A Study to Learn About the Vaccine RSVpreF In Pregnant Participants With HIV and Their Infants
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Prevention
Enrollment
681actual
Sites
14
Country
South Africa
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-03-12 | actual | When the study began enrolling |
| Primary completion | 2025-06-11 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-06-11 | actual | The whole study's end, after follow-up |
| First posted | 2024-03-22 | actual | When this record first appeared on the registry |
| Results posted | 2026-07-02 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-02 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Respiratory Syncytial Virus
Interventions
- Biological: RSVpreF vaccine
- Biological: Placebp
Primary outcomes
what the primary-completion date above is the date OFPercentage of Maternal Participants With Prespecified Local Reactions Within 7 Days After Vaccination
measured From Day 1 to Day 7 after vaccination
Percentage of Maternal Participants With Prespecified Systemic Events Within 7 Days After Vaccination
measured 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
measured From vaccination on Day 1 up to 1 month after vaccination
Percentage of Maternal Participants With Adverse Event of Special Interest (AESIs)
measured 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
measured 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
measured From birth up to 6 months of age
Number of Infant Participants With Reported Neonatal Deaths From Birth Through 1 Months of Age
measured Within 1 Month after birth
Number of Infant Participants With Congenital Malformations/Anomalies at Birth
measured At birth
Number of Infant Participants With Other Neonatal Problems at Birth
measured At birth
Number of Infant Participants According to Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute After Birth
measured 1 minute after birth
Number of Infant Participants According to APGAR Score at 5 Minutes After Birth
measured 5 minutes after birth
Number of Infant Participants According to APGAR Score at 10 Minutes After Birth
measured 10 minutes after birth
Number of Infant Participants According to Gestational Age (GA) at Birth
measured At birth
Number of Infant Participants Requiring Hospitalization at Birth
measured 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
measured From birth to 1 month of age
Percentage of Infant Participants With SAEs From Birth Through 6 Months of Age
measured 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
measured From birth to 6 months of age
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2023-08-24 · 825 KB · Prot_000.pdf
Statistical Analysis Planposted 2024-11-21 · 371 KB · SAP_001.pdf
Publications
- PMID 41441684 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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