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NCT04576702 · ClinicalTrials.gov registry record · Phase 2

Safety and Immunogenicity of an MF59-Adjuvanted Influenza Vaccine in Older Adults

A Phase 2 study, sponsored by Seqirus.

Completed
Registry status
Phase 2
Development phase
471
Enrollment target

NCT04576702 is a Phase 2 study that has completed, run by Seqirus. The registered enrollment target is 471 participants.

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The verdict

NCT04576702, a Phase 2 study, has completed, sponsored by Seqirus.

COMPLETED
Registry status
Phase 2
Development phase
471 participants
Enrollment target

Study Summary

This Phase 2, randomized, observer-blind, active controlled clinical study is evaluating the safety and immunogenicity of the investigational MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 480 subjects are to be randomized into 1 of 4 possible treatment groups (investigational Influenza Vaccine or licensed Quadrivalent Influenza Vaccine comparators) at 120 participants per group. Every participant will receive an influenza vaccine injection on Day 1 and will be followed up for approximately 6 months following injection. The primary immunogenicity analysis is based on Day 29 serum.

Interventions

  • BIOLOGICAL Investigational aIIV4c
  • BIOLOGICAL IIV4c
  • BIOLOGICAL aIIV4
  • BIOLOGICAL RIV4

Trial Details

FieldValue
Enrollment Target 471 participants
Start Date 2020-10-08
Est. Completion 2021-05-24
Phase Phase 2

Sponsor

Seqirus

25 total trials

What the Registry Record Tells You About NCT04576702

The ClinicalTrials.gov registry entry for NCT04576702 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 471 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seqirus, which has 25 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Investigational aIIV4c is the first listed.

NCT04576702 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04576702 about?

NCT04576702 is a clinical study titled "Safety and Immunogenicity of an MF59-Adjuvanted Influenza Vaccine in Older Adults". This Phase 2, randomized, observer-blind, active controlled clinical study is evaluating the safety and immunogenicity of the investigational MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 480 subjects are to be randomized into 1 of 4 possible treatment groups (inv...

What is the current status of trial NCT04576702?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 471 participants. The study started on 2020-10-08. Estimated completion is 2021-05-24.

What interventions are being tested in trial NCT04576702?

The interventions under investigation include: Investigational aIIV4c (BIOLOGICAL), IIV4c (BIOLOGICAL), aIIV4 (BIOLOGICAL), RIV4 (BIOLOGICAL).

Who is sponsoring clinical trial NCT04576702?

This trial is sponsored by Seqirus, which has 25 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.