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A Clinical Trial of Quadrivalent Influenza Virus Split Vaccine (MDCK Cells) for Individuals Aged 6 Months and Above. - Trial NCT06342349

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.

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NCT06342349
Phase 1
Not yet recruiting
biological
Trial Details
ClinicalTrials.gov โ€ข NCT06342349
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A Clinical Trial of Quadrivalent Influenza Virus Split Vaccine (MDCK Cells) for Individuals Aged 6 Months and Above.
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.

Study Focus

Influenza

Quadrivalent influenza virus split vaccine (MDCK cells)

Interventional

biological

Sponsor & Location

Shanghai Institute Of Biological Products

Timeline & Enrollment

Phase 1

Mar 31, 2024

Dec 30, 2024

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 pneumonia
Influenza due to identified seasonal influenza virus
Influenza with other manifestations, seasonal influenza virus identified
Influenza with pneumonia, seasonal influenza virus identified
Influenza due to identified zoonotic or pandemic influenza virus

Data Source

ClinicalTrials.gov

NCT06342349

Non-Device Trial