deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT03969212

Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households

A Phase IIIB, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Clinical Efficacy Study of Baloxavir Marboxil for the Reduction of Direct Transmission of Influenza From Otherwise Healthy Patients to Household Contacts

Sponsor: Hoffmann-La Roche

Conditions Influenza
Interventions Baloxavir Marboxil Placebo
Updated 63 times since 2019 Last updated: Jul 3, 2025 Started: Oct 10, 2019 Primary completion: May 10, 2024 Completion: May 10, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03969212, this PHASE3 trial focuses on Influenza and remains completed. Sponsored by Hoffmann-La Roche, it has been updated 63 times since 2019, reflecting substantial change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Mar 2022 · 28 days · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Jan 2024 · 31 days · monthly snapshot~Jan 2024 – ~Feb 2024 · 31 days · monthly snapshot~Feb 2024 – ~Mar 2024 · 29 days · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~May 2024 · 30 days · monthly snapshot~May 2024 – ~Jun 2024 · 31 days · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~May 2025 · 8 months · monthly snapshot~May 2025 – ~Jul 2025 · 2 months · monthly snapshot~Jul 2025 – ~Aug 2025 · 31 days · monthly snapshot~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – present · 9 months · monthly snapshot

Change History

63 versions recorded

  1. Oct 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Oct 2025 [monthly]

    Completed PHASE3

  3. Aug 2025 — Sep 2025 [monthly]

    Completed PHASE3

  4. Jul 2025 — Aug 2025 [monthly]

    Completed PHASE3

  5. May 2025 — Jul 2025 [monthly]

    Completed PHASE3

▶ Show 58 earlier versions

  1. Sep 2024 — May 2025 [monthly]

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. Jun 2024 — Jul 2024 [monthly]

    Completed PHASE3

    Status: Recruiting → Completed

  4. May 2024 — Jun 2024 [monthly]

    Recruiting PHASE3

  5. Apr 2024 — May 2024 [monthly]

    Recruiting PHASE3

  6. Mar 2024 — Apr 2024 [monthly]

    Recruiting PHASE3

  7. Feb 2024 — Mar 2024 [monthly]

    Recruiting PHASE3

  8. Jan 2024 — Feb 2024 [monthly]

    Recruiting PHASE3

  9. Dec 2023 — Jan 2024 [monthly]

    Recruiting PHASE3

  10. Nov 2023 — Dec 2023 [monthly]

    Recruiting PHASE3

  11. Oct 2023 — Nov 2023 [monthly]

    Recruiting PHASE3

  12. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE3

  13. Aug 2023 — Sep 2023 [monthly]

    Recruiting PHASE3

  14. Jul 2023 — Aug 2023 [monthly]

    Recruiting PHASE3

  15. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE3

  16. May 2023 — Jun 2023 [monthly]

    Recruiting PHASE3

  17. Apr 2023 — May 2023 [monthly]

    Recruiting PHASE3

  18. Mar 2023 — Apr 2023 [monthly]

    Recruiting PHASE3

  19. Feb 2023 — Mar 2023 [monthly]

    Recruiting PHASE3

  20. Jan 2023 — Feb 2023 [monthly]

    Recruiting PHASE3

  21. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE3

  22. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE3

  23. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE3

  24. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE3

  25. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE3

  26. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE3

  27. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE3

  28. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE3

  29. Feb 2022 — Mar 2022 [monthly]

    Recruiting PHASE3

  30. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE3

  31. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE3

  32. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE3

  33. Oct 2021 — Nov 2021 [monthly]

    Recruiting PHASE3

  34. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE3

  35. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  36. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE3

  37. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE3

  38. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE3

  39. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE3

  40. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE3

  41. Nov 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  42. Oct 2020 — Nov 2020 [monthly]

    Recruiting PHASE3

  43. Sep 2020 — Oct 2020 [monthly]

    Recruiting PHASE3

  44. Aug 2020 — Sep 2020 [monthly]

    Recruiting PHASE3

  45. Jul 2020 — Aug 2020 [monthly]

    Recruiting PHASE3

  46. Jun 2020 — Jul 2020 [monthly]

    Recruiting PHASE3

  47. May 2020 — Jun 2020 [monthly]

    Recruiting PHASE3

  48. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE3

  49. Mar 2020 — Apr 2020 [monthly]

    Recruiting PHASE3

  50. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE3

  51. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE3

  52. Dec 2019 — Jan 2020 [monthly]

    Recruiting PHASE3

  53. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE3

  54. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE3

  55. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE3

  56. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  57. Jul 2019 — Aug 2019 [monthly]

    Not Yet Recruiting PHASE3

  58. Jun 2019 — Jul 2019 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Hoffmann-La Roche
Data source: Hoffmann-La Roche

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Akashi, Japan , Ankara, Turkey (Türkiye) , Antalya, Turkey (Türkiye) , Athens, Greece , Atlanta, United States , Beijing, China , Bialystok, Poland , Birmingham, United States , Budapest, Hungary , Butte, United States and 100 more locations