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NCT01023776 · ClinicalTrials.gov registry record · Phase 4
Infectivity, Replication & Immunogenicity of Live nH1N1 Vaccine
A Phase 4 study, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT01023776: Completed Phase 4 study, sponsored by University of Rochester.
NCT01023776 is a Phase 4 study that has completed, run by University of Rochester. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01023776, a Phase 4 study, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of the study is to determine the amount of live virus that can be recovered from the nose of people who are vaccinated with the licensed live vaccine against H1N1, and to describe the immune response to vaccination.
Primary Outcome
number of participants who shed virus above the limit of detection at any timepoint after vaccine. The limit of detection is 0.5 tissue culture infectious doses per mL of nasal wash.
Interventions
- BIOLOGICAL A/California/07/09 live monovalent H1N1 vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2009-11 |
| Est. Completion | 2010-07 |
| Phase | Phase 4 |
What the finished NCT01023776 record still lists
NCT01023776 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which A/California/07/09 live monovalent H1N1 vaccine is the first listed.
NCT01023776 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01023776 about?
NCT01023776 is a clinical study titled "Infectivity, Replication & Immunogenicity of Live nH1N1 Vaccine". The purpose of the study is to determine the amount of live virus that can be recovered from the nose of people who are vaccinated with the licensed live vaccine against H1N1, and to describe the immune response to vaccination.
What is the current status of trial NCT01023776?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2009-11. Estimated completion is 2010-07.
What interventions are being tested in trial NCT01023776?
The interventions under investigation include: A/California/07/09 live monovalent H1N1 vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01023776?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01023776's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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