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NCT04453202 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults

A Phase 2 study of Healthy, sponsored by Janssen Vaccines & Prevention B.V..

Completed
Registry status
Phase 2
Development phase
459
Enrollment target
9
Study locations

NCT04453202: Completed Phase 2 study of Healthy, sponsored by Janssen Vaccines & Prevention B.V..

NCT04453202 is a Phase 2 study of Healthy that has completed, run by Janssen Vaccines & Prevention B.V.. The registered enrollment target is 459 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (29% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04453202, a Phase 2 study of Healthy, has completed, sponsored by Janssen Vaccines & Prevention B.V..

COMPLETED
Registry status
Phase 2
Development phase
459 participants
Enrollment target
9
Study locations

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

Healthy

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

FieldValue
Enrollment Target 459 participants
Start Date 2020-07-16
Est. Completion 2021-04-09
Phase Phase 2

Sponsor

Janssen Vaccines & Prevention B.V.

34 total trials

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What the Registry Record Tells You About NCT04453202

The ClinicalTrials.gov registry entry for NCT04453202 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 459 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (29% lower). The listed sponsor is Janssen Vaccines & Prevention B.V., which has 34 total studies on file at ClinicalTrials.gov.

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.

NCT04453202 reports 9 study locations spanning 8 distinct geographic areas - top geographies include Nebraska, California, Florida.

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.

What interventions are being tested in trial NCT04453202?

The interventions under investigation include: Placebo (OTHER), RSV Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT04453202?

This trial is sponsored by Janssen Vaccines & Prevention B.V., which has 34 total clinical trials registered on ClinicalTrials.gov.

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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Read our methodology - how this data is sourced, computed, and verified.
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.