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NCT04657198 · ClinicalTrials.gov registry record · Phase 2

Extension Study to Evaluate the Safety and Immunogenicity of a Revaccination Dose of the RSVPreF3 OA Investigational Vaccine in Adults 60 Years and Older Who Participated in the RSV OA=ADJ-002 Study

A Phase 2 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
126
Enrollment target

NCT04657198 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 126 participants.

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The verdict

NCT04657198, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
126 participants
Enrollment target

Study Summary

Nine different formulations of the RSVPreF3 OA investigational vaccine were tested in the parent study (NCT03814590). Based on safety and immunogenicity data from the parent study, RSVPreF3 OA investigational vaccine will be evaluated in further clinical research. Participants in selected groups will be invited to participate in this extension study. All participants who will be enrolled in the current extension study will receive the RSV investigational vaccine approximately 18 months after they received their respective dose-2 in the parent study.

Interventions

  • BIOLOGICAL RSVPreF3 OA investigational vaccine (GSK3844766A)

Trial Details

FieldValue
Enrollment Target 126 participants
Start Date 2020-12-09
Est. Completion 2021-10-25
Phase Phase 2

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT04657198

The ClinicalTrials.gov registry entry for NCT04657198 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which RSVPreF3 OA investigational vaccine (GSK3844766A) is the first listed.

NCT04657198 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04657198 about?

NCT04657198 is a clinical study titled "Extension Study to Evaluate the Safety and Immunogenicity of a Revaccination Dose of the RSVPreF3 OA Investigational Vaccine in Adults 60 Years and Older Who Participated in the RSV OA=ADJ-002 Study". Nine different formulations of the RSVPreF3 OA investigational vaccine were tested in the parent study (NCT03814590). Based on safety and immunogenicity data from the parent study, RSVPreF3 OA investigational vaccine will be evaluated in further clinical research. Participants in selected groups wil...

What is the current status of trial NCT04657198?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 126 participants. The study started on 2020-12-09. Estimated completion is 2021-10-25.

What interventions are being tested in trial NCT04657198?

The interventions under investigation include: RSVPreF3 OA investigational vaccine (GSK3844766A) (BIOLOGICAL).

Who is sponsoring clinical trial NCT04657198?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

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, or report a data error.