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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: Completed Phase 2 study, sponsored by Novavax.

NCT01014806 is a Phase 2 study that has completed, run by Novavax. The registered enrollment target is 467 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (251% higher). According to ClinicalTrials.gov, the official US trial registry.

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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
Novavax

31 total trials

What the finished NCT01014806 record still lists

NCT01014806 is an interventional study that assigns participants to a tested intervention. The registered 467 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (251% higher).

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

NCT01014806 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01014806's enrollment target sits among peer trials

467 80th of 2000 higher than 1,921 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 NCT01014806, the US trial registry maintained by the National Library of Medicine. NCT01014806 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.