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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: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (427% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Incidence is reported for solicited events for 7 days after the first injection. For all Groups the collection period for solicited adverse events following the first injection Day 0 to Day 7.
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 |
What the finished NCT01676402 record still lists
NCT01676402 is an interventional study that assigns participants to a tested intervention. The registered 316 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (427% higher).
The record links to 0 conditions, and to 2 interventions - of which TIV is the first listed.
NCT01676402 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01676402's enrollment target sits among peer trials
316 117th of 2000 higher than 1,884 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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