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A Study to Learn About Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Infants
EU CTIS ID: 2022-503070-36-00
What this study is testing
- To describe the safety and tolerability of GBS6 in maternal participants - To assess the safety of maternal immunization in infant participants born to pregnant individuals who were vaccinated with GBS6 during pregnancy - To assess the ability of GBS6 to induce anti-CPS IgG antibody levels predicted to provide protection from invasive GBS late-onset disease (LOD) caused by the 6 individual vaccine serotypes (Ia, Ib, II III, IV, and V) in infants when GBS6 is administered to healthy pregnant women - To assess the ability of GBS6 to induce anti-CPS IgG antibody levels predicted to provide protection from invasive GBS early-onset disease (EOD) caused by the 6 individual vaccine serotypes (Ia, Ib, II III, IV, and V) in infants when GBS6 is administered to healthy pregnant women - To evaluate the aggregate predicted VE combining all 6 serotypes in GBS6 to provide protection from invasive GBS LOD based on serotype-specific anti-CPS IgG concentrations measured in infants at birth - To evaluate the aggregate predicted VE combining all 6 serotypes in GBS6 to provide protection from invasive GBS EOD based on serotype-specific anti-CPS IgG concentrations measured in infants at birth
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Inclusion Criteria – Maternal Participants - 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 pregnancy complications
- Inclusion Criteria – Maternal Participants - Had a fetal anomaly ultrasound examination performed at ≥18 weeks of gestation with no significant fetal abnormalities observed
- Inclusion Criteria – Maternal Participants - 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
You likely can't join if
- Exclusion Criteria – Maternal Participants - Prepregnancy body mass index (BMI) of >40 kg/m2. If a prepregnancy BMI is not available, the BMI at the time of the first obstetric visit during the current pregnancy must be used
- Exclusion Criteria – Maternal Participants - Current pregnancy complications or abnormalities that may increase the risk associated with the participation in and completion of the study
- Exclusion Criteria – Maternal Participants - 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
- Exclusion Criteria – Maternal Participants - History of microbiologically proven invasive disease caused by GBS in the current pregnancy (eg, isolation of GBS from a sterile site: blood, cerebrospinal fluid [CSF], or synovial fluid). This does not include asymptomatic bacteriuria or urinary tract infection (UTI) unless associated with a positive blood culture
- Exclusion Criteria – Maternal Participants - 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)
- Exclusion Criteria – Maternal Participants - Congenital or acquired immunodeficiency disorder, rheumatologic disorder, or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies, within the year prior to enrollment
See the full eligibility criteria
- Inclusion Criteria – Maternal Participants - 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 pregnancy complications
- Inclusion Criteria – Maternal Participants - Had a fetal anomaly ultrasound examination performed at ≥18 weeks of gestation with no significant fetal abnormalities observed
- Inclusion Criteria – Maternal Participants - 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
- Exclusion Criteria – Maternal Participants - Prepregnancy body mass index (BMI) of >40 kg/m2. If a prepregnancy BMI is not available, the BMI at the time of the first obstetric visit during the current pregnancy must be used
- Exclusion Criteria – Maternal Participants - Current pregnancy complications or abnormalities that may increase the risk associated with the participation in and completion of the study
- Exclusion Criteria – Maternal Participants - 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
- Exclusion Criteria – Maternal Participants - History of microbiologically proven invasive disease caused by GBS in the current pregnancy (eg, isolation of GBS from a sterile site: blood, cerebrospinal fluid [CSF], or synovial fluid). This does not include asymptomatic bacteriuria or urinary tract infection (UTI) unless associated with a positive blood culture
- Exclusion Criteria – Maternal Participants - 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)
- Exclusion Criteria – Maternal Participants - Congenital or acquired immunodeficiency disorder, rheumatologic disorder, or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies, within the year prior to enrollment
- Exclusion Criteria – Maternal Participants - Receiving treatment with known systemic immunosuppressive therapy, including cytotoxic agents for cancer or an autoimmune disease, or radiotherapy, within 60 days before enrollment or planned receipt throughout the course of the study
- Exclusion Criteria – Maternal Participants - Receipt or planned receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration, or planned receipt through delivery, with 1 exception: Rho(D) immune globulin (eg, RhoGAM), which can be given at any time
- Exclusion Criteria – Maternal Participants - Receipt of monoclonal antibodies within the year prior to enrollment or the use of systemic corticosteroids (≥20 mg/day of prednisone or equivalent) for ≥14 days within 28 days prior to study vaccination and/or during study participation
The study team makes the final eligibility decision.
Where it's taking place
- Kenya
- Korea, Republic of
- Uganda
- Brazil
- South Africa
- United Kingdom
- Mexico
- United States
- Taiwan
- Argentina
- Canada
- Philippines
- Japan
- Ghana
- Gambia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years, in utero. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kenya; Korea, Republic of; Uganda; Brazil; South Africa; United Kingdom and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.