion criteria for follow-up dose times: In case of any of the following situations during the safety observation period, the subject can not continue to receive the vaccine, but can continue other research steps according to the judgment of the researcher: (1) Severe acute allergic reaction occurred after the previous dose of vaccine; (2) Serious adverse events related to the previous do
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibodies against meningococcal groups A, C, Y and W135 as measured by serum bactericidal assay (rSBA); | — |
Countries
China
Contacts
Public ContactLin Yuan
Walvax Biotechnology Co., Ltd.
Outcome results
None listed