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

NCT ID: NCT04032093

Last Updated: 2022-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-07
• Study Completion Date: 2021-09-30

Brief Summary

This Phase 2b study will evaluate the safety, tolerability, and immunogenicity of an RSV vaccine in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, and investigate safety and characteristics of antibodies in their infants.

Detailed Description

This Phase 2b, multicenter, randomized, placebo-controlled study will evaluate the safety, tolerability, and immunogenicity of a respiratory syncytial virus stabilized prefusion F subunit vaccine (RSV vaccine) in pregnant participants who receive either one of 2 dose levels of the vaccine, formulated with or without aluminum hydroxide, or placebo, as well as assess safety and characteristics of transplacentally transferred antibodies in their infants.

Conditions

Respiratory Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

RSV dose with aluminum hydroxide

RSV vaccine with aluminum hydroxide

Group Type: EXPERIMENTAL

RSV vaccine

Intervention Type: BIOLOGICAL

RSV vaccine

RSV dose without aluminum hydroxide

RSV vaccine without aluminum hydroxide

Group Type: EXPERIMENTAL

RSV vaccine

Intervention Type: BIOLOGICAL

RSV vaccine

Higher RSV dose with aluminum hydroxide

Higher dose level RSV vaccine with aluminum hydroxide

Group Type: EXPERIMENTAL

RSV vaccine

Intervention Type: BIOLOGICAL

RSV vaccine

Higher RSV dose without aluminum hydroxide

Higher dose level RSV vaccine without aluminum hydroxide

Group Type: EXPERIMENTAL

RSV vaccine

Intervention Type: BIOLOGICAL

RSV vaccine

Placebo dose

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

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

Interventions

RSV vaccine

RSV vaccine

Intervention Type: BIOLOGICAL

Placebo

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Healthy women 18 to 49 years of age between 24 and 36 weeks of gestation on the day of planned vaccination, with an uncomplicated pregnancy, who are at no known increased risk for complications, and whose fetus has no significant abnormalities observed on ultrasound.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Receiving prenatal standard of care.
• Had an ultrasound performed at >=18 weeks of pregnancy.
• Had a negative urinalysis for protein and glucose at the screening visit. Trace protein in the urine is acceptable if the blood pressure is also normal.
• Determined by medical history, physical examination, screening laboratory assessment, and clinical judgment to be appropriate for inclusion in the study.
• Documented negative human immunodeficiency virus antibody, hepatitis B virus surface antigen, hepatitis C virus antibody, and syphilis tests at the screening visit.
• Body mass index of </=40 kg/m2 at the time of the screening visit.
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document and in this protocol.
• Expected to be available for the duration of the study and willing to give informed consent for her infant to participate in the study.

• Evidence of a signed and dated ICD signed by the parent(s).
• Parent(s) willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria

• 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 to any component of the investigational product or any related vaccine.
• History of latex allergy.
• History of any severe allergic reaction.
• Participants with known or suspected immunodeficiency.
• Current pregnancy resulting from in vitro fertilization or other assisted reproductive technology.
• A prior history of or known current pregnancy complications or abnormalities that will increase the risk associated with the participant's participation in and completion of the study.
• Major illness of the mother or conditions of the fetus that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in, and completion of, the study or could preclude the evaluation of the participant's response.
• Participant with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention including but not limited to systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and insulin-dependent diabetes mellitus (type 1).
• 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 study entry and/or during study participation.
• Participants who receive treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids (such as for cancer or an autoimmune disease), or planned receipt of such treatment or agents during study participation. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 30 days before investigational product administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
• Current alcohol abuse or illicit drug use.
• Receipt of blood or plasma products or immunoglobulin, 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 receipt during study participation.
• Laboratory test results at the screening visit outside the normal reference value for pregnant women according to their trimester in pregnancy.
• Participants who are breastfeeding at the time of the screening visit.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Children's of Alabama

Birmingham, Alabama, United States

UAB Women & Infants Center - UAB Medicine

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Cullman Clinical Research, Inc

Cullman, Alabama, United States

Cullman Primary Care, PC

Cullman, Alabama, United States

Cullman Regional

Cullman, Alabama, United States

Arrowhead Hospital

Glendale, Arizona, United States

Abrazo West Campus Hospital

Goodyear, Arizona, United States

St. Joseph Hospital

Phoenix, Arizona, United States

MedPharmics, LLC

Phoenix, Arizona, United States

Mesquite Pediatrics

Tucson, Arizona, United States

Watching Over Mothers and Babies

Tucson, Arizona, United States

Join Clinical Trials

Bellflower, California, United States

Chowchilla Hospital Clinic

Chowchilla, California, United States

Join Clinical Trials

Huntington Park, California, United States

Matrix Clinical Research

Huntington Park, California, United States

Join Clinical Trials

Los Angeles, California, United States

East Los Angeles Doctors Hospital

Los Angeles, California, United States

White Memorial Medical Center

Los Angeles, California, United States

Join Clinical Trials

Los Angeles, California, United States

Matrix Clinical Research

Los Angeles, California, United States

Affiliated Physician Practice

Madera, California, United States

Charles E. Ugwu-Oju, MD, FACOG

Madera, California, United States

Madera Community Hospital

Madera, California, United States

Madera Family Medical Group

Madera, California, United States

Monterey Park Hospital

Monterey Park, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

University of Colorado Anschutz Inpatient Pavilion 2

Aurora, Colorado, United States

University of Colorado AO1

Aurora, Colorado, United States

University of Colorado Hospital Inpatient Pavilion

Aurora, Colorado, United States

University of Colorado Hospital Outpatient Pavilion

Aurora, Colorado, United States

University of Colorado Leprino Building

Aurora, Colorado, United States

University of Colorado Research II Building

Aurora, Colorado, United States

Emory Children's Center

Atlanta, Georgia, United States

Bingham Memorial Hospital

Blackfoot, Idaho, United States

Elite Clinical Trials LLLP

Blackfoot, Idaho, United States

Grove Creek Medical Center

Blackfoot, Idaho, United States

Clinical Research Prime

Idaho Falls, Idaho, United States

Eastern Idaho Regional Medical Center

Idaho Falls, Idaho, United States

Family First Medical Center

Idaho Falls, Idaho, United States

Mountain View Hospital

Idaho Falls, Idaho, United States

Snake River Research, PLLC

Idaho Falls, Idaho, United States

The Pediatric Center

Idaho Falls, Idaho, United States

Saltzer Medical Group

Nampa, Idaho, United States

ASR, LLC

Nampa, Idaho, United States

Saltzer Medical Group

Nampa, Idaho, United States

Pocatello Women's Health Clinic

Pocatello, Idaho, United States

Portneuf Medical Center

Pocatello, Idaho, United States

The Pediatric Center

Rigby, Idaho, United States

The Iowa Clinic

Ankeny, Iowa, United States

Methodist West Hospital

West Des Moines, Iowa, United States

The Iowa Clinic

West Des Moines, Iowa, United States

Alliance for Multispecialty Research, LLC

El Dorado, Kansas, United States

Hutchinson Clinic, P.A.

Hutchinson, Kansas, United States

Hutchinson Regional Medical Center

Hutchinson, Kansas, United States

Cambridge Medical Trials

Alexandria, Louisiana, United States

MedPharmics, LLC

Metairie, Louisiana, United States

Allina Health Blaine Clinic

Blaine, Minnesota, United States

Allina Health Coon Rapids Clinic

Coon Rapids, Minnesota, United States

Allina Health Mercy Women's Clinic

Coon Rapids, Minnesota, United States

Mercy Hospital (Allina Health)

Coon Rapids, Minnesota, United States

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

Coon Rapids, Minnesota, United States

Allina Health Fridley Clinic

Fridley, Minnesota, United States

Infectious Disease Research

Minneapolis, Minnesota, United States

Abbott Northwestern Hospital (Allina Health)

Minneapolis, Minnesota, United States

Oshsner Medical Center - Hancock

Bay Saint Louis, Mississippi, United States

Merit Health Biloxi

Biloxi, Mississippi, United States

Gulfport Memorial Hospital

Gulfport, Mississippi, United States

Gulfport OB-GYN

Gulfport, Mississippi, United States

MedPharmics, LLC

Gulfport, Mississippi, United States

Singing River Health System

Gulfport, Mississippi, United States

St Lukes Hospital

Chesterfield, Missouri, United States

Baer Pediatrics

St Louis, Missouri, United States

KDB Enterprises

St Louis, Missouri, United States

Mercy Hospital St. Louis

St Louis, Missouri, United States

Sundance Clinical Research, LLC

St Louis, Missouri, United States

Boeson Research

Great Falls, Montana, United States

Boeson Research

Missoula, Montana, United States

Bryan Health

Lincoln, Nebraska, United States

Bryan Women's Care Physicians

Lincoln, Nebraska, United States

Midwest Childrens Health Research Institute

Lincoln, Nebraska, United States

Meridian Clinical Research, LLC

Norfolk, Nebraska, United States

MedPharmics

Albuquerque, New Mexico, United States

Winthrop Women's Wellness

Hempstead, New York, United States

Sante Comprehensive Women's Healthcare

Johnson City, New York, United States

NYU Winthrop Hospital, Research Pharmacy

Mineola, New York, United States

NYU Winthrop Hospital

Mineola, New York, United States

NYU Winthrop Pediatric Infectious Diseases

Mineola, New York, United States

Women's Contemporary Care Associates

Mineola, New York, United States

University of Rochester Obstetrics and Gynecology

Rochester, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Duke Children's Primary Care - Roxboro Street

Durham, North Carolina, United States

Duke Regional Hospital

Durham, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Duke University Hospital

Durham, North Carolina, United States

Sugarcamp Family Practice

Dayton, Ohio, United States

Needmore Medical Center

Dayton, Ohio, United States

Kettering Medical Center

Dayton, Ohio, United States

HWC Women's Center Research

Englewood, Ohio, United States

Lowcountry Womens Specialists

Summerville, South Carolina, United States

Summerville Medical Center

Summerville, South Carolina, United States

Coastal Pediatric Research

Summerville, South Carolina, United States

Center for Women''s Health and Birthcare

Beaumont, Texas, United States

CHRISTUS St. Elizabeth Hospital

Beaumont, Texas, United States

Gadolin Research, LLC

Beaumont, Texas, United States

Pediatric Clinic of Dr. Alvin H. Prause

Beaumont, Texas, United States

Texas Health Harris Methodist Hurst-Euless-Bedford Hospital

Bedford, Texas, United States

Texas Health Huguley Hospital South

Burleson, Texas, United States

8th Avenue Obstetrics and Gynecology

Fort Worth, Texas, United States

Baylor Scott & White of Fort Worth

Fort Worth, Texas, United States

Texas Health Harris Methodist Hospital FTW

Fort Worth, Texas, United States

Ventavia Research Group, LLC

Fort Worth, Texas, United States

Texas Health Harris Methodist Hospital Southwest

Fort Worth, Texas, United States

University of Texas Medical Branch

Galveston, Texas, United States

Chisholm Trail Pediatrics

Georgetown, Texas, United States

FMC Science, LLC

Georgetown, Texas, United States

Georgetown OBGYN

Georgetown, Texas, United States

St. David's Georgetown Hospital

Georgetown, Texas, United States

Baylor Scott & White of Grapevine (Hospital)

Grapevine, Texas, United States

Dr Van Tran Family Practice

Houston, Texas, United States

HG Pediatrics

Houston, Texas, United States

Memorial Herman Greater Heights Hospital

Houston, Texas, United States

Ventavia Research Group, LLC

Houston, Texas, United States

Texas Center for Drug Development, Inc.

Houston, Texas, United States

Biopharma Informatic, LLC

Houston, Texas, United States

AdventHealth Family Medicine Rural Health Clinic, Inc.

Lampasas, Texas, United States

FMC Science

Lampasas, Texas, United States

DCOL Center For Clinical Research

Longview, Texas, United States

Diagnostic Clinic of Longview

Longview, Texas, United States

Longview Regional Medical Center

Longview, Texas, United States

Dr. Ruben Aleman and Associates

McAllen, Texas, United States

Exygon Clinical Research

Pharr, Texas, United States

Texas Health Presbyterian Hospital

Plano, Texas, United States

Ventavia Research Group LLC

Plano, Texas, United States

Ascension Seton Williamson

Round Rock, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

JBR Clinical Research

Salt Lake City, Utah, United States

Old Farm Obstetrics & Gynecology, LLC

Salt Lake City, Utah, United States

St. Marks Hospital

Salt Lake City, Utah, United States

Clinical Research Partners, LLC

Richmond, Virginia, United States

Johnston Willis Hospital

Richmond, Virginia, United States

Cabell Huntington Hospital

Huntington, West Virginia, United States

Marshall Health dba University Pediatrics

Huntington, West Virginia, United States

Marshall Health Department of Obstetrics and Gynecology

Huntington, West Virginia, United States

Translational Genomic Research Institute

Huntington, West Virginia, United States

Clinica Mayo De U.M.C.B. S.R.L.

San Miguel de Tucumán, Tucumán Province, Argentina

Instituto de Maternidad y Ginecologia, Nuestra Senora de Las Mercedes

San Miguel de Tucumán, Tucumán Province, Argentina

Hospital Base San Jose de Osorno

Osorno, Los Lagos Region, Chile

Hospital San Borja Arriaran

Santiago, RM, Chile

Clinica Universidad de los Andes

Santiago, Santiago Metropolitan, Chile

Instituto de Investigaciones Materno Infantil (IDIMI)

Santiago, Santiago Metropolitan, Chile

Hospital San Jose

Santiago, Santiago Metropolitan, Chile

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

Santiago, Santiago Metropolitan, Chile

Hospital Clinico Universidad de Chile

Santiago, Santiago Metropolitan, Chile

Centro Internacional de Estudios Clinicos - CIEC

Santiago, Santiago Metropolitan, Chile

Hospital Padre Hurtado

Santiago, Santiago Metropolitan, Chile

Christchurch Clinical Studies Trust Ltd

Christchurch, , New Zealand

Christchurch Hospital (Canterbury District Health Board)

Christchurch, , New Zealand

Respiratory and Meningeal Pathogens Research Unit (RMPRU)

Soweto, Gauteng, South Africa

Countries

United States; Argentina; Chile; New Zealand; South Africa

References

Simoes EAF, Center KJ, Tita ATN, Swanson KA, Radley D, Houghton J, McGrory SB, Gomme E, Anderson M, Roberts JP, Scott DA, Jansen KU, Gruber WC, Dormitzer PR, Gurtman AC. Prefusion F Protein-Based Respiratory Syncytial Virus Immunization in Pregnancy. N Engl J Med. 2022 Apr 28;386(17):1615-1626. doi: 10.1056/NEJMoa2106062.

Reference Type: DERIVED

PMID: 35476650 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C3671003

To obtain contact information for a study center near you, click here.

Other Identifiers

C3671003

Identifier Type: -

Identifier Source: org_study_id