BEATRIX Phase III Maternal GBS
For demographics: Infants (<12 months)
Every medical advancement begins with a first step. By taking part in this study, you and your little one could positively impact the health of babies around the world.
Purpose
We are researching an investigational maternal vaccine that is designed to protect pregnant women and their babies from the 6 most common types of GBS.
The study vaccine is designed to activate the immune system, so it creates antibodies that fight against GBS. Some of these disease-fighting antibodies may be passed on to the developing baby through the placenta.
GBS is a leading cause of serious bacterial infection in newborns, with over 300,000 cases each year. It may cause dangerous complications during pregnancy as well.
About Group B streptococcus (GBS)
Group B streptococcus (GBS) is a common type of bacteria that is found in about 1 in 5 pregnant women, which can cause complications during pregnancy and serious illness in babies. GBS can be passed to babies in the womb, at birth and after.
Babies are vulnerable to GBS infection because their immune systems are still developing.
Symptoms of GBS in babies may include:
- Fever
- Difficulty feeding
- Difficulty breathing
GBS can cause life-threatening illnesses like:
- Sepsis (blood infection)
- Meningitis (brain infection)
- Pneumonia (lung infection)
Even with treatment, GBS infection can lead to long-term health problems, including seizures, hearing loss and vision loss.
Participation Criteria
You may be able to be in our study if you are healthy and expecting a single healthy baby.
Participation Details
If you join this study, you will receive 1 dose of the study vaccine or placebo between weeks 24 and 36 of your pregnancy. A placebo looks like the study vaccine but has no active ingredients.
You will be in the study until about 6 months after your baby is born and will have at least 5-6 study visits. Your baby will be in the study until they are 12 months old and will have at least 4 study visits. Some of these visits may occur by phone.
The decision to join a clinical trial is completely voluntary. You and your baby can leave the study at any time if you decide that you no longer want to take part.
Additional Information
This study is a Phase III clinical trial being conducted by Pfizer.
More studies:
BEATRIX Phase III Maternal GBS
June 15, 2026