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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: Completed Phase 2 study, sponsored by Novavax.
NCT00754455 is a Phase 2 study that has completed, run by Novavax. The registered enrollment target is 317 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (138% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00754455 record still lists
NCT00754455 is an interventional study that assigns participants to a tested intervention. The registered 317 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 (138% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00754455 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00754455's enrollment target sits among peer trials
317 155th of 2000 higher than 1,846 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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