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

September 20, 2022 updated by: Pfizer

A PHASE 2B, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN PREGNANT WOMEN 18 THROUGH 49 YEARS OF AGE AND THEIR INFANTS

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1153

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, 4000
        • Clinica Mayo De U.M.C.B. S.R.L.
      • San Miguel de Tucuman, Tucuman, Argentina, 4000
        • Instituto de Maternidad y Ginecologia, Nuestra Senora de Las Mercedes
  • Chile
    • RM
      • Santiago, RM, Chile, 8360160
        • Hospital San Borja Arriarán
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile, 8380456
        • Hospital Clínico Universidad de Chile
      • Santiago, Region Metropolitana, Chile, 8880465
        • Hospital Padre Hurtado
    • Región DE LOS Lagos
      • Osorno, Región DE LOS Lagos, Chile, 5311523
        • Hospital Base San Jose de Osorno
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 7620157
        • Clínica Universidad de Los Andes
      • Santiago, Región Metropolitana, Chile, 8360160
        • Instituto de Investigaciones Materno Infantil (IDIMI)
      • Santiago, Región Metropolitana, Chile, 8420383
        • Centro Internacional de Estudios Clinicos - CIEC
      • Santiago, Región Metropolitana, Chile, 8380419
        • Hospital San José
      • Santiago, Región Metropolitana, Chile, 8380453
        • Grupo Estudios Clinicos Infectologia Respiratoria, Facultad de Medicina Universidad de Chile
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Christchurch Clinical Studies Trust Ltd
      • Christchurch, New Zealand, 8011
        • Christchurch Hospital (Canterbury District Health Board)
  • South Africa
    • Gauteng
      • Soweto, Gauteng, South Africa, 1862
        • Respiratory and Meningeal Pathogens Research Unit (RMPRU)
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35233
        • Children's of Alabama
      • Birmingham, Alabama, United States, 35233
        • UAB Women & Infants Center - UAB Medicine
      • Cullman, Alabama, United States, 35058
        • Cullman Clinical Research, Inc
      • Cullman, Alabama, United States, 35058
        • Cullman Primary Care, PC
      • Cullman, Alabama, United States, 35058
        • Cullman Regional
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Arrowhead Hospital
      • Goodyear, Arizona, United States, 85395
        • Abrazo West Campus Hospital
      • Phoenix, Arizona, United States, 85015
        • MedPharmics, LLC
      • Phoenix, Arizona, United States, 85013
        • St. Joseph Hospital
      • Tucson, Arizona, United States, 85712
        • Mesquite Pediatrics
      • Tucson, Arizona, United States, 85712
        • Watching Over Mothers and Babies
    • California
      • Bellflower, California, United States, 90706
        • Join Clinical Trials
      • Chowchilla, California, United States, 93610
        • Chowchilla Hospital Clinic
      • Huntington Park, California, United States, 90255
        • Matrix Clinical Research
      • Huntington Park, California, United States, 90255
        • Join Clinical Trials
      • Los Angeles, California, United States, 90033
        • White Memorial Medical Center
      • Los Angeles, California, United States, 90006
        • Join Clinical Trials
      • Los Angeles, California, United States, 90023
        • East Los Angeles Doctors Hospital
      • Los Angeles, California, United States, 90036
        • Join Clinical Trials
      • Los Angeles, California, United States, 90057
        • Matrix Clinical Research
      • Madera, California, United States, 93637
        • Affiliated Physician Practice
      • Madera, California, United States, 93637
        • Madera Community Hospital
      • Madera, California, United States, 93637
        • Madera Family Medical Group
      • Madera, California, United States, 93637
        • Charles E. Ugwu-Oju, MD, FACOG
      • Monterey Park, California, United States, 91754
        • Monterey Park Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Inpatient Pavilion 2
      • Aurora, Colorado, United States, 80045
        • University of Colorado AO1
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital Inpatient Pavilion
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital Outpatient Pavilion
      • Aurora, Colorado, United States, 80045
        • University of Colorado Leprino Building
      • Aurora, Colorado, United States, 80045
        • University of Colorado Research II Building
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Children's Center
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Bingham Memorial Hospital
      • Blackfoot, Idaho, United States, 83221
        • Elite Clinical Trials LLLP
      • Blackfoot, Idaho, United States, 83221
        • Grove Creek Medical Center
      • Idaho Falls, Idaho, United States, 83404
        • Clinical Research Prime
      • Idaho Falls, Idaho, United States, 83404
        • Snake River Research, PLLC
      • Idaho Falls, Idaho, United States, 83404
        • Eastern Idaho Regional Medical Center
      • Idaho Falls, Idaho, United States, 83404
        • Mountain View Hospital
      • Idaho Falls, Idaho, United States, 83404
        • The Pediatric Center
      • Idaho Falls, Idaho, United States, 83404
        • Family First Medical Center
      • Nampa, Idaho, United States, 83687
        • ASR, LLC
      • Nampa, Idaho, United States, 83686
        • Saltzer Medical Group
      • Nampa, Idaho, United States, 83687
        • Saltzer Medical Group
      • Pocatello, Idaho, United States, 83201
        • Pocatello Women's Health Clinic
      • Pocatello, Idaho, United States, 83201
        • Portneuf Medical Center
      • Rigby, Idaho, United States, 83442
        • The Pediatric Center
    • Iowa
      • Ankeny, Iowa, United States, 50023
        • The Iowa Clinic
      • West Des Moines, Iowa, United States, 50266
        • Methodist West Hospital
      • West Des Moines, Iowa, United States, 50266
        • The Iowa Clinic
    • Kansas
      • El Dorado, Kansas, United States, 67042
        • Alliance for Multispecialty Research, LLC
      • Hutchinson, Kansas, United States, 67502
        • Hutchinson Regional Medical Center
      • Hutchinson, Kansas, United States, 67502
        • Hutchinson Clinic, P.A.
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Cambridge Medical Trials
      • Metairie, Louisiana, United States, 70006
        • MedPharmics, LLC
    • Minnesota
      • Blaine, Minnesota, United States, 55449
        • Allina Health Blaine Clinic
      • Coon Rapids, Minnesota, United States, 55433
        • Allina Health Coon Rapids Clinic
      • Coon Rapids, Minnesota, United States, 55433
        • Allina Health Mercy Women's Clinic
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital (Allina Health)
      • Coon Rapids, Minnesota, United States, 55433
        • The Mother Baby Center at Mercy with Children's (Allina Health)
      • Fridley, Minnesota, United States, 55432
        • Allina Health Fridley Clinic
      • Minneapolis, Minnesota, United States, 55404
        • Infectious Disease Research
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital (Allina Health)
    • Mississippi
      • Bay Saint Louis, Mississippi, United States, 39520
        • Oshsner Medical Center - Hancock
      • Biloxi, Mississippi, United States, 39530
        • Merit Health Biloxi
      • Gulfport, Mississippi, United States, 39503
        • MedPharmics, LLC
      • Gulfport, Mississippi, United States, 39501
        • Gulfport Memorial Hospital
      • Gulfport, Mississippi, United States, 39503
        • Singing River Health System
      • Gulfport, Mississippi, United States, 39503
        • Gulfport OB-GYN
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • St Lukes Hospital
      • Saint Louis, Missouri, United States, 63141
        • Mercy Hospital St. Louis
      • Saint Louis, Missouri, United States, 63141
        • Sundance Clinical Research, LLC
      • Saint Louis, Missouri, United States, 63131
        • Baer Pediatrics
      • Saint Louis, Missouri, United States, 63141
        • KDB Enterprises
    • Montana
      • Great Falls, Montana, United States, 59405
        • Boeson Research
      • Missoula, Montana, United States, 59804
        • Boeson Research
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Bryan Health
      • Lincoln, Nebraska, United States, 68516
        • Midwest Childrens Health Research Institute
      • Lincoln, Nebraska, United States, 68510
        • Bryan Women's Care Physicians
      • Norfolk, Nebraska, United States, 68701
        • Meridian Clinical Research, LLC
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • MedPharmics
    • New York
      • Hempstead, New York, United States, 11550
        • Winthrop Women's Wellness
      • Johnson City, New York, United States, 13790
        • Sante Comprehensive Women's Healthcare
      • Mineola, New York, United States, 11501
        • NYU Winthrop Hospital
      • Mineola, New York, United States, 11501
        • NYU Winthrop Hospital, Research Pharmacy
      • Mineola, New York, United States, 11501
        • NYU Winthrop Pediatric Infectious Diseases
      • Mineola, New York, United States, 11501
        • Women's Contemporary Care Associates
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
      • Rochester, New York, United States, 14620
        • University of Rochester Obstetrics and Gynecology
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
      • Durham, North Carolina, United States, 27710
        • Duke University Hospital
      • Durham, North Carolina, United States, 27704
        • Duke Children's Primary Care - Roxboro Street
      • Durham, North Carolina, United States, 27704
        • Duke Regional Hospital
    • Ohio
      • Dayton, Ohio, United States, 45409
        • Sugarcamp Family Practice
      • Dayton, Ohio, United States, 45414
        • Needmore Medical Center
      • Dayton, Ohio, United States, 45429
        • Kettering Medical Center
      • Englewood, Ohio, United States, 45322
        • HWC Women's Center Research
    • South Carolina
      • Summerville, South Carolina, United States, 29485
        • Lowcountry Womens Specialists
      • Summerville, South Carolina, United States, 29485
        • Summerville Medical Center
      • Summerville, South Carolina, United States, 29486
        • Coastal Pediatric Research
    • Texas
      • Beaumont, Texas, United States, 77702
        • Center for Women''s Health and Birthcare
      • Beaumont, Texas, United States, 77702
        • Christus St. Elizabeth Hospital
      • Beaumont, Texas, United States, 77702
        • Gadolin Research, LLC
      • Beaumont, Texas, United States, 77702
        • Pediatric Clinic of Dr. Alvin H. Prause
      • Bedford, Texas, United States, 76022
        • Texas Health Harris Methodist Hurst-Euless-Bedford Hospital
      • Burleson, Texas, United States, 76028
        • Texas Health Huguley Hospital South
      • Fort Worth, Texas, United States, 76104
        • Ventavia Research Group, LLC
      • Fort Worth, Texas, United States, 76132
        • Texas Health Harris Methodist Hospital Southwest
      • Fort Worth, Texas, United States, 76104
        • 8th Avenue Obstetrics and Gynecology
      • Fort Worth, Texas, United States, 76104
        • Baylor Scott & White of Fort Worth
      • Fort Worth, Texas, United States, 76104
        • Texas Health Harris Methodist Hospital FTW
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch
      • Georgetown, Texas, United States, 78626
        • Chisholm Trail Pediatrics
      • Georgetown, Texas, United States, 78626
        • Georgetown OBGYN
      • Georgetown, Texas, United States, 78626
        • St. David's Georgetown Hospital
      • Georgetown, Texas, United States, 78626
        • Fmc Science, Llc
      • Grapevine, Texas, United States, 76051
        • Baylor Scott & White of Grapevine (Hospital)
      • Houston, Texas, United States, 77081
        • Texas Center for Drug Development, Inc.
      • Houston, Texas, United States, 77084
        • Biopharma Informatic, LLC
      • Houston, Texas, United States, 77008
        • HG Pediatrics
      • Houston, Texas, United States, 77008
        • Ventavia Research Group, LLC
      • Houston, Texas, United States, 77008
        • Dr Van Tran Family Practice
      • Houston, Texas, United States, 77008
        • Memorial Herman Greater Heights Hospital
      • Lampasas, Texas, United States, 76550
        • FMC Science
      • Lampasas, Texas, United States, 76550
        • AdventHealth Family Medicine Rural Health Clinic, Inc.
      • Longview, Texas, United States, 75605
        • DCOL Center for Clinical Research
      • Longview, Texas, United States, 75605
        • Longview Regional Medical Center
      • Longview, Texas, United States, 75605
        • Diagnostic Clinic of Longview
      • McAllen, Texas, United States, 78504
        • Dr. Ruben Aleman and Associates
      • Pharr, Texas, United States, 78577
        • Exygon Clinical Research
      • Plano, Texas, United States, 75093
        • Ventavia Research Group LLC
      • Plano, Texas, United States, 75093
        • Texas Health Presbyterian Hospital
      • Round Rock, Texas, United States, 78665
        • Ascension Seton Williamson
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
      • Salt Lake City, Utah, United States, 84107
        • JBR Clinical Research
      • Salt Lake City, Utah, United States, 84107
        • Old Farm Obstetrics & Gynecology, LLC
      • Salt Lake City, Utah, United States, 84124
        • St. Marks Hospital
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Clinical Research Partners, LLC
      • Richmond, Virginia, United States, 23235
        • Johnston Willis Hospital
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Cabell Huntington Hospital
      • Huntington, West Virginia, United States, 25701
        • Marshall Health dba University Pediatrics
      • Huntington, West Virginia, United States, 25701
        • Marshall Health Department of Obstetrics and Gynecology
      • Huntington, West Virginia, United States, 25701
        • Translational Genomic Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria - Maternal participants:

  • 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.

Inclusion Criteria - Infant Participants:

  • 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 - Maternal Participants:

  • 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.

Exclusion Criteria - Infant Participants:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RSV dose with aluminum hydroxide
RSV vaccine with aluminum hydroxide
Biological: RSV vaccine
RSV vaccine
Experimental: RSV dose without aluminum hydroxide
RSV vaccine without aluminum hydroxide
Biological: RSV vaccine
RSV vaccine
Experimental: Higher RSV dose with aluminum hydroxide
Higher dose level RSV vaccine with aluminum hydroxide
Biological: RSV vaccine
RSV vaccine
Experimental: Higher RSV dose without aluminum hydroxide
Higher dose level RSV vaccine without aluminum hydroxide
Biological: RSV vaccine
RSV vaccine
Placebo Comparator: Placebo dose
Normal saline solution for injection (0.9% sodium chloride injection)
Biological: Placebo
Normal saline solution for injection (0.9% sodium chloride injection)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Maternal Participants With Prespecified Local Reactions by Maximum Severity Within 7 Days After Vaccination
Time Frame: 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.
Within 7 days after vaccination
Percentage of Maternal Participants With Prespecified Systemic Events by Maximum Severity Within 7 Days After Vaccination
Time Frame: 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.
Within 7 days after vaccination
Percentage of Maternal Participants With Adverse Events (AEs) Within 1 Month After Vaccination
Time Frame: 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.
Within 1 month after vaccination
Percentage of Maternal Participants With Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Obstetric Complications
Time Frame: 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.
From day of vaccination (Day 1) up to 12 months post-delivery
Percentage of Infant Participants With Specific Birth Complications
Time Frame: 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.
At birth
Percentage of Infant Participants With Any AE Within 1 Month of Age
Time Frame: 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.
Within 1 month after birth
Percentage of Infant Participants With MAEs and SAEs Within 12 Months of Age
Time Frame: 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.
Within 12 months after birth
Percentage of Infant Participants With AEs of Special Interest of at Least Moderate Severity Within 12 Months of Age: Congenital Anomalies and Developmental Delay
Time Frame: 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.
Within 12 months after birth

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Maternal Participants
Time Frame: 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.
Before vaccination, 2 weeks and 1 month after vaccination and at delivery
Geometric Mean Fold Rise (GMFR) for Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibody Titers in Maternal Participants
Time Frame: 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.
2 weeks and 1 month after vaccination, at delivery
Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) and Subgroup B (RSV B) Neutralizing Antibodies in Infant Participants
Time Frame: 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.
At birth and at 1, 2, 4, 6 months after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C3671003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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