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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: Completed Phase 1 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required non-elective in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the subject or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.
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 |
What the finished NCT01498718 record still lists
NCT01498718 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01498718's enrollment target sits among peer trials
131 96th of 156 higher than 61 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza 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.
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