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NCT05895955Not yet recruiting

Safety and Immunogenicity of GPO Seasonal Tetravalent Inactivated Split Virion Influenza Vaccine in Healthy Thais

A Phase I/II Randomized Double Blind Controlled Study to Evaluate the Safety and Immunogenicity of GPO Seasonal Tetravalent Inactivated Split Virion Influenza Vaccine in Healthy Thais
Mahidol UniversityPhase 1/2ClinicalTrials.govbiological
Verified
Study focus
Disease/Condition
Influenza
Drug/Device/Intervention
TetraFluvac TF vaccine
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Mahidol University
Location
Bangkok, Thailand
Timeline & enrollment
Phase
Phase 1/2
Start date
Aug 15, 2023
End date
Dec 31, 2024
Enrollment
290 participants
Primary outcome

Number and percentage of Solicited local adverse events post-vaccination.,Number and percentage of Solicited local adverse events post-vaccination.,Number and percentage of Solicited local adverse events post-vaccination.,Number and percentage of Solicited local adverse events post-vaccination.,Number and percentage of Solicited local adverse events post-vaccination.,Number and percentage of Solicited local adverse events post-vaccination.,Number and percentage of Solicited local adverse events post-vaccination.,Number and percentage of Solicited local adverse events post-vaccination.,Number and percentage of Solicited systemic adverse events post-vaccination.,Number and percentage of Solicited systemic adverse events post-vaccination.,Number and percentage of Solicited systemic adverse events post-vaccination.,Number and percentage of Solicited systemic adverse events post-vaccination.,Number and percentage of Solicited systemic adverse events post-vaccination.,Number and percentage of Solicited systemic adverse events post-vaccination.,Number and percentage of Solicited systemic adverse events post-vaccination.,Number and percentage of Solicited systemic adverse events post-vaccination.,Number and percentage of participants with unsolicited adverse events,Number and percentage of participants with AESI,Number and percentage of participants with Medically-Attended Adverse Event,Number and percentage of participants with Serious Adverse Event

Summary

The study is aim to evaluate the safety and immunogenicity of one dose TetraFluvac TF vaccine
 (15 μg HA per strain per dose) of the GPO seasonal quadrivalent inactivated split virion
 influenza vaccine in healthy adults aged 18 years and above over 90 days post-injection.

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
NCT05895955
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05895955 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by Mahidol University and is currently Not yet recruiting. The study focuses on Influenza. Target enrollment is 290 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.