Evaluate the Safety and Immunogenicity of a Seasonal Influenza VLP Vaccine (Recombinant) in Healthy Adults
Public ClinicalTrials.gov record NCT00754455. 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.
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, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine (Recombinant) in Healthy Adults
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A Phase 2a Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine (recombinant) in Healthy Adults. Study Objectives: Primary: * To assess the tolerability and safety of Influenza VLP Vaccine * To assess the immunogenicity of Influenza VLP Vaccine as measured by hemagglutination inhibition (HAI) antibody titers to each of the three component viral strains Secondary: * To evaluate the cross-strain immunogenicity of Influenza VLP Vaccine as measured by hemagglutination inhibition (HAI) antibody titers against drifted strains * To quantify antibody against neuraminidase and hemagglutinin following administration of Influenza VLP Vaccine * To assess cell-mediated immune (CMI) responses to Influenza VLP Vaccine as quantified by interferon-gamma (IFNg) and Granzyme-B produced by peripheral blood mononuclear cells (PBMCs).
Study identification
- NCT ID
- NCT00754455
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 317 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 49 Years
- 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
- Aug 31, 2008
- Primary completion
- Feb 28, 2009
- Completion
- Feb 28, 2009
- Last update posted
- Jul 17, 2013
2008 – 2009
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University Clinical Research | Pembroke Pines | Florida | 33024 | — |
| The Center for Pharmacuetical Research | Kansas City | Missouri | 64114 | — |
| Omega Medical Research | Warwick | Rhode Island | 02886 | — |
| Benchmark Research | Austin | Texas | 78705 | — |
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 NCT00754455, 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 NCT00754455 live on ClinicalTrials.gov.