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NCT01248208 · ClinicalTrials.gov registry record · Phase 1
FluMist in Egg Allergic Patients
A Phase 1 study, sponsored by Walter Reed Army Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT01248208 is a Phase 1 study that has completed, run by Walter Reed Army Medical Center. The registered enrollment target is 17 participants.
The verdict
NCT01248208, a Phase 1 study, has completed, sponsored by Walter Reed Army Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
With the growing public health concerns of seasonal influenza and H1N1 in the United States, the primary means by which this can be addressed is with prevention, namely, vaccination against the influenza virus. The only individuals not able to receive this vaccination in the primary care provider's office are those patients with egg allergies and, in rare circumstances, individuals with allergies to other components of the vaccine. Current guidelines allow for the administration of the influenza vaccine to patients with egg allergy using vaccines with low egg protein (ovalbumin) content or by using skin testing followed by a 5-dose desensitization protocol. Since this is impractical to perform in the primary care office and cumbersome for allergists, many egg-allergic patients simply do not receive the influenza vaccine, leaving them more vulnerable to the disease and more likely to become a source of contagion. Several studies have suggested that influenza vaccination using a 1-2 dose protocol may be safe. This fact is due in large part to the low ovalbumin (egg protein) content in modern influenza vaccines. All studies of influenza vaccination in egg-allergic patients have been done using intramuscular trivalent inactivated influenza vaccine (TIV). However, the trivalent live-attenuated, cold-adapted influenza vaccine (LAIV), which is delivered intranasally, has a lower published ovalbumin content than the injectable vaccines, suggesting that it may also be well-tolerated by egg-allergic patients. According to several studies, LAIV may be more efficacious than TIV in children. It is the goal of the investigators to evaluate the safety of immunizing egg-allergic individuals with the LAIV.
Interventions
- BIOLOGICAL FluMist intranasal influenza vaccine
- BIOLOGICAL Intramuscular influenza injection ("flu shot")
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01248208
The ClinicalTrials.gov registry entry for NCT01248208 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Walter Reed Army Medical Center, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which FluMist intranasal influenza vaccine is the first listed.
NCT01248208 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01248208 about?
NCT01248208 is a clinical study titled "FluMist in Egg Allergic Patients". With the growing public health concerns of seasonal influenza and H1N1 in the United States, the primary means by which this can be addressed is with prevention, namely, vaccination against the influenza virus. The only individuals not able to receive this vaccination in the primary care provider's ...
What is the current status of trial NCT01248208?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2010-09. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01248208?
The interventions under investigation include: FluMist intranasal influenza vaccine (BIOLOGICAL), Intramuscular influenza injection ("flu shot") (BIOLOGICAL).
Who is sponsoring clinical trial NCT01248208?
This trial is sponsored by Walter Reed Army Medical Center, which has 24 total clinical trials registered on ClinicalTrials.gov.
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