Purpose of this Study
Participants will receive either the study vaccine or a placebo during pregnancy. Mothers will be followed until about 6 months after delivery, and babies will be followed until 12 months of age through study visits and phone calls. Some babies may also join an optional part of the study that includes routine childhood vaccines and extra study visits.
Who Can Participate?
Eligibility
Participants may be able to join if they are healthy pregnant women ages 19 to 49 with a healthy baby, plan to deliver at Duke University Hospital or Duke Regional Hospital, receive routine prenatal care, and can complete study visits and be reached by phone during the study.
Age Range
19-49
Sex/Genders
Female (cisgender)
Non-binary or gender fluid
Looking for Healthy Participants
Yes
What is Involved?
Description
The purpose of this study is to learn how the investigational vaccine, GBS6, works in women who are pregnant and their babies.
At birth, your baby's immune system is not quite ready to fight infections on its own. A maternal vaccine may offer the protection your little one needs to stay healthy.
Locations
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full Title
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 INDIVIDUALS AND THEIR INFANTS
Study Website
Principal Investigator
Sarah
Dotters-Katz
Protocol Number
PRO00118229
Phase
III
Enrollment Status
Pending Open to Enrollment