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Preliminary Safety Assessment of a Quadrivalent Subunit Influenza Vaccine in China

NCT07710586 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3105

Last updated 2026-07-20

No results posted yet for this study

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 \<0.01%), investigate the incidence of cerebral infarction following vaccination, and evaluate the incidence of systemic adverse events among participants aged 9 to 17 years.

Conditions

  • Influenza Vaccine

Interventions

BIOLOGICAL

quadrivalent subunit influenza vaccine

one dose of quadrivalent subunit influenza vaccine

Sponsors & Collaborators

  • Jiangsu Province Centers for Disease Control and Prevention

    collaborator NETWORK

  • Ab&B Bio-tech Co., Ltd.JS

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-15
Primary Completion
2025-05-29
Completion
2025-05-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07710586 on ClinicalTrials.gov