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NCT00921947 · ClinicalTrials.gov registry record · Phase 1
Comparative Safety and Immunogenicity of 1.0 µg Intramuscular (i.m.) and 2.0 µg Subcutaneous (s.c.) Dosing With VAX102 (M2e-flagellin) Universal Influenza Vaccine in Healthy Adults
A Phase 1 study, sponsored by VaxInnate Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT00921947 is a Phase 1 study that has completed, run by VaxInnate Corporation. The registered enrollment target is 60 participants.
The verdict
NCT00921947, a Phase 1 study, has completed, sponsored by VaxInnate Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
1. To assess the safety, reactogenicity, tolerability, and adverse events (AEs) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. in a healthy adult population. 2. To assess the immunogenicity (anti-M2e serum antibody concentration) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. as measured by an enzyme-linked immunosorbent assay (ELISA) in a healthy adult population.
Interventions
- BIOLOGICAL VAX102
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2009-06 |
| Est. Completion | 2009-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00921947
The ClinicalTrials.gov registry entry for NCT00921947 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VaxInnate Corporation, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which VAX102 is the first listed.
NCT00921947 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00921947 about?
NCT00921947 is a clinical study titled "Comparative Safety and Immunogenicity of 1.0 µg Intramuscular (i.m.) and 2.0 µg Subcutaneous (s.c.) Dosing With VAX102 (M2e-flagellin) Universal Influenza Vaccine in Healthy Adults". 1. To assess the safety, reactogenicity, tolerability, and adverse events (AEs) of the VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered i.m., or the 2.0 µg dose level delivered s.c. in a healthy adult population. 2. To assess the immunogenicity (anti-M2e ser...
What is the current status of trial NCT00921947?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2009-06. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00921947?
The interventions under investigation include: VAX102 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00921947?
This trial is sponsored by VaxInnate Corporation, which has 9 total clinical trials registered on ClinicalTrials.gov.
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