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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
NCT03303625 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Vaccines & Prevention B.V., which has 9 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03303625 reports 7 study locations spanning 2 distinct geographic areas — top geographies include Other, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03303625?
This trial is sponsored by Janssen Vaccines & Prevention B.V., which has 9 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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