Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Respiratory Tract Infections and Respiratory Syncytial Viruses, sponsored by Janssen Vaccines & Prevention B.V..
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with study vaccine. Solicited local AEs were precisely defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness.
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 |
What the finished NCT03303625 record still lists
NCT03303625 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 2,771-participant average among 15 other Respiratory Tract Infections trials with a reported enrollment target (98% lower).
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 lists 7 locations in 2 states (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.
Learn More About Clinical Trials
Similar trials for Respiratory Tract Infections
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 NCT03303625's enrollment target sits among peer trials
48 15th of 15 higher than 1 of 15 other Respiratory Tract Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Respiratory Tract Infections 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
-
Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep
COMPLETED · Phase 1
-
Comparison of Nasopharyngeal Swab v. Nasopharyngeal Saline Wash or Saliva Collection in Testing for Respiratory Viruses
RECRUITING · NA
-
How OMT Benefits Newly Diagnosed Patients With Respiratory Illness When Given Alongside Other Standard Care.
RECRUITING · NA
-
An Adjunct Test Distinguishing Bacterial From Viral Etiology Improves Resource Utilization and Efficiency in the ED.
RECRUITING · NA
-
Beetroot Juice NO Cold Study
RECRUITING · Phase 2
-
Dose Finding Study to Determine if BEZ235 Alone or in Combination With RAD001 Decreases the Incidence of Respiratory Tract Infections in the Elderly
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01765777 · 48 participants · NA
Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients With Chronic Lower Back Pain
- NCT03073343 · 48 participants · NA
A Prospective, Randomized, Open Label Trial of Two Doses of Oral Betaine
- NCT03431064 · 48 participants
Lung Recruitment Maneuver as a Potential Predictor of Fluid Responsiveness in Mechanically Ventilated Pediatric Patients
- NCT03514602 · 48 participants · NA
Maternal Smoking Cessation and Pediatric Obesity Prevention
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI