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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).

Primary Outcome

Geometric mean antibody titers (ELISA units per liter \[EU/L\]) to RSV preF protein using preF ELISA at 14 days after vaccination were reported.

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
Janssen Vaccines & Prevention B.V.

34 total trials

What the finished NCT04453202 record still lists

NCT04453202 is an interventional study that assigns participants to a tested intervention. The registered 459 participants enrollment target is mid-sized for trials with a published cap, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (29% lower).

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 lists 9 locations in 8 states (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.

Learn More About Clinical Trials

Similar trials for Healthy

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 NCT04453202's enrollment target sits among peer trials

459 53rd of 1090 higher than 1,038 of 1,090 other Healthy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Healthy 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

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Related registry views

Source: ClinicalTrials.gov NCT04453202, the US trial registry maintained by the National Library of Medicine. NCT04453202 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.