Clinical Investigation on Allergic-like Reactions and Oculo-respiratory Syndrome After the H1N1 Pandemic Vaccine

Summary

During the 2009-2010 immunization campaign against pandemic H1N1, some people reported having allergic-like reactions (anaphylaxis(a shock-like reaction), hives, swelling, etc.). A vaccine allergy may be more or less severe or intense. Patients may have skin reactions (rash with or without itching), respiratory problems (cough, spasm of the airways), angioedema (swelling) of various body parts (face, eyelids, throat etc.) and circulatory problems (low blood pressure or shock). Anaphylaxis is a severe allergic reaction that can sometimes be fatal. Other people vaccinated against pandemic H1N1 had an oculo-respiratory syndrome. Oculo-respiratory syndrome (ORS) is also a reaction to the influenza vaccine, which includes symptoms such as bilateral conjunctivitis (red eyes) with swelling of the face or respiratory symptoms (chest tightness, coughing, a sensation of throat closure, difficulty swallowing, hoarseness, wheezing or difficulty breathing). The investigators know that ORS is not a true allergic reaction. Because many signs and symptoms of ORS are similar to those observed during an allergic reaction, it is often difficult to distinguish ORS from an allergic reaction.

This study will compare three groups of patients: those who had allergic-like reactions, those who had ORS and vaccinated individuals who had no such adverse events. Pregnant women cannot participate in this study. The study has three goals. First, the investigators want to determine, among those who had allergic-like reactions after influenza vaccination, what proportion (percentage) of these people are actually allergic to the vaccine or its components. Second, among those who are not allergic to the vaccine, which other processes may have caused these symptoms. Finally, the investigators will try to identify whether there are features that distinguish patients who have a true allergic reaction from those affected by ORS, and those that had no adverse events.

Conditions

• Anaphylaxis
• Allergy
• Oculorespiratory Syndrome
• Allergic-like Reactions

Sponsors & Collaborators

• Institut National en Santé Publique du Québec

  collaborator OTHER

• Laval University

  collaborator OTHER

• University of British Columbia

  collaborator OTHER

• Stollery Children's Hospital

  collaborator OTHER

• University of Manitoba

  collaborator OTHER

• University of Toronto

  collaborator OTHER

• CHU de Quebec-Universite Laval

  collaborator OTHER

• St. Justine's Hospital

  collaborator OTHER

• Centre de recherche du Centre hospitalier universitaire de Sherbrooke

  collaborator OTHER

• Centre hospitalier de l'Université de Montréal (CHUM)

  collaborator OTHER

• Montreal Children's Hospital of the MUHC

  collaborator OTHER

• Montreal General Hospital

  collaborator OTHER

• Hopital Charles Lemoyne

  collaborator OTHER

• IWK Health Centre

  collaborator OTHER

• Université de Montréal

  collaborator OTHER

• University of Cincinnati

  collaborator OTHER

• McMaster University

  collaborator OTHER

• Public Health Agency of Canada (PHAC)

  collaborator OTHER_GOV

• British Columbia Centre for Disease Control

  collaborator OTHER_GOV

• PHAC/CIHR Influenza Research Network

  lead OTHER_GOV

Eligibility

Min Age

10 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-01-31

Primary Completion

2011-03-31

Completion

2012-11-30

Countries

• Canada

Study Locations