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NCT06521944 · ClinicalTrials.gov registry record
RSV Vaccine Pregnancy Registry
A clinical trial of Respiratory Syncytial Virus (RSV), sponsored by CorEvitas.
- Recruiting
- Registry status
- 2,062
- Enrollment target
- 1
- Study location
NCT06521944: Recruiting study of Respiratory Syncytial Virus (RSV), sponsored by CorEvitas.
NCT06521944 is a study of Respiratory Syncytial Virus (RSV) that is actively recruiting participants, run by CorEvitas. The registered enrollment target is 2,062 participants, below the 6,569-participant average among 11 other Respiratory Syncytial Virus (RSV) trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06521944, a study of Respiratory Syncytial Virus (RSV), is actively recruiting participants, sponsored by CorEvitas.
- RECRUITING
- Registry status
- 2,062 participants
- Enrollment target
- 1
- Study location
Study Summary
The research question is: What is the risk of adverse pregnancy outcomes, including preterm birth, hypertensive disorders, and other maternal and neonatal/infant outcomes, following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation in the CorEvitas Respiratory Syncytial Virus Vaccine Pregnancy Registry (RSV-PR)? The primary study objective is to estimate the risk of (1) preterm birth and (2) hypertensive disorders following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation. The secondary study objective is to estimate the risk of other safety outcomes of interest following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation, including: * Pregnancy-related outcomes: stillbirth, premature labor, premature rupture of membranes, preterm premature rupture of membranes, cesarean delivery, prolonged maternal duration of hospital stay * Maternal outcomes: thrombocytopenia, Guillain-Barré syndrome, other immune-mediated demyelinating conditions, polyneuropathies, atrial fibrillation, maternal death * Neonatal/infant outcomes: small for gestational age, large for gestational age, low birth weight, admission to a neonatal intensive care unit (NICU), NICU duration of stay, mechanical ventilation in neonatal period, neonatal death, postnatal growth at 1 year of age The exploratory study objective is to describe the most frequently reported maternal adverse events following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation.
Primary Outcome
Risk of preterm birth following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation
Conditions Studied
Interventions
- BIOLOGICAL RSV Vaccine
- OTHER Non-exposure to RSV Vaccine
Study Locations (1)
North Carolina
- PPD - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,062 participants |
| Start Date | 2024-06-28 |
| Est. Completion | 2030-09-30 |
What NCT06521944 shows while recruiting
NCT06521944 is an observational study that tracks outcomes without assigning an intervention. Its 2,062 participants enrollment target places it among the larger protocols in the corpus, below the 6,569-participant average among 11 other Respiratory Syncytial Virus (RSV) trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Respiratory Syncytial Virus (RSV) appearing as the primary indexed condition, and to 2 interventions - of which RSV Vaccine is the first listed.
NCT06521944 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06521944 about?
NCT06521944 is a clinical study titled "RSV Vaccine Pregnancy Registry". The research question is: What is the risk of adverse pregnancy outcomes, including preterm birth, hypertensive disorders, and other maternal and neonatal/infant outcomes, following exposure to RSV vaccine between 32 weeks, 0 days and 36 weeks, 6 days of gestation in the CorEvitas Respiratory Syncyt...
What is the current status of trial NCT06521944?
This trial is currently recruiting. The enrollment target is 2,062 participants. The study started on 2024-06-28. Estimated completion is 2030-09-30.
What conditions does trial NCT06521944 study?
This clinical trial studies the following conditions: Respiratory Syncytial Virus (RSV).
What interventions are being tested in trial NCT06521944?
The interventions under investigation include: RSV Vaccine (BIOLOGICAL), Non-exposure to RSV Vaccine (OTHER).
Who is sponsoring clinical trial NCT06521944?
This trial is sponsored by CorEvitas, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06521944 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06521944's enrollment target sits among peer trials
2,062 4th of 11 higher than 8 of 11 other Respiratory Syncytial Virus (RSV) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Respiratory Syncytial Virus (RSV) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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