Diphtheria Clinical Trials

Find Diphtheria Clinical Trials Near You

A Phase 3, Randomized, Placebo-Controlled, Double-Blinded Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Multivalent Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Infants

Status: Recruiting
Location: See all (158) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 49
Healthy Volunteers: t
View:

• 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.

⁃ \- Evidence of a signed and dated ICD signed by the parent(s)/legally authorized representative or legal guardian

Locations
United States
Alabama
Center for Research in Women's Health
RECRUITING
Birmingham
Children's of Alabama
RECRUITING
Birmingham
University of Alabama at Birmingham - School of Medicine
RECRUITING
Birmingham
University of Alabama at Birmingham Women & Infants Center
RECRUITING
Birmingham
SEC Clinical Research
RECRUITING
Dothan
Arizona
ClinMed
RECRUITING
Phoenix
Valleywise Comprehensive Health Center Women's Clinic
NOT_YET_RECRUITING
Phoenix
Valleywise Health Medical Center
NOT_YET_RECRUITING
Phoenix
Eclipse Clinical Research
RECRUITING
Tucson
Genesis OB/GYN
RECRUITING
Tucson
California
Antelope Valley Medical Center
RECRUITING
Lancaster
Chemidox Clinical Trials
RECRUITING
Lancaster
Lucile Packard Children's Hospital
NOT_YET_RECRUITING
Palo Alto
Stanford Obstetrics Clinic
NOT_YET_RECRUITING
Palo Alto
Stanford University
NOT_YET_RECRUITING
Palo Alto
Stanford University Medical Center
NOT_YET_RECRUITING
Palo Alto
Florida
South Florida Clinical Research Institute - Margate
RECRUITING
Margate
Citadelle Clinical Research
NOT_YET_RECRUITING
North Miami Beach
Emerald Coast OBGYN Clinical Research
RECRUITING
Panama City
HCA Florida Gulf Coast Hospital
RECRUITING
Panama City
Iowa
Accellacare - McFarland
RECRUITING
Ames
Mary Greeley Medical Center
RECRUITING
Ames
McFarland Clinic, PC
RECRUITING
Ames
Idaho
Advanced Specialty Research
RECRUITING
Boise
Express Lab
RECRUITING
Garden City
Clinical Research Prime
RECRUITING
Idaho Falls
Eastern Idaho Regional Medical Center
RECRUITING
Idaho Falls
Mountain View Hospital
RECRUITING
Idaho Falls
Madison Memorial Hospital
RECRUITING
Rexburg
Louisiana
Velocity Clinical Research, Covington
RECRUITING
Covington
Massachusetts
Boston Medical Center
RECRUITING
Boston
Maryland
Center for Immunization Research
NOT_YET_RECRUITING
Baltimore
Center for Immunization Research
NOT_YET_RECRUITING
Baltimore
Johns Hopkins Bayview Medical Center
NOT_YET_RECRUITING
Baltimore
Gynecology and Obstetrics at Johns Hopkins Health Care and Surgery Center- White Marsh
NOT_YET_RECRUITING
Nottingham
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Montana
Boeson Research GTF
RECRUITING
Great Falls
Origin Health GTF
RECRUITING
Great Falls
Boeson Research MSO
RECRUITING
Missoula
Origin Health
RECRUITING
Missoula
North Carolina
Duke University - Main Hospital and Clinics
NOT_YET_RECRUITING
Durham
Duke University - Main Hospital and Clinics
NOT_YET_RECRUITING
Durham
Duke Vaccine and Trials Unit
NOT_YET_RECRUITING
Durham
Nebraska
Velocity Clinical Research, Grand Island
RECRUITING
Grand Island
Bryan Health
RECRUITING
Lincoln
Midwest Children's Health Research Center
RECRUITING
Lincoln
Midwest Children's Health Research Center
RECRUITING
Lincoln
Midwest Children's Health Research Center
RECRUITING
Lincoln
Midwest Children's Health Research Institute
RECRUITING
Lincoln
Women's Health Care Center of Williamsburg
RECRUITING
Lincoln
Velocity Clinical Research, Norfolk
RECRUITING
Norfolk
New York
Stony Brook Medicine Clinical Research Center
RECRUITING
East Setauket
ACGC Research, NYU Ambulatory Care Garden City
RECRUITING
Garden City
NYU Langone Ambulatory Care Garden City
RECRUITING
Garden City
NYU Langone Long Island, Clinical Research Center 3-002 (Admin only)
RECRUITING
Mineola
Weill Cornell Medicine - New York Presbyterian Hospital
NOT_YET_RECRUITING
New York
Stony Brook University
RECRUITING
Stony Brook
Ohio
Cincinnati Children's Hospital Medical Center
NOT_YET_RECRUITING
Cincinnati
Cincinnati Children's Hospital Medical Center
NOT_YET_RECRUITING
Cincinnati
Hoxworth Center
NOT_YET_RECRUITING
Cincinnati
University of Cincinnati Medical Center
NOT_YET_RECRUITING
Cincinnati
University of Cincinnati Physicians Midtown
NOT_YET_RECRUITING
Cincinnati
University Hospitals
RECRUITING
Cleveland
Cincinnati Children's Hospital Medical Center Liberty
NOT_YET_RECRUITING
Liberty Township
Cincinnati Children's Hospital Medical Center Mason
NOT_YET_RECRUITING
Mason
Senders Pediatrics
RECRUITING
South Euclid
University of Cincinnati Medical Center West Chester
NOT_YET_RECRUITING
West Chester
University of Cincinnati Physicians
NOT_YET_RECRUITING
West Chester
Pennsylvania
UPMC Children's Hospital of Pittsburgh
NOT_YET_RECRUITING
Pittsburgh
UPMC Magee Women's Hospital
NOT_YET_RECRUITING
Pittsburgh
South Carolina
Tribe Clinical Research, LLC- Greer
RECRUITING
Greer
Tribe Clinical Research at Parkside Pediatrics Five Forks
RECRUITING
Simpsonville
Texas
Proactive Clinical Research LLC
NOT_YET_RECRUITING
Edinburg
Memorial Hermann Memorial City Hospital
RECRUITING
Houston
The University of Texas Health Science Center at Houston
RECRUITING
Houston
Maximos Ob/Gyn
RECRUITING
League City
Virginia
Inova Fairfax Medical Campus
RECRUITING
Falls Church
Sentara Leigh Hospital
RECRUITING
Norfolk
The Group For Women - Kempsville Office
RECRUITING
Norfolk
Tidewater Physicians for Women
RECRUITING
Norfolk
Womens Care Center
RECRUITING
Norfolk
Virginia Physicians For Women (VPFW)
RECRUITING
North Chesterfield
Clinical Research Partners, LLC
RECRUITING
Richmond
Washington
Seattle Childrens Hospital
NOT_YET_RECRUITING
Seattle
Seattle Childrens Research Institute
NOT_YET_RECRUITING
Seattle
UW Medical Center Montlake
NOT_YET_RECRUITING
Seattle
UW Medical Center Northwest
NOT_YET_RECRUITING
Seattle
Other Locations
Argentina
Centro de investigación Clínica OSECAC - Sede Jonas Salk
RECRUITING
Buenos Aires
Equipo Ciencia
RECRUITING
Buenos Aires
Fundación Respirar
RECRUITING
Ciudad Autónoma De Buenos Aires
Clinica Privada del Sol S.A
NOT_YET_RECRUITING
Córdoba
Clinica Del Niño Y La Madre
NOT_YET_RECRUITING
Mar Del Plata
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
RECRUITING
San Miguel De Tucumán
Instituto de Maternidad y Ginecología Nuestra Señora de las Mercedes
RECRUITING
San Miguel De Tucumán
Brazil
Centro de Pesquisa Clínica - Obras Sociais Irmã Dulce
NOT_YET_RECRUITING
Salvador
Fundação Faculdade Regional de Medicina de São José do Rio Preto
NOT_YET_RECRUITING
São José Do Rio Preto
Canada
CHU de Quebec-Universite Laval-Centre hospitalier de l'Universite Laval et Centre mere-enfant Soleil
NOT_YET_RECRUITING
Québec
Finland
MeVac - Meilahti Vaccine Research Center
RECRUITING
Helsinki
FVR, Kokkolan rokotetutkimusklinikka
NOT_YET_RECRUITING
Kokkola
FVR, Oulun rokotetutkimusklinikka
NOT_YET_RECRUITING
Oulu
FVR, Seinäjoen rokotetutkimusklinikka
NOT_YET_RECRUITING
Seinäjoki
FVR, Tampereen rokotetutkimusklinikka
NOT_YET_RECRUITING
Tampere
FVR, Turun rokotetutkimusklinikka
NOT_YET_RECRUITING
Turku
Japan
Beppu Medical Center
RECRUITING
Beppu-shi
Fukui Aiiku Hospital
RECRUITING
Fukui
Osaka Habikino Medical Center
RECRUITING
Habikino
Taniguchi Hospital
RECRUITING
Izumisano
Yamanashi Prefectural Central Hospital
RECRUITING
Kofu
St.Mary's Hospital
RECRUITING
Kurume
Rakuwakai Otowa Hospital
RECRUITING
Kyoto
Sendai City Hospital
RECRUITING
Sendai
Shizuoka General Hospital
RECRUITING
Shizuoka
Mexico
Unidad de Medicina Especializada SMA
NOT_YET_RECRUITING
San Juan Del Río
Netherlands
Jeroen Bosch Hospital
NOT_YET_RECRUITING
's-hertogenbosch
Republic of Korea
Kangwon National University Hospital
NOT_YET_RECRUITING
Chuncheon
Keimyung University Dongsan Hospital
NOT_YET_RECRUITING
Daegu
Chonnam National University Hospital
NOT_YET_RECRUITING
Gwangju
Korea University Guro Hospital
NOT_YET_RECRUITING
Seoul
Kyung Hee University Hospital at Gangdong
NOT_YET_RECRUITING
Seoul
Seoul National University Hospital
NOT_YET_RECRUITING
Seoul
South Africa
Josha Research
NOT_YET_RECRUITING
Bloemfontein
REIMED Reiger Park
NOT_YET_RECRUITING
Boksburg
Wits RHI Shandukani Research Centre
NOT_YET_RECRUITING
Johannesburg
Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit
NOT_YET_RECRUITING
Soweto
Spain
Hospital Antequera
RECRUITING
Antequera
Hospital Universitario La Zarzuela
RECRUITING
Aravaca
Hospital Sant Joan de Déu
NOT_YET_RECRUITING
Esplugues De Llobregat
Hospital General Universitario Gregorio Marañon
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario HM Puerta del Sur
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Costa del Sol
RECRUITING
Marbella
Hospital Universitario Quironsalud Madrid
RECRUITING
Pozuelo De Alarcón
CHUS - Hospital Clinico Universitario
NOT_YET_RECRUITING
Santiago De Compostela
Hospital Quirónsalud Sagrado Corazón
RECRUITING
Seville
Instituto Hispalense de Pediatria- IHP1
RECRUITING
Seville
Hospital Universitario de Torrejón
RECRUITING
Torrejón De Ardoz
Taiwan
Hsinchu Municipal Mackay Children's Hospital
RECRUITING
Hsinchu
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Mackay Memorial Hospital
NOT_YET_RECRUITING
Taipei
National Taiwan University Hospital
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch
RECRUITING
Taoyuan District
United Kingdom
Bristol Royal Hospital for Children
RECRUITING
Bristol
Bristol Royal Infirmary
RECRUITING
Bristol
St Michael's Hospital
RECRUITING
Bristol
University Hospitals Bristol NHS Foundation Trust
RECRUITING
Bristol
St James's University Hospital
RECRUITING
Leeds
Barnet Hospital
NOT_YET_RECRUITING
London
Imperial College Healthcare NHS Foundation Trust - St Mary's Hospital
RECRUITING
London
Royal Free Hospital
NOT_YET_RECRUITING
London
St. George's Hospital
NOT_YET_RECRUITING
London
North Manchester General Hospital
RECRUITING
Manchester
St Mary's Hospital (Manchester University NHS Foundation Trust)
RECRUITING
Manchester
Wythenshawe Hospital
RECRUITING
Manchester
The John Radcliffe Hospital
RECRUITING
Oxford
The Princess Royal Hospital
RECRUITING
Shropshire
Southampton General Hospital
RECRUITING
Southampton
The Royal Cornwall Hospital
RECRUITING
Truro
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-08-25
Estimated Completion Date: 2029-03-02
Participants
Target number of participants: 6000
Treatments
Experimental: GBS6
Multivalent group B streptococcus vaccine
Placebo_comparator: Placebo
Placebo
Experimental: Infanrix hexa
Commercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio), and Haemophilus influenzae type b (Hib)
Experimental: Prevenar 20
Commercially available vaccine that protects against 20 strains of Streptococcus pneumoniae
Experimental: Pediarix
Commercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and polio
Experimental: Prevnar 20
Commercially available vaccine that protects against 20 strains of Streptococcus pneumoniae
Experimental: Infanrix
Commercially available combination vaccine containing diphtheria, tetanus, and pertussis
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov