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NCT01385215 · ClinicalTrials.gov registry record · Early Phase 1
Strategies for Enhancing Mucosal Immunity to Influenza Vaccine
A Early Phase 1 study, sponsored by John Sundy.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 60
- Enrollment target
NCT01385215: Completed Early Phase 1 study, sponsored by John Sundy.
NCT01385215 is a Early Phase 1 study that has completed, run by John Sundy. The registered enrollment target is 60 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01385215, a Early Phase 1 study, has completed, sponsored by John Sundy.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and effectiveness of the influenza vaccine when administered nasally and intra-muscular (a "shot" of medicine given into a muscle). The investigators will measure the systemic (through out the body) and mucosal immune responses (how your body recognizes and defends itself against bacteria) to nasally administered influenza vaccine, and determine if nasal immunization results in immunity (your body's ability to avoid infections) within multiple mucosal compartments (ocular (eye), oral and reproductive), in comparison with intramuscular administration and placebo (inactive substance given in the same form as the active drug).
Primary Outcome
Assessments will include hemagglutination inhibition and antibody isotypes determination.
Interventions
- DRUG Fluzone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-04 |
| Est. Completion | 2011-06 |
| Phase | Early Phase 1 |
What the finished NCT01385215 record still lists
NCT01385215 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 1 intervention - of which Fluzone is the first listed.
NCT01385215 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01385215 about?
NCT01385215 is a clinical study titled "Strategies for Enhancing Mucosal Immunity to Influenza Vaccine". The purpose of this study is to determine the safety and effectiveness of the influenza vaccine when administered nasally and intra-muscular (a "shot" of medicine given into a muscle). The investigators will measure the systemic (through out the body) and mucosal immune responses (how your body reco...
What is the current status of trial NCT01385215?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 60 participants. The study started on 2011-04. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01385215?
The interventions under investigation include: Fluzone (DRUG).
Who is sponsoring clinical trial NCT01385215?
This trial is sponsored by John Sundy, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01385215's enrollment target sits among peer trials
60 403rd of 2000 higher than 1,564 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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