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NCT01685372 · ClinicalTrials.gov registry record · Phase 2
Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults
A Phase 2 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT01685372: Completed Phase 2 study, sponsored by University of Colorado, Denver.
NCT01685372 is a Phase 2 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01685372, a Phase 2 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether Fluzone High Dose increases the immune response to the influenza antigens contained in the vaccine compared to standard-dose Fluzone in immunocompromised children and young adults. Safety and efficacy data will also be collected.
Primary Outcome
Gathered data on influenza and influenza-like-illness during the influenza season for which the subject was vaccinated. Reported numbers of episodes of PCR-diagnosed influenza and rates of reported Influenza-Like-Illness (ILI) from Questionnaire #2 and also that were obtained from medical records. Data were categorized by the following: 1. Polymerase chain reaction (PCR)-proven diagnosis of influenza performed at Children's Hospital Colorado (CHC) 2. Diagnosis of influenza by non-PCR rapid-infl
Interventions
- BIOLOGICAL Fluzone
- BIOLOGICAL Fluzone High Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2012-09 |
| Est. Completion | 2017-09 |
| Phase | Phase 2 |
What the finished NCT01685372 record still lists
NCT01685372 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Fluzone is the first listed.
NCT01685372 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01685372 about?
NCT01685372 is a clinical study titled "Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults". The purpose of this study is to determine whether Fluzone High Dose increases the immune response to the influenza antigens contained in the vaccine compared to standard-dose Fluzone in immunocompromised children and young adults. Safety and efficacy data will also be collected.
What is the current status of trial NCT01685372?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2012-09. Estimated completion is 2017-09.
What interventions are being tested in trial NCT01685372?
The interventions under investigation include: Fluzone (BIOLOGICAL), Fluzone High Dose (BIOLOGICAL).
Who is sponsoring clinical trial NCT01685372?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01685372's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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