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)

February 4, 2025 updated by: GlaxoSmithKline

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

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 Overview

Status

Terminated

Conditions

Respiratory Syncytial Virus Infections

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11194

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, 1425
    - GSK Investigational Site
  - Ciudad AutOnoma de Buenos Aire, Argentina, C1141ACG
    - GSK Investigational Site
  - Ciudad AutOnoma de Buenos Aire, Argentina, C1425EFD
    - GSK Investigational Site
  - Cordoba, Argentina, 5800
    - GSK Investigational Site
  - San Miguel de TucumAn, Argentina, T4000IHE
    - GSK Investigational Site
  - Tucuman, Argentina, T4000IHE
    - GSK Investigational Site
Australia
- Queensland
  - South Brisbane, Queensland, Australia, 4101
    - GSK Investigational Site
  - Southport, Queensland, Australia, 4215
    - GSK Investigational Site
- Victoria
  - Clayton, Victoria, Australia, 3168
    - GSK Investigational Site
  - Geelong, Victoria, Australia, 3220
    - GSK Investigational Site
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - GSK Investigational Site
Bangladesh
- - Matlab, Bangladesh
    - GSK Investigational Site
  - Sylhet, Bangladesh, 3100
    - GSK Investigational Site
Belgium
- - Genk, Belgium, 3600
    - GSK Investigational Site
  - Gent, Belgium, 9000
    - GSK Investigational Site
  - Kortrijk, Belgium, 8500
    - GSK Investigational Site
  - Leuven, Belgium, 3000
    - GSK Investigational Site
  - Sint-Niklaas, Belgium, 9100
    - GSK Investigational Site
Brazil
- - Caxias do Sul, Brazil, 95070-560
    - GSK Investigational Site
  - Nova IguaCu, Brazil, 26030-380
    - GSK Investigational Site
  - Porto Alegre, Brazil, 90035001
    - GSK Investigational Site
  - RibeirAo PretoSP, Brazil, 14048-900
    - GSK Investigational Site
  - SAo JosE do Rio Preto, Brazil, 15090-000
    - GSK Investigational Site
  - Santa Maria, Brazil, 97105-900
    - GSK Investigational Site
Canada
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3K 6R8
    - GSK Investigational Site
- Ontario
  - Kingston, Ontario, Canada, K7L 2V7
    - GSK Investigational Site
- Quebec
  - Montreal, Quebec, Canada, H3T 1C5
    - GSK Investigational Site
  - Quebec City, Quebec, Canada, G1V 4G2
    - GSK Investigational Site
Colombia
- - Barranquilla, Colombia, 760002
    - GSK Investigational Site
  - Bogota, Colombia, 110111
    - GSK Investigational Site
  - Cali Colombia, Colombia, 760042
    - GSK Investigational Site
  - Chia, Colombia, 250001
    - GSK Investigational Site
  - Medellin, Colombia, 50042
    - GSK Investigational Site
  - Medellin, Colombia, 110111
    - GSK Investigational Site
Dominican Republic
- - Santo Domingo Este, Dominican Republic
    - GSK Investigational Site
Finland
- - Helsinki, Finland, 00290
    - GSK Investigational Site
  - Kokkola, Finland, 67100
    - GSK Investigational Site
  - Oulu, Finland, 90220
    - GSK Investigational Site
  - Tampere, Finland, 33100
    - GSK Investigational Site
  - Turku, Finland, 20520
    - GSK Investigational Site
France
- - Bordeaux, France, 33000
    - GSK Investigational Site
  - Clermont-Ferrand Cedex 1, France, 63100
    - GSK Investigational Site
  - Montpellier cedex, France, 34295
    - GSK Investigational Site
  - Paris, France, 75679
    - GSK Investigational Site
  - Pierre BEnite, France, 69495
    - GSK Investigational Site
Honduras
- - Comayagua, Honduras
    - GSK Investigational Site
  - San Pedro Sula, Honduras, 21101
    - GSK Investigational Site
India
- - Kolkata, India, 700017
    - GSK Investigational Site
  - Mangalore, India, 575001
    - GSK Investigational Site
  - Mysore, India, 570015
    - GSK Investigational Site
  - Nagpur, India, 441108
    - GSK Investigational Site
  - Pune, India, 411043
    - GSK Investigational Site
  - Vadu Budruk Pune, India, 412216
    - GSK Investigational Site
Italy
- - Bari, Italy, 70124
    - GSK Investigational Site
  - Messina, Italy, 98124
    - GSK Investigational Site
  - Milano, Italy, 20122
    - GSK Investigational Site
  - Milano, Italy, 20162
    - GSK Investigational Site
  - Milano, Italy, 20142
    - GSK Investigational Site
  - Milano, Italy, 20154
    - GSK Investigational Site
  - Novara, Italy, 28100
    - GSK Investigational Site
  - Palermo, Italy, 90127
    - GSK Investigational Site
  - Prato, Italy, 59100
    - GSK Investigational Site
  - Verona, Italy, 37126
    - GSK Investigational Site
Korea, Republic of
- - Daegu, Korea, Republic of, 42601
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 08308
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 3080
    - GSK Investigational Site
Mexico
- - Chihuahua, Mexico, 31000
    - GSK Investigational Site
  - Monterrey, Mexico, 64460
    - GSK Investigational Site
  - Monterrey, Mexico, 64570
    - GSK Investigational Site
  - Morelia, Mexico, 58260
    - GSK Investigational Site
  - Oaxaca, Mexico, 68000
    - GSK Investigational Site
  - San Juan Del RIo, Mexico, 76800
    - GSK Investigational Site
  - San Luis PotosI, Mexico, 78200
    - GSK Investigational Site
New Zealand
- - Grafton Auckland, New Zealand, 1010
    - GSK Investigational Site
  - Papatoetoe Auckland, New Zealand, 1701
    - GSK Investigational Site
  - Wellington, New Zealand, 6021
    - GSK Investigational Site
Panama
- - Ciudad de Panama, Panama, 32401
    - GSK Investigational Site
  - Panama, Panama, 1001
    - GSK Investigational Site
  - Panama, Panama, 0801
    - GSK Investigational Site
  - Panama, Panama, 32401
    - GSK Investigational Site
  - Panama City, Panama, 7096
    - GSK Investigational Site
Philippines
- - Cavite, Philippines, 4114
    - GSK Investigational Site
  - Manila, Philippines, 1000
    - GSK Investigational Site
  - Manila, Philippines, 1008
    - GSK Investigational Site
South Africa
- - Johannesburg, South Africa, 2112
    - GSK Investigational Site
  - Pretoria, South Africa, 0184
    - GSK Investigational Site
  - Soshanguve, South Africa, 0152
    - GSK Investigational Site
  - Soweto, South Africa, 2117
    - GSK Investigational Site
Spain
- - Aravaca, Spain, 28023
    - GSK Investigational Site
  - Barcelona, Spain, 08035
    - GSK Investigational Site
  - Barcelona, Spain, 08950
    - GSK Investigational Site
  - Barcelona, Spain, 08028
    - GSK Investigational Site
  - Bilbao, Spain, 48013
    - GSK Investigational Site
  - Boadilla Del Monte Madrid, Spain, 28660
    - GSK Investigational Site
  - Burgos, Spain, 09006
    - GSK Investigational Site
  - Getafe, Spain, 28905
    - GSK Investigational Site
  - Madrid, Spain, 28041
    - GSK Investigational Site
  - Madrid, Spain, 28007
    - GSK Investigational Site
  - Madrid, Spain, 28046
    - GSK Investigational Site
  - Madrid, Spain, 28222
    - GSK Investigational Site
  - Madrid, Spain, 28400
    - GSK Investigational Site
  - Malaga, Spain, 29010
    - GSK Investigational Site
  - Malaga, Spain, 29004
    - GSK Investigational Site
  - Marbella, Spain, 29603
    - GSK Investigational Site
  - Sevilla, Spain, 41013
    - GSK Investigational Site
  - Sevilla, Spain, 41014
    - GSK Investigational Site
  - TorrejOn Ardoz Madrid, Spain, 28850
    - GSK Investigational Site
  - Valencia, Spain, 46017
    - GSK Investigational Site
  - Valencia, Spain, 46702
    - GSK Investigational Site
  - Valladolid, Spain, 47012
    - GSK Investigational Site
Taiwan
- - Changhua, Taiwan, 500
    - GSK Investigational Site
  - Kaohsiung, Taiwan, 833
    - GSK Investigational Site
  - Taichung, Taiwan, 40447
    - GSK Investigational Site
  - Taipei, Taiwan, 10041
    - GSK Investigational Site
  - Taipei, Taiwan, 10449
    - GSK Investigational Site
  - Taipei, Taiwan, 0105
    - GSK Investigational Site
  - Taoyuan, Taiwan, 333
    - GSK Investigational Site
Thailand
- - Bangkok, Thailand, 10330
    - GSK Investigational Site
  - ChiangMai, Thailand, 50200
    - GSK Investigational Site
United Kingdom
- - Edinburgh, United Kingdom, EH16 4SA
    - GSK Investigational Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35205
    - GSK Investigational Site
  - Dothan, Alabama, United States, 36305
    - GSK Investigational Site
  - Mobile, Alabama, United States, 36608
    - GSK Investigational Site
- Arizona
  - Phoenix, Arizona, United States, 85006
    - GSK Investigational Site
  - Tucson, Arizona, United States, 85712
    - GSK Investigational Site
- California
  - Burbank, California, United States, 91506
    - GSK Investigational Site
  - Los Angeles, California, United States, 90057
    - GSK Investigational Site
- Florida
  - Miami, Florida, United States, 33174
    - GSK Investigational Site
- Idaho
  - Blackfoot, Idaho, United States, 83221
    - GSK Investigational Site
  - Idaho Falls, Idaho, United States, 83404
    - GSK Investigational Site
  - Nampa, Idaho, United States, 83686
    - GSK Investigational Site
  - Nampa, Idaho, United States, 83687
    - GSK Investigational Site
- Louisiana
  - Covington, Louisiana, United States, 70433
    - GSK Investigational Site
  - Lafayette, Louisiana, United States, 70508
    - GSK Investigational Site
  - Slidell, Louisiana, United States, 70458
    - GSK Investigational Site
- Michigan
  - Detroit, Michigan, United States, 48201
    - GSK Investigational Site
  - Saginaw, Michigan, United States, 48604
    - GSK Investigational Site
- Montana
  - Missoula, Montana, United States, 59804
    - GSK Investigational Site
- Nebraska
  - Grand Island, Nebraska, United States, 68803
    - GSK Investigational Site
  - Lincoln, Nebraska, United States, 68516
    - GSK Investigational Site
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - GSK Investigational Site
- Ohio
  - Englewood, Ohio, United States, 45322
    - GSK Investigational Site
- South Carolina
  - Greenville, South Carolina, United States, 29607
    - GSK Investigational Site
- Tennessee
  - Hendersonville, Tennessee, United States, 29708
    - GSK Investigational Site
- Texas
  - Arlington, Texas, United States, 75050
    - GSK Investigational Site
  - Austin, Texas, United States, 78705
    - GSK Investigational Site
  - Burleson, Texas, United States, 76028
    - GSK Investigational Site
  - Dallas, Texas, United States, 75231
    - GSK Investigational Site
  - Fort Worth, Texas, United States, 76104
    - GSK Investigational Site
  - Georgetown, Texas, United States, 78626
    - GSK Investigational Site
  - Houston, Texas, United States, 77058
    - GSK Investigational Site
  - Houston, Texas, United States, 77008
    - GSK Investigational Site
  - Houston, Texas, United States, 13760
    - GSK Investigational Site
  - Keller, Texas, United States, 76248
    - GSK Investigational Site
  - Lampasas, Texas, United States, 76550
    - GSK Investigational Site
  - League City, Texas, United States, 77573
    - GSK Investigational Site
  - McAllen, Texas, United States, 78503
    - GSK Investigational Site
  - Mesquite, Texas, United States, 75149
    - GSK Investigational Site
  - Plano, Texas, United States, 75093
    - GSK Investigational Site
  - Weatherford, Texas, United States, 76086
    - GSK Investigational Site
- Virginia
  - Norfolk, Virginia, United States, 68701
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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.
1st 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.
Who plan to reside in the study area for at least one year after delivery.
Willing to have the infant followed-up after delivery for a period of 12 months.

Infant participants

Live-born from the study pregnancy.
If required per local regulations/guidelines, re-signed (confirmed) written or witnessed/thumb printed informed consent for study participation of the infant obtained from the infant's mother and/or father and/or LAR, before performing any study specific procedure. OR, if permitted by local regulation, documented verbal consent for infant's participation obtained from the parent(s)/LAR(s) at birth, followed by written consent obtained by (or before) Visit 2-newborn.

Exclusion Criteria:

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
Cholestasis
Other pregnancy-related complications (per investigator's judgement)
Significant structural abnormalities of the uterus or cervix
History of 2 or more prior stillbirths or neonatal deaths/history of 2 or more preterm births at ≤34 weeks gestation/3 or more consecutive spontaneous abortions
Known HIV infection (as per serological tests performed during the current pregnancy)
Known or suspected HBV or HCV infection
Known or suspected infection during the current pregnancy with Toxoplasma, Parvovirus B19, Syphilis, Zika, Rubella, Varicella, CMV or primary genital Herpes Simplex
Active infection with tuberculosis
Known or suspected impairment of the immune system
Current autoimmune disorder for which the participant has received immune-modifying therapy within 6 months before study vaccination, or plans administration through delivery
Lymphoproliferative disorder or malignancy within 5 years before study vaccination
Acute or chronic clinically significant abnormality or poorly controlled pre-existent co-morbidities or any other clinical conditions that might pose additional risk to the participant due to participation in the study
Any conditions that may interfere with participant's ability to comply with study procedures or receipt of prenatal care
Any condition which would increase the risks of study participation to the unborn infant

Prior/Concomitant therapy

Prior receipt of an RSV vaccine in the current pregnancy
Use of any investigational/non-registered product other than the study vaccine/product as described below, or planned use during the period :
For a drug, vaccine or medical device: from 29 days before the dose of study vaccine
For immunoglobulins: 3 months before the dose of study vaccine/product.

The exception to this is investigational products administered in the setting of a pandemic which may be allowed following delivery

Planned administration/administration of any vaccine from 29 days before the dose of study vaccine or planned administration through delivery, except:
Seasonal influenza vaccines, tetanus vaccines, dTpa/Tdap - alone vaccines, dTpa/Tdap vaccines that also contain other antigens, Hepatitis B vaccines, and COVID-19 vaccines all of which may be administered according to standard of care ≥15 days before or after study vaccination
Administration of immunoglobulins (except anti-Rh0D IG, which may be administered at any time), blood products or plasma derivatives within 3 months before study vaccination or planned administration through delivery
Administration of immune-modifying therapy within 6 months before the study vaccination, or planned administration through delivery. This includes but is not limited to:
Azathioprine, mycophenolate mofetil, 6-mercaptopurine, cyclosporine, tacrolimus, monoclonal or polyclonal antibodies
Prednisone ≥5 mg/day or equivalent for ≥14 days; Inhaled, intra-articular/intra-bursal and topical steroids are allowed
Corticosteroids administered for fetal lung maturation

Prior/Concurrent clinical study experience

- Concurrently participating in another clinical study, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product

Other exclusions

Alcoholism or substance use disorder within the past 24 months based on DSM-5 criteria
A local condition that precludes injection of the study vaccine/product or precludes assessment of local reactogenicity
Consanguinity of maternal participant and her partner (second degree cousins or closer)
Any study personnel or their immediate dependants, family or household members

Infant participants

Concurrently participating in another clinical study, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product
Any condition which would increase the risks of study participation to the infant
Child in care.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RSV MAT Group - Mother Maternal participants received a single dose of the RSV MAT vaccine administered at Day 1 in this study.	Biological: RSV MAT One dose of RSV MAT vaccine reconstituted with NaCl solution, administered intramuscularly in the non-dominant arm at Day 1.
Placebo Comparator: Placebo Group - Mother Maternal participants received a single dose of placebo administered at Day 1 in this study.	Drug: Placebo One dose of placebo (lyophilized sucrose reconstituted with NaCl solution) administered intramuscularly in the non-dominant arm at Day 1.
No Intervention: RSV MAT Group - Infant This group consisted of infants born to mothers (from RSV MAT Group - Mother) who received a single dose of RSV MAT vaccine during pregnancy.
No Intervention: Placebo Group - Infant This group consisted of infants born to mothers (from Placebo Group - Mother) who received a single dose of placebo during pregnancy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: 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 Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials, GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2020

Primary Completion (Actual)

June 14, 2023

Study Completion (Actual)

June 14, 2023

Study Registration Dates

First Submitted

October 22, 2020

First Submitted That Met QC Criteria

October 22, 2020

First Posted (Actual)

October 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

212171
2020-001355-40 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
ICF
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiratory Syncytial Virus Infections

Nicola Irwin
The University of New South Wales; Kirby Institute

Completed

The Impact of the 2025 Infant and Maternal Respiratory Syncytial Virus (RSV) Prevention Program on RSV-related Hospitalisations in the Australian Capital Territory

Respiratory Syncytial Virus Hospitalizations | Respiratory Syncytial Virus (RSV) Infection | Respiratory Syncytial Virus Immunization

Australia
Nicola Irwin

Completed

First Year Impact of Nirsevimab on Paediatric Respiratory Syncytial Virus Infection and Hospitalisations in the Australian Capital Territory

Respiratory Syncytial Virus Hospitalizations | Respiratory Syncytial Virus Prevention | Respiratory Syncytial Viral (RSV) Infection

Australia
Simcere Pharmaceutical Co., Ltd

Recruiting

A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and Young Children

Respiratory Syncytial Virus Infection

China
Tam Anh Research Institute

Recruiting

Genotype and Disease Burden of RSV in Older Vietnamese Adults (RSV: Respiratory Syncytial Virus ) (RSV-VN-Elderly)

Respiratory Syncytial Virus Infections | Respiratory Syncytial Virus Infection

Vietnam
Guangzhou Patronus Biotech Co., Ltd.

Active, not recruiting

A Study to Evaluate the Immunogenicity and Safety of a Recombinant Respiratory Syncytial Virus Vaccine in Older Adults Aged 60 Years and Older

Respiratory Syncytial Virus Infection Prevention

China
Eskisehir Osmangazi University

Not yet recruiting

RSV-Positive Children <5 Years Presenting to Pediatric Emergency Departments in Türkiye: TRUST-RSV (TRUST-RSV)

Pneumonia | Respiratory Syncytial Virus Infection | Upper Respiratory Tract Infection | Acute Bronchiolitis Due to Respiratory Syncytial Virus
Clover Biopharmaceuticals AUS Pty

Completed

First-in-human Safety and Immunogenicity Study of SCB-1019 and SCB-1019T in Healthy Adults

Respiratory Syncytial Virus Vaccination

Australia
Sanofi Pasteur, a Sanofi Company

Completed

Study of a Respiratory Syncytial Virus Candidate Encapsulated in a Lipid Nanoparticle Based Formulation in Adults Aged 18 to 50 Years and 60 Years and Older

Respiratory Syncytial Virus Immunization

United States, Australia, Puerto Rico
Enanta Pharmaceuticals, Inc

Not yet recruiting

A Phase 2 Study to Investigate the Efficacy and Safety of Zelicapavir in Participants Aged ≥28 Days to ≤36 Months of Age Infected With Respiratory Syncytial Virus

Respiratory Syncytial Virus (RSV) | RSV Infection | RSV
National Institute of Allergy and Infectious Diseases...

Completed

The Immunology and Safety of Maternal RSV Vaccination (ABRYSVO), Infant Nirsevimab (BEYFORTUS) Immunization, or Both Products

Respiratory Syncytial Virus Infection

United States

Clinical Trials on RSV MAT

GlaxoSmithKline

Completed

Study of Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline's (GSK)Respiratory Syncytial Virus (RSV)Maternal Unadjuvanted Vaccine in Healthy Pregnant Women (Aged 18 to 40 Years) and Their Infants

Respiratory Syncytial Virus Infections

United States, Spain, Canada, Finland, Panama, South Africa, New Zealand, Australia, France
GlaxoSmithKline

Withdrawn

A Study of Safety, Reactogenicity and Immune Response of the Repeat Vaccination Against RSV When Given to Female Participants of 18-49 Years of Age During Their Subsequent Uncomplicated Pregnancy

Respiratory Syncytial Virus Infections

United States
GlaxoSmithKline

Terminated

A Study on the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine, in High Risk Pregnant Women Aged 15 to 49 Years and Infants Born to the Vaccinated Mothers

Respiratory Syncytial Virus Infections

United States, Spain, Canada, Finland, India, Panama, Italy, Brazil, South Africa
GlaxoSmithKline

Completed

A Study to Evaluate the Safety and Immune Response to an Unadjuvanted RSV Maternal Vaccine in Healthy Non-pregnant Females From 9 to 49 Years of Age

Respiratory Syncytial Virus Infections

United States
Gulhane School of Medicine

Not yet recruiting

Acupressure Mat on Perceived Stress, Sleep Quality and Premenstrual Symptoms

Premenstrual Symptoms | Effect of Acupressure Mat
Sanofi Pasteur, a Sanofi Company

Completed

Study to Evaluate the Safety and Immune Response of an Investigational Vaccine for the Prevention of RSV (Respiratory Syncytial Virus) and (hMPV) Human Metapneumovirus Infection in Participants Aged 60 to 75 Years

RSV Infection | hMPV

Australia
California Institute of Integral Studies

Not yet recruiting

The Grounded Brain: How Sleeping Grounded Affects Memory and Perceptions

Mild Cognitive Impairment | Chronic Inflammation
MedImmune LLC

Completed

A Study to Evaluate the Safety of the Respiratory Syncytial Virus Vaccine MEDI7510 in Older Adults

Respiratory Syncytial Virus (RSV)

United States
Yale University
National Institutes of Health (NIH)

Recruiting

Culturally Responsive Community Driven Substance Use Recovery for Black and Latinx Population (IMANI U)

Substance Use | Medication Assisted Treatment | Opioid Use | Mental Health Issue

United States
Spaarne Gasthuis
Flevoziekenhuis; Ziekenhuis Amstelland; OLVG; Gelre Hospitals; Medisch Spectrum Twente

Not yet recruiting

Multifactorial Approach Training for Anterior Shoulder Instability in Patients Undergoing Arthroscopic Bankart Repair (MATASI)

Shoulder Instability | Kinesiophobia | Shoulder Dislocation or Subluxation | Fear of Movement

Outcome Measure	Measure Description	Time Frame
Number of Infant Participants With RSV-associated Hospitalizations From Birth to Day 181 Post-birth Time Frame: From birth to Day 181 post-birth	RSV-associated hospitalization is defined as a confirmed RSV infection and hospitalized for acute medical condition. Hospitalization is defined as admission for observation or treatment based on the judgment of a health care provider.	From birth to Day 181 post-birth
Number of Infant Participants With All-cause LRTIs From Birth to Day 181 Post-birth Time Frame: From birth to Day 181 post-birth	All-cause LRTI was characterized by history of cough OR difficulty in breathing, AND SpO2 < 95%, OR respiratory rate increase.	From birth to Day 181 post-birth
Number of Infant Participants With All-cause LRTIs With Hospitalization From Birth to Day 181 Post-birth Time Frame: From birth to Day 181 post-birth	All-cause LRTI was characterized by history of cough OR difficulty in breathing, AND SpO2 < 95%, OR respiratory rate increase. Hospitalization is defined as admission for observation or treatment based on the judgment of a health care provider.	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 Time Frame: From birth to Day 366 post-birth	An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 <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 an 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 366 post-birth
Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity From Birth to Day 366 Post-birth Time Frame: From birth to Day 366 post-birth	An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 <95%, OR respiratory rate increase AND a confirmed RSV infection. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI.	From birth to Day 366 post-birth
Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs for RSV Subtype A and RSV Subtype B Separately From Birth to Day 181 Post-birth Time Frame: 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 an SpO2 <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 an 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. The RSV subtypes assessed for this analysis were RSV subtype A and RSV subtype B.	From birth to Day 181 post-birth
Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity for RSV Subtype A and RSV Subtype B Separately From Birth to Day 181 Post-birth Time Frame: 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 an SpO2 <95%, OR respiratory rate increase AND a confirmed RSV infection. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI. The RSV subtypes assessed for this analysis were RSV subtype A and RSV subtype B.	From birth to Day 181 post-birth
Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs From Birth to Day 121 Post-birth Time Frame: From birth to Day 121 post-birth	An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 <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 an 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 121 post-birth
Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity From Birth to Day 121 Post-birth Time Frame: From birth to Day 121 post-birth	An RSV-associated LRTI of any severity was characterized by a history of cough OR difficulty in breathing, AND an SpO2 <95%, OR respiratory rate increase AND a confirmed RSV infection. Medically assessed = the infant was evaluated by a healthcare professional for the LRTI.	From birth to Day 121 post-birth
Number of Infant Participants With All-cause Pneumonia From Birth to Day 181 Post-birth Time Frame: From birth to Day 181 post-birth	The number of infant participants with all-cause pneumonia is presented in this outcome measure.	From birth to Day 181 post-birth
Number of Infant Participants With RSV-associated Hospitalizations From Birth to Day 366 Post-birth Time Frame: From birth to Day 366 post-birth	RSV-associated hospitalization is defined as a confirmed RSV infection and hospitalized for acute medical condition. Hospitalization is defined as admission for observation or treatment based on the judgment of a health care provider.	From birth to Day 366 post-birth
Number of Maternal Participants With RSV-associated Medically Attended RTIs (RSV-MA-RTIs) From Study Intervention Administration (Day 1) to Day 181 Post-delivery Time Frame: From study intervention administration (Day 1) to Day 181 post-delivery	RSV-associated MA-RTI is defined as a medically attended visit for RTI symptoms and confirmed RSV infection.	From study intervention administration (Day 1) to Day 181 post-delivery
RSV-A Neutralizing Antibody Titers for Maternal Participants at Day 1, at Day 31 and at Delivery Time Frame: At Day 1 (before study intervention administration), at Day 31 and at delivery	RSV-A neutralizing titers were determined by neutralization assay and expressed as geometric mean titers (GMTs).	At Day 1 (before study intervention administration), at Day 31 and at delivery
RSV-A Neutralizing Antibody Titers for Infant Participants at Delivery or Within 72 Hours After Birth Time Frame: At delivery or within 72 hours after birth	RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs. The titers were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 72 hours after birth (if no cord blood sample could be obtained).	At delivery or within 72 hours after birth
RSV-A Neutralizing Antibody Titers for Infant Participants at Day 43 Post-birth Time Frame: At Day 43 post-birth	RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs.	At Day 43 post-birth
RSV-A Neutralizing Antibody Titers for Infant Participants at Day 121 Post-birth Time Frame: At Day 121 post-birth	RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs.	At Day 121 post-birth
RSV-A Neutralizing Antibody Titers for Infant Participants at Day 181 Post-birth Time Frame: At Day 181 post-birth	RSV-A neutralizing titers were determined by neutralization assay and expressed as GMTs.	At Day 181 post-birth
RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations for Maternal Participants at Delivery Time Frame: At delivery	RSV MAT IgG-specific antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (ELU/mL).	At delivery
RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Delivery or Within 72 Hours After Birth Time Frame: At delivery or within 72 hours after birth (only if no cord blood sample could be obtained at delivery)	RSV MAT IgG-specific antibody concentrations were determined by ELISA and expressed as GMCs in ELU/mL. The antibody concentrations were measured on the cord blood sample collected at delivery, or on a blood sample collected from the infant within 72 hours after birth (only if no cord blood sample could be obtained at delivery).	At delivery or within 72 hours after birth (only if no cord blood sample could be obtained at delivery)
Geometric Mean Ratio (GMR) Between Cord Blood and Maternal RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations Time Frame: At delivery (for maternal participants) or within 72 hours after birth (for infant participants, only if no cord blood could be obtained)	The placental transfer ratio of RSV-MAT IgG-specific antibody concentration was determined from cord blood over that of the blood sample from mother at delivery. If no cord blood could be obtained, an infant blood sample was collected 72 hours after birth.	At delivery (for maternal participants) or within 72 hours after birth (for infant participants, only if no cord blood could be obtained)
Number of Maternal Participants With Any Solicited Administration Site Events From Day 1 to Day 7 Included Time Frame: From Day 1 to Day 7 included	Assessed solicited administration site events included erythema, pain and swelling at the injection site. Any pain = occurrence of the symptom regardless of intensity grade. Any erythema and swelling = symptom reported with a surface diameter greater than or equal to 20 millimeters.	From Day 1 to Day 7 included
Number of Maternal Participants With Any Solicited Systemic Events From Day 1 to Day 7 Included Time Frame: From Day 1 to Day 7 included	Assessed solicited systemic events included abdominal pain, diarrhea, fatigue, headache, nausea, fever [temperature equal to or above (>=) 38 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F), regardless of the location of measurement] and vomiting. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination.	From Day 1 to Day 7 included
Number of Maternal Participants With Any Unsolicited AEs From Day 1 to Day 30 Included Time Frame: From Day 1 to Day 30 included	An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Any = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.	From Day 1 to Day 30 included
Number of Maternal Participants With at Least One SAE From Day 1 to Day 181 Post-delivery Time Frame: From Day 1 to Day 181 post-delivery	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 in the offspring of a study participant or resulted in abnormal pregnancy outcomes or 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 Day 1 to Day 181 post-delivery
Number of Maternal Participants With at Least One AE Leading to Study Withdrawal From Day 1 to Day 181 Post-delivery Time Frame: From Day 1 to Day 181 post-delivery	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 Day 1 to Day 181 post-delivery
Number of Maternal Participants With at Least One All-cause MA-RTI From Day 1 to Day 181 Post-delivery Time Frame: From Day 1 to Day 181 post-delivery	All-cause MA-RTI occurred when the maternal participant visited a healthcare professional (e.g., a General Practitioner) for any respiratory symptom, including (but not limited to) cough, sore throat, sputum production and difficulty breathing. At least one all-cause MA-RTI = occurrence of at least one all-cause MA-RTI regardless of intensity grade or relation to vaccination.	From Day 1 to Day 181 post-delivery
Number of Maternal Participants With at Least One MAE From Day 1 to Day 42 Post-delivery Time Frame: From Day 1 to Day 42 post-delivery, an average of 2 months	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 Day 1 to Day 42 post-delivery, an average of 2 months
Number of Maternal Participants With Pregnancy Outcomes From Day 1 to Day 42 Post-delivery Time Frame: From Day 1 to Day 42 post-delivery, an average of 2 months	Assessed pregnancy outcomes included live birth with no congenital anomalies, live birth with minor congenital anomaly(ies), live birth with at least 1 major congenital anomaly, fetal death/still birth with no congenital anomalies, fetal death/still birth with at least 1 major congenital anomaly and unknown outcome (includes participants withdrawn before/at delivery with no available data of pregnancy outcomes).	From Day 1 to Day 42 post-delivery, an average of 2 months
Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery Time Frame: From Day 1 to Day 42 post-delivery, an average of 2 months	Pregnancy-related AESIs included chorioamnionitis, fetal growth restriction, gestational diabetes mellitus, gestational hypertension, pre-eclampsia, pre-eclampsia with severe features including eclampsia, maternal death, premature preterm rupture of membranes, preterm labor, provider-initiated preterm birth.	From Day 1 to Day 42 post-delivery, an average of 2 months
Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth Time Frame: From birth to Day 42 post-birth, an average of 2 months	Neonatal/infant AESIs included congenital anomalies with functional defects, congenital anomalies with internal structural defects, congenital anomalies with major external structural defects, extremely low birth weight (<1000 grams), low birth weight (<2500 grams), very low birth weight (<1500 grams), neonatal death in a preterm live birth (gestational age >=28 and <37 weeks), neonatal death in a term live birth (>=37 weeks of gestational age), neonatal death in an extremely pre-term birth (gestational age >=22 and <28 weeks), preterm birth (<37 weeks of gestational age), small for gestational age.	From birth to Day 42 post-birth, an average of 2 months

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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Respiratory Syncytial Virus Infections

Clinical Trials on RSV MAT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations