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NCT03303625 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Tolerability and Immunogenicity of an Investigational RSV Vaccine Candidate (Ad26.RSV.preF) in Adults 18 to 50 Years of Age, and RSV-seropositive Toddlers 12 to 24 Months of Age
A Phase 1 study of Respiratory Tract Infections and Respiratory Syncytial Viruses, sponsored by Janssen Vaccines & Prevention B.V..
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 7
- Study locations
NCT03303625 is a Phase 1 study of Respiratory Tract Infections and Respiratory Syncytial Viruses that has completed, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 48 participants, below the 2,771-participant average among 15 other Respiratory Tract Infections trials with a reported enrollment target (98% lower). The trial reports 7 study locations across 2 states.
The verdict
NCT03303625, a Phase 1 study of Respiratory Tract Infections and Respiratory Syncytial Viruses, has completed, sponsored by Janssen Vaccines & Prevention B.V..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study is to assess the safety and tolerability of an intramuscular regimen of two doses (1\*10\^11 viral particles \[vp\]) of an investigational respiratory syncytial virus (RSV) vaccine candidate (adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F protein \[pre-F\] \[Ad26.RSV.preF\]) in adults aged 18 to 50 years and RSV-seropositive toddlers aged 12 to 24 months.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Ad26.RSV.preF (1*10^11 vp)
- BIOLOGICAL Ad26.RSV.preF (5*10^10 vp)
Study Locations (7)
Other
- Järvenpään rokotetutkimusklinikka - Jarvenpaa
- University of Tampere/Vaccine Research Center - Tampere
- University of Tampere/Vaccine Research Center - Turku
- Royal Manchester Children's Hospital - Manchester
- Oxford Vaccine Group - Oxford
- University Hospital Southampton NHS Foundation Trust - Southampton
Kansas
- Heartland Research Associates, LLC - Newton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2017-11-29 |
| Est. Completion | 2020-04-21 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03303625
The ClinicalTrials.gov registry entry for NCT03303625 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,771-participant average among 15 other Respiratory Tract Infections trials with a reported enrollment target (98% lower). The listed sponsor is Janssen Vaccines & Prevention B.V., which has 34 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Respiratory Tract Infections appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03303625 reports 7 study locations spanning 2 distinct geographic areas - top geographies include Other, Kansas.
Frequently Asked Questions
What is clinical trial NCT03303625 about?
NCT03303625 is a clinical study titled "A Study to Evaluate the Safety, Tolerability and Immunogenicity of an Investigational RSV Vaccine Candidate (Ad26.RSV.preF) in Adults 18 to 50 Years of Age, and RSV-seropositive Toddlers 12 to 24 Months of Age". The purpose of this study is to assess the safety and tolerability of an intramuscular regimen of two doses (1\*10\^11 viral particles \[vp\]) of an investigational respiratory syncytial virus (RSV) vaccine candidate (adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabili...
What is the current status of trial NCT03303625?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2017-11-29. Estimated completion is 2020-04-21.
What conditions does trial NCT03303625 study?
This clinical trial studies the following conditions: Respiratory Tract Infections, Respiratory Syncytial Viruses.
What interventions are being tested in trial NCT03303625?
The interventions under investigation include: Placebo (DRUG), Ad26.RSV.preF (1*10^11 vp) (BIOLOGICAL), Ad26.RSV.preF (5*10^10 vp) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03303625?
This trial is sponsored by Janssen Vaccines & Prevention B.V., which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03303625 being conducted?
This trial has 7 study locations across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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