Clinical Trials List
Protocol NumberC1091009
NCT Number(ClinicalTrials.gov Identfier)NCT07160244
Active
2025-07-31 - 2029-12-31
Phase III
Recruiting4
ICD-10B95.1
Streptococcus, group B, as the cause of diseases classified elsewhere
ICD-9041.02
Group B streptococcus infections of unspecified site
A phase 3, randomized, placebo-controlled, double-blind trial to evaluate the safety, tolerability, and immunogenicity of a multivalent group B streptococcal vaccine in healthy pregnant women and their infants
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Sponsor
Pfizer Pharmaceutical Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/07/23
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chun-yi Lu Division of Pediatrics
- Luan-Yin Chang Division of Pediatrics
- TING-YU YEN Division of Pediatrics
- 李建南 Division of Obstetrics & Gynecology
- 康巧鈺 Division of Obstetrics & Gynecology
- 林芯伃 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Cheng-Hsun Chiu
Co-Principal Investigator
- 林瑞瑩 Division of Pediatrics
- 朱世明 Division of Pediatrics
- Jen Fu Hsu Division of Pediatrics
- 傅仁煇 Division of Pediatrics
- 江明洲 Division of Pediatrics
- 楊長佑 Division of Pediatrics
- 李建忠 Division of Pediatrics
- 吳怡萱 Division of Pediatrics
- 賴美吟 Division of Pediatrics
- 許凱翔 Division of Pediatrics
- Yao-Lung Chang Division of Obstetrics & Gynecology
- 李彥璋 Division of Obstetrics & Gynecology
- 許晉婕 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
• Prespecified local reactions (redness, swelling, and pain at the injection site). • Prespecified systemic events (fever, nausea/vomiting, diarrhea, headache, fatigue, muscle pain, and joint pain). • Adverse events (AEs). • Serious Adverse Events (SAEs). • Adverse events requiring medical attention (MAAE).
Objectives
This randomized, placebo-controlled, double-blind, Phase 3 trial was designed to evaluate the safety and tolerability of GBS6 in maternal participants and its safety outcomes in their infants
Test Drug
PF-06760805
Active Ingredient
PF-06760805
Dosage Form
Injections
Dosage
120 μg in 0.5-mL dose
Endpoints
• Prespecified local reactions (redness, swelling, and pain at the injection site).
• Prespecified systemic events (fever, nausea/vomiting, diarrhea, headache, fatigue, muscle pain, and joint pain).
• Adverse events (AEs).
• Serious Adverse Events (SAEs).
• Adverse events requiring medical attention (MAAE).
• Prespecified systemic events (fever, nausea/vomiting, diarrhea, headache, fatigue, muscle pain, and joint pain).
• Adverse events (AEs).
• Serious Adverse Events (SAEs).
• Adverse events requiring medical attention (MAAE).
Inclution Criteria
Healthy pregnant women ≤ 49 years of age, 24 0/7 to 36 0/7 weeks gestation on the day of scheduled vaccination, with an uncomplicated, singleton pregnancy and no known increased risk of pregnancy complications.
NOTE: GA must be determined based on last menstrual cycle (LMP) and initial ultrasound performed at <22 weeks gestation. If LMP is uncertain/unknown, GA must be determined by initial ultrasound performed at <22 weeks gestation.
• Ultrasound examination for fetal anomalies at ≥18 weeks of gestation without significant fetal abnormalities observed.
• Documented negative human immunodeficiency virus (HIV) antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test results during this pregnancy and before random assignment.
NOTE: GA must be determined based on last menstrual cycle (LMP) and initial ultrasound performed at <22 weeks gestation. If LMP is uncertain/unknown, GA must be determined by initial ultrasound performed at <22 weeks gestation.
• Ultrasound examination for fetal anomalies at ≥18 weeks of gestation without significant fetal abnormalities observed.
• Documented negative human immunodeficiency virus (HIV) antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test results during this pregnancy and before random assignment.
Exclusion Criteria
Weight:
• Pre-pregnancy body mass index (BMI) > 40 kg/m2. If pre-pregnancy BMI is not available, the BMI from the first obstetrical visit during the current pregnancy must be used.
Medical condition:
• Complications or abnormalities in your current pregnancy may increase the risks associated with participating in and completing the trial.
• Complications or abnormalities in previous pregnancies may increase the risks associated with participation in and completion of the trial, as determined by the trial sponsor.
• History of microbiologically proven invasive disease caused by GBS in 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.
• Current pregnancy with a known or suspected infection that may increase the risk of complications during pregnancy (eg, open tuberculosis, syphilis, primary genital herpes simplex, malaria).
• Have had a congenital or acquired immunodeficiency disease, rheumatic disease, or other disease requiring chronic treatment with known immunosuppressive drugs (including monoclonal antibodies) within the year prior to inclusion.
Prior/concomitant therapies:
• Receiving treatment with known systemic immunosuppressive therapies, including cytotoxic drugs to treat cancer or autoimmune diseases, or radiation therapy, within 60 days prior to enrollment, or plan to receive such therapies throughout the trial.
• Have received or plan to receive blood/plasma preparations or immunoglobulins since 60 days before the administration of investigational treatment, or are expected to receive blood/plasma preparations or immunoglobulins until delivery, with 1 exception: Rho(D) immunoglobulins (e.g., RhoGAM) may be given at any time.
• Have received a monoclonal antibody within the year before inclusion, or have used systemic corticosteroids (≥ prednisone 20 mg daily or equivalent) for ≥ 14 days within 28 days before trial vaccination and/or during trial participation.
• Pre-pregnancy body mass index (BMI) > 40 kg/m2. If pre-pregnancy BMI is not available, the BMI from the first obstetrical visit during the current pregnancy must be used.
Medical condition:
• Complications or abnormalities in your current pregnancy may increase the risks associated with participating in and completing the trial.
• Complications or abnormalities in previous pregnancies may increase the risks associated with participation in and completion of the trial, as determined by the trial sponsor.
• History of microbiologically proven invasive disease caused by GBS in 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.
• Current pregnancy with a known or suspected infection that may increase the risk of complications during pregnancy (eg, open tuberculosis, syphilis, primary genital herpes simplex, malaria).
• Have had a congenital or acquired immunodeficiency disease, rheumatic disease, or other disease requiring chronic treatment with known immunosuppressive drugs (including monoclonal antibodies) within the year prior to inclusion.
Prior/concomitant therapies:
• Receiving treatment with known systemic immunosuppressive therapies, including cytotoxic drugs to treat cancer or autoimmune diseases, or radiation therapy, within 60 days prior to enrollment, or plan to receive such therapies throughout the trial.
• Have received or plan to receive blood/plasma preparations or immunoglobulins since 60 days before the administration of investigational treatment, or are expected to receive blood/plasma preparations or immunoglobulins until delivery, with 1 exception: Rho(D) immunoglobulins (e.g., RhoGAM) may be given at any time.
• Have received a monoclonal antibody within the year before inclusion, or have used systemic corticosteroids (≥ prednisone 20 mg daily or equivalent) for ≥ 14 days within 28 days before trial vaccination and/or during trial participation.
The Estimated Number of Participants
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Taiwan
159 participants
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Global
6000 participants
