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Clinical Trials List

Protocol NumberC1091009
NCT Number(ClinicalTrials.gov Identfier)NCT07160244
Not yet recruiting

2025-07-31 - 2029-12-31

Phase III

Recruiting5

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

  • Sponsor

    Pfizer

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Te Fu Chan Division of Obstetrics & Gynecology
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林千裕 Division of Pediatrics
Hsinchu Mackay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Li-Min Huang Division of Pediatrics
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Hsun Chiu
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃建霈 Division of Obstetrics & Gynecology
MacKay Memorial Hospital

Co-Principal Investigator

  • 陳宜雍 Division of Obstetrics & Gynecology
  • Chi Hsin Division of Obstetrics & Gynecology

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

a Multivalent Group B Streptococcus Vaccine

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.

Test Drug

Multivalent Group B streptococcus vaccine

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
-The proportion of maternal participants reporting prespecified systemic events
-The proportion of maternal participants reporting adverse events (AEs)
-The proportion of maternal participants reporting serious adverse events (SAEs)
-The proportion of maternal participants reporting medically attended adverse events (MAAEs)

Inclution Criteria

Key Inclusion criteria- Maternal:

-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.

Exclusion Criteria

Key Exclusion criteria- Maternal:

-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).

The Estimated Number of Participants

  • Taiwan

    159 participants

  • Global

    6000 participants

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