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COMPLETED Phase 3

A Study of 3 Lots of an Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Adults Aged 60 Years and Above

NCT05059301 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to assess the lot-to-lot consistency in terms of immunogenicity and evaluate the safety and reactogenicity of 3 lots of the RSVPreF3 OA investigational vaccine administered as a single dose in adults ≥ 60 years of age (YOA).

Interventions

  • BIOLOGICAL RSVPreF3 OA investigational vaccine

Study Locations (19)

Quebec

  • GSK Investigational Site — Québec
  • GSK Investigational Site — Saint-Charles-Borromée
  • GSK Investigational Site — Sherbrooke

Other

  • GSK Investigational Site — Eskilstuna
  • GSK Investigational Site — Karlskrona
  • GSK Investigational Site — Uppsala

Florida

  • GSK Investigational Site — Brooksville
  • GSK Investigational Site — Immokalee

Connecticut

  • GSK Investigational Site — Waterbury

Georgia

  • GSK Investigational Site — Buford

Minnesota

  • GSK Investigational Site — Minneapolis

Mississippi

  • GSK Investigational Site — Petal

Nebraska

  • GSK Investigational Site — Omaha

Trial Details

FieldValue
Enrollment Target 770 participants
Start Date 2021-10-01
Est. Completion 2022-06-30
Phase Phase 3

Sponsor

GlaxoSmithKline

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05059301

The ClinicalTrials.gov registry entry for NCT05059301 describes a study currently listed as completed. 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 770 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 investigational 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: NCT05059301 reports 19 study locations spanning 14 distinct geographic areas — top geographies include Quebec, Other, 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 NCT05059301 about?

NCT05059301 is a clinical study titled "A Study of 3 Lots of an Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Adults Aged 60 Years and Above". The purpose of this study is to assess the lot-to-lot consistency in terms of immunogenicity and evaluate the safety and reactogenicity of 3 lots of the RSVPreF3 OA investigational vaccine administered as a single dose in adults ≥ 60 years of age (YOA).

What is the current status of trial NCT05059301?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 770 participants. The study started on 2021-10-01. Estimated completion is 2022-06-30.

What conditions does trial NCT05059301 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 NCT05059301?

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

Who is sponsoring clinical trial NCT05059301?

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 NCT05059301 being conducted?

This trial has 19 study locations across Connecticut, Florida, Georgia, Minnesota, Mississippi. 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