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Completed Phase 2 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT01014806

Public ClinicalTrials.gov record NCT01014806. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 9, 2026, 8:28 AM EST

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Official title

A Phase 2a Randomized, Double-Blind, Active-Controlled Trial to Evaluate the Safety and Immunogenicity of a Trivalent Seasonal Influenza Virus-Like Particle (VLP) Vaccine (Recombinant) in Older Adults

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

* 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 \[A/Brisbane/59/2007 (H1N1); A/Brisbane/10/2007 (H3N2) and B/Brisbane/60/2008\].

Study identification

NCT ID
NCT01014806
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Novavax
Industry
Enrollment
467 participants

Conditions and interventions

Conditions

Interventions

Biological

Eligibility (public fields only)

Age range
60 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 2009 (Type not available)
Primary completion
May 2010 (Actual)
Completion
May 2010 (Actual)
Last update posted
Jul 18, 2013

2009 – 2010

United States locations

U.S. sites
6
U.S. states
5
U.S. cities
6
Facility City State ZIP Site status
Universtity Clinical Research Pembroke Pines Florida 33024 —
Mayo Clinic Rochester Minnesota 55905 —
Brown University Providence Rhode Island 02908 —
Coastal Carolina Research Center Mt. Pleasant South Carolina 29464 —
Research Across America Dallas Texas 75234 —
Clinical Trials of Texas, Inc. San Antonio Texas 78229 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01014806, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 18, 2013 · Synced Nov 9, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01014806 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →