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Completed
NCT07710586
Preliminary Safety Assessment of a Quadrivalent Subunit Influenza Vaccine in China
Conditions: Influenza Vaccine
Sex: All
Ages: 3 Years – N/A
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 3105
Sponsor: Ab&B Bio-tech Co., Ltd.JS
Location: Dongtai Center for Disease Control and Prevention Dongtai Jiangsu
Summary
This study evaluates the safety of the quadrivalent subunit influenza vaccine in individuals aged 3 years and older in Jiangsu Province, China. The primary objectives are to assess the occurrence of very rare adverse reactions (incidence \
Eligibility Criteria
Inclusion Criteria
1. Healthy individuals aged 3 years or above.
2. The participant (and/or their guardian/legal representative) has provided informed consent, voluntarily agreed to participate, signed the Informed Consent Form, and is able to comply with the requirements of this study protocol.
Exclusion Criteria
1. Individuals with a known allergy to any component of the vaccine, including eggs, excipients, formaldehyde, or Triton N-101.
2. Individuals suffering from an acute illness, severe chronic disease, an acute exacerbation of a chronic disease, common cold, or fever.
3. Individuals with uncontrolled epilepsy or other progressive neurological disorders, or a history of Guillain-Barré syndrome.
4. Any other condition considered by the investigator as inappropriate for participation in this study.
Source: ClinicalTrials.gov (NCT07710586). StuddyBuddy aggregates publicly available trial information.