About the Study
The SAVVY study is assessing the safety of an investigational Respiratory Syncytial Virus vaccine (RSV vaccine for short) given to healthy pregnant women. The study will also measure immune system response to a single study injection to evaluate the role the investigational vaccine may potentially play in protecting a baby’s health.
As part of your participation in the SAVVY study, you will receive a single injection that contains either the investigational RSV vaccine or a placebo.
Investigational vaccine. The vaccine being studied contains proteins that may activate your immune system. It does not contain any live virus. Multiple doses and types of the investigational RSV vaccine will be studied.
Placebo. The placebo is a saline (saltwater) solution and does not contain any active ingredients. Neither you nor anyone assessing your/your baby’s health will know which injection you receive. Using a placebo in this way will help researchers evaluate the investigational RSV vaccine.
Study injection assignment. Your study injection is assigned by chance, like rolling dice. You have an 80% chance of receiving investigational RSV vaccine and a 20% chance of receiving placebo.
Side effects. The study doctor will answer any questions you have about potential side effects. After your injection, you will remain at the study center long enough to observe any immediate reaction. At home, you will use a measuring device, a thermometer, and an electronic diary (e-diary) to monitor and record your body temperature and any redness or swelling at the injection site for 7 days beginning the day of your injection.
You may be able to join the study if you:
- Are 18 to 49 years of age
- Are a healthy pregnant woman expecting a healthy baby
- Will be between 24 and 36 weeks pregnant on the day of your study injection
- Meet additional requirements as determined by a screening process
Study participation is expected to last up to approximately 17 months for you and 12 months for your baby. Participating in the study is voluntary. If you choose to join the study, you may change your mind at any time and leave the study without losing any benefits or medical care to which you and your baby are otherwise entitled.
Study participant activities
- Informed Consent Process
- Screening Visit
- Study Injection Visit
- Home Assessments
- Study Visits
Informed Consent Process. The study informed consent document explains what to expect for yourself and your baby during this study. You will need to read the consent document carefully before deciding if participating in this study may be an option for you. You are encouraged to ask the study doctor any questions you have, and the study doctor will also discuss study details with you during this process.
Screening Visit. The study doctor will examine you, including checking on the health of your baby (like listening for heart sounds and measuring its size). You will provide blood and urine samples and answer questions about your health and medical care. The study doctor will analyze the results to determine if you may join the study.
Study Injection Visit. You will receive either the investigational RSV vaccine or placebo injection. You will also answer questions about your health, provide blood and urine samples for testing, and have a physical exam including checking on your baby’s health. After your injection, you will remain at the study center long enough to observe any immediate reaction to the injection before you go home.
Home Assessments. Study staff will show you how to measure redness or swelling of the injection site and answer questions in an electronic diary (e-diary for short). You will need to complete e-diary entries for 7 consecutive days beginning the night of your injection. You should call the study doctor if you have a large reaction at the injection site or any severe symptom.
Study Visits. You will attend 8 planned study visits, and your baby will attend 5. Some unplanned visits may also be necessary. At study visits you will answer questions about your health and your baby’s health. You/your baby will undergo study-related tests and procedures to monitor your/your baby’s health. Throughout the study, the study doctor and staff will answer your questions and address concerns you may have about any tests or procedures.
Print this study summary to discuss with your doctor.