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NCT01498718 · ClinicalTrials.gov registry record · Phase 1
Seasonal Influenza DNA Vaccine Prime With Trivalent Inactivated Vaccine (TIV) Boost Compared to TIV Alone
A Phase 1 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 131
- Enrollment target
- 4
- Study locations
NCT01498718 is a Phase 1 study of Influenza that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 131 participants, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT01498718, a Phase 1 study of Influenza, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 131 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a Phase 1b, randomized study in healthy younger (18-50 years) and older (51-70 years) adults to evaluate the safety, tolerability, and immunogenicity of a prime-boost vaccination regimen with an investigational plasmid DNA vaccine directed towards the 2011/12 influenza vaccine strains as a prime followed 36 weeks later by the 2012/13 influenza trivalent inactivated vaccine (TIV) as the booster injection, as compared to placebo prime followed by the 2012/13 seasonal TIV. The hypothesis is that the DNA vaccine will be safe for human administration and that the DNA vaccine prime-TIV boost schedule will elicit a better immune response than the seasonal TIV alone.
Conditions Studied
Interventions
- BIOLOGICAL DNA vaccine
- BIOLOGICAL TIV
Study Locations (4)
Georgia
- Hope Clinic of the Emory Vaccine Center - Decatur
Missouri
- St. Louis University - Doisy Research Center - St Louis
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01498718
The ClinicalTrials.gov registry entry for NCT01498718 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which DNA vaccine is the first listed.
NCT01498718 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Georgia, Missouri, Ohio.
Frequently Asked Questions
What is clinical trial NCT01498718 about?
NCT01498718 is a clinical study titled "Seasonal Influenza DNA Vaccine Prime With Trivalent Inactivated Vaccine (TIV) Boost Compared to TIV Alone". This is a Phase 1b, randomized study in healthy younger (18-50 years) and older (51-70 years) adults to evaluate the safety, tolerability, and immunogenicity of a prime-boost vaccination regimen with an investigational plasmid DNA vaccine directed towards the 2011/12 influenza vaccine strains as a p...
What is the current status of trial NCT01498718?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 131 participants. The study started on 2011-12. Estimated completion is 2013-04.
What conditions does trial NCT01498718 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT01498718?
The interventions under investigation include: DNA vaccine (BIOLOGICAL), TIV (BIOLOGICAL).
Who is sponsoring clinical trial NCT01498718?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01498718 being conducted?
This trial has 4 study locations across Georgia, Missouri, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.