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Phase IV Clinical Trial to Evaluate Effectiveness of Tri Fluvac, A Seasonal Trivalent Inactivated Split Virion Influenza Vaccine, in Thai Population

Phase IV Clinical Trial to Evaluate Effectiveness of Tri Fluvac, A Seasonal Trivalent Inactivated Split Virion Influenza Vaccine, in Thai Population

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20240909002
Enrollment
5000
Registered
2024-09-09
Start date
2024-09-19
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza-like-illness Influenza vaccine effectiveness Influenza-like-illness

Interventions

ILI participants with nasopharyngeal swab samples positive for influenza virus by RT-PCR,ILI participants with nasopharyngeal swab samples negative for influenza virus by RT-PCR
Prevention,Prevention

Sponsors

The Government Pharmaceutical Organization (GPO)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Thai adult aged 18 years and above 2.All gender 3.Residing in the catchment area of Lampang district provincial hospital and 13 sub- district health promoting hospitals. 4. Has acute respiratory infection with measured body temperature of >=37.8o C at enrollment (or history of fever and took anti-pyretic drug in the past 6 hours before the enrollment) and (cough or sorethroat) within the last 10 days regardless of self-test ATK/RDT results 5.Provide written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1.Patients who develops Influenza-like symptoms during hospital admission for other conditions 2.Patients who cannot confirm the information whether they have received influenza vaccination in the previous one year 3.Patients who had received influenza vaccine other than GPO Tri Fluvac since January 2024 onwards. 4. Patients who previously had antiviral agents (including favipiravir, oseltamivir, zanamivir, molnupiravir, baloxavir, or paxlovid) regardless of timing for this episode. 5. Patients who had GPO Tri Fluvac within 14 days before onset of symptoms

Design outcomes

Primary

MeasureTime frame
Influenza Infection 14 days to 1 year after receiving or not receiving GPO Tri Fluvac vaccine Influenza infection confirmed by RT-PCR,Severe Acute Respiratory Infection 14 days to 1 year after receiving or not receiving GPO Tri Fluvac vaccine Influenza infection confirmed by RT-PCR and hospitalization

Secondary

MeasureTime frame
Influenza Infection 14 days to 1 year after receiving or not receiving GPO Tri Fluvac vaccine Laboratory confirmed influenza infection by RT-PCR, stratified by virus subtype,Influenza Infection 14 days to 1 year after receiving or not receiving GPO Tri Fluvac vaccine Laboratory confirmed influenza infection by RT-PCR, stratified by age group (18-59 years and 60 years or older),Severe acute respiratory infection 14 days to 1 year after receiving or not receiving GPO Tri Fluvac vaccine Laboratory confirmed influenza infection by RT-PCR and hospitalization, stratified by virus subtype,Severe acute respiratory infection 14 days to 1 year after receiving or not receiving GPO Tri Fluvac vaccine Laboratory confirmed influenza infection by RT-PCR and hospitalization, stratified by age groups (18-59 years and 60 years or older),Genetic sequences of influenza virus 14 days to 1 year after receiving or not receiving GPO Tri Fluvac vaccine Third generation sequencing platform, Oxford Nanopore Sequencing Technology

Countries

Thailand

Contacts

Public ContactSaranath Niyom

Faculty of Tropical Medicine, Mahidol University

saranath.law@mahidol.edu023069188

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026