MedPath

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

Phase 3
Completed
Conditions
Respiratory Tract Infection
Interventions
Biological: Placebo
Biological: RSVpreF
Registration Number
NCT04424316
Lead Sponsor
Pfizer
Brief 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.

Detailed 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 & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
14699
Inclusion Criteria

Not provided

Read More
Exclusion Criteria

Not provided

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Placebo dosePlaceboPlacebo
RSVpreF vaccineRSVpreFRSVpreF
Primary Outcome Measures
NameTimeMethod
The percentage reduction in the incidence of medically attended severe LRTI due to RSV in infants through 180 days of lifeDelivery to 180 days after delivery

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

The percentage of infant participants with specific birth outcomesBirth

Describe specific birth outcomes for infant participants

The percentage of infant participants with serious adverse events (SAE) and newly diagnosed chronic medical conditions (NDCMCs) from birth to 24 months of ageFrom birth up to 24 months of age

Describe SAE and NDCMCs for infant participants from birth to 24 months of age

Percentage of maternal participants reporting local reactions and systemic events from day of vaccination (Day 1) until Day 7From day of vaccination until 7 days after vaccination

Describe local reactions and systemic events after vaccination

The percentage of infant participants with adverse events (AEs) from birth to 1 month of ageUp to 1 month of age

Describe AE for infant participants from birth to 1 month of age

The percentage reduction in the incidence of medically attended LRTI (MA-LRTI) due to RSV in infants through 180 days of lifeDelivery to 180 days after delivery

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

The percentage of infant participants with serious adverse events (SAE) and newly diagnosed chronic medical conditions (NDCMCs) from birth to 12 months of ageFrom birth up to 12 months of age

Describe SAE and NDCMCs for infant participants from birth to 12 months of age

Percentage of maternal participants reporting Adverse Events (AE) within 1 month after vaccinationWithin 1 month after vaccination

Describe adverse events (AE) after vaccination

Percentage of maternal participants reporting SAEsFrom enrollment up to 180 days after delivery

Describe serious adverse events from enrolment up to 180 days after delivery

Secondary Outcome Measures
NameTimeMethod
The percentage reduction in the incidence of MA-LRTI due to RSV in infants participantsDelivery to 360 days after delivery

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

The percentage reduction in the incidence of hospitalizations due to RSV in infants through 360 days of lifeDelivery to 360 days after delivery

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

The percentage reduction in the incidence of all-cause MA-LRTI in infant participantsDelivery to 360 days after delivery

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

Trial Locations

Locations (458)

Ronald Reagan UCLA Medical Center Drug Information Center Dept

🇺🇸

Los Angeles, California, United States

Wayne State University Physician Group

🇺🇸

Southfield, Michigan, United States

Emory University School of Medicine

🇺🇸

Atlanta, Georgia, United States

Banner Thunderbird Hospital

🇺🇸

Glendale, Arizona, United States

Abrazo West Campus Hospital

🇺🇸

Goodyear, Arizona, United States

Cullman Clinical Research, Inc

🇺🇸

Cullman, Alabama, United States

Cullman Regional

🇺🇸

Cullman, Alabama, United States

Banner University Medical Center

🇺🇸

Tucson, Arizona, United States

Banner University Medical Center ( North Campus )

🇺🇸

Tucson, Arizona, United States

Arrowhead Community Hospital

🇺🇸

Glendale, Arizona, United States

Loma Linda University Pediatric Clinic - Highland

🇺🇸

Highland, California, United States

St. Bernards Medical Center

🇺🇸

Jonesboro, Arkansas, United States

Mesquite Pediatrics

🇺🇸

Tucson, Arizona, United States

St. Bernards OBGYN Associates

🇺🇸

Jonesboro, Arkansas, United States

Watching Over Mothers and Babies

🇺🇸

Tucson, Arizona, United States

The Children's Clinic of Jonesboro, P.A.

🇺🇸

Jonesboro, Arkansas, United States

Century Research Institute

🇺🇸

Los Angeles, California, United States

University of Arizona

🇺🇸

Tucson, Arizona, United States

Loma Linda University Faculty Medical Clinics

🇺🇸

Loma Linda, California, United States

Barnes Jewish Hospital

🇺🇸

Saint Louis, Missouri, United States

Singing River Health System

🇺🇸

Gulfport, Mississippi, United States

Gulfport Memorial Hospital

🇺🇸

Gulfport, Mississippi, United States

MedPharmics

🇺🇸

Albuquerque, New Mexico, United States

The Birth Center

🇺🇸

Missoula, Montana, United States

Marcus Daly Memorial Hospital

🇺🇸

Hamilton, Montana, United States

Origin Health GTF

🇺🇸

Great Falls, Montana, United States

Velocity Clinical Research, Norfolk

🇺🇸

Norfolk, Nebraska, United States

University of New Mexico Hospital

🇺🇸

Albuquerque, New Mexico, United States

Dayton Clinical Research

🇺🇸

Dayton, Ohio, United States

Columbia Doctors

🇺🇸

New York, New York, United States

Meridian Clinical Research LLC

🇺🇸

Vestal, New York, United States

Reading Hospital - Children's Health Center

🇺🇸

West Reading, Pennsylvania, United States

Coastal Pediatric Research

🇺🇸

Summerville, South Carolina, United States

Sanford Women's Health Plaza (Recruitment, Consenting, and Follow Up)

🇺🇸

Sioux Falls, South Dakota, United States

Wise Health System Dectaur

🇺🇸

Decatur, Texas, United States

Aarhus Universitetshospital

🇩🇰

Aarhus N, Denmark

FVR, Tampere Clinic

🇫🇮

Tampere, Pirkanmaa, Finland

Hospital Padre Hurtado

🇨🇱

Santiago, Región Metropolitana, Chile

Nordsjællands Hospital

🇩🇰

Hillerod, Denmark

Hospital Italiano de Rosario

🇦🇷

Rosario, Santa FE, Argentina

Odense Universitets Hospital

🇩🇰

Odense, Denmark

Centro Internacional de Estudios Clinicos - CIEC

🇨🇱

Santiago, Región Metropolitana, Chile

Hvidovre Hospital

🇩🇰

Hvidovre, Denmark

Kokkola Vaccine Research Clinic

🇫🇮

Kokkola, Finland

FVR, Oulun rokotetutkimusklinikka

🇫🇮

Oulu, Finland

FVR, Pori Clinic

🇫🇮

Pori, Finland

Tampereen yliopisto Oulun Rokotetutkimusklinikka

🇫🇮

Oulu, Finland

FVR, Turku Clinic

🇫🇮

Turku, Finland

Hyogo Prefectural Amagasaki General Medical Center

🇯🇵

Amagasaki, Hyōgo, Japan

Pori Vaccine Research Clinic

🇫🇮

Pori, Finland

Turku Vaccine Research Clinic

🇫🇮

Turku, Finland

National Hospital Organization Tokyo Medical Center

🇯🇵

Meguro-ku, Tokyo, Japan

Saitama City hospital

🇯🇵

Saitama, Japan

Kuwana City Medical Center

🇯🇵

Kuwana-shi, MIE, Japan

Optimal Clinical Trials Ltd

🇳🇿

Auckland, New Zealand

Middlemore Clinical Trials(Middlemore Hospital)

🇳🇿

Auckland, New Zealand

Mackay Memorial Hospital

🇨🇳

Taipei City, Taiwan

Hany H. Ahmed, MD

🇺🇸

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

University of Washington Medical Center - Northwest

🇺🇸

Seattle, Washington, United States

UW Midwives Clinic at Northwest Outpatient Medical center

🇺🇸

Seattle, Washington, United States

Cincinnati Children's Hospital Medical Center

🇺🇸

Cincinnati, Ohio, United States

Affiliated Physician Practice

🇺🇸

Madera, California, United States

MedPharmics, LLC

🇺🇸

Gulfport, Mississippi, United States

The Children's Clinic of Jonesboro, PA

🇺🇸

Jonesboro, Arkansas, United States

Hollywood Presbyterian Medical Center

🇺🇸

Los Angeles, California, United States

Boeson Research

🇺🇸

Missoula, Montana, United States

Community Hospital

🇺🇸

Grand Junction, Colorado, United States

Emerson Clinical Research Institute

🇺🇸

Washington, District of Columbia, United States

Axcess Medical Research

🇺🇸

Loxahatchee Groves, Florida, United States

North Shore Medical Center

🇺🇸

Miami, Florida, United States

Citadelle Clinical Research

🇺🇸

North Miami Beach, Florida, United States

A1 Imaging of Aventura

🇺🇸

North Miami Beach, Florida, United States

Baldwin Pediatrics

🇺🇸

Panama City, Florida, United States

Rainbow 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

American Research Centers of Florida

🇺🇸

Pembroke Pines, Florida, United States

Emory Children's Center Illness POD

🇺🇸

Atlanta, Georgia, United States

Columbus Regional Research Institute

🇺🇸

Columbus, Georgia, United States

1st Choice Urgent Care & Family Medicine

🇺🇸

Blackfoot, Idaho, United States

Bingham Memorial Hospital

🇺🇸

Blackfoot, Idaho, United States

Duke Regional Hospital

🇺🇸

Durham, North Carolina, United States

Duke University.

🇺🇸

Durham, North Carolina, United States

Duke University Hospital

🇺🇸

Durham, North Carolina, United States

Elite Clinical Trials LLLP

🇺🇸

Rexburg, Idaho, United States

Grove Creek Medical Center

🇺🇸

Blackfoot, Idaho, United States

ASR, LLC

🇺🇸

Nampa, Idaho, United States

Saint Alphonsus Regional Medical Center

🇺🇸

Boise, Idaho, United States

St. Luke's Boise Medical Center

🇺🇸

Boise, Idaho, United States

West Valley Medical Center

🇺🇸

Caldwell, Idaho, 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

🇺🇸

Rigby, Idaho, United States

St. Luke's Meridian Medical Center

🇺🇸

Meridian, Idaho, United States

Saltzer Health

🇺🇸

Nampa, Idaho, United States

St. Luke's Nampa Medical Center

🇺🇸

Nampa, Idaho, United States

St. Alphonsus Medical Center- Nampa

🇺🇸

Nampa, 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

1st Choice Urgent Care

🇺🇸

Pocatello, Idaho, United States

Madison Memorial Hospital

🇺🇸

Rexburg, Idaho, United States

Dupont Pediatrics

🇺🇸

Fort Wayne, Indiana, United States

McFarland Clinic, P.C.

🇺🇸

Ames, Iowa, United States

The Iowa Clinic

🇺🇸

Ankeny, Iowa, United States

Owensboro Health Regional Hospital

🇺🇸

Owensboro, Kentucky, United States

Alexandria Cardiology Clinic - Secondary Research Site

🇺🇸

Alexandria, Louisiana, United States

Cambridge Medical Trials - Main Research Site

🇺🇸

Alexandria, Louisiana, United States

Rabie Clinic for Women

🇺🇸

Alexandria, Louisiana, United States

Cambridge Medical Trials

🇺🇸

Alexandria, Louisiana, United States

Rapides Regional Medical Center Labor and Delivery

🇺🇸

Alexandria, Louisiana, 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

🇺🇸

Gulfport, Mississippi, United States

Ochsner Health Center - West Bank

🇺🇸

Gretna, Louisiana, 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

MedPharmics LLC

🇺🇸

Metairie, Louisiana, United States

Crescent City Physicians and Obstetrics

🇺🇸

Metairie, Louisiana, United States

Slidell Memorial Hospital

🇺🇸

Slidell, Louisiana, United States

Boston Medical Center

🇺🇸

Boston, Massachusetts, United States

Investigational Pharmacy Service

🇺🇸

Boston, Massachusetts, United States

C.S. Mott Center

🇺🇸

Detroit, Michigan, United States

Boeson Research (BUT)

🇺🇸

Butte, Montana, United States

St James Healthcare

🇺🇸

Butte, Montana, United States

Benefis Health System

🇺🇸

Great Falls, Montana, United States

Boeson Research (GTF)

🇺🇸

Great Falls, Montana, United States

St Peters Health

🇺🇸

Helena, Montana, United States

Boeson Research (HLN)

🇺🇸

Helena, Montana, United States

Boeson Reseach (KAL)

🇺🇸

Kalispell, Montana, United States

Kalispell Regional Medical Center

🇺🇸

Kalispell, Montana, United States

Community Physicians Group-Maternal Fetal Medicine

🇺🇸

Missoula, Montana, United States

Boeson Research LLC

🇺🇸

Missoula, Montana, United States

Community Medical Center

🇺🇸

Missoula, Montana, United States

St Luke Community Clinic - Ronan

🇺🇸

Ronan, Montana, United States

Grand Island Regional Medical Center

🇺🇸

Grand Island, Nebraska, United States

North Valley Hospital

🇺🇸

Whitefish, Montana, United States

Mary Lanning

🇺🇸

Hastings, Nebraska, United States

Meridian Clinical Research

🇺🇸

Hastings, 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

Bryan Health

🇺🇸

Lincoln, Nebraska, United States

Women's Health Care Center of Williamsburg

🇺🇸

Lincoln, Nebraska, United States

Cullman Primary Care, PC

🇺🇸

Cullman, Alabama, United States

St Vincent's Hospital

🇺🇸

Birmingham, 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

Springhill Medical Center

🇺🇸

Mobile, Alabama, United States

Velocity Clinical Research, Gulfport

🇺🇸

Mobile, Alabama, United States

Chowchilla Medical Center

🇺🇸

Chowchilla, California, United States

Chemidox Clinical Trials

🇺🇸

Lancaster, California, United States

Leonard S. Kurian, M.D., A Medical Corporation

🇺🇸

Lancaster, California, United States

Matrix Clinical Research

🇺🇸

Huntington Park, California, United States

Women & Infants Pavilion, Antelope Valley Hospital

🇺🇸

Lancaster, California, United States

St Mary Medical Center

🇺🇸

Long Beach, California, United States

Loma Linda University Adventist Health Sciences Center

🇺🇸

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

Matrix Clinical Research..

🇺🇸

Los Angeles, California, United States

East LA Doctors Hospital

🇺🇸

Los Angeles, California, United States

White Memorial Medical Center

🇺🇸

Los Angeles, California, United States

Peter Morton Medical Building

🇺🇸

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

Charles E. Ugwu-Oju, M.D., F.A.C.O.G., Obstetrics & Gynecology

🇺🇸

Madera, California, United States

Fomat- Raymond Poliakin, MD.

🇺🇸

Thousand Oaks, California, United States

Lucile Packard Children's Hospital

🇺🇸

Palo Alto, California, United States

Madera Community Hospital

🇺🇸

Madera, California, United States

Stanford University

🇺🇸

Palo Alto, California, United States

Madera Family Medical Group

🇺🇸

Madera, California, United States

Monterey Park Hospital

🇺🇸

Monterey Park, California, United States

Carey Chronis, MD

🇺🇸

Ventura, California, United States

Emory University Hospital Midtown

🇺🇸

Atlanta, Georgia, United States

Emory Clinic

🇺🇸

Atlanta, Georgia, United States

Emory University Investigational Drug Service

🇺🇸

Atlanta, Georgia, United States

Piedmont Columbus Regional Midtown

🇺🇸

Columbus, Georgia, United States

Mcfarland Clinic PC

🇺🇸

Ames, Iowa, United States

Mary Greeley Medical Center

🇺🇸

Ames, Iowa, United States

Women's Health Advantage

🇺🇸

Fort Wayne, Indiana, United States

PMG Research of McFarland Clinic

🇺🇸

Ames, Iowa, United States

Methodist West Hospital

🇺🇸

West Des Moines, Iowa, United States

The Iowa Clinic, P.C.

🇺🇸

West Des Moines, Iowa, United States

Research Integrity, LLC

🇺🇸

Owensboro, Kentucky, United States

The Women's Pavillion, P.S.C

🇺🇸

Owensboro, Kentucky, United States

St. Louis Children's Hospital

🇺🇸

Saint Louis, Missouri, United States

Baer Pediatrics

🇺🇸

Saint Louis, Missouri, United States

KDB Enterprises

🇺🇸

Saint Louis, Missouri, United States

Sundance Clinical Research, LLC

🇺🇸

Saint Louis, Missouri, United States

Audubon Clinic

🇺🇸

New York, New York, United States

Jackson Heights Family Health Center

🇺🇸

Jackson Heights, New York, United States

Center for Prenatal Pediatrics

🇺🇸

New York, New York, United States

Lovelace Women's Hospital

🇺🇸

Albuquerque, New Mexico, United States

Women's Contemporary Care

🇺🇸

Mineola, 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

UNC OB/GYN at Panther Creek (recruitment, randomization, administration of IP)

🇺🇸

Cary, North Carolina, United States

Duke Children's Primary Care - Roxboro Street

🇺🇸

Durham, North Carolina, United States

Womack Army Medical Center

🇺🇸

Fort Bragg, North Carolina, United States

FirstHealth Clinical Trials

🇺🇸

Pinehurst, North Carolina, United States

FirstHealth Moore Regional Hospital

🇺🇸

Pinehurst, North Carolina, United States

FirstHealth Southern Pines Women's Health Center

🇺🇸

Southern Pines, North Carolina, United States

HWC Women's Research Center, LLC

🇺🇸

Englewood, Ohio, United States

The Christ Hospital

🇺🇸

Cincinnati, Ohio, United States

UC Health West Chester Hospital

🇺🇸

West Chester, Ohio, United States

Saint Vincent Hospital

🇺🇸

Erie, Pennsylvania, United States

Integris Yukon Hospital

🇺🇸

Yukon, Oklahoma, United States

Tekton Research

🇺🇸

Yukon, Oklahoma, United States

OBGYN Associates of Erie

🇺🇸

Erie, Pennsylvania, United States

Allegheny Health and Wellness Pavilion

🇺🇸

Erie, Pennsylvania, United States

Liberty Family Practice

🇺🇸

Erie, Pennsylvania, United States

Reading Hospital-Family Health Care Center

🇺🇸

West Reading, Pennsylvania, United States

South Texas Health System- Edinburg

🇺🇸

Edinburg, Texas, United States

Tekton Research, Inc.

🇺🇸

San Antonio, Texas, United States

Center for Women''s Health and Birthcare

🇺🇸

Beaumont, Texas, United States

Gadolin Research, LLC

🇺🇸

Beaumont, Texas, United States

Texas Health Harris Methodist Hospital Fort Worth

🇺🇸

Fort Worth, Texas, United States

FMC Science

🇺🇸

Lampasas, Texas, United States

Texas Health Harris Methodist Hospital Southwest

🇺🇸

Fort Worth, Texas, United States

Georgetown OBGYN

🇺🇸

Georgetown, Texas, United States

HG Pediatrics

🇺🇸

Houston, Texas, United States

St. David's Georgetown Hospital

🇺🇸

Georgetown, Texas, United States

Baylor Scott & White of Grapevine (Hospital)

🇺🇸

Grapevine, Texas, United States

Van Tran Family Clinic

🇺🇸

Houston, Texas, United States

AdventHealth Family Medicine Rural Health Clinic, Inc.

🇺🇸

Lampasas, Texas, United States

DCOL Center for Clinical Research

🇺🇸

Longview, Texas, United States

Diagnostic Clinic of Longview (Medical Circle)

🇺🇸

Longview, Texas, United States

Rio Grande Regional Hospital

🇺🇸

McAllen, Texas, United States

South Texas Health System- McAllen

🇺🇸

McAllen, Texas, United States

Longview Regional Medical Center

🇺🇸

Longview, Texas, United States

Texas Health Presbyterian Hospital Plano

🇺🇸

Plano, Texas, United States

UW Neighborhood South Lake Union Clinic

🇺🇸

Seattle, Washington, United States

University of Washington Medical Center- Montlake

🇺🇸

Seattle, Washington, 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

Cooper Faculty OBGYN at Cherry Hill

🇺🇸

Cherry Hill, New Jersey, United States

Saint Peters University Hospital

🇺🇸

New Brunswick, New Jersey, United States

Cooper Faculty OBGYN at Sewell

🇺🇸

Sewell, New Jersey, United States

Presbyterian Hospital

🇺🇸

Albuquerque, New Mexico, United States

Velocity Clinical Research, Albuquerque

🇺🇸

Albuquerque, New Mexico, United States

New York Presbyterian of Queens Hospital

🇺🇸

Flushing, New York, United States

Theresa Lang Children's Ambulatory Center

🇺🇸

Flushing, New York, United States

Fresh Meadows Family Health Center

🇺🇸

Fresh Meadows, New York, United States

Hollis Women's Center

🇺🇸

Hollis, New York, United States

NYU Langone Hospital - Long Island

🇺🇸

Mineola, New York, United States

Sandhills Pediatrics

🇺🇸

Southern Pines, North Carolina, United States

University of Cincinnati Medical Center Department of Obstetrics and Gynecology

🇺🇸

Cincinnati, Ohio, United States

Reading Hospital - Women's Health Center

🇺🇸

West Reading, Pennsylvania, United States

Prisma Health

🇺🇸

Greenville, South Carolina, United States

Lowcountry Womens Specialists

🇺🇸

Summerville, South Carolina, United States

Sanford Children's Specialty Clinic

🇺🇸

Sioux Falls, South Dakota, United States

Summerville Medical Center

🇺🇸

Summerville, South Carolina, United States

Sanford Obstetrics and Gynecology Clinic (Recruitment, Consenting, IP Administration, and Follow Up)

🇺🇸

Sioux Falls, South Dakota, United States

Sanford Obstetrics and Gynecology Clinic

🇺🇸

Sioux Falls, South Dakota, United States

Premier Medical Group

🇺🇸

Clarksville, Tennessee, United States

Sanford USD Medical Center (Main Hospital)

🇺🇸

Sioux Falls, South Dakota, United States

Texas Health Arlington Memorial Hospital

🇺🇸

Arlington, Texas, United States

University of Tennessee Medical Center

🇺🇸

Knoxville, Tennessee, United States

Ventavia Research Group, LLC

🇺🇸

Houston, Texas, United States

Medical City Arlington (Women's Hospital)

🇺🇸

Arlington, Texas, United States

Christus St. Elizabeth Hospital

🇺🇸

Beaumont, Texas, United States

Texas Health Harris Methodist Hospital Hurst-Euless-Bedford

🇺🇸

Bedford, Texas, United States

Child Care Pediatrics, P.A.

🇺🇸

Burleson, Texas, United States

Ventavia Research Group LLC

🇺🇸

Plano, Texas, United States

Texas Health Presbyterian Hospital Dallas

🇺🇸

Dallas, Texas, United States

Doctor's Hospital Womens Hospital

🇺🇸

Edinburg, Texas, United States

8th Avenue Obstetrics & Gynecology

🇺🇸

Fort Worth, Texas, United States

Baylor Scott & White All Saints Medical Center

🇺🇸

Fort Worth, Texas, United States

University of Texas Medical Branch

🇺🇸

Galveston, Texas, United States

Chisholm Trail Pediatrics

🇺🇸

Georgetown, Texas, United States

HCA: The Women's Hospital of Texas

🇺🇸

Houston, Texas, United States

Maximos Ob/Gyn

🇺🇸

League City, Texas, United States

Diagnostic Clinic of Longview (Hollybrook)

🇺🇸

Longview, Texas, United States

Dr. Ruben Aleman and Associates

🇺🇸

McAllen, Texas, United States

Medical City Plano

🇺🇸

Plano, Texas, United States

St. Luke's Baptist Hospital

🇺🇸

San Antonio, Texas, United States

DM Clinical Research

🇺🇸

Tomball, Texas, United States

Medical City Weatherford

🇺🇸

Weatherford, Texas, United States

Ventavia Research Group

🇺🇸

Weatherford, Texas, United States

Sentara Leigh Hospital

🇺🇸

Norfolk, Virginia, United States

Tidewater Physicians for Women

🇺🇸

Virginia Beach, Virginia, United States

The Group for Women

🇺🇸

Norfolk, Virginia, United States

Seattle Children's Hospital

🇺🇸

Seattle, Washington, United States

UW Neighborhood Ravenna Clinic

🇺🇸

Seattle, Washington, United States

UW Neighborhood Shoreline Clinic

🇺🇸

Shoreline, Washington, 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

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

Marshfield Medical Center - Marshfield

🇺🇸

Marshfield, Wisconsin, United States

Marshfield Medical Center

🇺🇸

Marshfield, Wisconsin, United States

Clínica del Niño y la Madre

🇦🇷

Mar del Plata, Buenos Aires, 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, Argentina

Sanatorio Mater Dei

🇦🇷

Buenos Aires, Argentina

Centro de Investigación Clinica OSECAC

🇦🇷

Buenos Aires, Argentina

Hospital Publico Materno Infantil

🇦🇷

Salta, Argentina

Women's and Children's Hospital

🇦🇺

North Adelaide, South Australia, Australia

Monash Children's Hospital

🇦🇺

Clayton, Victoria, Australia

Barwon Health, University Hospital Geelong

🇦🇺

Geelong, Victoria, Australia

Hospital Universitario/GAMP - Grupo de Apoio a Medicina Preventiva e a Saude Publica

🇧🇷

Canoas, RS, Brazil

Hospital Moinhos de Vento - HMV

🇧🇷

Porto Alegre, RS, Brazil

Maternidade Darcy Vargas

🇧🇷

Joinville, SC, Brazil

Clinica de Alergia Martti Antila S/S Ltda./ CMPC - Consultoria Medica e Pesquisa Clinica

🇧🇷

Sorocaba, SP, Brazil

Canadian Center for Vaccinology - IWK Health Centre

🇨🇦

Halifax, Nova Scotia, Canada

CHU Sainte-Justine

🇨🇦

Montreal, Quebec, Canada

CHU de Québec-Université Laval

🇨🇦

Quebec, Canada

Centro de Capacitación e Investigaciones Clínicas (CCIC)

🇨🇱

Santiago, Región Metropolitana, Chile

Hospital Base San José de Osorno (Servicio de Obstetricia y Ginecología)

🇨🇱

Osorno, Región DE LOS Lagos, Chile

Clinica Universidad de los Andes

🇨🇱

Santiago, Región Metropolitana, Chile

Satellite (Deliveries): Hospital San Juan de Dios (Maternidad)

🇨🇱

Santiago, Región Metropolitana, Chile

Instituto de Investigaciones Materno Infantil (IDIMI)

🇨🇱

Santiago, Región Metropolitana, Chile

Deliveries (satellite): Hospital San Jose

🇨🇱

Santiago, Región Metropolitana, Chile

Oulu Vaccine Research Clinic

🇫🇮

Oulu, Finland

Seinajoki Vaccine Research Clinic

🇫🇮

Seinajoki, Finland

Tampere Vaccine Research Clinic

🇫🇮

Tampere, Finland

Tampere University Vaccine Research Turku

🇫🇮

Turku, Finland

MRC Unit The Gambia

🇬🇲

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, Gambia

Fukui Aiiku Hospital

🇯🇵

Fukui-shi, Fukui, Japan

Shonan Fujisawa Tokushukai Hospital

🇯🇵

Fujisawa, Kanagawa, Japan

Rakuwakai Otowa Hospital

🇯🇵

Kyoto-shi, Kyoto, Japan

Sendai City Hospital

🇯🇵

Sendai-city, Miyagi, Japan

Osaka Habikino Medical Center

🇯🇵

Habikino, Osaka, Japan

National Hospital Organization Beppu Medical Center

🇯🇵

Beppu, Oita, Japan

Social Medical Corporation KARIYUSHIKAI Heartlife Hospital

🇯🇵

Nakagami-gun, Okinawa, Japan

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

Kyunghee University Hospital at Gangdong

🇰🇷

Seoul, Korea, Republic of

Korea University Guro Hospital

🇰🇷

Seoul, Korea, Republic of

Arke SMO S.A. de C.V.

🇲🇽

Veracruz, Mexico

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

🇲🇽

Monterrey, Nuevo LEON, Mexico

Spaarne Gasthuis (Kennemer Gasthuis)

🇳🇱

Hoofddorp, Netherlands

Diakonessenhuis Utrecht

🇳🇱

Utrecht, Netherlands

Hospital General de Durango

🇲🇽

Durango, Mexico

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

New Zealand Clinical Research (Christchurch)

🇳🇿

Christchurch, Canterbury, New Zealand

Aotearoa Clinical Trials Trust (ACTT)

🇳🇿

Auckland, New Zealand

Christchurch Hospital (Canterbury District Health Board)

🇳🇿

Christchurch, New Zealand

Capital, Coast and Hutt Valley District- Wellington Regional Hospital

🇳🇿

Wellington, New Zealand

Wellington Hospital (Capital and Coast District Health Board)

🇳🇿

Wellington, New Zealand

Asian Hospital and Medical Center

🇵🇭

Muntinlupa City, Metro Manila, Philippines

JOSHA Research

🇿🇦

Bloemfontein, FREE State, South Africa

Wits RHI Shandukani Research Centre

🇿🇦

Johannesburg, Gauteng, 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, South Africa

Limpopo Clinical Research Initiative

🇿🇦

Thabazimbi, Limpopo, South Africa

MRC Unit on Child and Adolescent Health

🇿🇦

Cape Town, Western CAPE, 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

Kraaifontein Satellite site

🇿🇦

Cape Town, South Africa

Worcester Satellite site

🇿🇦

Worcester, South Africa

CHUS - Hospital Clinico Universitario

🇪🇸

Santiago de Compostela, A Coruna, 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

Hospital Universitari i Politecnic La Fe

🇪🇸

Valencia, Spain

Hsinchu Mackay Memorial Hospital

🇨🇳

Hsinchu, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

🇨🇳

Kaohsiung, Taiwan

National Taiwan University Hospital

🇨🇳

Taipei, Taiwan

Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

🇨🇳

Taoyuan, Taiwan

Alpine Medical Group

🇺🇸

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

Holladay Family Practice

🇺🇸

Salt Lake City, Utah, United States

St. Marks Hospital

🇺🇸

Salt Lake City, Utah, United States

University of Utah Hospital

🇺🇸

Salt Lake City, Utah, United States

University of Utah

🇺🇸

Salt Lake City, Utah, United States

Alliance for Multispecialty Research, LLC

🇺🇸

Newton, Kansas, United States

Dino-Peds

🇺🇸

Grand Junction, Colorado, United States

Colorado Canyon's Hospital

🇺🇸

Fruita, Colorado, United States

SCL St. Mary's Medical Center

🇺🇸

Grand Junction, Colorado, United States

Delta Memorial Hospital

🇺🇸

Delta, Colorado, United States

Women's Health Care of Western Colorado

🇺🇸

Grand Junction, Colorado, United States

Montrose Memorial Hospital

🇺🇸

Montrose, Colorado, United States

Perth Children's Hospital

🇦🇺

Nedlands, Western Australia, Australia

St John of God Hospital Subiaco

🇦🇺

Subiaco, Western Australia, Australia

Telethon Kids Institute

🇦🇺

Nedlands, Western Australia, Australia

Washington University School of Medicine

🇺🇸

Saint Louis, Missouri, United States

Central Research Associates, Inc.

🇺🇸

Birmingham, Alabama, United States

Endocrinology and Internal Medicine Associates, PC

🇺🇸

Birmingham, Alabama, United States

OB/GYN Associates of Alabama, PC

🇺🇸

Birmingham, Alabama, United States

University of Alabama at Birmingham/Center for Women's Reproductive Health

🇺🇸

Birmingham, Alabama, United States

Sharp and Stone OB/GYN PC

🇺🇸

Birmingham, Alabama, United States

Children's of Alabama

🇺🇸

Birmingham, Alabama, United States

UAB Women & Infants Center - UAB Medicine

🇺🇸

Birmingham, Alabama, United States

Velocity Clinical Research - Pheonix

🇺🇸

Phoenix, Arizona, United States

Valleywise Comprehensive Health Center Women's Clinic

🇺🇸

Phoenix, Arizona, United States

St. Joseph's Hospital and Medical Center

🇺🇸

Phoenix, Arizona, United States

Valleywise Health Medical Center

🇺🇸

Phoenix, Arizona, United States

Hutzel-Harper Women's Hospital

🇺🇸

Detroit, Michigan, United States

University Health Center

🇺🇸

Detroit, Michigan, United States

CHI Health St. Francis

🇺🇸

Grand Island, Nebraska, United States

Deliveries (satellite): Hospital Clínico Universidad de Chile

🇨🇱

Santiago, Región Metropolitana, Chile

MeVac

🇫🇮

Helsinki, Finland

FVR, Kokkola Clinic

🇫🇮

Kokkola, Finland

Meridian Clinical Research, LLC

🇺🇸

Grand Island, Nebraska, United States

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

🇦🇷

Caba, Argentina

Grupo Estudios Clínicos Infectología Respiratoria

🇨🇱

Santiago, Región Metropolitana, Chile

FVR, Oulu Clinic

🇫🇮

Oulu, Pohjois-pohjanmaa, Finland

Shizuoka General Hospital

🇯🇵

Shizuoka, Japan

University Medical Center Utrecht

🇳🇱

Utrecht, Netherlands

Prisma Health-Upstate Office of Maternal Fetal Medicine

🇺🇸

Greenville, South Carolina, United States

Chonnam National University Hospital

🇰🇷

Gwangju, Korea, Republic of

University of Colorado AO1

🇺🇸

Aurora, Colorado, United States

University of Colorado Hospital

🇺🇸

Aurora, Colorado, United States

University of Colorado Hospital Outpatient Pavilion

🇺🇸

Aurora, Colorado, United States

Children's Hospital Colorado

🇺🇸

Aurora, Colorado, United States

University of Colorado Anschutz Inpatient Pavilion 2

🇺🇸

Aurora, Colorado, United States

University of Colorado Leprino Building

🇺🇸

Aurora, Colorado, United States

Yale School Medicine Church Street Research Unit

🇺🇸

New Haven, Connecticut, United States

University of Colorado Hospital Inpatient Pavilion

🇺🇸

Aurora, Colorado, United States

University of Colorado Research II Building

🇺🇸

Aurora, Colorado, United States

Ochsner Baptist Medical Center

🇺🇸

New Orleans, Louisiana, United States

Touro Infirmary

🇺🇸

New Orleans, Louisiana, United States

Ochsner Health Center for Children

🇺🇸

New Orleans, Louisiana, United States

Women Under Study, LLC

🇺🇸

New Orleans, Louisiana, United States

Ochsner Clinic Foundation

🇺🇸

New Orleans, Louisiana, 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

St. David's Medical Center

🇺🇸

Austin, Texas, United States

Clinical Research Partners, LLC

🇺🇸

Richmond, Virginia, United States

Virginia Commonwealth Univeristy Health Systems-Children's Pavilion

🇺🇸

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

VCU Health Adult Outpatient Pavillion

🇺🇸

Richmond, Virginia, United States

Virginia Commonwealth University

🇺🇸

Richmond, Virginia, United States

Reading Hospital

🇺🇸

West Reading, Pennsylvania, United States

Cline Pediatrics

🇺🇸

Dickinson, Texas, United States

Asociacion Mexicana para la Investigacion Clinica, A. C.

🇲🇽

Pachuca de Soto, Hidalgo, Mexico

University of Kansas Medical Center

🇺🇸

Kansas City, Kansas, United States

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