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
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
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:
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.
Key Inclusion criteria- Maternal:
Key Exclusion criteria- Maternal:
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
ClinicalTrials.gov_Inquiries@pfizer.com1-800-718-1021
Birmingham, Alabama 35233, United States
Birmingham, Alabama 35294, United States
Phoenix, Arizona 85008, United States
Nottingham, Maryland 21236, United States
St Louis, Missouri 63110, United States
Jackson Heights, New York 11372, United States
Mineola, New York 11501, United States
New York, New York 10065, United States
Liberty Township, Ohio 45044, United States
West Chester, Ohio 45069, United States
Simpsonville, South Carolina 29681, United States
Houston, Texas 77024, United States
Salt Lake City, Utah 84112, United States
Marshfield, Wisconsin 54449, United States
Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ABP, Argentina
San Miguel de Tucumán, Tucumán Province 4000, Argentina
San Miguel de Tucumán, Tucumán Province 4000, Argentina
Salvador, Estado de Bahia 40055-150, Brazil
Salvador, Estado de Bahia 40210-341, Brazil
Salvador, Estado de Bahia 41180-780, Brazil
Salvador, Estado de Bahia 41680-430, Brazil
Curitiba, Paraná 80.060-900, Brazil
Natal, Rio Grande do Norte 59025050, Brazil
São José do Rio Preto, São Paulo 15090000, Brazil
São Paulo, São Paulo, Brazil
Québec, Quebec G1V 4G2, Canada
Beppu-shi, Oita Prefecture 874-0011, Japan
Guadalajara, Jalisco 44670, Mexico
Soweto, Gauteng 1864, South Africa
Santiago de Compostela, A Coruña [LA Coruña] 15706, Spain
Fajara, PO Box 273, The Gambia
Manchester, Lancashire M13 9WL, United Kingdom
London, London, CITY of W2 1NY, United Kingdom
Shropshire, Telford AND Wrekin TF1 6TF, United Kingdom