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NCT01111162 · ClinicalTrials.gov registry record · Phase 4
H1N1 Influenza Vaccine Immunogenicity in HIV-1 Infected Patients
A Phase 4 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 4
- Development phase
- 120
- Enrollment target
NCT01111162: Completed Phase 4 study, sponsored by University of Pennsylvania.
NCT01111162 is a Phase 4 study that has completed, run by University of Pennsylvania. The registered enrollment target is 120 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01111162, a Phase 4 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 120 participants
- Enrollment target
Study Summary
The overall goal of this study is to study influenza vaccine responses in HIV infected individuals. Immunocompromised individuals require special protection from influenza, but may not respond appropriately to the standard killed vaccine. Patients who receive the H1N1 flu vaccine as part of their standard of care will be asked to donate blood samples for immunologic studies. These studies will determine whether participants were able to produce the appropriate antibodies to the vaccine and possibly identify predictors of vaccine responsiveness. Our hypothesis is that vaccine responsiveness to the new H1N1 influenza vaccine will be compromised in HIV infected patients.
Primary Outcome
To assess the safety of inactivated swine-origin H1N1 influenza vaccine in HIV-1 infected individuals (received as part of standard of care). Safety was assessed via 1. Adverse Events of Grade 3 or higher of abnormal laboratory values, signs and symptoms or diagnoses. 2. Solicited local AEs, including pain, tenderness, redness, and swelling post each vaccination. Solicited systemic AEs, including feverishness, malaise, body aches (exclusive of the injection site), nausea, and headache post eac
Interventions
- BIOLOGICAL H1N1 vaccination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2009-12 |
| Est. Completion | 2010-12 |
| Phase | Phase 4 |
What the finished NCT01111162 record still lists
NCT01111162 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which H1N1 vaccination is the first listed.
NCT01111162 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01111162 about?
NCT01111162 is a clinical study titled "H1N1 Influenza Vaccine Immunogenicity in HIV-1 Infected Patients". The overall goal of this study is to study influenza vaccine responses in HIV infected individuals. Immunocompromised individuals require special protection from influenza, but may not respond appropriately to the standard killed vaccine. Patients who receive the H1N1 flu vaccine as part of their st...
What is the current status of trial NCT01111162?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2009-12. Estimated completion is 2010-12.
What interventions are being tested in trial NCT01111162?
The interventions under investigation include: H1N1 vaccination (BIOLOGICAL).
Who is sponsoring clinical trial NCT01111162?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01111162's enrollment target sits among peer trials
120 673rd of 2000 higher than 1,289 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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