deltatrials
Completed PHASE1 INTERVENTIONAL 6-arm NCT03596801

Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children

Phase I Placebo-Controlled Study of the Infectivity, Safety and Immunogenicity of a Single Dose of a Recombinant Live-attenuated Respiratory Syncytial Virus Vaccine, RSV 6120/∆NS1, Lot RSV#018A, or RSV 6120/F1/G2/∆NS1, Lot RSV#016A, Delivered as Nose Drops to RSV-seropositive Children 12 to 59 Months of Age and RSV-seronegative Infants and Children 6 to 24 Months of Age

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Conditions RSV Infection
Interventions Placebo RSV 6120/F1/G2/∆NS1 RSV 6120/∆NS1
Updated 13 times since 2018 Last updated: Jan 26, 2026 Started: Jun 29, 2018 Primary completion: Apr 25, 2024 Completion: Apr 25, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03596801, this PHASE1 trial focuses on RSV Infection and remains completed. Sponsored by National Institute of Allergy and Infectious Diseases (NIAID), it has been updated 13 times since 2018, reflecting substantial change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

~Aug 2018 – ~Aug 2019 · 12 months · monthly snapshot~Aug 2019 – ~Oct 2020 · 14 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Mar 2022 · 14 months · monthly snapshot~Mar 2022 – ~Apr 2023 · 13 months · monthly snapshot~Apr 2023 – ~Jan 2024 · 9 months · monthly snapshot~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Apr 2025 · 7 months · monthly snapshot~Apr 2025 – ~May 2025 · 30 days · monthly snapshot~May 2025 – ~Jun 2025 · 31 days · monthly snapshot~Jun 2025 – ~Feb 2026 · 8 months · monthly snapshot~Feb 2026 – present · 7 months · monthly snapshot

Change History

13 versions recorded

  1. Feb 2026 — Present [monthly]

    Completed PHASE1

  2. Jun 2025 — Feb 2026 [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

  3. May 2025 — Jun 2025 [monthly]

    Active Not Recruiting PHASE1

  4. Apr 2025 — May 2025 [monthly]

    Active Not Recruiting PHASE1

  5. Sep 2024 — Apr 2025 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

▶ Show 8 earlier versions

  1. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE1

  2. Jan 2024 — Jul 2024 [monthly]

    Recruiting PHASE1

  3. Apr 2023 — Jan 2024 [monthly]

    Recruiting PHASE1

    Status: Active Not Recruiting → Recruiting

  4. Mar 2022 — Apr 2023 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  5. Jan 2021 — Mar 2022 [monthly]

    Recruiting PHASE1

  6. Oct 2020 — Jan 2021 [monthly]

    Recruiting PHASE1

  7. Aug 2019 — Oct 2020 [monthly]

    Recruiting PHASE1

  8. Aug 2018 — Aug 2019 [monthly]

    Recruiting PHASE1

    First recorded

Jun 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Institute of Allergy and Infectious Diseases (NIAID)
Data source: National Institute of Allergy and Infectious Diseases (NIAID)

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

Study Locations