A Clinical Trial of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector) in a 4 to 6 Year-old Population

Inclusion Criteria:

• Children aged 4~6 years old

• Complete at least two doses of basic immunization with polysaccharide influenzavaccine according to the immunization program

• The legal guardian or delegate has given informed consent, voluntarily signed theinformed consent form, and is able to comply with the requirements of the clinicalstudy protocol

Exclusion Criteria:

• Fever before inoculation, axillary temperature >37.0℃

• Previous history of immunization with meningococcal polysaccharide conjugate vaccine

• Congenital malformations or developmental disorders, genetic defects, severemalnutrition, etc.

• History of epilepsy, convulsions or seizures or a history of psychiatric illness orfamily history

• Volunteers with current meningitis or a history of meningitis

• Volunteers treated with immunosuppressive therapy, cytotoxic therapy,glucocorticoids (excluding topical treatment, surface treatment for acuteuncomplicated dermatitis, spray treatment for allergic rhinitis) within the past 6months (<6 months)

• Received blood/plasma products or immunoglobulins within 60 days (<60 days) prior tostudy vaccination or planned to receive blood/plasma products or immunoglobulinsthroughout the study period

• Suffering from serious chronic diseases or conditions that are in a progressivestage and cannot be controlled smoothly, such as thyroid disease

• Volunteers with known or suspected diseases that are judged by the investigator toaffect vaccination such as severe respiratory disease, acute infection or activechronic disease, severe cardiovascular disease, severe liver or kidney disease,malignancy, severe infectious or allergic skin disease

• History of serious adverse reactions associated with the vaccine and/or history ofsevere allergic reactions (e.g., systemic allergic reactions) to any component ofthe investigational vaccine

• Immunocompromised individuals with known or suspected immunodeficiency as determinedby medical history and/or physical examination (e.g., malignancy, HIV, etc.)

• Bleeding constitution or condition associated with prolonged bleeding, investigatorsconsider intramuscular injection to be contraindicated

• Live attenuated vaccine given within 14 days, other vaccines given within 7 days

• Participation in other studies involving interventions within 28 days (<28 days)prior to study entry and/or during study participation

• Other conditions judged by the investigator to be inappropriate for participation inthis clinical trial