Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01264601 · ClinicalTrials.gov registry record · NA
Safe Administration of Flu Vaccine to Egg Allergic Children
A NA study, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 31
- Enrollment target
NCT01264601 is a NA study that has completed, run by University of Michigan. The registered enrollment target is 31 participants.
The verdict
NCT01264601, a NA study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
Study Summary
Historically, providing influenza vaccination of egg allergic children and young adults (EAC) with a history of anaphylaxis to egg, or other severe symptoms of an allergic reaction to egg (e.g., severe hives, swelling, or asthma), has been contra-indicated, though vaccination of children with less severe egg allergy has been shown to be safe. Though many children with severe egg allergy, including anaphylaxis, have received past influenza vaccination anecdotally, very few data exist to show this procedure is safe. The investigators propose a double blind, placebo-controlled randomized, prospective multi-centered study to a) demonstrate seasonal trivalent influenza vaccine (TIV) can be safely given in a single dose (as opposed to through 2-step graded dosing of 10% then 90% of the vaccine dose) to EAC despite history of anaphylaxis or previous severe allergic reaction to egg; and b) provide further evidence that adverse outcomes are not related to ovalbumin (egg) content in TIV. Study participants must have a documented history of a severe egg allergy, substantiated by both a history of clinical reactivity AND either a positive skin test or ImmunoCAP/RAST test greater than 0.7 kUA/L. Participants will be randomized to receive either a 2-step graded challenge or a single dose given after a small placebo dose of saline (to mimic the graded challenge). If required, all participants will receive a booster vaccination as a single dose.
Interventions
- BIOLOGICAL Trivalent Influenza Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2010-10 |
| Est. Completion | 2012-08 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01264601
The ClinicalTrials.gov registry entry for NCT01264601 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Trivalent Influenza Vaccine is the first listed.
NCT01264601 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01264601 about?
NCT01264601 is a clinical study titled "Safe Administration of Flu Vaccine to Egg Allergic Children". Historically, providing influenza vaccination of egg allergic children and young adults (EAC) with a history of anaphylaxis to egg, or other severe symptoms of an allergic reaction to egg (e.g., severe hives, swelling, or asthma), has been contra-indicated, though vaccination of children with less s...
What is the current status of trial NCT01264601?
This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2010-10. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01264601?
The interventions under investigation include: Trivalent Influenza Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01264601?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.