Abstract | BACKGROUND: OBJECTIVE: To evaluate the safety of TIV among severely egg allergic children. METHODS: A 2-phase, multicenter study at 7 sites was conducted between October 2010 and March 2012. Inclusion criteria included a history of a severe reaction, including anaphylaxis, to the ingestion of egg and a positive skin test result or evidence of serum specific IgE antibody to egg. Phase 1 consisted of a randomized, prospective, double-blind, placebo controlled trial of TIV administration to egg allergic children, using a 2-step approach; group A received 0.1 mL of influenza vaccine, followed in 30 minutes if no reaction with the remainder of an age-appropriate dose, whereas group B received an injection of normal saline followed in 30 minutes if no reaction with the full 100% of the age-appropriate dose. Phase 2 was a retrospective analysis of single dose vs split-dose administration of TIV in eligible study participants who declined participation in the randomized controlled trial. RESULTS: Thirty-one study participants were prospectively evaluated in the randomized controlled trial (group A, 14; group B, 17); 45.1% had a history of anaphylaxis after egg ingestion. A total of 112 participants were retrospectively evaluated (87 with the single dose and 25 with the split dose); 77.6% of participants had a history of anaphylaxis after egg ingestion. All participants in both phases received TIV without developing an allergic reaction. CONCLUSION: TIV administration is safe even in children with histories of severe egg allergy. Use of 2-step split dosing appears unnecessary because a single dose was well tolerated.
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Authors | Matthew J Greenhawt, Jonathan M Spergel, Matthew A Rank, Todd D Green, Darlene Mansoor, Darlene Masnoor, Hemant Sharma, J Andrew Bird, Jinny E Chang, Divya Sinha Parikh, Divya Sinh, Esther Teich, John M Kelso, Georgiana M Sanders |
Journal | Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology
(Ann Allergy Asthma Immunol)
Vol. 109
Issue 6
Pg. 426-30
(Dec 2012)
ISSN: 1534-4436 [Electronic] United States |
PMID | 23176882
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2012 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved. |
Chemical References |
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Topics |
- Anaphylaxis
(immunology, prevention & control)
- Child
- Double-Blind Method
- Egg Hypersensitivity
(immunology)
- Female
- Humans
- Influenza Vaccines
(administration & dosage, adverse effects, immunology)
- Influenza, Human
(immunology, prevention & control)
- Male
- Prospective Studies
- Retrospective Studies
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