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A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults
NCT04453202 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to explore the dose-response relationship of immune responses induced by different dose levels of an Ad26.RSV.preF based vaccine (Cohort 1) and to assess the safety and reactogenicity of different dose levels of the Ad26.RSV.preF-based vaccine (Cohorts 2 and 3).
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL RSV Vaccine
Study Locations (9)
Nebraska
- Meridian Clinical Research, LLC — Norfolk
- Meridian Clinical Research - Omaha — Omaha
California
- Optimal Research — San Diego
Florida
- Clinical Research of South Florida, an AMR Company — Coral Gables
Kansas
- Heartland Research Associates, an AMR Company — El Dorado
Maryland
- Optimal Research — Rockville
Missouri
- The Center for Pharmaceutical Research (CPR) — Kansas City
Oklahoma
- Tekton Research Inc. — Yukon
Tennessee
- AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company — Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 459 participants |
| Start Date | 2020-07-16 |
| Est. Completion | 2021-04-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04453202
The ClinicalTrials.gov registry entry for NCT04453202 describes a study currently listed as completed. It is categorized as Phase 2, 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 459 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 1 condition, with Healthy appearing as the primary indexed condition, and to 2 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: NCT04453202 reports 9 study locations spanning 8 distinct geographic areas — top geographies include Nebraska, California, Florida. 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 NCT04453202 about?
NCT04453202 is a clinical study titled "A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults". The purpose of this study is to explore the dose-response relationship of immune responses induced by different dose levels of an Ad26.RSV.preF based vaccine (Cohort 1) and to assess the safety and reactogenicity of different dose levels of the Ad26.RSV.preF-based vaccine (Cohorts 2 and 3).
What is the current status of trial NCT04453202?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 459 participants. The study started on 2020-07-16. Estimated completion is 2021-04-09.
What conditions does trial NCT04453202 study?
This clinical trial studies the following conditions: Healthy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04453202?
The interventions under investigation include: Placebo (OTHER), RSV Vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04453202?
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 NCT04453202 being conducted?
This trial has 9 study locations across California, Florida, Kansas, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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