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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 Sep 18, 2026, 8:47 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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
Oct 31, 2009
Primary completion
Apr 30, 2010
Completion
Apr 30, 2010
Last update posted
Jul 17, 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 17, 2013 · Synced Sep 18, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01014806 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →