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NCT01014806 · ClinicalTrials.gov registry record · Phase 2

Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine in Older Adults

A Phase 2 study, sponsored by Novavax.

Completed
Registry status
Phase 2
Development phase
467
Enrollment target

NCT01014806 is a Phase 2 study that has completed, run by Novavax. The registered enrollment target is 467 participants.

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The verdict

NCT01014806, a Phase 2 study, has completed, sponsored by Novavax.

COMPLETED
Registry status
Phase 2
Development phase
467 participants
Enrollment target

Study Summary

* To assess the tolerability and safety of a single injection of Influenza VLP Vaccine when administered intramuscularly (IM) at 15 µg and 60 µg HA per each strain. * To assess the immunogenicity of Influenza VLP Vaccine administered at 15 µg and 60 µg HA per strain as measured by hemagglutination inhibition (HAI) antibody titers to each of the component viral strains \[A/Brisbane/59/2007 (H1N1); A/Brisbane/10/2007 (H3N2) and B/Brisbane/60/2008\].

Interventions

  • BIOLOGICAL TIV
  • BIOLOGICAL Influenza VLP Vaccine

Trial Details

FieldValue
Enrollment Target 467 participants
Start Date 2009-11
Est. Completion 2010-05
Phase Phase 2

Sponsor

Novavax

31 total trials

What the Registry Record Tells You About NCT01014806

The ClinicalTrials.gov registry entry for NCT01014806 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 467 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novavax, which has 31 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which TIV is the first listed.

NCT01014806 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01014806 about?

NCT01014806 is a clinical study titled "Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine in Older Adults". * To assess the tolerability and safety of a single injection of Influenza VLP Vaccine when administered intramuscularly (IM) at 15 µg and 60 µg HA per each strain. * To assess the immunogenicity of Influenza VLP Vaccine administered at 15 µg and 60 µg HA per strain as measured by hemagglutination i...

What is the current status of trial NCT01014806?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 467 participants. The study started on 2009-11. Estimated completion is 2010-05.

What interventions are being tested in trial NCT01014806?

The interventions under investigation include: TIV (BIOLOGICAL), Influenza VLP Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT01014806?

This trial is sponsored by Novavax, which has 31 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.