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NCT06374394 · ClinicalTrials.gov registry record · Phase 3

A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a COVID-19 mRNA Vaccine in Adults Aged 50 Years and Above

A Phase 3 study of Respiratory Syncytial Virus Infections, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
841
Enrollment target
20
Study locations

NCT06374394: Completed Phase 3 study of Respiratory Syncytial Virus Infections, sponsored by GlaxoSmithKline.

NCT06374394 is a Phase 3 study of Respiratory Syncytial Virus Infections that has completed, run by GlaxoSmithKline. The registered enrollment target is 841 participants, below the 1,051-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (20% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06374394, a Phase 3 study of Respiratory Syncytial Virus Infections, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
841 participants
Enrollment target
20
Study locations

Study Summary

This study is assessing the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when it is co-administered with a COVID-19 messenger ribonucleic acid (mRNA) vaccine (Omicron XBB.1.5), compared to administration of the vaccines separately in adults aged 50 years and above.

Primary Outcome

RSV-A neutralizing titers were provided as group GMTs and expressed as estimated dilution 60 (ED60) titers. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model adjusted for baseline differences (in the pre-dose titers) includes treatment group and age category (age at vaccination: 50-59, 60-69 or ≥70 years) as fixed effects, and the pre-dose log10-transformed titers as a covariate.

Conditions Studied

Respiratory Syncytial Virus Infections

Interventions

  • BIOLOGICAL RSVPreF3 OA investigational vaccine
  • BIOLOGICAL COVID-19 mRNA vaccine

Study Locations (20)

Other

  • GSK Investigational Site - Antwerp
  • GSK Investigational Site - Edegem
  • GSK Investigational Site - Ghent
  • GSK Investigational Site - Kluisbergen
  • GSK Investigational Site - Mechelen
  • GSK Investigational Site - Breda
  • GSK Investigational Site - Enschede
  • GSK Investigational Site - Utrecht
  • GSK Investigational Site - Zutphen
  • GSK Investigational Site - A Coruña
  • GSK Investigational Site - Barcelona
  • GSK Investigational Site - Barcelona

Florida

  • GSK Investigational Site - Coral Gables

Georgia

  • GSK Investigational Site - Savannah

Indiana

  • GSK Investigational Site - Evansville

Nebraska

  • GSK Investigational Site - Omaha

New York

  • GSK Investigational Site - Rochester

North Carolina

  • GSK Investigational Site - Winston-Salem

South Carolina

  • GSK Investigational Site - North Charleston

Trial Details

FieldValue
Enrollment Target 841 participants
Start Date 2024-04-29
Est. Completion 2025-03-31
Phase Phase 3
GlaxoSmithKline

1,345 total trials

What the finished NCT06374394 record still lists

NCT06374394 is an interventional study that assigns participants to a tested intervention. The registered 841 participants enrollment target is mid-sized for trials with a published cap, below the 1,051-participant average among 21 other Respiratory Syncytial Virus Infections trials with a reported enrollment target (20% lower).

The record links to 1 condition, with Respiratory Syncytial Virus Infections appearing as the primary indexed condition, and to 2 interventions - of which RSVPreF3 OA investigational vaccine is the first listed.

NCT06374394 names 20 study sites across 9 states, led by Other, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT06374394 about?

NCT06374394 is a clinical study titled "A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a COVID-19 mRNA Vaccine in Adults Aged 50 Years and Above". This study is assessing the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when it is co-administered with a COVID-19 messenger ribonucleic acid (mRNA) vaccine (Omicron XBB.1.5), compared to administration of the vaccines separately in adults aged 50 years and a...

What is the current status of trial NCT06374394?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 841 participants. The study started on 2024-04-29. Estimated completion is 2025-03-31.

What conditions does trial NCT06374394 study?

This clinical trial studies the following conditions: Respiratory Syncytial Virus Infections.

What interventions are being tested in trial NCT06374394?

The interventions under investigation include: RSVPreF3 OA investigational vaccine (BIOLOGICAL), COVID-19 mRNA vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT06374394?

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

Where is trial NCT06374394 being conducted?

This trial has 20 study locations across Florida, Georgia, Indiana, Nebraska, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Respiratory Syncytial Virus Infections

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 NCT06374394's enrollment target sits among peer trials

841 6th of 21 higher than 16 of 21 other Respiratory Syncytial Virus Infections trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Respiratory Syncytial Virus Infections 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 NCT06374394, the US trial registry maintained by the National Library of Medicine. NCT06374394 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.