Ocular and Respiratory Symptoms Attributable to Inactivated Split Influenza Vaccine: Evidence from a Controlled Trial Involving Adults

In 2000, an influenza vaccine was associated with unusual ocular and respiratory symptoms (known as "oculorespiratory syndrome" [ORS]) that possibly were due to numerous microaggregates of unsplit viruses present in the product. We assessed the potential for an improved vaccine formulation...

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Bibliographic Details
Published in:Clinical infectious diseases 2003-04, Vol.36 (7), p.850-857
Main Authors: Scheifele, David W., Duval, Bernard, Russell, Margaret L., Warrington, Richard, DeSerres, Gaston, Skowronski, Danuta M., Dionne, Marc, Kellner, James, Davies, Dele, MacDonald, Judy
Format: Article
Language:English
Subjects:
Adult
Age Distribution
Biological and medical sciences
Cough - etiology
Cross-Over Studies
Double-Blind Method
Eye Diseases - etiology
Female
Headache
Hoarseness
Hoarseness - etiology
Human viral diseases
Humans
Immunization
Infectious diseases
Influenza vaccines
Influenza Vaccines - adverse effects
Injections
Major Articles
Male
Medical sciences
Middle Aged
Operating rooms
Placebos
Respiratory symptoms
Symptoms
Vaccination
Vaccines, Inactivated - adverse effects
Viral diseases
Viral diseases of the respiratory system and ent viral diseases
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Summary:In 2000, an influenza vaccine was associated with unusual ocular and respiratory symptoms (known as "oculorespiratory syndrome" [ORS]) that possibly were due to numerous microaggregates of unsplit viruses present in the product. We assessed the potential for an improved vaccine formulation (for use in 2001-2002) to cause ORS and other symptoms in adults, using a double-blind, randomized, crossover study design. Symptoms were ascertained 24 h after 622 doses of vaccine and 626 doses of saline placebo were injected. The risk of ORS was 6.3% after vaccine injection and 3.4% after placebo injection, which yielded a significant vaccine-attributable risk of 2.9% (95% confidence interval, 0.6-5.2). ORS symptoms were mild. Significant differences in risk after injection of vaccine versus placebo existed for ocular soreness and/or itching (2.4%), coughing (1.6%), and hoarseness (1.2%). Vaccine-attributable general symptoms were infrequent. We conclude that certain mild oculorespiratory symptoms were triggered by an influenza vaccine that was otherwise minimally reactogenic and, hence, that such symptoms might be associated with influenza vaccines in general.
ISSN:1058-4838
1537-6591
DOI:10.1086/368189