BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Healthy
Спонсор: Pfizer
Налично на:
БГ
Обобщение
BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies.
This study is seeking healthy pregnant participants:
* aged 49 or younger who can join.
* between 24 and 36 weeks of gestation ("Gestational age" is a medical term used to describe how far along your pregnancy is)
* had a fetal ultrasound examination performed with no major fetal abnormalities observed
* documented negative for HIV, syphilis and Hepatitis B All participants in this study will receive only 1 shot in an arm. This could either be a group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6) or placebo. Placebo is an inactive substance used in the study for comparison purposes; in this study, the placebo injection will be saline (saltwater). The pregnant participants may take part in this study for a maximum of 14 months (6 months after delivery) , and their babies for about 12 months after they are born. The pregnant participants will need to visit the research site at least 3 to 4 times with some visits permitted to occur over the telephone.
A subset of infants will be asked to take part in the study for up to 19 months. The subset will receive diphtheria toxoid-containing vaccine and/or pneumococcal vaccine following each country's standard immunization plan and have blood drawn 1 month after completion of the primary and/or toddler (booster) doses.
Кой може да участва
Key Inclusion criteria- Maternal:
* Healthy pregnant 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, and who have no known increased risk of complications.
* Had a fetal anomaly ultrasound examination with no significant fetal abnormalities observed.
* Documented negative human immunodeficiency virus (HIV) antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization.
* Capable of giving personal signed informed consent.
* Willing to give informed consent for her infant to participate in the study.
Key Exclusion criteria- Maternal:
* Prepregnancy body mass index (BMI) of \>40 kg/m2.
* Current pregnancy complications or abnormalities that may increase the risk associated with the participation in and completion of the study.
* Prior pregnancy complications or abnormalities that, based on the investigator's judgment, may increase the risk associated with the participation in and completion of the study.
* History of microbiologically proven invasive disease caused by GBS in the current pregnancy.
* A known or suspected infection during the current pregnancy that may increase the risk of complications in pregnancy (eg, active tuberculosis, syphilis, primary genital herpes simplex, malaria).
Key Inclusion criteria- Infant Participants
\- Evidence of a signed and dated ICD signed by the parent(s)/legally authorized representative or legal guardian
Key Exclusion Criteria - Infant Participants:
\- Children or grandchildren who are direct descendants of investigator site staff or sponsor and sponsor delegate employees directly involved in the conduct of the study.
Key Exclusion Criteria - Infant immunogenicity subset Participants:
\- Children with a known or suspected contraindication to any vaccine administered in the infant vaccine immunogenicity subset.
Refer to the study contact for further eligibility details
Интервенции
Multivalent Group B streptococcus vaccine
BIOLOGICAL
Placebo
BIOLOGICAL
Infanrix hexa
BIOLOGICAL
Prevenar 20
BIOLOGICAL
Pediarix
BIOLOGICAL
Prevnar 20
BIOLOGICAL
Infanrix
BIOLOGICAL
Места на провеждане
162
Argentina (7)
Centro de investigación Clínica OSECAC - Sede Jonas Salk
Buenos Aires
Equipo Ciencia
Buenos Aires
Fundación Respirar
Ciudad Autónoma de Buenos Aires , Buenos Aires
Clinica Privada del Sol S.A
Córdoba , Córdoba Province
NOT_YET_RECRUITING
Clinica Del Niño Y La Madre
Mar del Plata , Buenos Aires
NOT_YET_RECRUITING
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
San Miguel de Tucumán , Tucumán Province
Instituto de Maternidad y Ginecología Nuestra Señora de las Mercedes
San Miguel de Tucumán , Tucumán Province
Бразилия (3)
Centro de Pesquisa Clínica - Obras Sociais Irmã Dulce
Salvador , Estado de Bahia
NOT_YET_RECRUITING
Universidade Federal de Santa Maria.
Santa Maria , Rio Grande do Sul
NOT_YET_RECRUITING
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto , São Paulo
NOT_YET_RECRUITING
Канада (2)
Kingston Health Sciences Centre - Kingston General Site
Kingston , Ontario
NOT_YET_RECRUITING
CHU de Quebec-Universite Laval-Centre hospitalier de l'Universite Laval et Centre mere-enfant Soleil
Québec , Quebec
Финландия (6)
MeVac - Meilahti Vaccine Research Center
Helsinki , Uusimaa
FVR, Kokkolan rokotetutkimusklinikka
Kokkola , Keski-Pohjanmaa
NOT_YET_RECRUITING
FVR, Oulun rokotetutkimusklinikka
Oulu , North Ostrobothnia
NOT_YET_RECRUITING
FVR, Seinäjoen rokotetutkimusklinikka
Seinäjoki , South Ostrobothnia
NOT_YET_RECRUITING
FVR, Tampereen rokotetutkimusklinikka
Tampere , Pirkanmaa
NOT_YET_RECRUITING
FVR, Turun rokotetutkimusklinikka
Turku , Southwest Finland
NOT_YET_RECRUITING
Япония (9)
Beppu Medical Center
Beppu-shi , Oita Prefecture
Fukui Aiiku Hospital
Fukui
Osaka Habikino Medical Center
Habikino , Osaka
Taniguchi Hospital
Izumisano , Osaka
Yamanashi Prefectural Central Hospital
Kofu , Yamanashi
St.Mary's Hospital
Kurume , Fukuoka
Rakuwakai Otowa Hospital
Kyoto
Sendai City Hospital
Sendai , Miyagi
Shizuoka General Hospital
Shizuoka
Mexico (1)
Unidad de Medicina Especializada SMA
San Juan del Río , Querétaro
NOT_YET_RECRUITING
Нидерландия (1)
Jeroen Bosch Hospital
's-Hertogenbosch , North Brabant
NOT_YET_RECRUITING
South Africa (6)
Josha Research
Bloemfontein , Free State
NOT_YET_RECRUITING
REIMED Reiger Park
Boksburg , Gauteng
MRC Unit on Child And Adolescent Health
Cape Town , Western Cape
NOT_YET_RECRUITING
Gugulethu Green Clinic
Cape Town , Western Cape
NOT_YET_RECRUITING
Wits RHI Shandukani Research Centre
Johannesburg , Gauteng
NOT_YET_RECRUITING
Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit
Soweto , Gauteng
Южна Корея (6)
Kangwon National University Hospital
Chuncheon , Gangwon-do
Keimyung University Dongsan Hospital
Daegu , Taegu-kwangyǒkshi
NOT_YET_RECRUITING
Chonnam National University Hospital
Gwangju , Kwangju-kwangyǒkshi
NOT_YET_RECRUITING
Seoul National University Hospital
Seoul , Seoul-teukbyeolsi [seoul]
NOT_YET_RECRUITING
Korea University Guro Hospital
Seoul , Seoul-teukbyeolsi [seoul]
Kyung Hee University Hospital at Gangdong
Seoul
NOT_YET_RECRUITING
Испания (13)
Hospital Antequera
Antequera
Hospital Universitario La Zarzuela
Aravaca
Hospital Sant Joan de Déu
Esplugues de Llobregat , Barcelona [barcelona]
Hospital Universitario La Paz
Madrid , Madrid, Comunidad de
Hospital Universitario HM Puerta del Sur
Madrid , Madrid, Comunidad de
Hospital General Universitario Gregorio Marañon
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Costa del Sol
Marbella , Malaga
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón , Madrid
CHUS - Hospital Clinico Universitario
Santiago de Compostela , A Coruña [LA Coruña]
Hospital Quirónsalud Sagrado Corazón
Seville
Instituto Hispalense de Pediatria- IHP1
Seville
Hospital Universitario de Torrejón
Torrejón de Ardoz , Madrid
Taiwan (5)
Hsinchu Municipal Mackay Children's Hospital
Hsinchu , Hsinchu
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
National Taiwan University Hospital
Taipei
Mackay Memorial Hospital
Taipei
NOT_YET_RECRUITING
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District
Великобритания (16)
University Hospitals Bristol NHS Foundation Trust
Bristol , Bristol, CITY of
St Michael's Hospital
Bristol , Bristol, CITY of
Bristol Royal Hospital for Children
Bristol
Bristol Royal Infirmary
Bristol
St James's University Hospital
Leeds
Barnet Hospital
London , England
NOT_YET_RECRUITING
St. George's Hospital
London , England
NOT_YET_RECRUITING
Imperial College Healthcare NHS Foundation Trust - St Mary's Hospital
London , London, CITY of
Royal Free Hospital
London
NOT_YET_RECRUITING
North Manchester General Hospital
Manchester , England
St Mary's Hospital (Manchester University NHS Foundation Trust)
Manchester , Lancashire
Wythenshawe Hospital
Manchester
The John Radcliffe Hospital
Oxford , Oxfordshire
The Princess Royal Hospital
Shropshire , Telford AND Wrekin
Southampton General Hospital
Southampton , Hampshire
The Royal Cornwall Hospital
Truro , England
САЩ (87)
Accellacare - McFarland
Ames , Iowa
Mary Greeley Medical Center
Ames , Iowa
McFarland Clinic, PC
Ames , Iowa
Center for Immunization Research
Baltimore , Maryland
Center for Immunization Research
Baltimore , Maryland
Johns Hopkins Bayview Medical Center
Baltimore , Maryland
Center for Research in Women's Health
Birmingham , Alabama
Children's of Alabama
Birmingham , Alabama
University of Alabama at Birmingham - School of Medicine
Birmingham , Alabama
University of Alabama at Birmingham Women & Infants Center
Birmingham , Alabama
Advanced Specialty Research
Boise , Idaho
Boston Medical Center
Boston , Massachusetts
Cincinnati Children's Hospital Medical Center
Cincinnati , Ohio
University of Cincinnati Physicians Midtown
Cincinnati , Ohio
Hoxworth Center
Cincinnati , Ohio
University of Cincinnati Medical Center
Cincinnati , Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati , Ohio
University Hospitals
Cleveland , Ohio
Velocity Clinical Research, Covington
Covington , Louisiana
SEC Clinical Research
Dothan , Alabama
Duke Vaccine and Trials Unit
Durham , North Carolina
Duke University - Main Hospital and Clinics
Durham , North Carolina
Duke University - Main Hospital and Clinics
Durham , North Carolina
Stony Brook Medicine Clinical Research Center
East Setauket , New York
Proactive Clinical Research LLC
Edinburg , Texas
NOT_YET_RECRUITING
Inova Fairfax Medical Campus
Falls Church , Virginia
Express Lab
Garden City , Idaho
ACGC Research, NYU Ambulatory Care Garden City
Garden City , New York
NYU Langone Ambulatory Care Garden City
Garden City , New York
Velocity Clinical Research, Grand Island
Grand Island , Nebraska
Boeson Research GTF
Great Falls , Montana
Origin Health GTF
Great Falls , Montana
Tribe Clinical Research, LLC- Greer
Greer , South Carolina
Memorial Hermann Memorial City Hospital
Houston , Texas
The University of Texas Health Science Center at Houston
Houston , Texas
Clinical Research Prime
Idaho Falls , Idaho
Eastern Idaho Regional Medical Center
Idaho Falls , Idaho
Mountain View Hospital
Idaho Falls , Idaho
Antelope Valley Medical Center
Lancaster , California
Chemidox Clinical Trials
Lancaster , California
Maximos Ob/Gyn
League City , Texas
Cincinnati Children's Hospital Medical Center Liberty
Liberty Township , Ohio
Midwest Children's Health Research Center
Lincoln , Nebraska
Midwest Children's Health Research Center
Lincoln , Nebraska
Bryan Health
Lincoln , Nebraska
Midwest Children's Health Research Institute
Lincoln , Nebraska
Women's Health Care Center of Williamsburg
Lincoln , Nebraska
Midwest Children's Health Research Center
Lincoln , Nebraska
South Florida Clinical Research Institute - Margate
Margate , Florida
Cincinnati Children's Hospital Medical Center Mason
Mason , Ohio
NYU Langone Long Island, Clinical Research Center 3-002 (Admin only)
Mineola , New York
Boeson Research MSO
Missoula , Montana
Origin Health
Missoula , Montana
Weill Cornell Medicine - New York Presbyterian Hospital
New York , New York
NOT_YET_RECRUITING
Velocity Clinical Research, Norfolk
Norfolk , Nebraska
Sentara Leigh Hospital
Norfolk , Virginia
The Group For Women - Kempsville Office
Norfolk , Virginia
Tidewater Physicians for Women
Norfolk , Virginia
Womens Care Center
Norfolk , Virginia
Virginia Physicians For Women (VPFW)
North Chesterfield , Virginia
Citadelle Clinical Research
North Miami Beach , Florida
NOT_YET_RECRUITING
Gynecology and Obstetrics at Johns Hopkins Health Care and Surgery Center- White Marsh
Nottingham , Maryland
Lucile Packard Children's Hospital
Palo Alto , California
NOT_YET_RECRUITING
Stanford Obstetrics Clinic
Palo Alto , California
NOT_YET_RECRUITING
Stanford University Medical Center
Palo Alto , California
NOT_YET_RECRUITING
Stanford University
Palo Alto , California
NOT_YET_RECRUITING
Emerald Coast OBGYN Clinical Research
Panama City , Florida
HCA Florida Gulf Coast Hospital
Panama City , Florida
ClinMed
Phoenix , Arizona
Valleywise Comprehensive Health Center Women's Clinic
Phoenix , Arizona
NOT_YET_RECRUITING
Valleywise Health Medical Center
Phoenix , Arizona
NOT_YET_RECRUITING
UPMC Children's Hospital of Pittsburgh
Pittsburgh , Pennsylvania
NOT_YET_RECRUITING
UPMC Magee Women's Hospital
Pittsburgh , Pennsylvania
NOT_YET_RECRUITING
Madison Memorial Hospital
Rexburg , Idaho
Clinical Research Partners, LLC
Richmond , Virginia
Seattle Childrens Research Institute
Seattle , Washington
NOT_YET_RECRUITING
Seattle Childrens Hospital
Seattle , Washington
NOT_YET_RECRUITING
UW Medical Center Northwest
Seattle , Washington
NOT_YET_RECRUITING
UW Medical Center Montlake
Seattle , Washington
NOT_YET_RECRUITING
Tribe Clinical Research at Parkside Pediatrics Five Forks
Simpsonville , South Carolina
Senders Pediatrics
South Euclid , Ohio
Washington University School of Medicine
St Louis , Missouri
Stony Brook University
Stony Brook , New York
Genesis OB/GYN
Tucson , Arizona
Eclipse Clinical Research
Tucson , Arizona
University of Cincinnati Medical Center West Chester
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