Terminated PHASE3 INTERVENTIONAL 4-arm NCT04605159

A Phase III, Double-blind Study to Assess Safety and Efficacy of an RSV Maternal Unadjuvanted Vaccine, in Pregnant Women and Infants Born to Vaccinated Mothers (GRACE)

A Phase III, Randomized, Double-blind, Placebo-controlled Multi-country Study to Demonstrate Efficacy of a Single Dose of Unadjuvanted RSV Maternal Vaccine, Administered IM to Pregnant Women 18 to 49 Years of Age, for Prevention of RSV Associated LRTIs in Their Infants up to 6 Months of Age

Sponsor: GlaxoSmithKline

Conditions Respiratory Syncytial Virus Infections

Interventions Placebo RSV MAT

Updated 24 times since 2020 Last updated: Feb 4, 2025 Started: Nov 20, 2020 Primary completion: Jun 14, 2023 Completion: Jun 14, 2023

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study.

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This PHASE3 trial investigates Respiratory Syncytial Virus Infections and is currently terminated or withdrawn. GlaxoSmithKline leads this study, which shows 24 recorded versions since 2020 — indicating substantial longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

Change History

24 versions recorded

Sep 2025 — Present [monthly]

Terminated PHASE3
Mar 2025 — Sep 2025 [monthly]

Terminated PHASE3
Oct 2024 — Mar 2025 [monthly]

Terminated PHASE3
Sep 2024 — Oct 2024 [monthly]

Terminated PHASE3
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE3

▶ Show 19 earlier versions

Mar 2024 — Jul 2024 [monthly]

Terminated PHASE3

Status: Active Not Recruiting → Terminated
May 2023 — Mar 2024 [monthly]

Active Not Recruiting PHASE3
Jan 2023 — May 2023 [monthly]

Active Not Recruiting PHASE3
Dec 2022 — Jan 2023 [monthly]

Active Not Recruiting PHASE3
Nov 2022 — Dec 2022 [monthly]

Active Not Recruiting PHASE3
Sep 2022 — Nov 2022 [monthly]

Active Not Recruiting PHASE3
Jun 2022 — Sep 2022 [monthly]

Active Not Recruiting PHASE3
May 2022 — Jun 2022 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Mar 2022 — May 2022 [monthly]

Recruiting PHASE3
Jan 2022 — Mar 2022 [monthly]

Recruiting PHASE3
Dec 2021 — Jan 2022 [monthly]

Recruiting PHASE3
Oct 2021 — Dec 2021 [monthly]

Recruiting PHASE3
Sep 2021 — Oct 2021 [monthly]

Recruiting PHASE3
Jun 2021 — Sep 2021 [monthly]

Recruiting PHASE3
May 2021 — Jun 2021 [monthly]

Recruiting PHASE3
Feb 2021 — May 2021 [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Jan 2021 — Feb 2021 [monthly]

Not Yet Recruiting PHASE3
Dec 2020 — Jan 2021 [monthly]

Not Yet Recruiting PHASE3
Nov 2020 — Dec 2020 [monthly]

Not Yet Recruiting PHASE3

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

GlaxoSmithKline

Data source: GlaxoSmithKline

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

Study Locations

Albuquerque, United States , Aravaca, Spain , Arlington, United States , Austin, United States , Bangkok, Thailand , Barcelona, Spain , Bari, Italy , Barranquilla, Colombia , Bilbao, Spain , Birmingham, United States and 124 more locations