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

StatusCompleted
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Final enrollment: 250 participants (planned 290) · Study completion date changed from estimate of Jul 31, 2025 to Jan 28, 2025 · Eligibility criteria expanded, about 20 words · 1 more Show 4 more changesShow less
    • Final enrollment: 250 participants (planned 290)
    • Study completion date changed from estimate of Jul 31, 2025 to Jan 28, 2025
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 6 of 6 entries
  2. Collaborator revisedv10 See this version in full on ClinicalTrials.gov ↗
  3. Primary completion date changed from estimate of Jun 30, 2024 to Mar 25, 2024 Completion date: Jun 30, 2025 to Jul 31, 2025v9 Show 1 more changeShow less
    • Completion date: Jun 30, 2025 to Jul 31, 2025
  4. Trial status: Recruiting to Active, Not Recruiting Site details revisedv8 Show 1 more changeShow less
    • Site details revised
  5. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Apr 30, 2024 to Jun 30, 2024 · Completion date: Apr 30, 2025 to Jun 30, 2025 · Start date changed from estimate of Nov 3, 2023 to Nov 4, 2023 · 1 morev7 Show 4 more changesShow less
    • Primary completion date: Apr 30, 2024 to Jun 30, 2024
    • Completion date: Apr 30, 2025 to Jun 30, 2025
    • Start date changed from estimate of Nov 3, 2023 to Nov 4, 2023
    • Site details revised
Show 5 earlier versionsHide 5 earlier versions
  1. Start date: Oct 3, 2023 to Nov 3, 2023 Primary completion date: Mar 31, 2024 to Apr 30, 2024 · Completion date: Mar 31, 2025 to Apr 30, 2025 · Study description expanded, about 32 wordsv6 Show 3 more changesShow less
    • Primary completion date: Mar 31, 2024 to Apr 30, 2024
    • Completion date: Mar 31, 2025 to Apr 30, 2025
    • Study description expanded, about 32 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Jan 31, 2024 to Mar 31, 2024 Completion date: Dec 31, 2024 to Mar 31, 2025 · Start date: Sep 20, 2023 to Oct 3, 2023v5 Show 2 more changesShow less
    • Completion date: Dec 31, 2024 to Mar 31, 2025
    • Start date: Sep 20, 2023 to Oct 3, 2023
  3. Start date: Aug 15, 2023 to Sep 20, 2023 Interventions: Commercially available seasonal quadrivalent split vaccine for Southern Hemisphere in 2023 (Biological), TetraFluvac TF vaccine (Biological) to TetraFluvac TF vaccine (Biological), Vaxigrip vaccine (Biological) · Eligibility criteria shortened, about 2 words · Study description expanded, about 5 wordsv4 Show 3 more changesShow less
    • Interventions: Commercially available seasonal quadrivalent split vaccine for Southern Hemisphere in 2023 (Biological), TetraFluvac TF vaccine (Biological) to TetraFluvac TF vaccine (Biological), Vaxigrip vaccine (Biological)
    • Eligibility criteria shortened, about 2 words
    • Study description expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  4. Start date: Jul 15, 2023 to Aug 15, 2023 Interventions: TetraFluvac TF vaccine (Biological), seasonal quadrivalent split vaccine for Southern Hemisphere in 2023 (Biological) to Commercially available seasonal quadrivalent split vaccine for Southern Hemisphere in 2023 (Biological), TetraFluvac TF vaccine (Biological) · Study description expanded, about 97 wordsv3 Show 2 more changesShow less
    • Interventions: TetraFluvac TF vaccine (Biological), seasonal quadrivalent split vaccine for Southern Hemisphere in 2023 (Biological) to Commercially available seasonal quadrivalent split vaccine for Southern Hemisphere in 2023 (Biological), TetraFluvac TF vaccine (Biological)
    • Study description expanded, about 97 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary endpoints: 12 to 20 Enrollment target: 340 to 290 · Primary completion date: Dec 31, 2023 to Jan 31, 2024 · Start date: Jul 1, 2023 to Jul 15, 2023 · 3 morev2 Show 6 more changesShow less
    • Enrollment target: 340 to 290
    • Primary completion date: Dec 31, 2023 to Jan 31, 2024
    • Start date: Jul 1, 2023 to Jul 15, 2023
    • Interventions: Seasonal quadrivalent vaccine-split subunit vaccine with the strains 2023 (Biological), TetraFluvac TF vaccine (Biological) to TetraFluvac TF vaccine (Biological), seasonal quadrivalent split vaccine for Southern Hemisphere in 2023 (Biological)
    • Eligibility criteria expanded, about 16 words
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05895955
Lead Sponsor Mahidol University
Collaborators: The Government Pharmaceutical Organization
Conditions Influenza
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov