About this trial
This trial adopts an open-label design combined with randomized, blinded, placebo-controlled and active-controlled design. The purpose of this trial is to evaluate the safety and immunogenicity of a Group ACYW135X Meningococcal Conjugate Vaccine. This study is planned to enroll 150 participants in total, with healthy individuals aged 2 to 59 years as participants. Among them, participants aged 18 to 59 years and 7 to 17 years will be assigned to the open-label design arm, while participants aged 4 to 6 years will be assigned to the randomized, blinded, placebo-controlled design arms.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy participants aged 2 to 59 years;
The participant and/or their legal guardian can understand and voluntarily sign the informed consent form (for participants aged 8 to 17 years, the form must be signed jointly by the participant and their legal guardian);
Be willing and able to comply with all visit schedules, sample collection procedures, vaccination protocols and other trial-related requirements, and maintain contact at any time during the study period;
Provide valid legal identification documents of the participant and/or their legal guardian;
Disqualifiers
History of meningococcal disease;
History of asthma; history of hypersensitivity to any vaccine or vaccine components (including serogroup A/C/Y/W135/X meningococcal capsular polysaccharide, mannitol, sucrose, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride, and water for injection), manifested as symptoms such as urticaria, dyspnea, or angioedema; or history of other severe adverse reactions following previous vaccination;
For children aged 2 to 6 years: history of previous vaccination with group ACYW135 meningococcal polysaccharide vaccine; or history of previous vaccination with any meningococcal conjugate vaccine other than group AC meningococcal conjugate vaccine; an interval of ≤ 12 months from the last dose of group A or group AC meningococcal polysaccharide vaccine or group AC meningococcal conjugate vaccine; history of vaccination with meningococcal conjugate vaccine since reaching 1 year of age. No vaccination history restrictions apply to participants aged 7 to 59 years;
Presence of autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);
Trial design
Sequential
Treatments tested in this trial
high-dose Group ACYW135X Meningococcal Conjugate Vaccine
Biological/Vaccinehigh-dose Group ACYW135X Meningococcal Conjugate Vaccine
medium-dose Group ACYW135X Meningococcal Conjugate Vaccine
Biological/Vaccinemedium-dose Group ACYW135X Meningococcal Conjugate Vaccine
low-dose Group ACYW135X Meningococcal Conjugate Vaccine
Biological/Vaccinelow-dose Group ACYW135X Meningococcal Conjugate Vaccine
Group ACYW135 Meningococcal Conjugate Vaccine (CRM197)
Biological/VaccineGroup ACYW135 Meningococcal Conjugate Vaccine (CRM197)
Placebo
Biological/Vaccineplacebo
Treatment groups
Trial outcomes
Primary outcomes
Evaluate the safety of experimental vaccine among participants in different age groups (based on adverse reactions)
The incidence rates of adverse reactions 30 days after vaccination
Secondary outcomes
Evaluate the safety of experimental vaccine among participants in different age groups (based on AE and laboratory abnormalities)
The incidence rate of adverse events 30 days after vaccination
Evaluate the safety of experimental vaccine among participants in different age groups (based on AE and laboratory abnormalities)
The incidence rate of clinically significant abnormal blood biochemistry, blood routine, and urine routine indexes within 3 days after vaccination
Evaluate the safety of experimental vaccine among participants in different age groups (based on AE and laboratory abnormalities)
The incidence rate of serious adverse events 6 months after vaccination
Evaluate the immunogenicity of experimental vaccine among participants aged 2~6 years old
The seropositive rates, seroconversion rate, GMT and GMFR of Nm antibody against serogroups A, C, Y, W135, and X at 30 days after vaccination
Locations
Sponsors and contacts
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