Phase IV Clinical Study of Immunogenicity of ACYW135 Group Meningococcal Polysaccharide Conjugate Vaccine (CRM197 Vector)
Epidemic Meningitis
About this trial
This is an interventional prevention trial for Epidemic Meningitis focused on measuring ACYW135, CRM197, Immunogenicity, Persistence, 6~23 months of age
Eligibility Criteria
Inclusion Criteria: Children aged 6 to 23 months at the time of screening Volunteers who have not received any vaccine containing a epidemic encephalitis component or who have received only the group A polysaccharide flu vaccine and have been vaccinated more than 6 months since their last vaccination. 6 months or more between the last vaccination and the last vaccination The legal guardian or delegate has given informed consent, voluntarily signed the informed consent form, and is able to comply with the requirements of the clinical study protocol Exclusion Criteria: Fever before inoculation, axillary temperature >37.0℃ History of epilepsy, convulsions or seizures or history of psychiatric disorders or family history During an acute illness episode; with a serious chronic illness or a condition that is in a progressive stage that cannot be smoothly controlled (or an acute episode) Known allergy to a component of the vaccine, especially to diphtheria toxoid Live attenuated vaccine received within 14 days or other vaccine received within 7 days prior to enrollment Other circumstances that, in the judgment of the investigator, make participation in this clinical study inappropriate Those who had a severe allergic reaction after the previous dose of vaccine Those with serious adverse reactions causally related to the previous dose of vaccination Newly identified or newly occurred cases after the first vaccination that do not meet the inclusion criteria for the first dose or meet the exclusion criteria for the first dose will be determined by the investigator whether to continue to participate in the study
Sites / Locations
- Wuzhi County Center for Disease Control and PreventionRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Vaccine Group A
Vaccine Group B
2 dose of ACYW135 group meningococcal polysaccharide conjugate vaccine(MCV4) (0.5ml)
2 dose of (MCV4) (0.5ml)