Most Recent Group B Streptococcus Trails in the United States

It is essential for clinicians to remain informed about emerging clinical trial opportunities and resulting data that may inform therapeutic strategies, affect clinical guidelines, expand treatment options, and ultimately improve patient quality of life.

Today, we are featuring ongoing and the most recently completed Phase 2, 3 clinical trials related to Group B Streptococcus. Clinical trials are arranged by start date, and all are active in, or were completed in, the United States. Some trials featured today had extensive primary completion measures listed, so for brevity, we directed interested readers to consult the source pages for the full look at those particular primary completion measures and their associated time frames.

Quick View Table of Group B Streptococcus Clinical Trials

Featured Phase 3 Clinical Trials

BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies

• Sponsor: Pfizer
• Goal: 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.
• Interventions: Multivalent Group B streptococcus vaccine, placebo, infanrix hexa, prevenar 20, pediarix, prevnar 20, infanrix
• Primary Outcome Measures: Due to the number of primary outcomes measures and time frames for this clinical trial, we invite you to view the extensive listing at the source link featured below.
• Time Frames: Due to the number of primary outcomes measures and time frames for this clinical trial, we invite you to view the extensive listing at the source link featured below.
• Study Details
• Source

Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women

• Sponsor: Pfizer
• Goal: This phase 2B, placebo-controlled, randomized, observer-blinded trial will evaluate the safety, tolerability, and immunogenicity of the investigational multivalent group B streptococcus vaccine administered concomitantly with Tdap in healthy nonpregnant women 18 through 49 years of age.
• Interventions: Multivalent Group B streptococcus vaccine, tetanus, diphtheria, and acellular pertussis vaccine, placebo
• Primary Outcome Measure: Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination; Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination; Percentage of Participants Reporting Adverse Events (AEs) Through 1 Month After Vaccination; Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 6 Months After Vaccination; Percentage of Participants Achieving Anti-tetanus Toxoid (Anti-TTd) and Anti-diphtheria Toxoid (Anti-DTd) Antibody Concentration >=0.1 IU/mL at 1 Month After Vaccination: GBS6 + Tdap and Placebo + Tdap Groups; Geometric Mean Concentration (GMC) of Anti-Pertussis Toxin (PT), Anti-Filamentous Hemagglutinin (FHA), and Anti-Pertactin (PRN) Antibodies; GMR of Anti-PT, Anti-FHA, and Anti-PRN for GBS6 + Tdap to Placebo + Tdap at 1 Month After Vaccination; GMC of GBS Capsular Polysaccharide (CPS) Serotype-Specific Immunoglobulin G (IgG) Antibodies; GMR of GBS CPS Serotype-specific IgG Antibodies for GBS6 + Tdap to Placebo + Tdap at 1 Month After Vaccination.
• Time Frames: Day one (day of vaccination) to day seven; Day one (day of vaccination) to day seven; Day one (day of vaccination) through one month post-vaccination; Day one (day of vaccination) through six months post vaccination; One month after vaccination (day one, day of vaccination); One month after vaccination (day one, day of vaccination); One month after vaccination (day one, day of vaccination).
• Study Details
• Source

Group B Streptococcus Response After Probiotic Exposure (GRAPE)

• Sponsor: University of New Mexico
• Goal: This is an open-label randomized control trial and feasibility study designed to determine the feasibility of a larger RCT in our setting that would examine prenatal probiotic use in Group B Strep (GBS) positive pregnant women at term.
• Intervention: Probiotic dietary supplement
• Primary Outcome Measure: GBS Culture Result (Positive Versus Negative)
• Time Frame: T2 (admission to Labor and Delivery; 36 - 42 weeks gestational age)
• Study Details
• Source

Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants

• Sponsor: Pfizer
• Goal: [To] evaluate the safety, tolerability and immunogenicity of the investigational multivalent group B streptococcus vaccine administered at one dose level (various formulations) in healthy nonpregnant women (various formulations at one dose level), and then in healthy pregnant women (various formulations at three dose levels), and finally in healthy pregnant women at a selected dose level/formulation.
• Interventions: Multivalent Group B streptococcus vaccine, placebo
• Primary Outcome Measure: Due to the number of primary outcomes measures and time frames for this clinical trial, we invite you to view the extensive listing at the wource link featured below.
• Time Frame: Due to the number of primary outcomes measures and time frames for this clinical trial, we invite you to view the extensive listing at the source link featured below.
• Study Details
• Source

Related Guidelines:

• Screening of Pregnant Women for Intrapartum Antibiotic Prophylaxis for the Prevention of Early Onset Group B Streptococcus Disease in New Borns
  • World Health Organization
  • September 2024

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