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

Phase 2

Completed

Conditions: Respiratory Tract Infection

Interventions: Biological: RSV vaccine
Biological: Placebo

Registration Number: NCT04032093

Lead Sponsor: Pfizer

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 1153

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RSV dose without aluminum hydroxide	RSV vaccine	RSV vaccine without aluminum hydroxide
RSV dose with aluminum hydroxide	RSV vaccine	RSV vaccine with aluminum hydroxide
Higher RSV dose with aluminum hydroxide	RSV vaccine	Higher dose level RSV vaccine with aluminum hydroxide
Higher RSV dose without aluminum hydroxide	RSV vaccine	Higher dose level RSV vaccine without aluminum hydroxide
Placebo dose	Placebo	Normal saline solution for injection (0.9% sodium chloride injection)

Primary Outcome Measures

Name	Time	Method
Percentage of Maternal Participants With Adverse Events (AEs) Within 1 Month After Vaccination	Within 1 month after vaccination	An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.
Percentage of Infant Participants With Specific Birth Complications	At birth	Specific birth complications included clavicle fracture, torticollis, cephalhematoma, premature baby, acute respiratory failure, meconium aspiration syndrome, neonatal pneumothorax, neonatal respiratory depression, neonatal respiratory distress, neonatal respiratory distress syndrome, neonatal respiratory failure, pneumothorax, respiratory distress, transient tachypnea of the newborn and subgaleal hemorrhage. Percentage of participants with any specific birth complications were reported in this outcome measure.
Percentage of Infant Participants With Any AE Within 1 Month of Age	Within 1 month after birth	An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.
Percentage of Infant Participants With AEs of Special Interest of at Least Moderate Severity Within 12 Months of Age: Congenital Anomalies and Developmental Delay	Within 12 months after birth	AEs of special interest for infant participants included congenital anomalies and developmental delays. Congenital anomalies were defined as structural or functional anomalies that occurred during intrauterine life and could be identified prenatally, at birth or later in life. Severity was assessed based on the study investigator's judgement and graded as grade 1= mild (does not interfere with participant's usual function); grade 2= moderate (interferes to some extent with participant's usual function); grade 3= severe (interferes significantly with participant's usual function) and grade 4= life-threatening (life-threatening consequences; urgent intervention indicated). Percentage of infant participants with AEs of special interest of at least moderate severity were presented.
Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications	From day of vaccination (Day 1) up to 12 months post-delivery	MAE was defined as a non-serious AE that results in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. Obstetric complications were determined as per the study clinician's judgement.
Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination	Within 7 days after vaccination	Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (\>) 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity and severe: prevented daily activity. The maximum severity was defined as highest grading of each local reaction within 7 days of vaccination.
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination	Within 7 days after vaccination	Systemic events included fever, fatigue, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and were recorded by participants in an e-diary. Fever was categorized as: grade 1: mild (\>=38.0 to 38.4 degrees \[deg\] Celsius \[C\]), grade 2: moderate (\>38.4 to 38.9 deg C), grade 3: severe (\>38.9 to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. The maximum severity was defined as highest grading of each systemic event within 7 days of vaccination.
Percentage of Infant Participants With MAEs and SAEs Within 12 Months of Age	Within 12 months after birth	MAE was defined as a non-serious AE that results in an evaluation at a medical facility. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect.

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants	At birth and at 1, 2, 4, 6 months after birth	GMT of the 50% RSV A and RSV B neutralizing antibody were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% CI was based on the Student t distribution. GMRs of the RSV vaccine group to the placebo group for the RSV A and RSV B neutralizing antibody titers at each time point was calculated and reported in statistical analysis.
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants	Before vaccination, 2 weeks and 1 month after vaccination and at delivery	GMT of the 50% RSV A and RSV B neutralizing antibody were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% confidence interval (CI) was based on the Student t distribution. Geometric mean ratios (GMRs) of the RSV vaccine group to the placebo group for the RSV A and RSV B neutralizing antibody titers at each time point was calculated and reported in statistical analysis.
Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants	2 weeks and 1 month after vaccination, at delivery	GMFRs for RSV A and RSV B neutralizing antibody titers from before vaccination to each available time point after vaccination were calculated by exponentiating the mean logarithm of the fold rises. Corresponding 95% CI was based on the Student t distribution. Data for this outcome measure was planned to be analyzed for maternal participants only.

Trial Locations

Locations (148): Children's of Alabama
🇺🇸
Birmingham, Alabama, United States
Abrazo West Campus Hospital
🇺🇸
Goodyear, Arizona, United States
Cullman Clinical Research, Inc
🇺🇸
Cullman, Alabama, United States
MedPharmics, LLC
🇺🇸
Gulfport, Mississippi, United States
University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Children's Hospital Colorado
🇺🇸
Aurora, Colorado, United States
University of Colorado Hospital Inpatient Pavilion
🇺🇸
Aurora, Colorado, United States
Chowchilla Hospital Clinic
🇺🇸
Chowchilla, California, United States
Monterey Park Hospital
🇺🇸
Monterey Park, California, United States
Mesquite Pediatrics
🇺🇸
Tucson, Arizona, United States
UAB Women & Infants Center - UAB Medicine
🇺🇸
Birmingham, Alabama, United States
Elite Clinical Trials LLLP
🇺🇸
Blackfoot, Idaho, United States
The Iowa Clinic
🇺🇸
West Des Moines, Iowa, United States
Allina Health Fridley Clinic
🇺🇸
Fridley, Minnesota, United States
Infectious Disease Research
🇺🇸
Minneapolis, Minnesota, United States
8th Avenue Obstetrics and Gynecology
🇺🇸
Fort Worth, Texas, United States
Meridian Clinical Research, LLC
🇺🇸
Norfolk, Nebraska, United States
Texas Health Huguley Hospital South
🇺🇸
Burleson, Texas, United States
University of Colorado Research II Building
🇺🇸
Aurora, Colorado, United States
Bingham Memorial Hospital
🇺🇸
Blackfoot, Idaho, United States
Grove Creek Medical Center
🇺🇸
Blackfoot, Idaho, United States
The Pediatric Center
🇺🇸
Rigby, Idaho, United States
Allina Health Blaine Clinic
🇺🇸
Blaine, Minnesota, United States
Methodist West Hospital
🇺🇸
West Des Moines, Iowa, United States
Pediatric Clinic of Dr. Alvin H. Prause
🇺🇸
Beaumont, Texas, United States
Merit Health Biloxi
🇺🇸
Biloxi, Mississippi, United States
Sante Comprehensive Women's Healthcare
🇺🇸
Johnson City, New York, United States
DCOL Center For Clinical Research
🇺🇸
Longview, Texas, United States
Longview Regional Medical Center
🇺🇸
Longview, Texas, United States
Abbott Northwestern Hospital (Allina Health)
🇺🇸
Minneapolis, Minnesota, United States
Gulfport Memorial Hospital
🇺🇸
Gulfport, Mississippi, United States
Exygon Clinical Research
🇺🇸
Pharr, Texas, United States
Kettering Medical Center
🇺🇸
Dayton, Ohio, United States
Center for Women''s Health and Birthcare
🇺🇸
Beaumont, Texas, United States
Georgetown OBGYN
🇺🇸
Georgetown, Texas, United States
JBR Clinical Research
🇺🇸
Salt Lake City, Utah, United States
Diagnostic Clinic of Longview
🇺🇸
Longview, Texas, United States
St. Marks Hospital
🇺🇸
Salt Lake City, Utah, United States
Cabell Huntington Hospital
🇺🇸
Huntington, West Virginia, United States
Christchurch Clinical Studies Trust Ltd
🇳🇿
Christchurch, New Zealand
Instituto de Maternidad y Ginecologia, Nuestra Senora de Las Mercedes
🇦🇷
San Miguel de Tucuman, Tucuman, Argentina
Christchurch Hospital (Canterbury District Health Board)
🇳🇿
Christchurch, New Zealand
Join Clinical Trials
🇺🇸
Los Angeles, California, United States
Matrix Clinical Research
🇺🇸
Los Angeles, California, United States
East Los Angeles Doctors Hospital
🇺🇸
Los Angeles, California, United States
White Memorial Medical Center
🇺🇸
Los Angeles, California, United States
Affiliated Physician Practice
🇺🇸
Madera, California, United States
Madera Family Medical Group
🇺🇸
Madera, California, United States
Emory Children's Center
🇺🇸
Atlanta, Georgia, United States
Eastern Idaho Regional Medical Center
🇺🇸
Idaho Falls, Idaho, United States
Snake River Research, PLLC
🇺🇸
Idaho Falls, Idaho, United States
ASR, LLC
🇺🇸
Nampa, Idaho, United States
The Mother Baby Center at Mercy with Children's (Allina Health)
🇺🇸
Coon Rapids, Minnesota, United States
Boeson Research
🇺🇸
Missoula, Montana, United States
Ascension Seton Williamson
🇺🇸
Round Rock, Texas, United States
Ventavia Research Group, LLC
🇺🇸
Houston, Texas, United States
HG Pediatrics
🇺🇸
Houston, Texas, United States
Texas Center for Drug Development, Inc.
🇺🇸
Houston, Texas, United States
Biopharma Informatic, LLC
🇺🇸
Houston, Texas, United States
Hutchinson Clinic, P.A.
🇺🇸
Hutchinson, Kansas, United States
Hutchinson Regional Medical Center
🇺🇸
Hutchinson, Kansas, United States
Arrowhead Hospital
🇺🇸
Glendale, Arizona, United States
Cullman Primary Care, PC
🇺🇸
Cullman, Alabama, United States
Watching Over Mothers and Babies
🇺🇸
Tucson, Arizona, United States
Madera Community Hospital
🇺🇸
Madera, California, United States
Charles E. Ugwu-Oju, MD, FACOG
🇺🇸
Madera, California, 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 Outpatient Pavilion
🇺🇸
Aurora, Colorado, United States
University of Colorado Leprino Building
🇺🇸
Aurora, Colorado, United States
Clinical Research Prime
🇺🇸
Idaho Falls, Idaho, United States
Alliance for Multispecialty Research, LLC
🇺🇸
El Dorado, Kansas, United States
Mercy Hospital (Allina Health)
🇺🇸
Coon Rapids, Minnesota, United States
Gulfport OB-GYN
🇺🇸
Gulfport, Mississippi, United States
Singing River Health System
🇺🇸
Gulfport, Mississippi, United States
Bryan Health
🇺🇸
Lincoln, Nebraska, United States
Bryan Women's Care Physicians
🇺🇸
Lincoln, Nebraska, United States
NYU Winthrop Hospital, Research Pharmacy
🇺🇸
Mineola, New York, United States
NYU Winthrop Pediatric Infectious Diseases
🇺🇸
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
Lowcountry Womens Specialists
🇺🇸
Summerville, South Carolina, United States
Texas Health Harris Methodist Hurst-Euless-Bedford Hospital
🇺🇸
Bedford, Texas, United States
Gadolin Research, LLC
🇺🇸
Beaumont, Texas, United States
Texas Health Harris Methodist Hospital Southwest
🇺🇸
Fort Worth, Texas, United States
St. David's Georgetown Hospital
🇺🇸
Georgetown, Texas, United States
Baylor Scott & White of Grapevine (Hospital)
🇺🇸
Grapevine, Texas, United States
Memorial Herman Greater Heights Hospital
🇺🇸
Houston, Texas, United States
FMC Science
🇺🇸
Lampasas, Texas, United States
Ventavia Research Group LLC
🇺🇸
Plano, Texas, United States
Clinical Research Partners, LLC
🇺🇸
Richmond, 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 Tucuman, Tucuman, Argentina
Hospital Padre Hurtado
🇨🇱
Santiago, Region Metropolitana, Chile
Instituto de Investigaciones Materno Infantil (IDIMI)
🇨🇱
Santiago, Región Metropolitana, Chile
Hospital San Jose
🇨🇱
Santiago, Región Metropolitana, Chile
Respiratory and Meningeal Pathogens Research Unit (RMPRU)
🇿🇦
Soweto, Gauteng, South Africa
Cullman Regional
🇺🇸
Cullman, Alabama, United States
Baer Pediatrics
🇺🇸
Saint Louis, Missouri, United States
Sundance Clinical Research, LLC
🇺🇸
Saint Louis, Missouri, United States
Allina Health Coon Rapids Clinic
🇺🇸
Coon Rapids, Minnesota, United States
University of Texas Medical Branch
🇺🇸
Galveston, Texas, United States
Baylor Scott & White of Fort Worth
🇺🇸
Fort Worth, Texas, United States
Chisholm Trail Pediatrics
🇺🇸
Georgetown, Texas, United States
Dr Van Tran Family Practice
🇺🇸
Houston, Texas, United States
AdventHealth Family Medicine Rural Health Clinic, Inc.
🇺🇸
Lampasas, Texas, United States
Family First Medical Center
🇺🇸
Idaho Falls, Idaho, United States
Mountain View Hospital
🇺🇸
Idaho Falls, Idaho, United States
Portneuf Medical Center
🇺🇸
Pocatello, Idaho, United States
Pocatello Women's Health Clinic
🇺🇸
Pocatello, Idaho, United States
Allina Health Mercy Women's Clinic
🇺🇸
Coon Rapids, Minnesota, United States
MedPharmics
🇺🇸
Albuquerque, New Mexico, United States
Oshsner Medical Center - Hancock
🇺🇸
Bay Saint Louis, Mississippi, United States
KDB Enterprises
🇺🇸
Saint Louis, Missouri, United States
Midwest Childrens Health Research Institute
🇺🇸
Lincoln, Nebraska, United States
Winthrop Women's Wellness
🇺🇸
Hempstead, New York, United States
Women's Contemporary Care Associates
🇺🇸
Mineola, New York, United States
Sugarcamp Family Practice
🇺🇸
Dayton, Ohio, United States
Needmore Medical Center
🇺🇸
Dayton, Ohio, United States
Summerville Medical Center
🇺🇸
Summerville, South Carolina, United States
Coastal Pediatric Research
🇺🇸
Summerville, South Carolina, United States
Saltzer Medical Group
🇺🇸
Nampa, Idaho, United States
St Lukes Hospital
🇺🇸
Chesterfield, Missouri, United States
Duke Regional Hospital
🇺🇸
Durham, North Carolina, United States
Texas Health Harris Methodist Hospital FTW
🇺🇸
Fort Worth, Texas, United States
Mercy Hospital St. Louis
🇺🇸
Saint Louis, Missouri, United States
HWC Women's Center Research
🇺🇸
Englewood, Ohio, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Johnston Willis Hospital
🇺🇸
Richmond, Virginia, United States
NYU Winthrop Hospital
🇺🇸
Mineola, New York, United States
Hospital Clinico Universidad de Chile
🇨🇱
Santiago, Region Metropolitana, Chile
Hospital Base San Jose de Osorno
🇨🇱
Osorno, Región DE LOS Lagos, Chile
Clinica Universidad de los Andes
🇨🇱
Santiago, Región Metropolitana, Chile
Grupo Estudios Clinicos Infectologia Respiratoria, Facultad de Medicina Universidad de Chile
🇨🇱
Santiago, Región Metropolitana, Chile
Centro Internacional de Estudios Clinicos - CIEC
🇨🇱
Santiago, Región Metropolitana, Chile
Hospital San Borja Arriaran
🇨🇱
Santiago, RM, Chile
St. Joseph Hospital
🇺🇸
Phoenix, Arizona, United States
Cambridge Medical Trials
🇺🇸
Alexandria, Louisiana, United States
Duke University Hospital
🇺🇸
Durham, North Carolina, United States
CHRISTUS St. Elizabeth Hospital
🇺🇸
Beaumont, Texas, United States
FMC Science, LLC
🇺🇸
Georgetown, Texas, United States
Dr. Ruben Aleman and Associates
🇺🇸
McAllen, Texas, United States
Texas Health Presbyterian Hospital
🇺🇸
Plano, Texas, United States
Intermountain Medical Center
🇺🇸
Murray, Utah, United States
Old Farm Obstetrics & Gynecology, LLC
🇺🇸
Salt Lake City, Utah, United States
Marshall Health dba University Pediatrics
🇺🇸
Huntington, West Virginia, United States
Marshall Health Department of Obstetrics and Gynecology
🇺🇸
Huntington, West Virginia, United States