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NCT02566265 · ClinicalTrials.gov registry record · Phase 2

Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients

A Phase 2 study, sponsored by Yale University.

Completed
Registry status
Phase 2
Development phase
122
Enrollment target

NCT02566265: Completed Phase 2 study, sponsored by Yale University.

NCT02566265 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 122 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02566265, a Phase 2 study, has completed, sponsored by Yale University.

COMPLETED
Registry status
Phase 2
Development phase
122 participants
Enrollment target

Study Summary

The investigators' hypothesis is that the administration of Fluzone® High-Dose with booster to all patients with monoclonal gammopathies (irrespective of age) will lead to seroconversion rates exceeding 50% and more importantly, will reduce influenza-related morbidity, reduce interruptions in cancer therapy and may reduce disease progression at the end of the flu season

Primary Outcome

Any documented flu infection during the 2015-2016 flu season or evidence of disease progression.

Interventions

  • BIOLOGICAL Fluzone High Dose Vaccine
  • BIOLOGICAL Standard of care/Placebo

Trial Details

FieldValue
Enrollment Target 122 participants
Start Date 2015-09
Est. Completion 2018-06
Phase Phase 2
Yale University

1,492 total trials

What the finished NCT02566265 record still lists

NCT02566265 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which Fluzone High Dose Vaccine is the first listed.

NCT02566265 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02566265 about?

NCT02566265 is a clinical study titled "Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients". The investigators' hypothesis is that the administration of Fluzone® High-Dose with booster to all patients with monoclonal gammopathies (irrespective of age) will lead to seroconversion rates exceeding 50% and more importantly, will reduce influenza-related morbidity, reduce interruptions in cancer...

What is the current status of trial NCT02566265?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 122 participants. The study started on 2015-09. Estimated completion is 2018-06.

What interventions are being tested in trial NCT02566265?

The interventions under investigation include: Fluzone High Dose Vaccine (BIOLOGICAL), Standard of care/Placebo (BIOLOGICAL).

Who is sponsoring clinical trial NCT02566265?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02566265's enrollment target sits among peer trials

122 565th of 2000 higher than 1,434 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT02566265, the US trial registry maintained by the National Library of Medicine. NCT02566265 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.