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NCT07158814 · ClinicalTrials.gov registry record · Phase 4
Safety of RSV Preventive Monoclonal Antibody
A Phase 4 study of Fever and Adverse Event Following Immunisation, sponsored by Duke University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 524
- Enrollment target
- 6
- Study locations
NCT07158814: Recruiting Phase 4 study of Fever and Adverse Event Following Immunisation, sponsored by Duke University.
NCT07158814 is a Phase 4 study of Fever and Adverse Event Following Immunisation that is actively recruiting participants, run by Duke University. The registered enrollment target is 524 participants, roughly in line with the 570-participant average among 18 other Fever trials with a reported enrollment target. The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07158814, a Phase 4 study of Fever and Adverse Event Following Immunisation, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 524 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is a prospective, randomized, open-label clinical trial to evaluate the safety of administration of respiratory syncytial virus (RSV) preventive monoclonal antibody and other routine childhood vaccines given simultaneously at Visit 1, as compared to sequential administration of respiratory syncytial virus (RSV) preventive monoclonal antibody and other vaccines at separate visits (Visits 1 and 2).
Primary Outcome
Number of infants with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1 and/or Visit 2.
Conditions Studied
Interventions
- DRUG Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody
Study Locations (6)
Georgia
- Emory University - Atlanta
- Centers for Disease Control and Prevention - Atlanta
California
- Kaiser Permanente Northern California - Oakland
New York
- Columbia University - New York
North Carolina
- Duke University - Durham
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 524 participants |
| Start Date | 2025-10-02 |
| Est. Completion | 2027-04 |
| Phase | Phase 4 |
What NCT07158814 shows while recruiting
NCT07158814 is an interventional study that assigns participants to a tested intervention. The registered 524 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 570-participant average among 18 other Fever trials with a reported enrollment target.
The record links to 2 conditions, with Fever appearing as the primary indexed condition, and to 1 intervention - of which Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody is the first listed.
NCT07158814 lists 6 locations in 5 states (Georgia, California, New York).
Frequently Asked Questions
What is clinical trial NCT07158814 about?
NCT07158814 is a clinical study titled "Safety of RSV Preventive Monoclonal Antibody". This is a prospective, randomized, open-label clinical trial to evaluate the safety of administration of respiratory syncytial virus (RSV) preventive monoclonal antibody and other routine childhood vaccines given simultaneously at Visit 1, as compared to sequential administration of respiratory sync...
What is the current status of trial NCT07158814?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 524 participants. The study started on 2025-10-02. Estimated completion is 2027-04.
What conditions does trial NCT07158814 study?
This clinical trial studies the following conditions: Fever, Adverse Event Following Immunisation.
What interventions are being tested in trial NCT07158814?
The interventions under investigation include: Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody (DRUG).
Who is sponsoring clinical trial NCT07158814?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07158814 being conducted?
This trial has 6 study locations across California, Georgia, New York, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fever
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07158814's enrollment target sits among peer trials
524 5th of 18 higher than 14 of 18 other Fever trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fever 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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