A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.

Respiratory Tract Infection Clinical Trial

Official title:

A PHASE 3, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING PREGNANCY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04424316
• Other study ID #: C3671008
• Secondary ID: 2019-002943-85
• Status: Completed
• Phase: Phase 3
• Start date: June 17, 2020
• Est. completion date: October 27, 2023

Study information

• Verified date: March 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) in infants.

Description:

This is a Phase 3, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy, safety, and immunogenicity of RSVpreF or placebo (1:1 randomization) in infants born to healthy women vaccinated during pregnancy, as well as the safety and immunogenicity in the pregnant women. This will be a global study which will span multiple RSV seasons.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14699
• Est. completion date: October 27, 2023
• Est. primary completion date: October 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 0 Years to 49 Years

Eligibility

Inclusion Criteria - Maternal Participants:

• Healthy women =49 years of age who are between 24 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Receiving prenatal standard of care based on country requirements.
• Had a fetal anomaly ultrasound examination performed at =18 weeks of pregnancy with no significant fetal abnormalities observed.
• Determined by medical history, physical examination, and clinical judgment to be appropriate for inclusion in the study.
• Documented negative HIV antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization (Visit 1).
• Intention to deliver at a hospital or birthing facility where study procedures can be obtained.
• Expected to be available for the duration of the study and can be contacted by telephone during study participation.
• Participant is willing to give informed consent for her infant to participate in the study.
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol OR If the maternal participant is illiterate, a thumbprinted informed consent must be obtained, which must be signed and dated by an impartial witness who was present throughout the entire informed consent process confirming that the maternal participant has been informed of all pertinent aspects of the study.

Inclusion Criteria -Infant Participants:

• Evidence of a signed and dated ICD signed by the parent(s)/legal guardian(s) OR If the infant participant's maternal participant/parent(s)/legal guardian(s) is illiterate, a thumbprinted informed consent must have been obtained, which must have been signed and dated by an impartial witness who was present throughout the entire informed consent process confirming that the maternal participant/parent(s)/legal guardian(s) has been informed of all pertinent aspects of the study for herself (maternal participant) and her fetus/infant prior to taking part in the study.
• Parent(s)/legal guardian(s) willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria - Maternal Participants:

• Prepregnancy body mass index (BMI) of >40 kg/m2. If prepregnancy BMI is not available, the BMI at the time of the first obstetric visit during the current pregnancy may be used.
• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any related vaccine.
• Current pregnancy resulting from in vitro fertilization.
• Current pregnancy complications or abnormalities at the time of consent that will increase the risk associated with the participation in and completion of the study,

including but not limited to the following:

• Preeclampsia, eclampsia, or uncontrolled gestational hypertension.
• Placental abnormality.
• Polyhydramnios or oligohydramnios.
• Significant bleeding or blood clotting disorder.
• Endocrine disorders, including untreated hyperthyroidism or untreated hypothyroidism. This also includes disorders of glucose intolerance (eg, diabetes mellitus type 1 or 2) antedating pregnancy or occurring during pregnancy if uncontrolled at the time of consent.
• Any signs of premature labor with the current pregnancy or having ongoing intervention (medical/surgical) in the current pregnancy to prevent preterm birth.
• Prior pregnancy complications or abnormalities at the time of consent, based on the investigator's judgment, that will increase the risk associated with the participation

in and completion of the study, including but not limited to the following:

• Prior preterm delivery =34 weeks' gestation.
• Prior stillbirth or neonatal death.
• Previous infant with a known genetic disorder or significant congenital anomaly.
• Major illness of the maternal participant or conditions of the fetus that, in the investigator's judgment, will substantially increase the risk associated with the maternal or infant participant's participation in, and completion of, the study or could preclude the evaluation of the maternal participant's response (includes positive serologic testing for regional endemic conditions assessed during routine maternal care, as per local standards of care and obstetric recommendations).
• Congenital or acquired immunodeficiency disorder, or rheumatologic disorder or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies, within the year prior to enrollment.
• Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
• Participation in other studies involving investigational drug(s) within 28 days prior to consent and/or during study participation.
• Receipt of monoclonal antibodies within the year prior to enrollment or the use of systemic corticosteroids for >14 days within 28 days prior to study enrollment. Permitted treatments include the receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) monoclonal antibodies, prednisone doses of <20 mg/day for =14 days and, inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids.
• Current alcohol abuse or illicit drug use. Note: Marijuana use is not considered an exclusion criterion for the study when elicited in participant screening, though it may be considered illicit in some locales.
• Receipt of blood or plasma products or immunoglobulin (Ig), from 60 days before investigational product administration, or planned receipt through delivery, with 1 exception, Rho(D) immune globulin (eg, RhoGAM), which can be given at any time.
• Previous vaccination with any licensed or investigational RSV vaccine or planned. Note: Licensed COVID-19 vaccines or COVID-19 vaccines authorized for temporary or emergency use will not be prohibited during the course of this study.
• Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
• Participants who are breastfeeding at the time of enrollment. Exclusion Criteria -Infant Participants: o Infant who is a direct descendant (eg, child or grandchild) of the study personnel.

Related Conditions & MeSH terms

• Respiratory Tract Infection
• Respiratory Tract Infections

Intervention

Biological:
• RSVpreF
RSV vaccine (RSVpreF)
• Placebo
Placebo

Locations

Country	Name	City	State
Argentina	Centro de Investigación Clinica OSECAC	Buenos Aires
Argentina	Sanatorio Mater Dei	Buenos Aires
Argentina	Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich	Caba
Argentina	Clínica del Niño y la Madre	Mar del Plata	Buenos Aires
Argentina	Hospital Italiano de Rosario	Rosario	Santa FE
Argentina	Hospital Publico Materno Infantil	Salta
Argentina	Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L	San Miguel de Tucuman	Tucuman
Argentina	Instituto de Maternidad y Ginecologia: "Nuestra Senora de las Mercedes"	San Miguel de Tucuman	Tucuman
Australia	Monash Children's Hospital	Clayton	Victoria
Australia	Barwon Health, University Hospital Geelong	Geelong	Victoria
Australia	Perth Children's Hospital	Nedlands	Western Australia
Australia	Telethon Kids Institute	Nedlands	Western Australia
Australia	Women's and Children's Hospital	North Adelaide	South Australia
Australia	St John of God Hospital Subiaco	Subiaco	Western Australia
Brazil	Hospital Universitario/GAMP - Grupo de Apoio a Medicina Preventiva e a Saude Publica	Canoas	RS
Brazil	Maternidade Darcy Vargas	Joinville	SC
Brazil	Hospital Moinhos de Vento - HMV	Porto Alegre	RS
Brazil	Hospital Moinhos de Vento - HMV	Porto Alegre	RS
Brazil	Clinica de Alergia Martti Antila S/S Ltda./ CMPC - Consultoria Medica e Pesquisa Clinica	Sorocaba	SP
Canada	Canadian Center for Vaccinology - IWK Health Centre	Halifax	Nova Scotia
Canada	CHU Sainte-Justine	Montreal	Quebec
Canada	CHU de Québec-Université Laval	Quebec
Chile	Hospital Base San José de Osorno (Servicio de Obstetricia y Ginecología)	Osorno	Región DE LOS Lagos
Chile	Centro de Capacitación e Investigaciones Clínicas (CCIC)	Santiago	Región Metropolitana
Chile	Centro Internacional de Estudios Clinicos - CIEC	Santiago	Región Metropolitana
Chile	Clinica Universidad de los Andes	Santiago	Región Metropolitana
Chile	Deliveries (satellite): Hospital Clínico Universidad de Chile	Santiago	Región Metropolitana
Chile	Deliveries (satellite): Hospital San Jose	Santiago	Región Metropolitana
Chile	Grupo Estudios Clínicos Infectología Respiratoria	Santiago	Región Metropolitana
Chile	Hospital Padre Hurtado	Santiago	Región Metropolitana
Chile	Instituto de Investigaciones Materno Infantil (IDIMI)	Santiago	Región Metropolitana
Chile	Satellite (Deliveries): Hospital San Juan de Dios (Maternidad)	Santiago	Región Metropolitana
Denmark	Aarhus Universitetshospital	Aarhus N
Denmark	Nordsjællands Hospital	Hillerod
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Odense Universitets Hospital	Odense
Finland	MeVac	Helsinki
Finland	FVR, Kokkola Clinic	Kokkola
Finland	Kokkola Vaccine Research Clinic	Kokkola
Finland	FVR, Oulu Clinic	Oulu	Pohjois-pohjanmaa
Finland	FVR, Oulun rokotetutkimusklinikka	Oulu
Finland	Oulu Vaccine Research Clinic	Oulu
Finland	Tampereen yliopisto Oulun Rokotetutkimusklinikka	Oulu
Finland	FVR, Pori Clinic	Pori
Finland	Pori Vaccine Research Clinic	Pori
Finland	Seinajoki Vaccine Research Clinic	Seinajoki
Finland	FVR, Tampere Clinic	Tampere	Pirkanmaa
Finland	Tampere Vaccine Research Clinic	Tampere
Finland	FVR, Turku Clinic	Turku
Finland	Tampere University Vaccine Research Turku	Turku
Finland	Turku Vaccine Research Clinic	Turku
Gambia	MRC Unit The Gambia	Fajara	Banjul
Gambia	Medical Research Council Unit the Gambia at the London School of Hygiene & Tropical Medicine	Fajara KMC
Gambia	MRC Unit The Gambia	Fajara KMC
Gambia	Medical Research Council Unit the Gambia at the London School of Hygiene & Tropical Medicine	Fajara, KMC
Gambia	Medical Research Council Unit the Gambia at the London School of Hygiene & Tropical Medicine	Faraja, KMC
Gambia	Medical Research Council Unit the Gambia at the London School of Hygiene & Tropical Medicine (LSHTM)	Sukuta
Japan	Hyogo Prefectural Amagasaki General Medical Center	Amagasaki	Hyogo
Japan	National Hospital Organization Beppu Medical Center	Beppu	Oita
Japan	Shonan Fujisawa Tokushukai Hospital	Fujisawa	Kanagawa
Japan	Fukui Aiiku Hospital	Fukui-shi	Fukui
Japan	Osaka Habikino Medical Center	Habikino	Osaka
Japan	Kuwana City Medical Center	Kuwana-shi	MIE
Japan	Rakuwakai Otowa Hospital	Kyoto-shi	Kyoto
Japan	National Hospital Organization Tokyo Medical Center	Meguro-ku	Tokyo
Japan	Social Medical Corporation KARIYUSHIKAI Heartlife Hospital	Nakagami-gun	Okinawa
Japan	Saitama City hospital	Saitama
Japan	Sendai City Hospital	Sendai-city	Miyagi
Japan	Shizuoka General Hospital	Shizuoka
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Kyunghee University Hospital at Gangdong	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Mexico	Arke SMO S.A. de C.V.	Cuauhtemoc	Ciudad DE Mexico
Mexico	Hospital General de Durango	Durango
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo LEON
Mexico	Asociacion Mexicana para la Investigacion Clinica, A. C.	Pachuca de Soto	Hidalgo
Mexico	Arke SMO S.A. de C.V.	Veracruz
Netherlands	Spaarne Gasthuis (Kennemer Gasthuis)	Hoofddorp
Netherlands	Diakonessenhuis Utrecht	Utrecht
Netherlands	University Medical Center Utrecht	Utrecht
New Zealand	Aotearoa Clinical Trials Trust (ACTT)	Auckland
New Zealand	Middlemore Clinical Trials(Middlemore Hospital)	Auckland
New Zealand	Optimal Clinical Trials Ltd	Auckland
New Zealand	Christchurch Hospital (Canterbury District Health Board)	Christchurch
New Zealand	New Zealand Clinical Research (Christchurch)	Christchurch	Canterbury
New Zealand	Botany Downs Primary Birthing Unit	Golflands	Auckland
New Zealand	Papakura Primary Birthing Unit	Papakura North	Auckland
New Zealand	Middlemore Hospital	Papatoetoe	Auckland
New Zealand	Pukekohe Primary Birthing Unit	Pukekohe	Auckland
New Zealand	Capital, Coast and Hutt Valley District- Wellington Regional Hospital	Wellington
New Zealand	Wellington Hospital (Capital and Coast District Health Board)	Wellington
Philippines	Asian Hospital and Medical Center	Muntinlupa City	Metro Manila
South Africa	JOSHA Research	Bloemfontein	FREE State
South Africa	Kraaifontein Satellite site	Cape Town
South Africa	MRC Unit on Child and Adolescent Health	Cape Town	Western CAPE
South Africa	Wits RHI Shandukani Research Centre	Johannesburg	Gauteng
South Africa	Khayelitsha Satellite Site: Michael Mapongwana Community Health Centre	Khayelitsha	Western CAPE
South Africa	FAMCRU, University of Stellenbosch, Paediatric	Parow Valley	Western CAPE
South Africa	Into Research, West Wing Medical Centre	Pretoria	Gauteng
South Africa	Setshaba Research Centre	Soshanguve	Gauteng
South Africa	University of the Witwatersrand Vaccines & Infectious Diseases Analytics (VIDA)	Soweto	Gauteng
South Africa	University of the Witwatersrand Vaccines & Infectious Diseases Analytics (VIDA)	Soweto
South Africa	Limpopo Clinical Research Initiative	Thabazimbi	Limpopo
South Africa	Worcester Satellite site	Worcester
Spain	Hospital de Antequera	Antequera	Malaga
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Madrid Puerta del Sur Mostoles	Mostoles
Spain	CHUS - Hospital Clinico Universitario	Santiago de Compostela	A Coruna
Spain	Hospital Universitari i Politecnic La Fe	Valencia
Taiwan	Hsinchu Mackay Memorial Hospital	Hsinchu
Taiwan	Hsinchu Mackay Memorial Hospital	Hsinchu City
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Mackay Memorial Hospital	Taipei City
Taiwan	Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital	Taoyuan
United States	Lovelace Women's Hospital	Albuquerque	New Mexico
United States	MedPharmics	Albuquerque	New Mexico
United States	Presbyterian Hospital	Albuquerque	New Mexico
United States	University of New Mexico Hospital	Albuquerque	New Mexico
United States	Velocity Clinical Research, Albuquerque	Albuquerque	New Mexico
United States	Alexandria Cardiology Clinic - Secondary Research Site	Alexandria	Louisiana
United States	Cambridge Medical Trials	Alexandria	Louisiana
United States	Cambridge Medical Trials - Main Research Site	Alexandria	Louisiana
United States	Rabie Clinic for Women	Alexandria	Louisiana
United States	Rapides Regional Medical Center Labor and Delivery	Alexandria	Louisiana
United States	Mary Greeley Medical Center	Ames	Iowa
United States	Mcfarland Clinic PC	Ames	Iowa
United States	McFarland Clinic, P.C.	Ames	Iowa
United States	PMG Research of McFarland Clinic	Ames	Iowa
United States	The Iowa Clinic	Ankeny	Iowa
United States	Medical City Arlington (Women's Hospital)	Arlington	Texas
United States	Texas Health Arlington Memorial Hospital	Arlington	Texas
United States	Ventavia Research Group, LLC	Arlington	Texas
United States	Emory Children's Center Illness POD	Atlanta	Georgia
United States	Emory Clinic	Atlanta	Georgia
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Emory University Investigational Drug Service	Atlanta	Georgia
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	University of Colorado Anschutz Inpatient Pavilion 2	Aurora	Colorado
United States	University of Colorado AO1	Aurora	Colorado
United States	University of Colorado Hospital	Aurora	Colorado
United States	University of Colorado Hospital Inpatient Pavilion	Aurora	Colorado
United States	University of Colorado Hospital Outpatient Pavilion	Aurora	Colorado
United States	University of Colorado Leprino Building	Aurora	Colorado
United States	University of Colorado Research II Building	Aurora	Colorado
United States	St. David's Medical Center	Austin	Texas
United States	Tekton Research, Inc.	Austin	Texas
United States	Center for Women''s Health and Birthcare	Beaumont	Texas
United States	Christus St. Elizabeth Hospital	Beaumont	Texas
United States	Gadolin Research, LLC	Beaumont	Texas
United States	Texas Health Harris Methodist Hospital Hurst-Euless-Bedford	Bedford	Texas
United States	Century Research Institute	Bellflower	California
United States	Central Research Associates, Inc.	Birmingham	Alabama
United States	Children's of Alabama	Birmingham	Alabama
United States	Endocrinology and Internal Medicine Associates, PC	Birmingham	Alabama
United States	OB/GYN Associates of Alabama, PC	Birmingham	Alabama
United States	Sharp and Stone OB/GYN PC	Birmingham	Alabama
United States	St Vincent's Hospital	Birmingham	Alabama
United States	UAB Women & Infants Center - UAB Medicine	Birmingham	Alabama
United States	University of Alabama at Birmingham/Center for Women's Reproductive Health	Birmingham	Alabama
United States	1st Choice Urgent Care & Family Medicine	Blackfoot	Idaho
United States	Bingham Memorial Hospital	Blackfoot	Idaho
United States	Elite Clinical Trials LLLP	Blackfoot	Idaho
United States	Grove Creek Medical Center	Blackfoot	Idaho
United States	ASR, LLC	Boise	Idaho
United States	Saint Alphonsus Regional Medical Center	Boise	Idaho
United States	St. Luke's Boise Medical Center	Boise	Idaho
United States	Boston Medical Center	Boston	Massachusetts
United States	Investigational Pharmacy Service	Boston	Massachusetts
United States	Child Care Pediatrics, P.A.	Burleson	Texas
United States	Ventavia Research Group LLC	Burleson	Texas
United States	Boeson Research (BUT)	Butte	Montana
United States	St James Healthcare	Butte	Montana
United States	West Valley Medical Center	Caldwell	Idaho
United States	Cooper University Hospital	Camden	New Jersey
United States	Jaffe Family Womens Care Center	Camden	New Jersey
United States	Pediatrics at Sheridan Pavilion- Three Cooper Plaza	Camden	New Jersey
United States	UNC OB/GYN at Panther Creek (recruitment, randomization, administration of IP)	Cary	North Carolina
United States	UNC Children's Hospital (Pediatric follow up)	Chapel Hill	North Carolina
United States	UNC Healthcare (recruitment, randomization, administration of IP)	Chapel Hill	North Carolina
United States	UNC OB/GYN at Weaver Crossing (recruitment, randomization, administration of IP)	Chapel Hill	North Carolina
United States	Bon Secours St. Francis Hospital	Charleston	South Carolina
United States	Charleston 0B/GYN	Charleston	South Carolina
United States	Coastal Pediatric Research	Charleston	South Carolina
United States	Cooper Faculty OBGYN at Cherry Hill	Cherry Hill	New Jersey
United States	Chowchilla Medical Center	Chowchilla	California
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	The Christ Hospital	Cincinnati	Ohio
United States	University of Cincinnati Medical Center Department of Obstetrics and Gynecology	Cincinnati	Ohio
United States	Premier Medical Group	Clarksville	Tennessee
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	Piedmont Columbus Regional Midtown	Columbus	Georgia
United States	Lakeview Regional Medical Center	Covington	Louisiana
United States	Medpharmics, LLC	Covington	Louisiana
United States	St. Tammany Parish Hospital	Covington	Louisiana
United States	Velocity Clinical Research	Covington	Louisiana
United States	Cullman Clinical Research, Inc	Cullman	Alabama
United States	Cullman Primary Care, PC	Cullman	Alabama
United States	Cullman Regional	Cullman	Alabama
United States	Texas Health Presbyterian Hospital Dallas	Dallas	Texas
United States	Ventavia Research Group LLC	Dallas	Texas
United States	Dayton Clinical Research	Dayton	Ohio
United States	Wise Health System Dectaur	Decatur	Texas
United States	Delta Memorial Hospital	Delta	Colorado
United States	C.S. Mott Center	Detroit	Michigan
United States	Hutzel-Harper Women's Hospital	Detroit	Michigan
United States	University Health Center	Detroit	Michigan
United States	Cline Pediatrics	Dickinson	Texas
United States	Duke Children's Primary Care - Roxboro Street	Durham	North Carolina
United States	Duke Regional Hospital	Durham	North Carolina
United States	Duke University Hospital	Durham	North Carolina
United States	Duke University.	Durham	North Carolina
United States	Doctor's Hospital Womens Hospital	Edinburg	Texas
United States	South Texas Health System- Edinburg	Edinburg	Texas
United States	Alliance for Multispecialty Research, LLC	El Dorado	Kansas
United States	HWC Women's Research Center, LLC	Englewood	Ohio
United States	Allegheny Health and Wellness Pavilion	Erie	Pennsylvania
United States	Liberty Family Practice	Erie	Pennsylvania
United States	OBGYN Associates of Erie	Erie	Pennsylvania
United States	Saint Vincent Hospital	Erie	Pennsylvania
United States	New York Presbyterian of Queens Hospital	Flushing	New York
United States	Theresa Lang Children's Ambulatory Center	Flushing	New York
United States	Womack Army Medical Center	Fort Bragg	North Carolina
United States	Dupont Pediatrics	Fort Wayne	Indiana
United States	Women's Health Advantage	Fort Wayne	Indiana
United States	8th Avenue Obstetrics & Gynecology	Fort Worth	Texas
United States	Baylor Scott & White All Saints Medical Center	Fort Worth	Texas
United States	Texas Health Harris Methodist Hospital Fort Worth	Fort Worth	Texas
United States	Texas Health Harris Methodist Hospital Southwest	Fort Worth	Texas
United States	Ventavia Research Group, LLC	Fort Worth	Texas
United States	Fresh Meadows Family Health Center	Fresh Meadows	New York
United States	Colorado Canyon's Hospital	Fruita	Colorado
United States	University of Texas Medical Branch	Galveston	Texas
United States	Chisholm Trail Pediatrics	Georgetown	Texas
United States	FMC Science	Georgetown	Texas
United States	Georgetown OBGYN	Georgetown	Texas
United States	St. David's Georgetown Hospital	Georgetown	Texas
United States	Arrowhead Community Hospital	Glendale	Arizona
United States	Banner Thunderbird Hospital	Glendale	Arizona
United States	Abrazo West Campus Hospital	Goodyear	Arizona
United States	CHI Health St. Francis	Grand Island	Nebraska
United States	Grand Island Regional Medical Center	Grand Island	Nebraska
United States	Grand Island Regional Medical Center	Grand Island	Nebraska
United States	Meridian Clinical Research, LLC	Grand Island	Nebraska
United States	Boeson Research	Grand Junction	Colorado
United States	Boeson Research	Grand Junction	Colorado
United States	Community Hospital	Grand Junction	Colorado
United States	Dino-Peds	Grand Junction	Colorado
United States	SCL St. Mary's Medical Center	Grand Junction	Colorado
United States	Women's Health Care of Western Colorado	Grand Junction	Colorado
United States	Baylor Scott & White of Grapevine (Hospital)	Grapevine	Texas
United States	Ventavia Research Group, LLC	Grapevine	Texas
United States	Benefis Health System	Great Falls	Montana
United States	Boeson Research (GTF)	Great Falls	Montana
United States	Boeson Research (GTF)	Great Falls	Montana
United States	Origin Health GTF	Great Falls	Montana
United States	Prisma Health	Greenville	South Carolina
United States	Prisma Health-Upstate Office of Maternal Fetal Medicine	Greenville	South Carolina
United States	Ochsner Health Center - West Bank	Gretna	Louisiana
United States	Gulfport Memorial Hospital	Gulfport	Mississippi
United States	MedPharmics	Gulfport	Mississippi
United States	MedPharmics, LLC	Gulfport	Mississippi
United States	Singing River Health System	Gulfport	Mississippi
United States	Velocity Clinical Research	Gulfport	Mississippi
United States	Marcus Daly Memorial Hospital	Hamilton	Montana
United States	North Oaks Medical Center	Hammond	Louisiana
United States	North Oaks Obstetrics & Gynecology	Hammond	Louisiana
United States	North Oaks Rural Health Clinic	Hammond	Louisiana
United States	Mary Lanning	Hastings	Nebraska
United States	Meridian Clinical Research	Hastings	Nebraska
United States	Boeson Research (HLN)	Helena	Montana
United States	St Peters Health	Helena	Montana
United States	Loma Linda University Pediatric Clinic - Highland	Highland	California
United States	Hollis Women's Center	Hollis	New York
United States	Hany H. Ahmed, MD	Houston	Texas
United States	HCA: The Women's Hospital of Texas	Houston	Texas
United States	HG Pediatrics	Houston	Texas
United States	Javara Inc.	Houston	Texas
United States	Memorial Hermann Memorial City	Houston	Texas
United States	Privia Medical Group Gulf Coast, PLLC	Houston	Texas
United States	Texas Center for Drug Development, Inc	Houston	Texas
United States	UT Health Women's Research Center at Memorial City	Houston	Texas
United States	Van Tran Family Clinic	Houston	Texas
United States	Ventavia Research Group, LLC	Houston	Texas
United States	Cabell Huntington Hospital	Huntington	West Virginia
United States	Marshall Health	Huntington	West Virginia
United States	University Physicians and Surgeons dba Marshall Health Department of Obstetrics and Gynecology	Huntington	West Virginia
United States	University Physicians and Surgeons dba Marshall Health Department of Pediatrics	Huntington	West Virginia
United States	Century Research Institute	Huntington Park	California
United States	Matrix Clinical Research	Huntington Park	California
United States	Clinical Research Prime	Idaho Falls	Idaho
United States	Eastern Idaho Regional Medical Center	Idaho Falls	Idaho
United States	Mountain View Hospital	Idaho Falls	Idaho
United States	The Pediatric Center	Idaho Falls	Idaho
United States	Jackson Heights Family Health Center	Jackson Heights	New York
United States	St. Bernards Medical Center	Jonesboro	Arkansas
United States	St. Bernards OBGYN Associates	Jonesboro	Arkansas
United States	The Children's Clinic of Jonesboro, P.A.	Jonesboro	Arkansas
United States	The Children's Clinic of Jonesboro, PA	Jonesboro	Arkansas
United States	Boeson Reseach (KAL)	Kalispell	Montana
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	MedPharmics LLC	Lafayette	Louisiana
United States	AdventHealth Family Medicine Rural Health Clinic, Inc.	Lampasas	Texas
United States	FMC Science	Lampasas	Texas
United States	Chemidox Clinical Trials	Lancaster	California
United States	Leonard S. Kurian, M.D., A Medical Corporation	Lancaster	California
United States	Women & Infants Pavilion, Antelope Valley Hospital	Lancaster	California
United States	Maximos Ob/Gyn	League City	Texas
United States	Bryan Health	Lincoln	Nebraska
United States	Midwest Children's Health Research Institute	Lincoln	Nebraska
United States	Midwest Children's Health Research Institute	Lincoln	Nebraska
United States	Midwest Children's Health Research Institute.	Lincoln	Nebraska
United States	Midwest Childrens Health Research Institute	Lincoln	Nebraska
United States	Women's Health Care Center of Williamsburg	Lincoln	Nebraska
United States	Loma Linda University Adventist Health Sciences Center	Loma Linda	California
United States	Loma Linda University Faculty Medical Clinics	Loma Linda	California
United States	Loma Linda University Pediatric Clinics	Loma Linda	California
United States	Loma Linda Unversity Children's Hospital	Loma Linda	California
United States	Long Beach Clinical Trials	Long Beach	California
United States	Long Beach Memorial Medical Center	Long Beach	California
United States	St Mary Medical Center	Long Beach	California
United States	DCOL Center for Clinical Research	Longview	Texas
United States	Diagnostic Clinic of Longview (Hollybrook)	Longview	Texas
United States	Diagnostic Clinic of Longview (Medical Circle)	Longview	Texas
United States	Longview Regional Medical Center	Longview	Texas
United States	Century Research Institute	Los Angeles	California
United States	Century Research Institute	Los Angeles	California
United States	Century Research Institute	Los Angeles	California
United States	East LA Doctors Hospital	Los Angeles	California
United States	Hollywood Presbyterian Medical Center	Los Angeles	California
United States	Matrix Clinical Research..	Los Angeles	California
United States	Peter Morton Medical Building	Los Angeles	California
United States	Ronald Reagan UCLA Medical Center Drug Information Center Dept	Los Angeles	California
United States	Ronald Reagan University of California Los Angeles Medical Center	Los Angeles	California
United States	UCLA David Geffen School of Medicine	Los Angeles	California
United States	White Memorial Medical Center	Los Angeles	California
United States	Axcess Medical Research	Loxahatchee Groves	Florida
United States	Affiliated Physician Practice	Madera	California
United States	Charles E. Ugwu-Oju, M.D., F.A.C.O.G., Obstetrics & Gynecology	Madera	California
United States	Madera Community Hospital	Madera	California
United States	Madera Family Medical Group	Madera	California
United States	Marshfield Medical Center	Marshfield	Wisconsin
United States	Marshfield Medical Center - Marshfield	Marshfield	Wisconsin
United States	Dr. Ruben Aleman and Associates	McAllen	Texas
United States	Rio Grande Regional Hospital	McAllen	Texas
United States	South Texas Health System- McAllen	McAllen	Texas
United States	Saltzer Health	Meridian	Idaho
United States	St. Luke's Meridian Medical Center	Meridian	Idaho
United States	Crescent City Physicians and Obstetrics	Metairie	Louisiana
United States	MedPharmics LLC	Metairie	Louisiana
United States	North Shore Medical Center	Miami	Florida
United States	NYU Langone Hospital - Long Island	Mineola	New York
United States	Women's Contemporary Care	Mineola	New York
United States	Boeson Research	Missoula	Montana
United States	Boeson Research LLC	Missoula	Montana
United States	Community Medical Center	Missoula	Montana
United States	Community Physicians Group-Maternal Fetal Medicine	Missoula	Montana
United States	The Birth Center	Missoula	Montana
United States	Springhill Medical Center	Mobile	Alabama
United States	University of South Alabama Children's and Women's Hospital	Mobile	Alabama
United States	USA Health Strada Patient Care Center	Mobile	Alabama
United States	Velocity Clinical Research, Gulfport	Mobile	Alabama
United States	Monterey Park Hospital	Monterey Park	California
United States	Montrose Memorial Hospital	Montrose	Colorado
United States	ASR, LLC	Nampa	Idaho
United States	Saltzer Health	Nampa	Idaho
United States	Saltzer Health	Nampa	Idaho
United States	St. Alphonsus Medical Center- Nampa	Nampa	Idaho
United States	St. Luke's Nampa Medical Center	Nampa	Idaho
United States	Saint Peters University Hospital	New Brunswick	New Jersey
United States	Yale School Medicine Church Street Research Unit	New Haven	Connecticut
United States	Ochsner Baptist Medical Center	New Orleans	Louisiana
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Ochsner Health Center for Children	New Orleans	Louisiana
United States	Touro Infirmary	New Orleans	Louisiana
United States	Women Under Study, LLC	New Orleans	Louisiana
United States	Audubon Clinic	New York	New York
United States	Center for Prenatal Pediatrics	New York	New York
United States	Columbia Doctors	New York	New York
United States	Columbia University Irving Medical Center	New York	New York
United States	Herbert Irving Pavilion	New York	New York
United States	Morgan Stanley Childrens Hospital	New York	New York
United States	Alliance for Multispecialty Research, LLC	Newton	Kansas
United States	Sentara Leigh Hospital	Norfolk	Virginia
United States	The Group for Women	Norfolk	Virginia
United States	Tidewater Physicians for Women	Norfolk	Virginia
United States	Velocity Clinical Research, Norfolk	Norfolk	Nebraska
United States	Clinical Research Partners, LLC	North Chesterfield	Virginia
United States	A1 Imaging of Aventura	North Miami Beach	Florida
United States	Citadelle Clinical Research	North Miami Beach	Florida
United States	Owensboro Health Regional Hospital	Owensboro	Kentucky
United States	Research Integrity, LLC	Owensboro	Kentucky
United States	The Women's Pavillion, P.S.C	Owensboro	Kentucky
United States	Lucile Packard Children's Hospital	Palo Alto	California
United States	Stanford University	Palo Alto	California
United States	Baldwin Pediatrics	Panama City	Florida
United States	Emerald Coast Obstetrics and Gynecology	Panama City	Florida
United States	Emerald Coast Pediatrics	Panama City	Florida
United States	Gulf Coast Regional Medical Center	Panama City	Florida
United States	Rainbow Pediatrics	Panama City	Florida
United States	Rainbow Pediatrics	Panama City Beach	Florida
United States	American Research Centers of Florida	Pembroke Pines	Florida
United States	MedPharmics, LLC	Phoenix	Arizona
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	Valleywise Comprehensive Health Center Women's Clinic	Phoenix	Arizona
United States	Valleywise Health Medical Center	Phoenix	Arizona
United States	Velocity Clinical Research - Pheonix	Phoenix	Arizona
United States	Velocity Clinical Research - Pheonix	Phoenix	Arizona
United States	FirstHealth Clinical Trials	Pinehurst	North Carolina
United States	FirstHealth Moore Regional Hospital	Pinehurst	North Carolina
United States	Medical City Plano	Plano	Texas
United States	Texas Health Presbyterian Hospital Plano	Plano	Texas
United States	Ventavia Research Group LLC	Plano	Texas
United States	1st Choice Urgent Care	Pocatello	Idaho
United States	Pocatello Women's Health Clinic	Pocatello	Idaho
United States	Portneuf Medical Center	Pocatello	Idaho
United States	Clinical Research Prime Rexburg	Rexburg	Idaho
United States	Elite Clinical Trials LLLP	Rexburg	Idaho
United States	Madison Memorial Hospital	Rexburg	Idaho
United States	Clinical Research Partners, LLC	Richmond	Virginia
United States	VCU Health Adult Outpatient Pavillion	Richmond	Virginia
United States	Virginia Commonwealth Univeristy Health Systems-Children's Pavilion	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Virginia Commonwealth University Health System-Main Hospital	Richmond	Virginia
United States	Virginia Commonwealth University Health System-Nelson Clinic	Richmond	Virginia
United States	The Pediatric Center	Rigby	Idaho
United States	St Luke Community Clinic - Ronan	Ronan	Montana
United States	Baer Pediatrics	Saint Louis	Missouri
United States	Barnes Jewish Hospital	Saint Louis	Missouri
United States	KDB Enterprises	Saint Louis	Missouri
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Sundance Clinical Research, LLC	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Alpine Medical Group	Salt Lake City	Utah
United States	Holladay Family Practice	Salt Lake City	Utah
United States	Intermountain Medical Center	Salt Lake City	Utah
United States	JBR Clinical Research	Salt Lake City	Utah
United States	Old Farm Obstetrics & Gynecology, LLC	Salt Lake City	Utah
United States	St. Marks Hospital	Salt Lake City	Utah
United States	University of Utah	Salt Lake City	Utah
United States	University of Utah Hospital	Salt Lake City	Utah
United States	St. Luke's Baptist Hospital	San Antonio	Texas
United States	Tekton Research, Inc.	San Antonio	Texas
United States	Seattle Children's Hospital	Seattle	Washington
United States	University of Washington Medical Center - Northwest	Seattle	Washington
United States	University of Washington Medical Center- Montlake	Seattle	Washington
United States	UW Midwives Clinic at Northwest Outpatient Medical center	Seattle	Washington
United States	UW Neighborhood Ravenna Clinic	Seattle	Washington
United States	UW Neighborhood South Lake Union Clinic	Seattle	Washington
United States	Sandhills Pediatrics	Seven Lakes	North Carolina
United States	Cooper Faculty OBGYN at Sewell	Sewell	New Jersey
United States	UW Neighborhood Shoreline Clinic	Shoreline	Washington
United States	Sanford Children's Specialty Clinic	Sioux Falls	South Dakota
United States	Sanford Obstetrics and Gynecology Clinic	Sioux Falls	South Dakota
United States	Sanford Obstetrics and Gynecology Clinic (Recruitment, Consenting, IP Administration, and Follow Up)	Sioux Falls	South Dakota
United States	Sanford USD Medical Center (Main Hospital)	Sioux Falls	South Dakota
United States	Sanford Women's Health Plaza (Recruitment, Consenting, and Follow Up)	Sioux Falls	South Dakota
United States	MedPharmics, LLC	Slidell	Louisiana
United States	Slidell Memorial Hospital	Slidell	Louisiana
United States	Velocity Clinical Research	Slidell	Louisiana
United States	FirstHealth Southern Pines Women's Health Center	Southern Pines	North Carolina
United States	Sandhills Pediatrics	Southern Pines	North Carolina
United States	Wayne State University Physician Group	Southfield	Michigan
United States	Coastal Pediatric Research	Summerville	South Carolina
United States	Lowcountry Womens Specialists	Summerville	South Carolina
United States	Summerville Medical Center	Summerville	South Carolina
United States	MultiCare Health System - Mary Bridge Children's Health Center	Tacoma	Washington
United States	Multicare Health System-Multicare Women's Center Tacoma	Tacoma	Washington
United States	Multicare Health System-Pediatrics Northwest	Tacoma	Washington
United States	Multicare Health System-Tacoma General Hospital	Tacoma	Washington
United States	MultiCare Institute for Research & Innovation	Tacoma	Washington
United States	Fomat- Raymond Poliakin, MD.	Thousand Oaks	California
United States	DM Clinical Research	Tomball	Texas
United States	Banner University Medical Center	Tucson	Arizona
United States	Banner University Medical Center ( North Campus )	Tucson	Arizona
United States	Mesquite Pediatrics	Tucson	Arizona
United States	University of Arizona	Tucson	Arizona
United States	Watching Over Mothers and Babies	Tucson	Arizona
United States	Carey Chronis, MD	Ventura	California
United States	Meridian Clinical Research LLC	Vestal	New York
United States	Tidewater Physicians for Women	Virginia Beach	Virginia
United States	Emerson Clinical Research Institute	Washington	District of Columbia
United States	Medical City Weatherford	Weatherford	Texas
United States	Ventavia Research Group	Weatherford	Texas
United States	UC Health West Chester Hospital	West Chester	Ohio
United States	Methodist West Hospital	West Des Moines	Iowa
United States	The Iowa Clinic, P.C.	West Des Moines	Iowa
United States	Reading Hospital	West Reading	Pennsylvania
United States	Reading Hospital - Children's Health Center	West Reading	Pennsylvania
United States	Reading Hospital - Women's Health Center	West Reading	Pennsylvania
United States	Reading Hospital-Family Health Care Center	West Reading	Pennsylvania
United States	North Valley Hospital	Whitefish	Montana
United States	Integris Yukon Hospital	Yukon	Oklahoma
United States	Tekton Research	Yukon	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Chile,  Denmark,  Finland,  Gambia,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Philippines,  South Africa,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage reduction in the incidence of medically attended LRTI (MA-LRTI) due to RSV in infants through 180 days of life	The percentage relative risk reduction in the incidence of MA-LRTI due to RSV in the RSV vaccine group, relative to the placebo group will be assessed at specified timepoints in infant participants	Delivery to 180 days after delivery
Primary	The percentage reduction in the incidence of medically attended severe LRTI due to RSV in infants through 180 days of life	The percentage relative risk reduction in the incidence of severe MA-LRTI due to RSV in the RSV vaccine group, relative to the placebo group will be assessed at specified timepoints in infant participants	Delivery to 180 days after delivery
Primary	The percentage of infant participants with specific birth outcomes	Describe specific birth outcomes for infant participants	Birth
Primary	The percentage of infant participants with adverse events (AEs) from birth to 1 month of age	Describe AE for infant participants from birth to 1 month of age	Up to 1 month of age
Primary	The percentage of infant participants with serious adverse events (SAE) and newly diagnosed chronic medical conditions (NDCMCs) from birth to 12 months of age	Describe SAE and NDCMCs for infant participants from birth to 12 months of age	From birth up to 12 months of age
Primary	The percentage of infant participants with serious adverse events (SAE) and newly diagnosed chronic medical conditions (NDCMCs) from birth to 24 months of age	Describe SAE and NDCMCs for infant participants from birth to 24 months of age	From birth up to 24 months of age
Primary	Percentage of maternal participants reporting local reactions and systemic events from day of vaccination (Day 1) until Day 7	Describe local reactions and systemic events after vaccination	From day of vaccination until 7 days after vaccination
Primary	Percentage of maternal participants reporting Adverse Events (AE) within 1 month after vaccination	Describe adverse events (AE) after vaccination	Within 1 month after vaccination
Primary	Percentage of maternal participants reporting SAEs	Describe serious adverse events from enrolment up to 180 days after delivery	From enrollment up to 180 days after delivery
Secondary	The percentage reduction in the incidence of hospitalizations due to RSV in infants through 360 days of life	The percentage relative risk reduction in the incidence of hospitalization due to RSV in the RSV vaccine group, relative to the placebo group will be assessed at specified timepoints in infant participants	Delivery to 360 days after delivery
Secondary	The percentage reduction in the incidence of all-cause MA-LRTI in infant participants	The percentage relative risk reduction in the incidence of all-cause MA-LRTI in the RSV vaccine group, relative to the placebo group will be assessed at specified timepoints in infant participants	Delivery to 360 days after delivery
Secondary	The percentage reduction in the incidence of MA-LRTI due to RSV in infants participants	The percentage relative risk reduction in the incidence of MA-LRTI due to RSV in the RSV vaccine group, relative to the placebo group will be assessed at specified timepoints in infant participants	Delivery to 360 days after delivery

External Links

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