The purpose of the study is to learn about the safety and immune activity of the RSVpreF vaccine. It will be studied in infants born to mothers living with HIV. These infants may have higher chances of getting sick or dying due to RSV infection. Respiratory Syncytial Virus (RSV) is a common type of virus (germ) that can cause severe illness (airway diseases), where medical help is needed. Vaccines help your body make antibodies which help fight against diseases. The antibodies are substances your body uses to fight off an infection. The antibodies can be passed to the infant through the placenta of the mother. The study will look at the safety, tolerability, and immune activity in mothers and their infants. This study is seeking pregnant women who are: * Less than or equal to 49 years old and have HIV (Human immunodeficiency virus - * Receiving standard medical care during the pregnancy * Do not have syphilis (bacterial sexually transmitted disease), Hepatitis B Virus ((HBV) liver infection), Tuberculosis ((TB) bacterial lung infection). * Have been on stable (anti-retroviral) HIV treatment for more than or equal to 90 days. * agree to be present for all study visits, procedures, and blood draws. Participants will either receive: * RSVpreF vaccine * A placebo. A placebo does not have any medicine it but looks just like the study vaccine. Pregnant participants will be involved in the study from: * consent during their current pregnancy, and * for 6 months after delivery of their baby (around 10 months in total). Pregnant participants will have at least 5 planned visits in this study. Infant participants: All eligible babies born to enrolled mothers will be followed up from birth for up to 6 months. Infant participants will have at least 3 study visits, with some site visits allowed to happen via home visits or over the telephone.
Age range
0 Years – 49 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Percentage of Maternal Participants With Prespecified Local Reactions Within 7 Days After Vaccination
Timeframe: From Day 1 to Day 7 after vaccination
Percentage of Maternal Participants With Prespecified Systemic Events Within 7 Days After Vaccination
Timeframe: From Day 1 to Day 7 after vaccination
Percentage of Maternal Participants With Adverse Events (AEs) From the Time of Vaccination Through 1 Month After Vaccination
Timeframe: From vaccination on Day 1 up to 1 month after vaccination
Percentage of Maternal Participants With Adverse Event of Special Interest (AESIs)
Timeframe: From vaccination on Day 1 up to 6 months after delivery (up to maximum of 10 months)
Percentage of Maternal Participants With SAEs From Vaccination Throughout the Study
Timeframe: From vaccination on Day 1 up to 6 months after delivery (up to maximum of 10 months)
Percentage of Infant Participants With AESIs From Birth Through 6 Months of Age
Timeframe: From birth up to 6 months of age
Number of Infant Participants With Reported Neonatal Deaths From Birth Through 1 Months of Age
Timeframe: Within 1 Month after birth
Number of Infant Participants With Congenital Malformations/Anomalies at Birth
Timeframe: At birth
Number of Infant Participants With Other Neonatal Problems at Birth
Timeframe: At birth
Number of Infant Participants According to Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute After Birth
Timeframe: 1 minute after birth
Number of Infant Participants According to APGAR Score at 5 Minutes After Birth
Timeframe: 5 minutes after birth
Number of Infant Participants According to APGAR Score at 10 Minutes After Birth
Timeframe: 10 minutes after birth
Number of Infant Participants According to Gestational Age (GA) at Birth
Timeframe: At birth
Number of Infant Participants Requiring Hospitalization at Birth
Timeframe: From birth until discharge from hospitalization (up to a maximum of 72 hours)
Percentage of Infant Participants With AEs From Birth to 1 Month of Age
Timeframe: From birth to 1 month of age
Percentage of Infant Participants With SAEs From Birth Through 6 Months of Age
Timeframe: From birth to 6 months of age
Percentage of Infant Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Birth Through 6 Months of Age
Timeframe: From birth to 6 months of age