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NCT00754455 · ClinicalTrials.gov registry record · Phase 2
Evaluate the Safety and Immunogenicity of a Seasonal Influenza VLP Vaccine (Recombinant) in Healthy Adults
A Phase 2 study, sponsored by Novavax.
- Completed
- Registry status
- Phase 2
- Development phase
- 317
- Enrollment target
NCT00754455 is a Phase 2 study that has completed, run by Novavax. The registered enrollment target is 317 participants.
The verdict
NCT00754455, a Phase 2 study, has completed, sponsored by Novavax.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 317 participants
- Enrollment target
Study Summary
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).
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Influenza VLP Vaccine (recombinant)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 317 participants |
| Start Date | 2008-09 |
| Est. Completion | 2009-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00754455
The ClinicalTrials.gov registry entry for NCT00754455 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 317 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 Placebo is the first listed.
NCT00754455 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00754455 about?
NCT00754455 is a clinical study titled "Evaluate the Safety and Immunogenicity of a Seasonal Influenza VLP Vaccine (Recombinant) in Healthy Adults". 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 asses...
What is the current status of trial NCT00754455?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 317 participants. The study started on 2008-09. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00754455?
The interventions under investigation include: Placebo (BIOLOGICAL), Influenza VLP Vaccine (recombinant) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00754455?
This trial is sponsored by Novavax, which has 31 total clinical trials registered on ClinicalTrials.gov.
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