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NCT01676402 · ClinicalTrials.gov registry record · Phase 1
Seasonal Influenza HA DNA With Trivalent Inactivated Vaccine (TIV) Administered ID or IM in Healthy Adults 18-70 Years
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 316
- Enrollment target
NCT01676402 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 316 participants.
The verdict
NCT01676402, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 316 participants
- Enrollment target
Study Summary
This is a Phase Ib study in healthy adults (18-70 years) to evaluate the safety, tolerability, and immunogenicity of same season and sequential season vaccination schedules consisting of the 2012/2013 seasonal influenza DNA vaccine (HA DNA) and licensed trivalent influenza vaccine (TIV) administered intradermally (ID) or intramuscularly (IM). The hypothesis is that evaluation of these investigational schedules will inform development of novel influenza vaccine strategies that may offer improved and cross-protective immunity against antigenically diverse influenza strains.
Interventions
- BIOLOGICAL TIV
- BIOLOGICAL Seasonal Influenza DNA vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 316 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01676402
The ClinicalTrials.gov registry entry for NCT01676402 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 316 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 0 conditions, and to 2 interventions - of which TIV is the first listed.
NCT01676402 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01676402 about?
NCT01676402 is a clinical study titled "Seasonal Influenza HA DNA With Trivalent Inactivated Vaccine (TIV) Administered ID or IM in Healthy Adults 18-70 Years". This is a Phase Ib study in healthy adults (18-70 years) to evaluate the safety, tolerability, and immunogenicity of same season and sequential season vaccination schedules consisting of the 2012/2013 seasonal influenza DNA vaccine (HA DNA) and licensed trivalent influenza vaccine (TIV) administered...
What is the current status of trial NCT01676402?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 316 participants. The study started on 2012-08. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01676402?
The interventions under investigation include: TIV (BIOLOGICAL), Seasonal Influenza DNA vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01676402?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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