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NCT05559476 · ClinicalTrials.gov registry record · Phase 3

A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 65 Years and Above

A Phase 3 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
1,029
Enrollment target

NCT05559476: Completed Phase 3 study, sponsored by GlaxoSmithKline.

NCT05559476 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,029 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05559476, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
1,029 participants
Enrollment target

Study Summary

The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when co-administered with the high dose quadrivalent influenza (FLU HD) vaccine in adults aged 65 years and above compared to separate administration of the vaccines.

Primary Outcome

RSV-A neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60).

Interventions

  • BIOLOGICAL RSVPreF3 OA investigational vaccine
  • BIOLOGICAL FLU HD vaccine

Trial Details

FieldValue
Enrollment Target 1,029 participants
Start Date 2022-10-20
Est. Completion 2023-08-15
Phase Phase 3
GlaxoSmithKline

1,345 total trials

What the finished NCT05559476 record still lists

NCT05559476 is an interventional study that assigns participants to a tested intervention. Its 1,029 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% higher).

The record links to 0 conditions, and to 2 interventions - of which RSVPreF3 OA investigational vaccine is the first listed.

NCT05559476 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05559476 about?

NCT05559476 is a clinical study titled "A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 65 Years and Above". The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the RSVPreF3 OA investigational vaccine when co-administered with the high dose quadrivalent influenza (FLU HD) vaccine in adults aged 65 years and above compared to separate administration of the vaccines.

What is the current status of trial NCT05559476?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,029 participants. The study started on 2022-10-20. Estimated completion is 2023-08-15.

What interventions are being tested in trial NCT05559476?

The interventions under investigation include: RSVPreF3 OA investigational vaccine (BIOLOGICAL), FLU HD vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT05559476?

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

How this trial's enrollment target compares

Where NCT05559476's enrollment target sits among peer trials

1,029 288th of 2000 higher than 1,713 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT05559476, the US trial registry maintained by the National Library of Medicine. NCT05559476 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.