NCT06342349

A Clinical Trial of Quadrivalent Influenza Virus Split Vaccine (MDCK Cells) for Individuals Aged 6 Months and Above.

Name: Clinical Trial NCT06342349
Creator: Shanghai Institute Of Biological Products
Keywords: Influenza, Quadrivalent influenza virus split vaccine (MDCK cells), Phase 1, biological, clinical trial

A Randomized, Double-blind, Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of the Quadrivalent Influenza Virus Split Vaccine (MDCK Cells) for Individuals Aged 6 Months and Above.

Shanghai Institute Of Biological Products·Phase 1·ClinicalTrials.gov·biologicalNot yet recruiting

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Influenza
Drug/Device/Intervention: Quadrivalent influenza virus split vaccine (MDCK cells)
Study type: Interventional
Intervention type: biological

Sponsor & location

Primary sponsor: Shanghai Institute Of Biological Products

Timeline & enrollment

Phase: Phase 1
Start date: Mar 31, 2024
End date: Dec 30, 2024
Enrollment: 300 participants

Primary outcome

Solicited Adverse Events (AEs),Unsolicited Adverse Events,Serious Adverse Events (SAE)

Summary

To evaluate the safety of administering 1 or 2 doses of the quadrivalent influenza virus split vaccine (MDCK cells) (0.5ml/dose) in individuals aged 6 months and above.

ICD-10 classifications

Influenza and pneumoniaInfluenza due to identified seasonal influenza virusInfluenza with other manifestations, seasonal influenza virus identifiedInfluenza with pneumonia, seasonal influenza virus identifiedInfluenza due to identified zoonotic or pandemic influenza virus

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06342349
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06342349 through Pure Global AI's free database. This Phase 1 trial is sponsored by Shanghai Institute Of Biological Products and is currently Not yet recruiting. The study focuses on Influenza. Target enrollment is 300 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.