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Not Yet Recruiting
NCT07885371
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Conditions: Meningococcal Disease; Meningococcal Meningitis
Sex: All
Ages: 13 Years – 15 Years
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 200
Sponsor: Zhejiang Provincial Center for Disease Control and Prevention
Summary
The sample size of this study is 200 participants, aiming to evaluate the protective effect after vaccination with quadrivalent meningococcal polysaccharide vaccine in the 13-15 age group, and to provide scientific evidence and practical guidance for meningococcal vaccination in the adolescent population.
Eligibility Criteria
Inclusion Criteria:
* Healthy individuals who meet the observation age range for this immunogenicity/safety study (13-15 years old) and are determined by the researchers based on their medical history.
* Obtain informed consent from the participant's guardian and have them sign the informed consent form.
* The participants and their guardians can adhere to the requirements of the clinical research protocol and persist in participating in the entire follow-up process.
* You have not received any other vaccines (including commercially available vaccines or investigational vaccines) within 30 days prior to the vaccination of the study vaccine.
* Before the age of 7, complete 4 doses of meningococcal vaccine according to the immunization program requirements (non-EPI vaccines are allowed to be used to replace corresponding doses).
Exclusion Criteria:
* Individuals who are known to be allergic to any component of this vaccine;
* Individuals who, upon evaluation by the researchers, are deemed unsuitable for participation in this study;
* Individuals with a history of vaccine or drug allergies (including but not limited to anaphylactic shock, allergic laryngeal edema, allergic purpura, and local allergic necrosis reaction (Arthus reaction)).
* Individuals with a history of epilepsy, convulsions, brain disorders, and allergies.
* People with kidney disease, heart disease, and active tuberculosis.
* Screen for individuals who have experienced fever, acute illnesses, or are in the acute phase of chronic diseases within the past three days.
Source: ClinicalTrials.gov (NCT07885371). StuddyBuddy aggregates publicly available trial information.