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Randomized Controlled Trial of Previously Affected Persons

Gaston De Serres, MD, PhD; Danuta M. Skowronski, MD, FRCPC; Maryse Guay, MD, FRCPC; Louis Rochette, MSc; Karen Jacobsen, BEd; Theresa Fuller, CRC; Bernard Duval, MD, FRCPC

Arch Intern Med. 2004;164:2266-2272.

Background  Oculorespiratory syndrome (ORS) after influenza vaccination has many features of an allergic reaction.

Methods  The objective of the study was to estimate the recurrence rate of ORS after receipt of either of 2 influenza vaccines available in Canada for the 2002-2003 influenza season in individuals who experienced ORS in 2000 or 2001. We designed a randomized, crossover, double-blind, placebo-controlled trial in which patients received the vaccine and the placebo 7 days apart. Patients were contacted by telephone at 24 hours and seen at 7 days to collect information about the recurrence of ORS symptoms. The 146 patients belonged to 3 groups: group A (46 patients) had ORS in 2000 but were not revaccinated in 2001, group B (50 patients) had ORS in 2000 and were revaccinated in 2001, and group C (50 patients) had ORS in 2001 but not in 2000. Half of the participants received Fluviral S/F (Shire Biologics) and half received Vaxigrip (Aventis Pasteur). The main outcome measure was the risk difference in ORS symptoms in the 24 hours after receiving the vaccine and after receiving placebo.

Results  Recurrence attributable to the vaccine occurred in 34% (95% confidence interval, 21%-47%) of patients after receiving Fluviral S/F and in 15% (95% confidence interval, 2%-28%) after receiving Vaxigrip. The rate was twice as high in group A vs groups B and C. The risk of ORS was highest and most significant in group A patients vaccinated with Fluviral S/F. Most cases were mild, with 94% of patients with recurrence indicating that they would still be revaccinated the next year.

Conclusions  Despite high recurrence rates, revaccination of persons previously affected by ORS seems to be safe. Oculorespiratory syndrome is not anaphylactic, and most recurrences are benign. Most patients remain willing to be revaccinated.

Author Affiliations: Institut National de Santé Publique du Québec, Québec (Drs De Serres, Guay, and Duval); Public Health Research Unit, CHUL Research Center, Laval University, Québec (Drs De Serres and Duval and Mr Rochette); British Columbia Center for Disease Control, Vancouver (Dr Skowronski); Direction de Santé Publique de la Montérégie, Montérégie, Québec (Dr Guay); and Westcoast Clinical Research, Vancouver (Mss Jacobsen and Fuller).

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