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Evaluate the Safety and Efficacy of Quadrivalent Influenza in Real-world Situations.

NCT06334510 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4900

Last updated 2024-03-28

No results posted yet for this study

Summary

To evaluate the inter-batch consistency (CI) of quadrivalent influenza vaccine (split virion) among healthy people aged 18-59 years； Secondly, to evaluate the safety and immunogenicity of quadrivalent influenza vaccine (split virion) in the expanded population aged 3 years and above, in order to observe the rare adverse reaction of 1‰.

Conditions

  • GCP

Interventions

BIOLOGICAL

One dose of quadrivalent influenza virus split vaccine was administered

Safety observation: All 4900 vaccine recipients participated in the safety observation after vaccination, and were followed up for adverse events (AE) within 30 minutes and 0-30 days after vaccination, and SAEs within 6 months after vaccination. In addition to 1050 recipients aged 18-59 years who were included in the first layer test, 350 recipients aged 3-17 years and 350 recipients aged ≥60 years were randomly selected from each group. Blood samples were collected before and 30 days after vaccination for influenza virus HI antibody detection.

Sponsors & Collaborators

  • Hualan Biological Bacterin Co. Ltd.

    lead INDUSTRY

Eligibility

Min Age
3 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-17
Primary Completion
2023-01-20
Completion
2023-03-28

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 NCT06334510 on ClinicalTrials.gov