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ACTIVE NOT RECRUITING Phase 3

An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study

NCT06534892 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is: * To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose, * To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons (approximately 60 months) of a single dose of RSVPreF3 OA vaccine, * To give the opportunity to participants who received only placebo in the RSVOA=ADJ- 006 study, to receive a dose of the RSVPreF3 OA vaccine and collect additional safety information.

Interventions

  • BIOLOGICAL RSVPreF3 OA vaccine

Study Locations (20)

Florida

  • GSK Investigational Site — Doral
  • GSK Investigational Site — Fort Myers
  • GSK Investigational Site — Jacksonville
  • GSK Investigational Site — Lake City
  • GSK Investigational Site — Melbourne
  • GSK Investigational Site — Miami
  • GSK Investigational Site — Orlando
  • GSK Investigational Site — Pinellas Park
  • GSK Investigational Site — The Villages
  • GSK Investigational Site — West Palm Beach

Alabama

  • GSK Investigational Site — Birmingham
  • GSK Investigational Site — Birmingham
  • GSK Investigational Site — Huntsville

Arizona

  • GSK Investigational Site — Phoenix
  • GSK Investigational Site — Tucson

Georgia

  • GSK Investigational Site — Atlanta
  • GSK Investigational Site — Savannah

California

  • GSK Investigational Site — Cerritos

Illinois

  • GSK Investigational Site — Chicago

Indiana

  • GSK Investigational Site — Evansville

Trial Details

FieldValue
Enrollment Target 10,212 participants
Start Date 2024-08-01
Est. Completion 2026-09-30
Phase Phase 3

Sponsor

GlaxoSmithKline

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06534892

The ClinicalTrials.gov registry entry for NCT06534892 describes a study currently listed as active not recruiting. It is categorized as Phase 3, 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 10,212 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 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 Respiratory Syncytial Virus Infections appearing as the primary indexed condition, and to 1 intervention — of which RSVPreF3 OA vaccine 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: NCT06534892 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, Alabama, Arizona. 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 NCT06534892 about?

NCT06534892 is a clinical study titled "An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study". The purpose of this study is: * To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose, * To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons (approximately 60 months) of a single dose of RSVPreF3 OA vaccine, * To give the ...

What is the current status of trial NCT06534892?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 10,212 participants. The study started on 2024-08-01. Estimated completion is 2026-09-30.

What conditions does trial NCT06534892 study?

This clinical trial studies the following conditions: Respiratory Syncytial Virus Infections. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06534892?

The interventions under investigation include: RSVPreF3 OA vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06534892?

This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06534892 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial