For prevention of infectious diseases caused by group A and C meningococci
Conditions
Interventions
Study group 1 for subjects aged 6-11 months:Administer one dose at Month 0, 1 and 2 respectively
a booster dose will be administered at the age of 18 months
the Diphtheria, Tetanus and Acellular Pertussis Combined Vaccine, Adsorbed will be administered in the same regimen as adopted for the Group A and C Meningococcal Polysaccharide Conjugate V
Sponsors
Shanxi Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
0.3 Years to 0.4 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all the following inclusion criteria: (1) Healthy infants at the observation age (3 to 5 months) prescribed in the protocol of this clinical study; (2) The legal guardians of the subject voluntarily consent to the participation of their child in the study and sign the informed consent form (if the legal guardian is away, an authorized person assigned by the legal guardians may sign on behalf of the legal guardians on the premise of a written authorization); (3) The subject and his/her legal guardians have the ability to participate in this study based on the clinical study protocol; (4) The subject has not received any meningococcal vaccine (including but not limited to: group A and C polysaccharide conjugate vaccine, group A and C polysaccharide vaccine, group A polysaccharide vaccine, and group ACYW135 polysaccharide vaccine), and have not received any pertussis, diphtheria, or tetanus vaccine (including but not limited to the corresponding monovalent vaccine, DTaP combined vaccine, DTaP-Hib-IPV combined vaccine, etc.). (5) The interval between the day of vaccination and that of other subunit vaccines or inactivated vaccines should be no less than 7 days; the interval between the day of vaccination and that of other attenuated live vaccines should be no less than 14 days; (6) The axillary temperature of the subject was < 38.0 degree C in the past 3 days; (7) On the day of vaccination, the axillary temperature of the subject is <=37.0 degree C.
Exclusion criteria
Exclusion criteria: Exclusion criteria for the first dose: (1) The subject was premature infants (delivered before the 37th week of pregnancy), the birth weight of the subject was low (birth weight < 2300g for girls, < 2500g for boys) or the subject had conditions such as congenital malformations, developmental disorders, genetic defects, severe malnutrition, etc.; (2) The subject was born in abnormal labor process (dystocia, instrumental delivery); the subject had a history of first-aid for asphyxiation or nerve organ damage; (3) The subject was diagnosed to have pathologic jaundice or had suffered from pathologic jaundice (lasted for 2-4 weeks, repeatedly); (4) The subject is known to be allergic to certain components of the vaccine used in this clinical study, including group A and C meningococcal capsular polysaccharides, tetanus toxoid, effective components of Bordetella pertussis, diphtheria toxoid, etc.; (5) The subject had a history of severe allergy to vaccination or drugs (such as anaphylactic shock, anaphylactic laryngeal edema, Henoch-Schonlein purpura, thrombocytopenic purpura, local anaphylactic necrotic reaction (Arthus reaction)); (6) The subject had a personal history or family history of convulsion, epilepsy, encephalopathy and mental illness; (7) The subject had a well-established history of thrombocytopenia or other coagulation disorders; (8) The subject is known or suspected to have immunological defects, including being treated with immunosuppressants (such as radiotherapy, chemotherapy, corticosteroids, antimetabolic drugs, cytotoxic drugs, etc.) and being infected with HIV; (9) The subject had a history of meningitis; (10) subject is known to have clinically diagnosed severe chronic diseases (such as Down syndrome, diabetes, sickle cell anemia or thalassemia, neurological disorders, Guillain-Barre syndrome, etc.); (11) The subject is known or suspected to have diseases including: severe respiratory diseases, acute or chronic active diseases, severe cardiovascular and cerebrovascular diseases, liver and kidney diseases, malignant tumors, severe skin diseases, and active tuberculosis; (12) The subject was treated with blood products or globulin (except hepatitis B immunoglobulin); (13) The subjects are participating in or plan to participate in clinical studies for other drugs; (14) Other exclusion criteria affirmed by the investigators; Exclusion criteria for follow-up doses: If any of the following occurs during the safety observation period of the study, the subject cannot continue to be vaccinated, but other study steps may be continued according to the judgment of the investigators. (1) Severe allergic reactions were observed during previous vaccination with the same vaccine; (2) During previous vaccination with the same vaccine, serious adverse events that had a causal relationship with vaccination were observed; (3) Newly discovered or newly occurred subjects who met the exclusion criteria of the first dose after previous vaccination; (4) Other exclusion criteria affirmed by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibody titers as measured by by serum bactericidal assay (rSBA) before/after immunization;Antibody titers against diphtheria toxoid (DT), tetanus toxoid (TT), pertussis toxoid (PT) and filamentous hemagglutinin (FHA) as measured by ELISA; | — |
Countries
China
Contacts
Public ContactZhen Huang
Yuxi Walvax Biotechnology Co., Ltd.
Outcome results
None listed