A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN

PHASE2CompletedINTERVENTIONAL
Enrollment

1,153

Participants

Timeline

Start Date

August 7, 2019

Primary Completion Date

September 30, 2021

Study Completion Date

September 30, 2021

Conditions
Respiratory Tract Infection
Interventions
BIOLOGICAL

RSV vaccine

RSV vaccine

BIOLOGICAL

Placebo

Normal saline solution for injection (0.9% sodium chloride injection)

Trial Locations (159)

1862

Respiratory and Meningeal Pathogens Research Unit (RMPRU), Soweto

4000

Clinica Mayo De U.M.C.B. S.R.L., San Miguel de Tucumán

Instituto de Maternidad y Ginecologia, Nuestra Senora de Las Mercedes, San Miguel de Tucumán

8011

Christchurch Clinical Studies Trust Ltd, Christchurch

Christchurch Hospital (Canterbury District Health Board), Christchurch

11501

NYU Winthrop Hospital, Research Pharmacy, Mineola

NYU Winthrop Hospital, Mineola

NYU Winthrop Pediatric Infectious Diseases, Mineola

Women's Contemporary Care Associates, Mineola

11550

Winthrop Women's Wellness, Hempstead

13790

Sante Comprehensive Women's Healthcare, Johnson City

14620

University of Rochester Obstetrics and Gynecology, Rochester

14642

University of Rochester Medical Center, Rochester

23235

Clinical Research Partners, LLC, Richmond

Johnston Willis Hospital, Richmond

25701

Cabell Huntington Hospital, Huntington

Marshall Health dba University Pediatrics, Huntington

Marshall Health Department of Obstetrics and Gynecology, Huntington

Translational Genomic Research Institute, Huntington

27704

Duke Children's Primary Care - Roxboro Street, Durham

Duke Regional Hospital, Durham

27705

Duke University Medical Center, Durham

27710

Duke University Hospital, Durham

29485

Lowcountry Womens Specialists, Summerville

Summerville Medical Center, Summerville

29486

Coastal Pediatric Research, Summerville

30322

Emory Children's Center, Atlanta

35058

Cullman Clinical Research, Inc, Cullman

Cullman Primary Care, PC, Cullman

Cullman Regional, Cullman

35233

Children's of Alabama, Birmingham

UAB Women & Infants Center - UAB Medicine, Birmingham

University of Alabama at Birmingham, Birmingham

39501

Gulfport Memorial Hospital, Gulfport

39503

Gulfport OB-GYN, Gulfport

MedPharmics, LLC, Gulfport

Singing River Health System, Gulfport

39520

Oshsner Medical Center - Hancock, Bay Saint Louis

39530

Merit Health Biloxi, Biloxi

45322

HWC Women's Center Research, Englewood

45409

Sugarcamp Family Practice, Dayton

45414

Needmore Medical Center, Dayton

45429

Kettering Medical Center, Dayton

50023

The Iowa Clinic, Ankeny

50266

Methodist West Hospital, West Des Moines

The Iowa Clinic, West Des Moines

55404

Infectious Disease Research, Minneapolis

55407

Abbott Northwestern Hospital (Allina Health), Minneapolis

55432

Allina Health Fridley Clinic, Fridley

55433

Allina Health Coon Rapids Clinic, Coon Rapids

Allina Health Mercy Women's Clinic, Coon Rapids

Mercy Hospital (Allina Health), Coon Rapids

The Mother Baby Center at Mercy with Children's (Allina Health), Coon Rapids

55449

Allina Health Blaine Clinic, Blaine

59405

Boeson Research, Great Falls

59804

Boeson Research, Missoula

63017

St Lukes Hospital, Chesterfield

63131

Baer Pediatrics, St Louis

63141

KDB Enterprises, St Louis

Mercy Hospital St. Louis, St Louis

Sundance Clinical Research, LLC, St Louis

67042

Alliance for Multispecialty Research, LLC, El Dorado

67502

Hutchinson Clinic, P.A., Hutchinson

Hutchinson Regional Medical Center, Hutchinson

68506

Bryan Health, Lincoln

68510

Bryan Women's Care Physicians, Lincoln

68516

Midwest Childrens Health Research Institute, Lincoln

68701

Meridian Clinical Research, LLC, Norfolk

70006

MedPharmics, LLC, Metairie

71301

Cambridge Medical Trials, Alexandria

75093

Texas Health Presbyterian Hospital, Plano

Ventavia Research Group LLC, Plano

75605

DCOL Center For Clinical Research, Longview

Diagnostic Clinic of Longview, Longview

Longview Regional Medical Center, Longview

76022

Texas Health Harris Methodist Hurst-Euless-Bedford Hospital, Bedford

76028

Texas Health Huguley Hospital South, Burleson

76051

Baylor Scott & White of Grapevine (Hospital), Grapevine

76104

8th Avenue Obstetrics and Gynecology, Fort Worth

Baylor Scott & White of Fort Worth, Fort Worth

Texas Health Harris Methodist Hospital FTW, Fort Worth

Ventavia Research Group, LLC, Fort Worth

76132

Texas Health Harris Methodist Hospital Southwest, Fort Worth

76550

AdventHealth Family Medicine Rural Health Clinic, Inc., Lampasas

FMC Science, Lampasas

77008

Dr Van Tran Family Practice, Houston

HG Pediatrics, Houston

Memorial Herman Greater Heights Hospital, Houston

Ventavia Research Group, LLC, Houston

77081

Texas Center for Drug Development, Inc., Houston

77084

Biopharma Informatic, LLC, Houston

77555

University of Texas Medical Branch, Galveston

77702

Center for Women''s Health and Birthcare, Beaumont

CHRISTUS St. Elizabeth Hospital, Beaumont

Gadolin Research, LLC, Beaumont

Pediatric Clinic of Dr. Alvin H. Prause, Beaumont

78504

Dr. Ruben Aleman and Associates, McAllen

78577

Exygon Clinical Research, Pharr

78626

Chisholm Trail Pediatrics, Georgetown

FMC Science, LLC, Georgetown

Georgetown OBGYN, Georgetown

St. David's Georgetown Hospital, Georgetown

78665

Ascension Seton Williamson, Round Rock

80045

Children's Hospital Colorado, Aurora

University of Colorado Anschutz Inpatient Pavilion 2, Aurora

University of Colorado AO1, Aurora

University of Colorado Hospital Inpatient Pavilion, Aurora

University of Colorado Hospital Outpatient Pavilion, Aurora

University of Colorado Leprino Building, Aurora

University of Colorado Research II Building, Aurora

83201

Pocatello Women's Health Clinic, Pocatello

Portneuf Medical Center, Pocatello

83221

Bingham Memorial Hospital, Blackfoot

Elite Clinical Trials LLLP, Blackfoot

Grove Creek Medical Center, Blackfoot

83404

Clinical Research Prime, Idaho Falls

Eastern Idaho Regional Medical Center, Idaho Falls

Family First Medical Center, Idaho Falls

Mountain View Hospital, Idaho Falls

Snake River Research, PLLC, Idaho Falls

The Pediatric Center, Idaho Falls

83442

The Pediatric Center, Rigby

83686

Saltzer Medical Group, Nampa

83687

ASR, LLC, Nampa

Saltzer Medical Group, Nampa

84107

Intermountain Medical Center, Murray

JBR Clinical Research, Salt Lake City

Old Farm Obstetrics & Gynecology, LLC, Salt Lake City

84124

St. Marks Hospital, Salt Lake City

85013

St. Joseph Hospital, Phoenix

85015

MedPharmics, LLC, Phoenix

85308

Arrowhead Hospital, Glendale

85395

Abrazo West Campus Hospital, Goodyear

85712

Mesquite Pediatrics, Tucson

Watching Over Mothers and Babies, Tucson

87102

MedPharmics, Albuquerque

90006

Join Clinical Trials, Los Angeles

90023

East Los Angeles Doctors Hospital, Los Angeles

90033

White Memorial Medical Center, Los Angeles

90036

Join Clinical Trials, Los Angeles

90057

Matrix Clinical Research, Los Angeles

90255

Join Clinical Trials, Huntington Park

Matrix Clinical Research, Huntington Park

90706

Join Clinical Trials, Bellflower

91754

Monterey Park Hospital, Monterey Park

93610

Chowchilla Hospital Clinic, Chowchilla

93637

Affiliated Physician Practice, Madera

Charles E. Ugwu-Oju, MD, FACOG, Madera

Madera Community Hospital, Madera

Madera Family Medical Group, Madera

5311523

Hospital Base San Jose de Osorno, Osorno

7620157

Clinica Universidad de los Andes, Santiago

8360160

Hospital San Borja Arriaran, Santiago

Instituto de Investigaciones Materno Infantil (IDIMI), Santiago

8380419

Hospital San Jose, Santiago

8380453

Grupo Estudios Clinicos Infectologia Respiratoria, Facultad de Medicina Universidad de Chile, Santiago

8380456

Hospital Clinico Universidad de Chile, Santiago

8420383

Centro Internacional de Estudios Clinicos - CIEC, Santiago

8880465

Hospital Padre Hurtado, Santiago

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT04032093 - A PHASE 2B PLACEBO-CONTROLLED, RANDOMIZED STUDY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN | Biotech Hunter | Biotech Hunter