Study Stopped
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.
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
2 other identifiers
interventional
11,194
24 countries
159
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2020
Typical duration for phase_3
159 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2020
CompletedFirst Posted
Study publicly available on registry
October 27, 2020
CompletedStudy Start
First participant enrolled
November 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2023
CompletedResults Posted
Study results publicly available
September 5, 2024
CompletedFebruary 20, 2025
February 1, 2025
2.6 years
October 22, 2020
June 13, 2024
February 4, 2025
Conditions
Outcome Measures
Primary Outcomes (7)
Number of Infant Participants With Medically Assessed, RSV-associated Lower Respiratory Tract Illnesses (LRTIs) of Any Severity and RSV-associated Severe LRTIs From Birth to Day 181 Post-birth
An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND a blood oxygen saturation by pulse oximetry (SpO2) lower than (\<) 95%, OR respiratory rate increase AND a confirmed RSV infection. An RSV-associated severe LRTI met the case definition of RSV-LRTI AND was additionally characterized by a SpO2 \<93%, OR lower chest wall in-drawing, OR inability to feed, OR failure to respond/unconscious. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI.
From birth to Day 181 post-birth
Number of Infant Participants With at Least One Serious Adverse Event (SAE) From Birth to Day 181 Post-birth
An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. At least one SAE = occurrence of at least one SAE regardless of intensity grade or relation to vaccination.
From birth to Day 181 post-birth
Number of Infant Participants With at Least One Adverse Event (AE) Leading to Study Withdrawal From Birth to Day 181 Post-birth
A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. Participants who were withdrawn from the study because of AEs were clearly distinguished from participants who were withdrawn for other reasons. Investigators followed participants who were withdrawn from the study as a result of an AE until the event was resolved. At least one AE leading to study withdrawal = occurrence of at least one AE leading to study withdrawal regardless of intensity grade or relation to vaccination.
From birth to Day 181 post-birth
Number of Infant Participants With at Least One Medically Attended AE (MAE) From Birth to Day 181 Post-birth
An MAE is defined as an unsolicited AE, such as a symptom or illness, which required hospitalization, or emergency room visit, or visit to/by a health care provider. At least one MAE = occurrence of at least one MAE regardless of intensity grade or relation to vaccination.
From birth to Day 181 post-birth
Number of Infant Participants With at Least One SAE From Birth to Day 366 Post-birth
An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect or resulted in other situations that were considered serious per medical or scientific judgment. At least one SAE = occurrence of at least one SAE regardless of intensity grade or relation to vaccination.
From birth to Day 366 post-birth
Number of Infant Participants With at Least One AE Leading to Study Withdrawal From Birth to Day 366 Post-birth
A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact. Participants who were withdrawn from the study because of AEs were clearly distinguished from participants who were withdrawn for other reasons. Investigators followed participants who were withdrawn from the study as a result of an AE until the event was resolved. At least one AE leading to study withdrawal = occurrence of at least one AE leading to study withdrawal regardless of intensity grade or relation to vaccination.
From birth to Day 366 post-birth
Number of Infant Participants With at Least One MAE From Birth to Day 366 Post-birth
An MAE is defined as an unsolicited AE, such as a symptom or illness, which required hospitalization, or emergency room visit, or visit to/by a health care provider. At least one MAE = occurrence of at least one MAE regardless of intensity grade or relation to vaccination.
From birth to Day 366 post-birth
Secondary Outcomes (30)
Number of Infant Participants With RSV-associated Hospitalizations From Birth to Day 181 Post-birth
From birth to Day 181 post-birth
Number of Infant Participants With All-cause LRTIs From Birth to Day 181 Post-birth
From birth to Day 181 post-birth
Number of Infant Participants With All-cause LRTIs With Hospitalization From Birth to Day 181 Post-birth
From birth to Day 181 post-birth
Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs From Birth to Day 366 Post-birth
From birth to Day 366 post-birth
Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity From Birth to Day 366 Post-birth
From birth to Day 366 post-birth
- +25 more secondary outcomes
Study Arms (4)
RSV MAT Group - Mother
EXPERIMENTALMaternal participants received a single dose of the RSV MAT vaccine administered at Day 1 in this study.
Placebo Group - Mother
PLACEBO COMPARATORMaternal participants received a single dose of placebo administered at Day 1 in this study.
RSV MAT Group - Infant
NO INTERVENTIONThis group consisted of infants born to mothers (from RSV MAT Group - Mother) who received a single dose of RSV MAT vaccine during pregnancy.
Placebo Group - Infant
NO INTERVENTIONThis group consisted of infants born to mothers (from Placebo Group - Mother) who received a single dose of placebo during pregnancy.
Interventions
One dose of RSV MAT vaccine reconstituted with NaCl solution, administered intramuscularly in the non-dominant arm at Day 1.
One dose of placebo (lyophilized sucrose reconstituted with NaCl solution) administered intramuscularly in the non-dominant arm at Day 1.
Eligibility Criteria
You may qualify if:
- Maternal participants
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Participants who give written or witnessed/thumb printed informed consent after the study has been explained, and before any study specific procedures are performed, as per local regulations regulatory requirements.
- Age 18 to 49 years, inclusive, at the time of study intervention.
- Pre-pregnancy BMI 17.0 to 39.9 kg/m2, inclusive.
- In good general maternal health as established by medical history and clinical examination before entering into the study.
- Singleton pregnancy (including instances where the singleton pregnancy derives from a vanishing twin syndrome).
- At 24\^0/7 to 34\^0/7 weeks of gestation at the time of study vaccination (Visit 1), as established by:
- last menstrual period (LMP) date corroborated by first or second trimester ultrasound examination (U/S) i.e. at or before 28 weeks of gestation.
- st or 2nd trimester U/S only, if LMP is unknown/uncertain
- Certain LMP, corroborated by an U/S performed after 28 weeks of gestation is also acceptable.
- No fetal genetic abnormalities (based on genetic testing, if performed).
- No significant congenital malformations, as assessed by fetal anomaly ultrasound scan conducted at or beyond 18 weeks of gestation.
- Willing to provide cord blood.
- Who do not plan to give their child for adoption.
- +5 more criteria
You may not qualify if:
- Maternal participants Medical conditions
- History of allergic disease or reactions likely to be exacerbated by any component of the RSV vaccine
- Hypersensitivity to latex
- Significant complications in the current pregnancy:
- Gestational hypertension unless blood pressure it is controlled and maintained in the normal range (\<140mmHg and \<90mmHg) through diet and/or antihypertensive medications
- Gestational diabetes not controlled by medication, diet and/or exercise
- Pre-eclampsia
- Eclampsia
- Intrauterine Growth Restriction/Fetal Growth Restriction
- Placenta previa
- Placental abruption, placenta accreta/percreta/increta, chorioamnionitis or any abnormalities that can impair the maternal-fetal circulation
- Polyhydramnios
- Oligohydramnios
- Preterm labour or history of preterm labour in the current pregnancy
- Any intervention to prevent preterm delivery or medical treatment for suspected preterm delivery, including administration of systemic corticosteroids for fetal lung maturation
- +37 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (159)
GSK Investigational Site
Birmingham, Alabama, 35205, United States
GSK Investigational Site
Dothan, Alabama, 36305, United States
GSK Investigational Site
Mobile, Alabama, 36608, United States
GSK Investigational Site
Phoenix, Arizona, 85006, United States
GSK Investigational Site
Tucson, Arizona, 85712, United States
GSK Investigational Site
Burbank, California, 91506, United States
GSK Investigational Site
Los Angeles, California, 90057, United States
GSK Investigational Site
Miami, Florida, 33174, United States
GSK Investigational Site
Blackfoot, Idaho, 83221, United States
GSK Investigational Site
Idaho Falls, Idaho, 83404, United States
GSK Investigational Site
Nampa, Idaho, 83686, United States
GSK Investigational Site
Nampa, Idaho, 83687, United States
GSK Investigational Site
Covington, Louisiana, 70433, United States
GSK Investigational Site
Lafayette, Louisiana, 70508, United States
GSK Investigational Site
Slidell, Louisiana, 70458, United States
GSK Investigational Site
Detroit, Michigan, 48201, United States
GSK Investigational Site
Saginaw, Michigan, 48604, United States
GSK Investigational Site
Missoula, Montana, 59804, United States
GSK Investigational Site
Grand Island, Nebraska, 68803, United States
GSK Investigational Site
Lincoln, Nebraska, 68516, United States
GSK Investigational Site
Albuquerque, New Mexico, 87102, United States
GSK Investigational Site
Englewood, Ohio, 45322, United States
GSK Investigational Site
Greenville, South Carolina, 29607, United States
GSK Investigational Site
Hendersonville, Tennessee, 29708, United States
GSK Investigational Site
Arlington, Texas, 75050, United States
GSK Investigational Site
Austin, Texas, 78705, United States
GSK Investigational Site
Burleson, Texas, 76028, United States
GSK Investigational Site
Dallas, Texas, 75231, United States
GSK Investigational Site
Fort Worth, Texas, 76104, United States
GSK Investigational Site
Georgetown, Texas, 78626, United States
GSK Investigational Site
Houston, Texas, 13760, United States
GSK Investigational Site
Houston, Texas, 77008, United States
GSK Investigational Site
Houston, Texas, 77058, United States
GSK Investigational Site
Keller, Texas, 76248, United States
GSK Investigational Site
Lampasas, Texas, 76550, United States
GSK Investigational Site
League City, Texas, 77573, United States
GSK Investigational Site
McAllen, Texas, 78503, United States
GSK Investigational Site
Mesquite, Texas, 75149, United States
GSK Investigational Site
Plano, Texas, 75093, United States
GSK Investigational Site
Weatherford, Texas, 76086, United States
GSK Investigational Site
Norfolk, Virginia, 68701, United States
GSK Investigational Site
Buenos Aires, 1425, Argentina
GSK Investigational Site
Ciudad AutOnoma de Buenos Aire, C1141ACG, Argentina
GSK Investigational Site
Ciudad AutOnoma de Buenos Aire, C1425EFD, Argentina
GSK Investigational Site
Córdoba, 5800, Argentina
GSK Investigational Site
San Miguel de Tucumán, T4000IHE, Argentina
GSK Investigational Site
South Brisbane, Queensland, 4101, Australia
GSK Investigational Site
Southport, Queensland, 4215, Australia
GSK Investigational Site
Clayton, Victoria, 3168, Australia
GSK Investigational Site
Geelong, Victoria, 3220, Australia
GSK Investigational Site
Nedlands, Western Australia, 6009, Australia
GSK Investigational Site
Matlab, Bangladesh
GSK Investigational Site
Sylhet, 3100, Bangladesh
GSK Investigational Site
Genk, 3600, Belgium
GSK Investigational Site
Ghent, 9000, Belgium
GSK Investigational Site
Kortrijk, 8500, Belgium
GSK Investigational Site
Leuven, 3000, Belgium
GSK Investigational Site
Sint-Niklaas, 9100, Belgium
GSK Investigational Site
Caxias do Sul, 95070-560, Brazil
GSK Investigational Site
Nova Iguaçu, 26030-380, Brazil
GSK Investigational Site
Porto Alegre, 90035001, Brazil
GSK Investigational Site
RibeirAo PretoSP, 14048-900, Brazil
GSK Investigational Site
Santa Maria, 97105-900, Brazil
GSK Investigational Site
São José do Rio Preto, 15090-000, Brazil
GSK Investigational Site
Halifax, Nova Scotia, B3K 6R8, Canada
GSK Investigational Site
Kingston, Ontario, K7L 2V7, Canada
GSK Investigational Site
Montreal, Quebec, H3T 1C5, Canada
GSK Investigational Site
Québec, Quebec, G1V 4G2, Canada
GSK Investigational Site
Barranquilla, 760002, Colombia
GSK Investigational Site
Bogotá, 110111, Colombia
GSK Investigational Site
Cali Colombia, 760042, Colombia
GSK Investigational Site
Chía, 250001, Colombia
GSK Investigational Site
Medellín, 110111, Colombia
GSK Investigational Site
Medellín, 50042, Colombia
GSK Investigational Site
Santo Domingo Este, Dominican Republic
GSK Investigational Site
Helsinki, 00290, Finland
GSK Investigational Site
Kokkola, 67100, Finland
GSK Investigational Site
Oulu, 90220, Finland
GSK Investigational Site
Tampere, 33100, Finland
GSK Investigational Site
Turku, 20520, Finland
GSK Investigational Site
Bordeaux, 33000, France
GSK Investigational Site
Clermont-Ferrand, 63100, France
GSK Investigational Site
Montpellier, 34295, France
GSK Investigational Site
Paris, 75679, France
GSK Investigational Site
Pierre-Bénite, 69495, France
GSK Investigational Site
Comayagua, Honduras
GSK Investigational Site
San Pedro Sula, 21101, Honduras
GSK Investigational Site
Kolkata, 700017, India
GSK Investigational Site
Mangalore, 575001, India
GSK Investigational Site
Mysore, 570015, India
GSK Investigational Site
Nagpur, 441108, India
GSK Investigational Site
Pune, 411043, India
GSK Investigational Site
Vadu Budruk Pune, 412216, India
GSK Investigational Site
Bari, 70124, Italy
GSK Investigational Site
Messina, 98124, Italy
GSK Investigational Site
Milan, 20122, Italy
GSK Investigational Site
Milan, 20142, Italy
GSK Investigational Site
Milan, 20154, Italy
GSK Investigational Site
Milan, 20162, Italy
GSK Investigational Site
Novara, 28100, Italy
GSK Investigational Site
Palermo, 90127, Italy
GSK Investigational Site
Prato, 59100, Italy
GSK Investigational Site
Verona, 37126, Italy
GSK Investigational Site
Chihuahua City, 31000, Mexico
GSK Investigational Site
Monterrey, 64460, Mexico
GSK Investigational Site
Monterrey, 64570, Mexico
GSK Investigational Site
Morelia, 58260, Mexico
GSK Investigational Site
Oaxaca City, 68000, Mexico
GSK Investigational Site
San Juan del Río, 76800, Mexico
GSK Investigational Site
San Luis Potosí City, 78200, Mexico
GSK Investigational Site
Grafton Auckland, 1010, New Zealand
GSK Investigational Site
Papatoetoe Auckland, 1701, New Zealand
GSK Investigational Site
Wellington, 6021, New Zealand
GSK Investigational Site
Panama City, 0801, Panama
GSK Investigational Site
Panama City, 1001, Panama
GSK Investigational Site
Panama City, 32401, Panama
GSK Investigational Site
Panama City, 7096, Panama
GSK Investigational Site
Cavite, 4114, Philippines
GSK Investigational Site
Manila, 1000, Philippines
GSK Investigational Site
Manila, 1008, Philippines
GSK Investigational Site
Johannesburg, 2112, South Africa
GSK Investigational Site
Pretoria, 0184, South Africa
GSK Investigational Site
Soshanguve, 0152, South Africa
GSK Investigational Site
Soweto, 2117, South Africa
GSK Investigational Site
Daegu, 42601, South Korea
GSK Investigational Site
Seoul, 08308, South Korea
GSK Investigational Site
Seoul, 3080, South Korea
GSK Investigational Site
Aravaca, 28023, Spain
GSK Investigational Site
Barcelona, 08028, Spain
GSK Investigational Site
Barcelona, 08035, Spain
GSK Investigational Site
Barcelona, 08950, Spain
GSK Investigational Site
Bilbao, 48013, Spain
GSK Investigational Site
Boadilla Del Monte Madrid, 28660, Spain
GSK Investigational Site
Burgos, 09006, Spain
GSK Investigational Site
Getafe, 28905, Spain
GSK Investigational Site
Madrid, 28007, Spain
GSK Investigational Site
Madrid, 28041, Spain
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
Madrid, 28222, Spain
GSK Investigational Site
Madrid, 28400, Spain
GSK Investigational Site
Marbella, 29603, Spain
GSK Investigational Site
Málaga, 29004, Spain
GSK Investigational Site
Málaga, 29010, Spain
GSK Investigational Site
Seville, 41013, Spain
GSK Investigational Site
Seville, 41014, Spain
GSK Investigational Site
TorrejOn Ardoz Madrid, 28850, Spain
GSK Investigational Site
Valencia, 46017, Spain
GSK Investigational Site
Valencia, 46702, Spain
GSK Investigational Site
Valladolid, 47012, Spain
GSK Investigational Site
Changhua, 500, Taiwan
GSK Investigational Site
Kaohsiung City, 833, Taiwan
GSK Investigational Site
Taichung, 40447, Taiwan
GSK Investigational Site
Taipei, 0105, Taiwan
GSK Investigational Site
Taipei, 10041, Taiwan
GSK Investigational Site
Taipei, 10449, Taiwan
GSK Investigational Site
Taoyuan District, 333, Taiwan
GSK Investigational Site
Bangkok, 10330, Thailand
GSK Investigational Site
Chiang Mai, 50200, Thailand
GSK Investigational Site
Edinburgh, EH16 4SA, United Kingdom
Related Publications (3)
Dieussaert I, Hyung Kim J, Luik S, Seidl C, Pu W, Stegmann JU, Swamy GK, Webster P, Dormitzer PR. RSV Prefusion F Protein-Based Maternal Vaccine - Preterm Birth and Other Outcomes. N Engl J Med. 2024 Mar 14;390(11):1009-1021. doi: 10.1056/NEJMoa2305478.
PMID: 38477988BACKGROUNDBanooni P, Gonik B, Epalza C, Reyes O, Madhi SA, Gomez-Go GD, Zaman K, Llapur CJ, Lopez-Medina E, Stanley T, Kantele A, Huang LM, Mussi-Pinhata MM, Dewulf J, Langley JM, Seidl C, Ota M, Kirabo M, Anspach B, Dieussaert I, Henry O, Kim JH, Picciolato M. Efficacy, immunogenicity, and safety of an investigational maternal respiratory syncytial virus prefusion F protein-based vaccine. Clin Infect Dis. 2025 Jan 29:ciaf033. doi: 10.1093/cid/ciaf033. Online ahead of print.
PMID: 39879629DERIVEDGinsburg AS, Srikantiah P. Respiratory syncytial virus: promising progress against a leading cause of pneumonia. Lancet Glob Health. 2021 Dec;9(12):e1644-e1645. doi: 10.1016/S2214-109X(21)00455-1. Epub 2021 Nov 11. No abstract available.
PMID: 34774184DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Following the decision to stop enrollment and vaccination, the study/site staff and maternal participants no longer stayed blinded.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2020
First Posted
October 27, 2020
Study Start
November 20, 2020
Primary Completion
June 14, 2023
Study Completion
June 14, 2023
Last Updated
February 20, 2025
Results First Posted
September 5, 2024
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
- Access Criteria
- Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf