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
Public ClinicalTrials.gov record NCT04605159. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study was to evaluate the ability of a single dose of the investigational RSV Maternal vaccine, administered intramuscularly (IM) to pregnant women aged 18-49 years, in good general maternal health, in preventing medically assessed RSV associated Lower Respiratory Tract Illnesses (LRTIs) in infants born to vaccinated mothers. The study also evaluated the safety of the investigational RSV Maternal vaccine both in vaccinated mothers and in their corresponding infant. 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. Ongoing study participants at that time continued to be monitored as part of the study.
Study identification
- NCT ID
- NCT04605159
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 11,194 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 49 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 20, 2020 (Actual)
- Primary completion
- Jun 14, 2023 (Actual)
- Completion
- Jun 14, 2023 (Actual)
- Last update posted
- Feb 20, 2025
2020 – 2023
United States locations
- U.S. sites
- 41
- U.S. states
- 15
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35205 | — |
| GSK Investigational Site | Dothan | Alabama | 36305 | — |
| GSK Investigational Site | Mobile | Alabama | 36608 | — |
| GSK Investigational Site | Phoenix | Arizona | 85006 | — |
| GSK Investigational Site | Tucson | Arizona | 85712 | — |
| GSK Investigational Site | Burbank | California | 91506 | — |
| GSK Investigational Site | Los Angeles | California | 90057 | — |
| GSK Investigational Site | Miami | Florida | 33174 | — |
| GSK Investigational Site | Blackfoot | Idaho | 83221 | — |
| GSK Investigational Site | Idaho Falls | Idaho | 83404 | — |
| GSK Investigational Site | Nampa | Idaho | 83686 | — |
| GSK Investigational Site | Nampa | Idaho | 83687 | — |
| GSK Investigational Site | Covington | Louisiana | 70433 | — |
| GSK Investigational Site | Lafayette | Louisiana | 70508 | — |
| GSK Investigational Site | Slidell | Louisiana | 70458 | — |
| GSK Investigational Site | Detroit | Michigan | 48201 | — |
| GSK Investigational Site | Saginaw | Michigan | 48604 | — |
| GSK Investigational Site | Missoula | Montana | 59804 | — |
| GSK Investigational Site | Grand Island | Nebraska | 68803 | — |
| GSK Investigational Site | Lincoln | Nebraska | 68516 | — |
| GSK Investigational Site | Albuquerque | New Mexico | 87102 | — |
| GSK Investigational Site | Englewood | Ohio | 45322 | — |
| GSK Investigational Site | Greenville | South Carolina | 29607 | — |
| GSK Investigational Site | Hendersonville | Tennessee | 29708 | — |
| GSK Investigational Site | Arlington | Texas | 75050 | — |
| GSK Investigational Site | Austin | Texas | 78705 | — |
| GSK Investigational Site | Burleson | Texas | 76028 | — |
| GSK Investigational Site | Dallas | Texas | 75231 | — |
| GSK Investigational Site | Fort Worth | Texas | 76104 | — |
| GSK Investigational Site | Georgetown | Texas | 78626 | — |
| GSK Investigational Site | Houston | Texas | 13760 | — |
| GSK Investigational Site | Houston | Texas | 77008 | — |
| GSK Investigational Site | Houston | Texas | 77058 | — |
| GSK Investigational Site | Keller | Texas | 76248 | — |
| GSK Investigational Site | Lampasas | Texas | 76550 | — |
| GSK Investigational Site | League City | Texas | 77573 | — |
| GSK Investigational Site | McAllen | Texas | 78503 | — |
| GSK Investigational Site | Mesquite | Texas | 75149 | — |
| GSK Investigational Site | Plano | Texas | 75093 | — |
| GSK Investigational Site | Weatherford | Texas | 76086 | — |
| GSK Investigational Site | Norfolk | Virginia | 68701 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 118 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04605159, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 20, 2025 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04605159 live on ClinicalTrials.gov.