Clinical Trials List
Protocol NumberC1091009
NCT Number(ClinicalTrials.gov Identfier)202501396A4
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-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY PREGNANT WOMEN AND THEIR INFANTS
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Sponsor
PFIZER LIMITED
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/18
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Luan-Yin Chang Division of Pediatrics
- 李建南 Division of Obstetrics & Gynecology
- 林芯伃 Division of Obstetrics & Gynecology
- Chun-yi Lu Division of Pediatrics
- TING-YU YEN Division of Pediatrics
- 康巧鈺 Division of Obstetrics & Gynecology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Cheng-Hsun Chiu
Co-Principal Investigator
- 朱世明 Division of Pediatrics
- 李建忠 Division of Pediatrics
- 吳怡萱 Division of Pediatrics
- Yao-Lung Chang Division of Obstetrics & Gynecology
- 許晉婕 Division of Obstetrics & Gynecology
- 江明洲 Division of Pediatrics
- 楊長佑 Division of Pediatrics
- 李彥璋 Division of Obstetrics & Gynecology
- Jen Fu Hsu Division of Pediatrics
- 許凱翔 Division of Pediatrics
- 傅仁煇 Division of Pediatrics
- 林瑞瑩 Division of Pediatrics
- 賴美吟 Division of Pediatrics
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Healthy
Objectives
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.
Test Drug
PF-06760805
Active Ingredient
PF-06760805
Dosage Form
Injection
Dosage
120 μg in 0.5-mL dose
Endpoints
The proportion of maternal participants reporting prespecified local reactions within 7 days following study intervention Within 7 days
The proportion of maternal participants reporting prespecified systemic events within 7 days following study intervention Within 7 days
The proportion of maternal participants reporting adverse events (AEs) through 1 month following study intervention 1 month
The proportion of maternal participants reporting serious adverse events (SAEs) through 6 months after delivery 6 months after delivery
The proportion of maternal participants reporting medically attended adverse events (MAAEs) through 6 months after delivery 6 months after delivery
The proportion of maternal participants reporting adverse events of special interest (AESIs) through 6 months after delivery. 6 months after delivery
The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting adverse events (AEs) from birth through 1 month of age Birth to 1 month of age
The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting serious adverse events (SAEs) from birth through end of the study Through study completion, at least 1 year
The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting medically attended adverse events (MAAEs) from birth through 6 months of age Birth to 6 months of age
The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting adverse events of special interest (AESIs) from birth through end of study Through study completion, at least 1 year
To measure the relative risk reduction in the proportion of infant participants at birth with GBS serotype-specific IgG antibody concentrations below predefined serotype-specific GBS late onset disease thresholds in the GBS6 group to the placebo group Birth
To measure the relative risk reduction in the proportion of infant participants at birth with GBS serotype-specific IgG antibody concentrations below predefined serotype-specific GBS early onset disease thresholds in the GBS6 group to the placebo group Birth
To evaluate the aggregate predicted VE combining all 6 serotypes in GBS6 to provide protection from invasive GBS late onset disease based on serotype specific anti-CPS IgG concentrations measured in infants at birth. Birth
To evaluate the aggregate predicted VE combining all 6 serotypes in GBS6 to provide protection from invasive GBS early onset disease based on serotype specific anti-CPS IgG concentrations measured in infants at birth. Birth
The proportion of maternal participants reporting prespecified systemic events within 7 days following study intervention Within 7 days
The proportion of maternal participants reporting adverse events (AEs) through 1 month following study intervention 1 month
The proportion of maternal participants reporting serious adverse events (SAEs) through 6 months after delivery 6 months after delivery
The proportion of maternal participants reporting medically attended adverse events (MAAEs) through 6 months after delivery 6 months after delivery
The proportion of maternal participants reporting adverse events of special interest (AESIs) through 6 months after delivery. 6 months after delivery
The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting adverse events (AEs) from birth through 1 month of age Birth to 1 month of age
The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting serious adverse events (SAEs) from birth through end of the study Through study completion, at least 1 year
The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting medically attended adverse events (MAAEs) from birth through 6 months of age Birth to 6 months of age
The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting adverse events of special interest (AESIs) from birth through end of study Through study completion, at least 1 year
To measure the relative risk reduction in the proportion of infant participants at birth with GBS serotype-specific IgG antibody concentrations below predefined serotype-specific GBS late onset disease thresholds in the GBS6 group to the placebo group Birth
To measure the relative risk reduction in the proportion of infant participants at birth with GBS serotype-specific IgG antibody concentrations below predefined serotype-specific GBS early onset disease thresholds in the GBS6 group to the placebo group Birth
To evaluate the aggregate predicted VE combining all 6 serotypes in GBS6 to provide protection from invasive GBS late onset disease based on serotype specific anti-CPS IgG concentrations measured in infants at birth. Birth
To evaluate the aggregate predicted VE combining all 6 serotypes in GBS6 to provide protection from invasive GBS early onset disease based on serotype specific anti-CPS IgG concentrations measured in infants at birth. Birth
Inclution Criteria
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.
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.
Exclusion Criteria
Prepregnancy body mass index (BMI) of >40 kg/m2.
Current pregnancy complications or abnormalities that may increase the risk associated with the participation in and completion of the study.
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.
History of microbiologically proven invasive disease caused by GBS in the current pregnancy.
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).
Current pregnancy complications or abnormalities that may increase the risk associated with the participation in and completion of the study.
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.
History of microbiologically proven invasive disease caused by GBS in the current pregnancy.
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).
The Estimated Number of Participants
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Taiwan
159 participants
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Global
6000 participants
