Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Respiratory Syncytial Virus Infections
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2020-10-27
Enrollment: 11194
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: From birth to Day 181 post-birth
measure: Number of Infant Participants With at Least One Serious Adverse Event (SAE) From Birth to Day 181 Post-birth
timeFrame: From birth to Day 181 post-birth
measure: Number of Infant Participants With at Least One Adverse Event (AE) Leading to Study Withdrawal From Birth to Day 181 Post-birth
timeFrame: From birth to Day 181 post-birth
measure: Number of Infant Participants With at Least One Medically Attended AE (MAE) From Birth to Day 181 Post-birth
timeFrame: From birth to Day 181 post-birth
measure: Number of Infant Participants With at Least One SAE From Birth to Day 366 Post-birth
timeFrame: From birth to Day 366 post-birth
measure: Number of Infant Participants With at Least One AE Leading to Study Withdrawal From Birth to Day 366 Post-birth
timeFrame: From birth to Day 366 post-birth
measure: Number of Infant Participants With at Least One MAE From Birth to Day 366 Post-birth
timeFrame: From birth to Day 366 post-birth
Secondary outcomes:
measure: Number of Infant Participants With RSV-associated Hospitalizations From Birth to Day 181 Post-birth
timeFrame: From birth to Day 181 post-birth
measure: Number of Infant Participants With All-cause LRTIs From Birth to Day 181 Post-birth
timeFrame: From birth to Day 181 post-birth
measure: Number of Infant Participants With All-cause LRTIs With Hospitalization From Birth to Day 181 Post-birth
timeFrame: From birth to Day 181 post-birth
measure: Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs From Birth to Day 366 Post-birth
timeFrame: From birth to Day 366 post-birth
measure: Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity From Birth to Day 366 Post-birth
timeFrame: From birth to Day 366 post-birth
measure: 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
timeFrame: From birth to Day 181 post-birth
measure: 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
timeFrame: From birth to Day 181 post-birth
measure: Number of Infant Participants With Medically Assessed, RSV-associated Severe LRTIs From Birth to Day 121 Post-birth
timeFrame: From birth to Day 121 post-birth
measure: Number of Infant Participants With Medically Assessed, RSV-associated LRTIs of Any Severity From Birth to Day 121 Post-birth
timeFrame: From birth to Day 121 post-birth
measure: Number of Infant Participants With All-cause Pneumonia From Birth to Day 181 Post-birth
timeFrame: From birth to Day 181 post-birth
measure: Number of Infant Participants With RSV-associated Hospitalizations From Birth to Day 366 Post-birth
timeFrame: From birth to Day 366 post-birth
measure: Number of Maternal Participants With RSV-associated Medically Attended RTIs (RSV-MA-RTIs) From Study Intervention Administration (Day 1) to Day 181 Post-delivery
timeFrame: From study intervention administration (Day 1) to Day 181 post-delivery
measure: RSV-A Neutralizing Antibody Titers for Maternal Participants at Day 1, at Day 31 and at Delivery
timeFrame: At Day 1 (before study intervention administration), at Day 31 and at delivery
measure: RSV-A Neutralizing Antibody Titers for Infant Participants at Delivery or Within 72 Hours After Birth
timeFrame: At delivery or within 72 hours after birth
measure: RSV-A Neutralizing Antibody Titers for Infant Participants at Day 43 Post-birth
timeFrame: At Day 43 post-birth
measure: RSV-A Neutralizing Antibody Titers for Infant Participants at Day 121 Post-birth
timeFrame: At Day 121 post-birth
measure: RSV-A Neutralizing Antibody Titers for Infant Participants at Day 181 Post-birth
timeFrame: At Day 181 post-birth
measure: RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations for Maternal Participants at Delivery
timeFrame: At delivery
measure: RSV MAT IgG-specific Antibody Concentrations for Infant Participants at Delivery or Within 72 Hours After Birth
timeFrame: At delivery or within 72 hours after birth (only if no cord blood sample could be obtained at delivery)
measure: Geometric Mean Ratio (GMR) Between Cord Blood and Maternal RSV MAT Immunoglobulin G (IgG)-Specific Antibody Concentrations
timeFrame: At delivery (for maternal participants) or within 72 hours after birth (for infant participants, only if no cord blood could be obtained)
measure: Number of Maternal Participants With Any Solicited Administration Site Events From Day 1 to Day 7 Included
timeFrame: From Day 1 to Day 7 included
measure: Number of Maternal Participants With Any Solicited Systemic Events From Day 1 to Day 7 Included
timeFrame: From Day 1 to Day 7 included
measure: Number of Maternal Participants With Any Unsolicited AEs From Day 1 to Day 30 Included
timeFrame: From Day 1 to Day 30 included
measure: Number of Maternal Participants With at Least One SAE From Day 1 to Day 181 Post-delivery
timeFrame: From Day 1 to Day 181 post-delivery
measure: Number of Maternal Participants With at Least One AE Leading to Study Withdrawal From Day 1 to Day 181 Post-delivery
timeFrame: From Day 1 to Day 181 post-delivery
measure: Number of Maternal Participants With at Least One All-cause MA-RTI From Day 1 to Day 181 Post-delivery
timeFrame: From Day 1 to Day 181 post-delivery
measure: Number of Maternal Participants With at Least One MAE From Day 1 to Day 42 Post-delivery
timeFrame: From Day 1 to Day 42 post-delivery, an average of 2 months
measure: Number of Maternal Participants With Pregnancy Outcomes From Day 1 to Day 42 Post-delivery
timeFrame: From Day 1 to Day 42 post-delivery, an average of 2 months
measure: Number of Maternal Participants With Pregnancy-related Adverse Events of Special Interest (AESIs) From Day 1 to Day 42 Post-delivery
timeFrame: From Day 1 to Day 42 post-delivery, an average of 2 months
measure: Number of Infant Participants With Neonatal AESIs From Birth to Day 42 Post-birth
timeFrame: From birth to Day 42 post-birth, an average of 2 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Dothan
country: United States
facility: GSK Investigational Site
state: Alabama
city: Mobile
country: United States
facility: GSK Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: GSK Investigational Site
state: Arizona
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Burbank
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Blackfoot
country: United States
facility: GSK Investigational Site
state: Idaho
city: Idaho Falls
country: United States
facility: GSK Investigational Site
state: Idaho
city: Nampa
country: United States
facility: GSK Investigational Site
state: Idaho
city: Nampa
country: United States
facility: GSK Investigational Site
state: Idaho
city: Covington
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Lafayette
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Slidell
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Detroit
country: United States
facility: GSK Investigational Site
state: Michigan
city: Saginaw
country: United States
facility: GSK Investigational Site
state: Michigan
city: Missoula
country: United States
facility: GSK Investigational Site
state: Montana
city: Grand Island
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Lincoln
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: Englewood
country: United States
facility: GSK Investigational Site
state: Ohio
city: Greenville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Hendersonville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Arlington
country: United States
facility: GSK Investigational Site
state: Texas
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Burleson
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: Georgetown
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Keller
country: United States
facility: GSK Investigational Site
state: Texas
city: Lampasas
country: United States
facility: GSK Investigational Site
state: Texas
city: League City
country: United States
facility: GSK Investigational Site
state: Texas
city: McAllen
country: United States
facility: GSK Investigational Site
state: Texas
city: Mesquite
country: United States
facility: GSK Investigational Site
state: Texas
city: Plano
country: United States
facility: GSK Investigational Site
state: Texas
city: Weatherford
country: United States
facility: GSK Investigational Site
state: Texas
city: Norfolk
country: United States
facility: GSK Investigational Site
state: Virginia
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Ciudad AutOnoma de Buenos Aire
country: Argentina
facility: GSK Investigational Site
city: Ciudad AutOnoma de Buenos Aire
country: Argentina
facility: GSK Investigational Site
city: Cordoba
country: Argentina
facility: GSK Investigational Site
city: San Miguel de TucumAn
country: Argentina
facility: GSK Investigational Site
city: Tucuman
country: Argentina
facility: GSK Investigational Site
city: South Brisbane
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Southport
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Clayton
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Geelong
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Nedlands
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Matlab
country: Bangladesh
facility: GSK Investigational Site
city: Sylhet
country: Bangladesh
facility: GSK Investigational Site
city: Genk
country: Belgium
facility: GSK Investigational Site
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Kortrijk
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Sint-Niklaas
country: Belgium
facility: GSK Investigational Site
city: Caxias do Sul
country: Brazil
facility: GSK Investigational Site
city: Nova IguaCu
country: Brazil
facility: GSK Investigational Site
city: Porto Alegre
country: Brazil
facility: GSK Investigational Site
city: RibeirAo PretoSP
country: Brazil
facility: GSK Investigational Site
city: Santa Maria
country: Brazil
facility: GSK Investigational Site
city: SAo JosE do Rio Preto
country: Brazil
facility: GSK Investigational Site
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Kingston
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Quebec City
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Barranquilla
country: Colombia
facility: GSK Investigational Site
city: Bogota
country: Colombia
facility: GSK Investigational Site
city: Cali Colombia
country: Colombia
facility: GSK Investigational Site
city: Chia
country: Colombia
facility: GSK Investigational Site
city: Medellin
country: Colombia
facility: GSK Investigational Site
city: Medellin
country: Colombia
facility: GSK Investigational Site
city: Santo Domingo Este
country: Dominican Republic
facility: GSK Investigational Site
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Kokkola
country: Finland
facility: GSK Investigational Site
city: Oulu
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Turku
country: Finland
facility: GSK Investigational Site
city: Bordeaux
country: France
facility: GSK Investigational Site
city: Clermont-Ferrand Cedex 1
country: France
facility: GSK Investigational Site
city: Montpellier cedex
country: France
facility: GSK Investigational Site
city: Paris
country: France
facility: GSK Investigational Site
city: Pierre BEnite
country: France
facility: GSK Investigational Site
city: Comayagua
country: Honduras
facility: GSK Investigational Site
city: San Pedro Sula
country: Honduras
facility: GSK Investigational Site
city: Kolkata
country: India
facility: GSK Investigational Site
city: Mangalore
country: India
facility: GSK Investigational Site
city: Mysore
country: India
facility: GSK Investigational Site
city: Nagpur
country: India
facility: GSK Investigational Site
city: Pune
country: India
facility: GSK Investigational Site
city: Vadu Budruk Pune
country: India
facility: GSK Investigational Site
city: Bari
country: Italy
facility: GSK Investigational Site
city: Messina
country: Italy
facility: GSK Investigational Site
city: Milano
country: Italy
facility: GSK Investigational Site
city: Milano
country: Italy
facility: GSK Investigational Site
city: Milano
country: Italy
facility: GSK Investigational Site
city: Milano
country: Italy
facility: GSK Investigational Site
city: Novara
country: Italy
facility: GSK Investigational Site
city: Palermo
country: Italy
facility: GSK Investigational Site
city: Prato
country: Italy
facility: GSK Investigational Site
city: Verona
country: Italy
facility: GSK Investigational Site
city: Daegu
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Chihuahua
country: Mexico
facility: GSK Investigational Site
city: Monterrey
country: Mexico
facility: GSK Investigational Site
city: Monterrey
country: Mexico
facility: GSK Investigational Site
city: Morelia
country: Mexico
facility: GSK Investigational Site
city: Oaxaca
country: Mexico
facility: GSK Investigational Site
city: San Juan Del RIo
country: Mexico
facility: GSK Investigational Site
city: San Luis PotosI
country: Mexico
facility: GSK Investigational Site
city: Grafton Auckland
country: New Zealand
facility: GSK Investigational Site
city: Papatoetoe Auckland
country: New Zealand
facility: GSK Investigational Site
city: Wellington
country: New Zealand
facility: GSK Investigational Site
city: Ciudad de Panama
country: Panama
facility: GSK Investigational Site
city: Panama City
country: Panama
facility: GSK Investigational Site
city: Panama
country: Panama
facility: GSK Investigational Site
city: Panama
country: Panama
facility: GSK Investigational Site
city: Panama
country: Panama
facility: GSK Investigational Site
city: Cavite
country: Philippines
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Johannesburg
country: South Africa
facility: GSK Investigational Site
city: Pretoria
country: South Africa
facility: GSK Investigational Site
city: Soshanguve
country: South Africa
facility: GSK Investigational Site
city: Soweto
country: South Africa
facility: GSK Investigational Site
city: Aravaca
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Bilbao
country: Spain
facility: GSK Investigational Site
city: Boadilla Del Monte Madrid
country: Spain
facility: GSK Investigational Site
city: Burgos
country: Spain
facility: GSK Investigational Site
city: Getafe
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Malaga
country: Spain
facility: GSK Investigational Site
city: Malaga
country: Spain
facility: GSK Investigational Site
city: Marbella
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: TorrejOn Ardoz Madrid
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valladolid
country: Spain
facility: GSK Investigational Site
city: Changhua
country: Taiwan
facility: GSK Investigational Site
city: Kaohsiung
country: Taiwan
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taoyuan
country: Taiwan
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: ChiangMai
country: Thailand
facility: GSK Investigational Site
city: Edinburgh
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Ginsburg 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.