AzTrials
AzTrials

Respiratory Tract InfectionPhase 3NCT04424316

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

A Phase 3 study testing RSVpreF in people with Respiratory Tract Infection, run by Pfizer at 464 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 0 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
Respiratory Tract Infection
What is being tested?
RSVpreF
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
14,727 participants
Where
464 sitesin 18 countries
Study dates
17 Jun 2020to 27 Oct 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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).
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  • 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.
  • 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.

Who cannot join

  • 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.
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  • 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.
  • o Infant who is a direct descendant (eg, child or grandchild) of the study personnel.

Trial locations and contacts

464 sites in 18 countries.

401 sites in 18 countries

United States300 sites

  • MedPharmics

    Albuquerque, New Mexico, 87102

  • Presbyterian Hospital

    Albuquerque, New Mexico, 87106

  • University of New Mexico Hospital

    Albuquerque, New Mexico, 87106

  • Velocity Clinical Research, Albuquerque

    Albuquerque, New Mexico, 87107

  • Lovelace Women's Hospital

    Albuquerque, New Mexico, 87109

  • Alexandria Cardiology Clinic - Secondary Research Site

    Alexandria, Louisiana, 71301

  • Cambridge Medical Trials - Main Research Site

    Alexandria, Louisiana, 71301

  • Cambridge Medical Trials

    Alexandria, Louisiana, 71301

  • Rabie Clinic for Women

    Alexandria, Louisiana, 71301

  • Rapides Regional Medical Center Labor and Delivery

    Alexandria, Louisiana, 71301

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • Mcfarland Clinic PC

    Ames, Iowa, 50010

  • McFarland Clinic, P.C.

    Ames, Iowa, 50010

  • The Iowa Clinic

    Ankeny, Iowa, 50023

  • Texas Health Arlington Memorial Hospital

    Arlington, Texas, 76012

  • Ventavia Research Group, LLC

    Arlington, Texas, 76012

  • Medical City Arlington (Women's Hospital)

    Arlington, Texas, 76015

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory Clinic

    Atlanta, Georgia, 30322

  • Emory University Investigational Drug Service

    Atlanta, Georgia, 30322

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

  • University of Colorado Anschutz Inpatient Pavilion 2

    Aurora, Colorado, 80045

  • University of Colorado AO1

    Aurora, Colorado, 80045

  • University of Colorado Hospital Inpatient Pavilion

    Aurora, Colorado, 80045

  • University of Colorado Hospital Outpatient Pavilion

    Aurora, Colorado, 80045

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • University of Colorado Leprino Building

    Aurora, Colorado, 80045

  • University of Colorado Research II Building

    Aurora, Colorado, 80045

  • St. David's Medical Center

    Austin, Texas, 78705

  • Tekton Research, Inc.

    Austin, Texas, 78705

  • Center for Women''s Health and Birthcare

    Beaumont, Texas, 77702

  • Christus St. Elizabeth Hospital

    Beaumont, Texas, 77702

  • Gadolin Research, LLC

    Beaumont, Texas, 77702

  • Texas Health Harris Methodist Hospital Hurst-Euless-Bedford

    Bedford, Texas, 76022

  • Century Research Institute

    Bellflower, California, 90706

  • Central Research Associates, Inc.

    Birmingham, Alabama, 35205

  • Endocrinology and Internal Medicine Associates, PC

    Birmingham, Alabama, 35205

  • OB/GYN Associates of Alabama, PC

    Birmingham, Alabama, 35205

  • Sharp and Stone OB/GYN PC

    Birmingham, Alabama, 35205

  • St Vincent's Hospital

    Birmingham, Alabama, 35205

  • Children's of Alabama

    Birmingham, Alabama, 35233

  • UAB Women & Infants Center - UAB Medicine

    Birmingham, Alabama, 35233

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

    Birmingham, Alabama, 35233

  • 1st Choice Urgent Care & Family Medicine

    Blackfoot, Idaho, 83221

  • Bingham Memorial Hospital

    Blackfoot, Idaho, 83221

  • Elite Clinical Trials LLLP

    Blackfoot, Idaho, 83221

  • Grove Creek Medical Center

    Blackfoot, Idaho, 83221

  • ASR, LLC

    Boise, Idaho, 83702

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • St. Luke's Boise Medical Center

    Boise, Idaho, 83712

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Investigational Pharmacy Service

    Boston, Massachusetts, 02118

  • Child Care Pediatrics, P.A.

    Burleson, Texas, 76028

  • Ventavia Research Group LLC

    Burleson, Texas, 76028

  • Boeson Research (BUT)

    Butte, Montana, 59701

  • St James Healthcare

    Butte, Montana, 59701

  • West Valley Medical Center

    Caldwell, Idaho, 83605

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • Jaffe Family Womens Care Center

    Camden, New Jersey, 08103

  • Pediatrics at Sheridan Pavilion- Three Cooper Plaza

    Camden, New Jersey, 08103

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

    Cary, North Carolina, 27519

  • UNC Children's Hospital (Pediatric follow up)

    Chapel Hill, North Carolina, 27514

  • UNC Healthcare (recruitment, randomization, administration of IP)

    Chapel Hill, North Carolina, 27514

  • UNC OB/GYN at Weaver Crossing (recruitment, randomization, administration of IP)

    Chapel Hill, North Carolina, 27514

  • Bon Secours St. Francis Hospital

    Charleston, South Carolina, 29414

  • Charleston 0B/GYN

    Charleston, South Carolina, 29414

  • Coastal Pediatric Research

    Charleston, South Carolina, 29414

  • Cooper Faculty OBGYN at Cherry Hill

    Cherry Hill, New Jersey, 08034

  • Chowchilla Medical Center

    Chowchilla, California, 93610

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • University of Cincinnati Medical Center Department of Obstetrics and Gynecology

    Cincinnati, Ohio, 45219

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Premier Medical Group

    Clarksville, Tennessee, 37040

  • Piedmont Columbus Regional Midtown

    Columbus, Georgia, 31901

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Lakeview Regional Medical Center

    Covington, Louisiana, 70433

  • St. Tammany Parish Hospital

    Covington, Louisiana, 70433

  • Velocity Clinical Research

    Covington, Louisiana, 70433

  • Cullman Clinical Research, Inc

    Cullman, Alabama, 35058

  • Cullman Primary Care, PC

    Cullman, Alabama, 35058

  • Cullman Regional

    Cullman, Alabama, 35058

  • Texas Health Presbyterian Hospital Dallas

    Dallas, Texas, 75231

  • Ventavia Research Group LLC

    Dallas, Texas, 75231

  • Dayton Clinical Research

    Dayton, Ohio, 45409

  • Wise Health System Dectaur

    Decatur, Texas, 76243

  • Delta Memorial Hospital

    Delta, Colorado, 81416

  • C.S. Mott Center

    Detroit, Michigan, 48201

  • Hutzel-Harper Women's Hospital

    Detroit, Michigan, 48201

  • University Health Center

    Detroit, Michigan, 48201

  • Cline Pediatrics

    Dickinson, Texas, 77539

  • Duke Children's Primary Care - Roxboro Street

    Durham, North Carolina, 27704

  • Duke Regional Hospital

    Durham, North Carolina, 27704

  • Duke University.

    Durham, North Carolina, 27705

  • Duke University Hospital

    Durham, North Carolina, 27710

  • Doctor's Hospital Womens Hospital

    Edinburg, Texas, 78539

  • South Texas Health System- Edinburg

    Edinburg, Texas, 78539

  • Alliance for Multispecialty Research, LLC

    El Dorado, Kansas, 67042

  • HWC Women's Research Center, LLC

    Englewood, Ohio, 45322

  • Allegheny Health and Wellness Pavilion

    Erie, Pennsylvania, 16506

  • OBGYN Associates of Erie

    Erie, Pennsylvania, 16507

  • Liberty Family Practice

    Erie, Pennsylvania, 16508

  • Saint Vincent Hospital

    Erie, Pennsylvania, 16544

  • New York Presbyterian of Queens Hospital

    Flushing, New York, 11355

  • Theresa Lang Children's Ambulatory Center

    Flushing, New York, 11355

  • Womack Army Medical Center

    Fort Bragg, North Carolina, 28310

  • Dupont Pediatrics

    Fort Wayne, Indiana, 46825

  • Women's Health Advantage

    Fort Wayne, Indiana, 46825

  • 8th Avenue Obstetrics & Gynecology

    Fort Worth, Texas, 76104

  • Baylor Scott & White All Saints Medical Center

    Fort Worth, Texas, 76104

  • Texas Health Harris Methodist Hospital Fort Worth

    Fort Worth, Texas, 76104

  • Ventavia Research Group, LLC

    Fort Worth, Texas, 76104

  • Texas Health Harris Methodist Hospital Southwest

    Fort Worth, Texas, 76132

  • Fresh Meadows Family Health Center

    Fresh Meadows, New York, 11365

  • Colorado Canyon's Hospital

    Fruita, Colorado, 81521

  • University of Texas Medical Branch

    Galveston, Texas, 77555

  • Chisholm Trail Pediatrics

    Georgetown, Texas, 78626

  • FMC Science

    Georgetown, Texas, 78626

  • St. David's Georgetown Hospital

    Georgetown, Texas, 78626

  • Grand Island Regional Medical Center

    Grand Island, Nebraska, 68801

  • CHI Health St. Francis

    Grand Island, Nebraska, 68803

  • Meridian Clinical Research, LLC

    Grand Island, Nebraska, 68803

  • Boeson Research

    Grand Junction, Colorado, 81501

  • Dino-Peds

    Grand Junction, Colorado, 81501

  • Women's Health Care of Western Colorado

    Grand Junction, Colorado, 81501

  • Boeson Research

    Grand Junction, Colorado, 81505

  • Community Hospital

    Grand Junction, Colorado, 81505

  • SCL St. Mary's Medical Center

    Grand Junction, Colorado, 81505

  • Baylor Scott & White of Grapevine (Hospital)

    Grapevine, Texas, 76051

  • Ventavia Research Group, LLC

    Grapevine, Texas, 76051

  • Benefis Health System

    Great Falls, Montana, 59405

  • Origin Health GTF

    Great Falls, Montana, 59405

  • Boeson Research (GTF)

    Great Falls, Montana, 59804

  • Prisma Health-Upstate Office of Maternal Fetal Medicine

    Greenville, South Carolina, 29605

  • Prisma Health

    Greenville, South Carolina, 29605

  • Ochsner Health Center - West Bank

    Gretna, Louisiana, 70056

  • Velocity Clinical Research

    Gulfport, Mississippi, 39503

  • Marcus Daly Memorial Hospital

    Hamilton, Montana, 59840

  • North Oaks Medical Center

    Hammond, Louisiana, 70131

  • North Oaks Obstetrics & Gynecology

    Hammond, Louisiana, 70403

  • North Oaks Rural Health Clinic

    Hammond, Louisiana, 70403

  • Mary Lanning

    Hastings, Nebraska, 68901

  • Meridian Clinical Research

    Hastings, Nebraska, 68901

  • Boeson Research (HLN)

    Helena, Montana, 59601

  • St Peters Health

    Helena, Montana, 59601

  • Loma Linda University Pediatric Clinic - Highland

    Highland, California, 92346

  • Hollis Women's Center

    Hollis, New York, 11423

  • Hany H. Ahmed, MD

    Houston, Texas, 77008

  • HG Pediatrics

    Houston, Texas, 77008

  • Van Tran Family Clinic

    Houston, Texas, 77008

  • Ventavia Research Group, LLC

    Houston, Texas, 77008

  • Memorial Hermann Memorial City

    Houston, Texas, 77024

  • UT Health Women's Research Center at Memorial City

    Houston, Texas, 77024

  • HCA: The Women's Hospital of Texas

    Houston, Texas, 77054

  • Javara Inc.

    Houston, Texas, 77054

  • Privia Medical Group Gulf Coast, PLLC

    Houston, Texas, 77054

  • Texas Center for Drug Development, Inc

    Houston, Texas, 77081

  • Cabell Huntington Hospital

    Huntington, West Virginia, 25701

  • Marshall Health

    Huntington, West Virginia, 25701

  • University Physicians and Surgeons dba Marshall Health Department of Obstetrics and Gynecology

    Huntington, West Virginia, 25701

  • University Physicians and Surgeons dba Marshall Health Department of Pediatrics

    Huntington, West Virginia, 25701

  • Century Research Institute

    Huntington Park, California, 90255

  • Matrix Clinical Research

    Huntington Park, California, 90255

  • Clinical Research Prime

    Idaho Falls, Idaho, 83404

  • Eastern Idaho Regional Medical Center

    Idaho Falls, Idaho, 83404

  • Mountain View Hospital

    Idaho Falls, Idaho, 83404

  • The Pediatric Center

    Idaho Falls, Idaho, 83404

  • Jackson Heights Family Health Center

    Jackson Heights, New York, 11372

  • St. Bernards Medical Center

    Jonesboro, Arkansas, 72401

  • St. Bernards OBGYN Associates

    Jonesboro, Arkansas, 72401

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

    Jonesboro, Arkansas, 72401

  • The Children's Clinic of Jonesboro, PA

    Jonesboro, Arkansas, 72401

  • Boeson Reseach (KAL)

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • MedPharmics LLC

    Lafayette, Louisiana, 70508

  • AdventHealth Family Medicine Rural Health Clinic, Inc.

    Lampasas, Texas, 76550

  • FMC Science

    Lampasas, Texas, 76550

  • Chemidox Clinical Trials

    Lancaster, California, 93534

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

    Lancaster, California, 93534

  • Women & Infants Pavilion, Antelope Valley Hospital

    Lancaster, California, 93534

  • Maximos Ob/Gyn

    League City, Texas, 77573

  • Midwest Children's Health Research Institute

    Lincoln, Nebraska, 68504

  • Midwest Children's Health Research Institute.

    Lincoln, Nebraska, 68505

  • Bryan Health

    Lincoln, Nebraska, 68506

  • Midwest Childrens Health Research Institute

    Lincoln, Nebraska, 68516

  • Women's Health Care Center of Williamsburg

    Lincoln, Nebraska, 68516

  • Midwest Children's Health Research Institute

    Lincoln, Nebraska, 68522

  • Loma Linda University Adventist Health Sciences Center

    Loma Linda, California, 92354

  • Loma Linda University Faculty Medical Clinics

    Loma Linda, California, 92354

  • Loma Linda University Pediatric Clinics

    Loma Linda, California, 92354

  • Loma Linda Unversity Children's Hospital

    Loma Linda, California, 92354

  • Long Beach Clinical Trials

    Long Beach, California, 90806

  • Long Beach Memorial Medical Center

    Long Beach, California, 90806

  • St Mary Medical Center

    Long Beach, California, 90806

  • DCOL Center for Clinical Research

    Longview, Texas, 75605

  • Diagnostic Clinic of Longview (Hollybrook)

    Longview, Texas, 75605

  • Diagnostic Clinic of Longview (Medical Circle)

    Longview, Texas, 75605

  • Longview Regional Medical Center

    Longview, Texas, 75605

  • Century Research Institute

    Los Angeles, California, 90006

  • Matrix Clinical Research..

    Los Angeles, California, 90006

  • East LA Doctors Hospital

    Los Angeles, California, 90023

  • Hollywood Presbyterian Medical Center

    Los Angeles, California, 90027

  • Century Research Institute

    Los Angeles, California, 90033

  • White Memorial Medical Center

    Los Angeles, California, 90033

  • Peter Morton Medical Building

    Los Angeles, California, 90095

  • Ronald Reagan UCLA Medical Center Drug Information Center Dept

    Los Angeles, California, 90095

  • Ronald Reagan University of California Los Angeles Medical Center

    Los Angeles, California, 90095

  • UCLA David Geffen School of Medicine

    Los Angeles, California, 90095

  • Axcess Medical Research

    Loxahatchee Groves, Florida, 33470

  • Affiliated Physician Practice

    Madera, California, 93637

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

    Madera, California, 93637

  • Madera Community Hospital

    Madera, California, 93637

  • Madera Family Medical Group

    Madera, California, 93637

  • Marshfield Medical Center - Marshfield

    Marshfield, Wisconsin, 54449

  • Marshfield Medical Center

    Marshfield, Wisconsin, 54449

  • Rio Grande Regional Hospital

    McAllen, Texas, 78503

  • South Texas Health System- McAllen

    McAllen, Texas, 78503

  • Dr. Ruben Aleman and Associates

    McAllen, Texas, 78504

  • Saltzer Health

    Meridian, Idaho, 83642

  • St. Luke's Meridian Medical Center

    Meridian, Idaho, 83642

  • Crescent City Physicians and Obstetrics

    Metairie, Louisiana, 70005

  • MedPharmics LLC

    Metairie, Louisiana, 70006

  • North Shore Medical Center

    Miami, Florida, 33150

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501

  • Women's Contemporary Care

    Mineola, New York, 11501

  • The Birth Center

    Missoula, Montana, 59803

  • Boeson Research LLC

    Missoula, Montana, 59804

  • Boeson Research

    Missoula, Montana, 59804

  • Community Medical Center

    Missoula, Montana, 59804

  • Community Physicians Group-Maternal Fetal Medicine

    Missoula, Montana, 59804

  • University of South Alabama Children's and Women's Hospital

    Mobile, Alabama, 36604

  • USA Health Strada Patient Care Center

    Mobile, Alabama, 36604

  • Springhill Medical Center

    Mobile, Alabama, 36608

  • Velocity Clinical Research, Gulfport

    Mobile, Alabama, 36608

  • Monterey Park Hospital

    Monterey Park, California, 91754

  • Montrose Memorial Hospital

    Montrose, Colorado, 81401

  • Saltzer Health

    Nampa, Idaho, 83686

  • ASR, LLC

    Nampa, Idaho, 83687

  • Saltzer Health

    Nampa, Idaho, 83687

  • St. Alphonsus Medical Center- Nampa

    Nampa, Idaho, 83687

  • St. Luke's Nampa Medical Center

    Nampa, Idaho, 83687

  • Saint Peters University Hospital

    New Brunswick, New Jersey, 08901

  • Yale School Medicine Church Street Research Unit

    New Haven, Connecticut, 06519

  • Ochsner Baptist Medical Center

    New Orleans, Louisiana, 70115

  • Touro Infirmary

    New Orleans, Louisiana, 70115

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Ochsner Health Center for Children

    New Orleans, Louisiana, 70121

  • Women Under Study, LLC

    New Orleans, Louisiana, 70125

  • Columbia Doctors

    New York, New York, 10019

  • Audubon Clinic

    New York, New York, 10032

  • Center for Prenatal Pediatrics

    New York, New York, 10032

  • Columbia University Irving Medical Center

    New York, New York, 10032

  • Herbert Irving Pavilion

    New York, New York, 10032

  • Morgan Stanley Childrens Hospital

    New York, New York, 10032

  • Alliance for Multispecialty Research, LLC

    Newton, Kansas, 67114

  • Velocity Clinical Research, Norfolk

    Norfolk, Nebraska, 68701

  • Sentara Leigh Hospital

    Norfolk, Virginia, 23502

  • The Group for Women

    Norfolk, Virginia, 23502

  • Tidewater Physicians for Women

    Norfolk, Virginia, 23502

  • Clinical Research Partners, LLC

    North Chesterfield, Virginia, 23235

  • Citadelle Clinical Research

    North Miami Beach, Florida, 33162

  • A1 Imaging of Aventura

    North Miami Beach, Florida, 33180

  • Owensboro Health Regional Hospital

    Owensboro, Kentucky, 42303

  • Research Integrity, LLC

    Owensboro, Kentucky, 42303

  • The Women's Pavillion, P.S.C

    Owensboro, Kentucky, 42303

  • Lucile Packard Children's Hospital

    Palo Alto, California, 94304

  • Stanford University

    Palo Alto, California, 94304

  • Baldwin Pediatrics

    Panama City, Florida, 32405

  • Emerald Coast Obstetrics and Gynecology

    Panama City, Florida, 32405

  • Emerald Coast Pediatrics

    Panama City, Florida, 32405

  • Gulf Coast Regional Medical Center

    Panama City, Florida, 32405

  • Rainbow Pediatrics

    Panama City, Florida, 32405

  • Rainbow Pediatrics

    Panama City Beach, Florida, 32407

  • American Research Centers of Florida

    Pembroke Pines, Florida, 33027

  • Velocity Clinical Research - Pheonix

    Phoenix, Arizona, 85006

  • Valleywise Comprehensive Health Center Women's Clinic

    Phoenix, Arizona, 85008

  • Valleywise Health Medical Center

    Phoenix, Arizona, 85008

  • FirstHealth Clinical Trials

    Pinehurst, North Carolina, 28374

  • FirstHealth Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • Medical City Plano

    Plano, Texas, 75075

  • Texas Health Presbyterian Hospital Plano

    Plano, Texas, 75093

  • Ventavia Research Group LLC

    Plano, Texas, 75093

  • Pocatello Women's Health Clinic

    Pocatello, Idaho, 83201

  • Portneuf Medical Center

    Pocatello, Idaho, 83201

  • 1st Choice Urgent Care

    Pocatello, Idaho, 83204

  • Clinical Research Prime Rexburg

    Rexburg, Idaho, 83440

  • Elite Clinical Trials LLLP

    Rexburg, Idaho, 83440

  • Madison Memorial Hospital

    Rexburg, Idaho, 83440

  • Virginia Commonwealth Univeristy Health Systems-Children's Pavilion

    Richmond, Virginia, 23219

  • Virginia Commonwealth University Health System-Main Hospital

    Richmond, Virginia, 23219

  • Virginia Commonwealth University Health System-Nelson Clinic

    Richmond, Virginia, 23219

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23226

  • VCU Health Adult Outpatient Pavillion

    Richmond, Virginia, 23298

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • The Pediatric Center

    Rigby, Idaho, 83442

  • St Luke Community Clinic - Ronan

    Ronan, Montana, 59864

  • Alpine Medical Group

    Salt Lake City, Utah, 84102

  • Intermountain Medical Center

    Salt Lake City, Utah, 84107

Other trials in United States

Japan12 sites

  • Hyogo Prefectural Amagasaki General Medical Center

    Amagasaki, Hyōgo, 660-8550

  • National Hospital Organization Beppu Medical Center

    Beppu, Oita Prefecture, 874-0011

  • Shonan Fujisawa Tokushukai Hospital

    Fujisawa, Kanagawa, 251-0041

  • Fukui Aiiku Hospital

    Fukui-shi, Fukui, 910-0833

  • Osaka Habikino Medical Center

    Habikino, Osaka, 583-8588

  • Kuwana City Medical Center

    Kuwana-shi, Mie-ken, 511-0061

  • Rakuwakai Otowa Hospital

    Kyoto, Kyoto, 607-8062

  • National Hospital Organization Tokyo Medical Center

    Meguro-ku, Tokyo, 152-8902

  • Social Medical Corporation KARIYUSHIKAI Heartlife Hospital

    Nakagami-gun, Okinawa, 901-2492

  • Saitama City hospital

    Saitama, 336-8522

  • Sendai City Hospital

    Sendai, Miyagi, 982-8502

  • Shizuoka General Hospital

    Shizuoka, 420-8527

Other trials in Japan

South Africa11 sites

  • JOSHA Research

    Bloemfontein, Free State, 9300

  • MRC Unit on Child and Adolescent Health

    Cape Town, Western Cape, 7700

  • Kraaifontein Satellite site

    Cape Town, 7570

  • Wits RHI Shandukani Research Centre

    Johannesburg, Gauteng, 2001

  • Khayelitsha Satellite Site: Michael Mapongwana Community Health Centre

    Khayelitsha, Western Cape, 7784

  • FAMCRU, University of Stellenbosch, Paediatric

    Parow Valley, Western Cape, 7505

  • Into Research, West Wing Medical Centre

    Pretoria, Gauteng, 0181

  • Setshaba Research Centre

    Soshanguve, Gauteng, 0152

  • University of the Witwatersrand Vaccines & Infectious Diseases Analytics (VIDA)

    Soweto, Gauteng, 1862

  • Limpopo Clinical Research Initiative

    Thabazimbi, Limpopo, 0380

  • Worcester Satellite site

    Worcester, 6850

Other trials in South Africa

Chile10 sites

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

    Osorno, Los Lagos Region, 5311523

  • Centro de Capacitación e Investigaciones Clínicas (CCIC)

    Santiago, Santiago Metropolitan, 7510186

  • Clinica Universidad de los Andes

    Santiago, Santiago Metropolitan, 7620157

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

    Santiago, Santiago Metropolitan, 8350488

  • Instituto de Investigaciones Materno Infantil (IDIMI)

    Santiago, Santiago Metropolitan, 8360160

  • Deliveries (satellite): Hospital San Jose

    Santiago, Santiago Metropolitan, 8380419

  • Grupo Estudios Clínicos Infectología Respiratoria

    Santiago, Santiago Metropolitan, 8380453

  • Deliveries (satellite): Hospital Clínico Universidad de Chile

    Santiago, Santiago Metropolitan, 8380456

  • Centro Internacional de Estudios Clinicos - CIEC

    Santiago, Santiago Metropolitan, 8420383

  • Hospital Padre Hurtado

    Santiago, Santiago Metropolitan, 8880465

Other trials in Chile

New Zealand9 sites

  • Optimal Clinical Trials Ltd

    Auckland, 1010

  • Aotearoa Clinical Trials Trust (ACTT)

    Auckland, 2025

  • New Zealand Clinical Research (Christchurch)

    Christchurch, Canterbury, 8011

  • Christchurch Hospital (Canterbury District Health Board)

    Christchurch, 8011

  • Botany Downs Primary Birthing Unit

    Golflands, Auckland, 2013

  • Papakura Primary Birthing Unit

    Papakura North, Auckland, 2110

  • Middlemore Hospital

    Papatoetoe, Auckland, 2025

  • Pukekohe Primary Birthing Unit

    Pukekohe, Auckland, 2120

  • Capital, Coast and Hutt Valley District- Wellington Regional Hospital

    Wellington, 6021

Other trials in New Zealand

Argentina8 sites

  • Sanatorio Mater Dei

    Buenos Aires, 1425

  • Centro de Investigación Clinica OSECAC

    Buenos Aires, C1040 AAL

  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

    CABA, C1426BOS

  • Clínica del Niño y la Madre

    Mar del Plata, Buenos Aires, 7600

  • Hospital Italiano de Rosario

    Rosario, Santa Fe Province, 2000

  • Hospital Publico Materno Infantil

    Salta, 4400

  • Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L

    San Miguel de Tucumán, Tucumán Province, 4000

  • Instituto de Maternidad y Ginecologia: "Nuestra Senora de las Mercedes"

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Finland8 sites

  • MeVac

    Helsinki, 00290

  • Kokkola Vaccine Research Clinic

    Kokkola, 67100

  • Oulu Vaccine Research Clinic

    Oulu, 90220

  • Tampereen yliopisto Oulun Rokotetutkimusklinikka

    Oulu, 90220

  • Pori Vaccine Research Clinic

    Pori, 28100

  • Seinajoki Vaccine Research Clinic

    Seinäjoki, 60100

  • Tampere Vaccine Research Clinic

    Tampere, 33100

  • Turku Vaccine Research Clinic

    Turku, 20520

Other trials in Finland

Spain6 sites

  • Hospital de Antequera

    Antequera, Malaga, 29200

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Madrid Puerta del Sur Mostoles

    Móstoles, 28938

  • CHUS - Hospital Clinico Universitario

    Santiago de Compostela, A Coruna, 15706

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Australia5 sites

  • Monash Children's Hospital

    Clayton, Victoria, 3168

  • Barwon Health, University Hospital Geelong

    Geelong, Victoria, 3220

  • Telethon Kids Institute

    Nedlands, Western Australia, 6009

  • Women's and Children's Hospital

    North Adelaide, South Australia, 5006

  • St John of God Hospital Subiaco

    Subiaco, Western Australia, 6008

Other trials in Australia

Brazil5 sites

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

    Canoas, Rio Grande do Sul, 92425-900

  • Maternidade Darcy Vargas

    Joinville, Santa Catarina, 89202-190

  • Hospital Moinhos de Vento - HMV

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Hospital Moinhos de Vento - HMV

    Porto Alegre, Rio Grande do Sul, 90560-030

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

    Sorocaba, São Paulo, 18040-425

Other trials in Brazil

Mexico5 sites

  • Arke SMO S.A. de C.V.

    Cuauhtémoc, Mexico City, 06700

  • Hospital General de Durango

    Durango, 34000

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 64460

  • Asociacion Mexicana para la Investigacion Clinica, A. C.

    Pachuca, Hidalgo, 42070

  • Arke SMO S.A. de C.V.

    Veracruz, 91910

Other trials in Mexico

Taiwan5 sites

  • Hsinchu MacKay Memorial Hospital

    Hsinchu, 30071

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • National Taiwan University Hospital

    Taipei, 100

  • Mackay Memorial Hospital

    Taipei, 10449

  • Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

Denmark4 sites

  • Aarhus Universitetshospital

    Aarhus N, 8200

  • Nordsjællands Hospital

    Hillerød, 3400

  • Hvidovre Hospital

    Hvidovre, 2650

  • Odense Universitets Hospital

    Odense, DK-5000

Other trials in Denmark

South Korea4 sites

  • Chonnam National University Hospital

    Gwangju, 61469

  • Seoul National University Hospital

    Seoul, 03080

  • Kyunghee University Hospital at Gangdong

    Seoul, 05278

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

Canada3 sites

  • Canadian Center for Vaccinology - IWK Health Centre

    Halifax, Nova Scotia, B3K 6R8

  • CHU Sainte-Justine

    Montreal, Quebec, H3T 1C5

  • CHU de Québec-Université Laval

    Québec, Quebec, G1V 4G2

Other trials in Canada

Netherlands3 sites

  • Spaarne Gasthuis (Kennemer Gasthuis)

    Hoofddorp, 2134 TM

  • Diakonessenhuis Utrecht

    Utrecht, 3582 KE

  • University Medical Center Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

The Gambia2 sites

  • Medical Research Council Unit the Gambia at the London School of Hygiene & Tropical Medicine

    Fajara KMC

  • Medical Research Council Unit the Gambia at the London School of Hygiene & Tropical Medicine (LSHTM)

    Sukuta

Other trials in The Gambia

Philippines1 site

  • Asian Hospital and Medical Center

    Muntinlupa City, National Capital Region, 1780

Other trials in Philippines

About this study

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

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.

Read the 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.

Being tested
RSVpreF, Placebo
Keywords
Respiratory Tract infection, RSV, Vaccine, Maternal
Medical subject headings
Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RSVpreFBiological

    RSV vaccine (RSVpreF)

  • PlaceboBiological

    Placebo

Study groups in NCT04424316
Study groupRoleWhat they receive
RSVpreF vaccineExperimentalRSVpreF
Receives: Biological: RSVpreF
Placebo dosePlacebo comparatorPlacebo
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Infant Participants With Medically Attended Lower Respiratory Tract Illness (MA-LRTI) Cases Due to RSV Occurring Within 90 Days After Birth (Efficacy)

    Results are presented as confirmed by endpoint adjudication committee. MA-LRTI case: infant with an MA-RTI visit with age related fast breathing (respiratory rate [RR] more than or equal to [>=] 60 breaths per minute [bpm] for less than [<] 2 months of age [<60 days of age], >=50 bpm for >=2 months to <12 months of age, or >=40 bpm for >=12 months to 24 months of age) or oxygen saturation (SpO2) <95 percent (%) or chest wall indrawing and RSV positive test results by reverse transcription-polymerase chain reaction (RT-PCR) testing of midturbinate nasal swab samples.

    Measured: Within 90 days after birth

  2. Percentage of Infant Participants With MA-LRTI Cases Due to RSV Occurring Within 120 Days After Birth (Efficacy)

    Results are presented as confirmed by endpoint adjudication committee. MA-LRTI case: Infant with an MA-RTI visit with age related fast breathing (RR >=60 bpm for <2 months of age [<60 days of age], >=50 bpm for >=2 months to <12 months of age, or >=40 bpm for >=12 months to 24 months of age) or SpO2 <95% or chest wall indrawing and RSV positive test results by RT-PCR testing of midturbinate nasal swab samples.

    Measured: Within 120 days after birth

  3. Percentage of Infant Participants With MA-LRTI Cases Due to RSV Occurring Within 150 Days After Birth (Efficacy)

    Results are presented as confirmed by endpoint adjudication committee. MA-LRTI case: Infant with an MA-RTI visit with age related fast breathing (RR >=60 bpm for <2 months of age [<60 days of age], >=50 bpm for >=2 months to <12 months of age, or >=40 bpm for >=12 months to 24 months of age) or SpO2 <95% or chest wall indrawing and RSV positive test results by RT-PCR testing of midturbinate nasal swab samples.

    Measured: Within 150 days after birth

  4. Percentage of Infant Participants With MA-LRTI Cases Due to RSV Occurring Within 180 Days After Birth (Efficacy)

    Results are presented as confirmed by endpoint adjudication committee. MA-LRTI case: Infant with an MA-RTI visit with age related fast breathing (RR >=60 bpm for <2 months of age [<60 days of age], >=50 bpm for >=2 months to <12 months of age, or >=40 bpm for >=12 months to 24 months of age) or SpO2 <95% or chest wall indrawing and RSV positive test results by RT-PCR testing of midturbinate nasal swab samples.

    Measured: Within 180 days after birth

  5. Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 90 Days After Birth (Efficacy)

    Results are presented as confirmed by endpoint adjudication committee. Severe MA-LRTI cases were a subset of MA-LRTI cases, and all severe MA-LRTI cases included MA-LRTI cases. Severe MA-LRTI case was an RSV positively adjudicated event which met the following defined criteria: an infant with an MA-RTI visit and aged associated fast breathing (RR >=70 bpm for <2 months of age [<60 days of age], >=60 bpm for >=2 months to <12 months of age, or >=50 bpm for >=12 months to 24 months of age) or SpO2 <93% or high-flow nasal cannula or mechanical ventilation (i.e., invasive or non-invasive) or intensive care unit (ICU) admission for more than (>) 4 hours or failure to respond/unconscious.

    Measured: Within 90 days after birth

  6. Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 120 Days After Birth (Efficacy)

    Results are presented as confirmed by endpoint adjudication committee. Severe MA-LRTI cases were a subset of MA-LRTI cases, and all severe MA-LRTI cases were included MA-LRTI cases. Severe MA-LRTI case was an RSV positively adjudicated event which met the following defined criteria: an infant with an MA-RTI visit and aged associated fast breathing (RR >=70 bpm for <2 months of age [<60 days of age], >=60 bpm for >=2 months to <12 months of age, or >=50 bpm for >=12 months to 24 months of age) or SpO2 <93% or high-flow nasal cannula or mechanical ventilation (i.e., invasive or non-invasive) or ICU admission for >4 hours or failure to respond/unconscious.

    Measured: Within 120 days after birth

  7. Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 150 Days After Birth (Efficacy)

    Results are presented as confirmed by endpoint adjudication committee. Severe MA-LRTI cases were a subset of MA-LRTI cases, and all severe MA-LRTI cases were included MA-LRTI cases. Severe MA-LRTI case was an RSV positively adjudicated event which met the following defined criteria: an infant with an MA-RTI visit and aged associated fast breathing (RR >=70 bpm for <2 months of age [<60 days of age], >=60 bpm for >=2 months to <12 months of age, or >=50 bpm for >=12 months to 24 months of age) or SpO2 <93% or high-flow nasal cannula or mechanical ventilation (i.e., invasive or non-invasive) or ICU admission for >4 hours or failure to respond/unconscious.

    Measured: Within 150 days after birth

  8. Percentage of Infant Participants With Severe MA-LRTI Cases Due to RSV Occurring Within 180 Days After Birth (Efficacy)

    Results are presented as confirmed by endpoint adjudication committee. Severe MA-LRTI cases were a subset of MA-LRTI cases, and all severe MA-LRTI cases were included MA-LRTI cases. Severe MA-LRTI case was an RSV positively adjudicated event which met the following defined criteria: an infant with an MA-RTI visit and aged associated fast breathing (RR >=70 bpm for <2 months of age [<60 days of age], >=60 bpm for >=2 months to <12 months of age, or >=50 bpm for >=12 months to 24 months of age) or SpO2 <93% or high-flow nasal cannula or mechanical ventilation (i.e., invasive or non-invasive) or ICU admission for >4 hours or failure to respond/unconscious.

    Measured: Within 180 days after birth

  9. Percentage of Infant Participants With Adverse Events of Special Interest (AESI) (Safety)

    AESI are a subset of targeted medical events based on review of known pharmacology, toxicology findings, possible class effects, published literature, and signals arising from safety data assessments, and on population under study. AESIs were based on targeted medical events associated with pregnant maternal participants and their infants prior to/during delivery and at birth. For infant participants the following were considered as protocol defined AESIs: Preterm birth (born at <37 weeks gestation); birth weight 1001-2500 grams; developmental delay; positive viral (polymerase chain reaction [PCR] or antigen-based) testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), when not reported during MA-RTI visit, were reported as SARS-CoV-2 test positive. Extremely preterm birth (<28 weeks) and extremely low birth weight (=<1000 grams [g]) were reported as serious AESIs.

    Measured: From birth to 24 months of age

  10. Percentage of Infant Participants With Neonatal Deaths (Safety)

    Neonatal death was defined as the death of a live-born infant that occurred within a month after birth.

    Measured: Within 1 Month after birth

  11. Percentage of Infant Participants With Congenital Malformations/Anomalies (Safety)

    Congenital malformations/ anomalies were defined as structural or functional anomalies that occurred during intrauterine life and could be identified prenatally, at birth or later in life.

    Measured: At birth

  12. Percentage of Infant Participants With Other Neonatal Events (Safety)

    Other Neonatal problem included dysmaturity, neonatal illness, hospitalization, drug therapies, and neonatal death.

    Measured: Within 1 Month after birth

  13. Number of Infant Participants According to Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute After Birth (Safety)

    APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health. APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing). Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health. A score of 7 to 10 was good, 4 to <7 was moderate, and <4 was poor.

    Measured: 1 minute after birth

  14. Number of Infant Participants According to APGAR Score at 5 Minutes After Birth (Safety)

    APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health. APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing). Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health. A score of 7 to 10 was good, 4 to <7 was moderate, and <4 was poor.

    Measured: 5 minutes after birth

  15. Number of Infant Participants According to APGAR Score at 10 Minutes After Birth (Safety)

    APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health. APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing). Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health. A score of 7 to 10 was good, 4 to <7 was moderate, and <4 was poor.

    Measured: 10 minutes after birth

  16. Percentage of Infant Participants With Adverse Events (AEs) From Birth to 1 Month of Age (Safety)

    An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: From birth to 1 month of age

  17. Percentage of Infant Participants With Serious Adverse Events (SAEs) and Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Birth Through 6 Months of Age (Safety)

    An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

    Measured: From birth to 6 months of age

  18. Percentage of Infant Participants With SAEs and NDCMCs From Birth Through 12 Months of Age (Safety)

    An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

    Measured: From birth to 12 months of age

  19. Percentage of Infant Participants With SAEs and NDCMCs From Birth Through 24 Months of Age (Safety)

    An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

    Measured: From birth to 24 months of age

  20. Percentage of Maternal Participants With Prespecified Local Reactions Within 7 Days After Vaccination (Safety)

    Local reactions included redness, swelling, and pain at injection site and were recorded in electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit= 0.5 centimetre (cm). Redness and swelling were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization for the severe pain at the injection site). Grade 4 reactions were classified by the investigator or medically qualified person.

    Measured: From Day 1 to Day 7 after vaccination

  21. Percentage of Maternal Participants With Prespecified Systemic Events Within 7 Days After Vaccination (Safety)

    Systemic events included: fever, fatigue, headache, nausea, muscle pain, joint pain, vomiting and diarrhea and were recorded by participants in an e-diary. Fever was defined as an oral temperature >=38.0 degree Celsius [C]) and classified as mild (38.0 to 38.4), moderate (38.5 to 38.9), severe (39.0 to 40.0) and grade 4 (>40.0 degree C). Headache, nausea, fatigue, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily activity). Vomiting: mild (1-2 times in 24 hours [H]), moderate (>2 times in 24 H), severe (required intravenous [IV] hydration). Diarrhea: mild (2-3 loose stools in 24 H), moderate (4-5 loose stools in 24 H), severe (>=6 in 24 H). For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by investigator or medically qualified person.

    Measured: From Day 1 to Day 7 after vaccination

  22. Percentage of Maternal Participants With AEs From the Time of Vaccination Through 1 Month After Vaccination (Safety)

    An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included in this outcome measure.

    Measured: From vaccination on Day 1 up to 1 month after vaccination

  23. Percentage of Maternal Participants With SAEs Throughout the Study Period (Safety)

    An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event.

    Measured: From vaccination on Day 1 up to 6 months after delivery (maximum up to 10 months)

Secondary outcomes (3)

  1. Percentage of Infant Participants With Cases of Hospitalization Due to RSV Within 90, 120, 150, 180 and 360 Days After Birth (Efficacy)

    Results are reported as confirmed by endpoint adjudication committee.

    Measured: Within 90, 120, 150, 180 and 360 days after birth

  2. Percentage of Infant Participants With MA-LRTI Cases Due to Any Cause With Protocol Defined Criteria Occurring Within 90, 120, 150, 180 and 360 Days After Birth (Efficacy)

    MA-LRTI cases due to any cause was defined as an infant with a MA-RTI visit with age related fast breathing (RR >=60 bpm for <2 months of age [<60 days of age], >=50 bpm for >=2 months to <12 months of age, or >=40 bpm for >=12 months to 24 months of age) or SpO2 <95% or chest wall indrawing.

    Measured: Within 90, 120, 150, 180 and 360 days after birth

  3. Percentage of Infant Participants With MA-LRTI Cases Due to RSV Occurring Within 210, 240, 270 and 360 Days After Birth (Efficacy)

    Results are presented as confirmed by endpoint adjudication committee. MA-LRTI case: Infant with an MA-RTI visit with age related fast breathing (RR >=60 bpm for <2 months of age [<60 days of age], >=50 bpm for >=2 months to <12 months of age, or >=40 bpm for >=12 months to 24 months of age) or SpO2 <95% or chest wall indrawing and RSV positive test results by RT-PCR testing of midturbinate nasal swab samples.

    Measured: Within 210, 240, 270 and 360 days after birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2020
  2. Study start17 Jun 2020
  3. Primary completion27 Oct 2023
  4. Study completion27 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
14,727 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04424316
Sponsor's protocol ID
C3671008
Other IDs
2019-002943-85, 2019
Status last verified
Jan 2025
First submitted
3 Jun 2020
Last updated
11 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Shittu E, Pahud BA, Radley D, Gurtman A, Munjal I. Efficacy and safety outcomes from the MATISSE phase 3 trial of maternal bivalent RSVpreF vaccination among pregnant women vaccinated at 32 to 36 weeks of gestation. Swiss Med Wkly. 2026 Jan 31;156:4711. doi: 10.57187/4711.

    PubMed 41962084

  • Bolanos R, Araos R, Gonzalez C, Sepulveda D, Falconi JF, Averin A, Atwood M, Quinn E, Law AW, Mendes D. Cost-effectiveness of strategies using preventive interventions to protect infants in Chile from respiratory syncytial virus. Expert Rev Vaccines. 2025 Dec;24(1):904-913. doi: 10.1080/14760584.2025.2562201. Epub 2025 Oct 2.

    PubMed 40958705

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RSVpreF in people with Respiratory Tract Infection, run by Pfizer at 464 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 464 sites in United States, Japan, South Africa, Chile, New Zealand and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Infant Participants With Medically Attended Lower Respiratory Tract Illness (MA-LRTI) Cases Due to RSV Occurring Within 90 Days After Birth (Efficacy) (time frame: Within 90 days after birth). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04424316, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.

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