Clinical Investigation on Allergic-like Reactions and Oculo-respiratory Syndrome After the H1N1 Pandemic Vaccine
NCT ID: NCT01247415
Last Updated: 2012-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
138 participants
OBSERVATIONAL
2011-01-31
2012-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Anaphylaxis
Anaphylaxis: these patients will have to meet at least level 3 of diagnostic certainty according to the Brighton Collaboration criteria for anaphylaxis
No interventions assigned to this group
Allergic-like reactions
Allergic-like reactions: These patients will have to have displayed at least one sign or symptom of an allergic reaction (any of the minor or major criteria of anaphylaxis) but will exclude patients with conjunctivitis who will belong to the ORS group
No interventions assigned to this group
ORS cases
ORS cases: According to the Public Health Agency case definition, these patients should have presented a bilateral conjunctivitis plus ≥1 of the seven respiratory symptoms (cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness or sore throat) that started within 24 hrs of vaccination, with or without facial oedema (no restriction for duration) (ref: Public Health Agency of Canada: User Guide: Report of Adverse Events Following Immunization (AEFI) Appendix III National Case Definitions of AEFIs of Special Interest: oculo-respiratory Syndrome. http://www.phac-pc.gc.ca/im/aefi\_guide/ann3-eng.php
No interventions assigned to this group
Controls
Controls will be individuals who received the pH1N1 vaccine but did not present any of the above mentioned adverse events after their vaccine.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Anaphylaxis: these patients will have to meet at least level 3 of diagnostic certainty according to the Brighton Collaboration criteria for anaphylaxis
* Allergic-like reactions: These patients will have to have displayed at least one sign or symptom of an allergic reaction (any of the minor or major criteria of anaphylaxis) but will exclude patients with conjunctivitis who will belong to the ORS group (see below).
* ORS cases: According to the Public Health Agency case definition, these patients should have presented a bilateral conjunctivitis plus ≥1 of the seven respiratory symptoms (cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness or sore throat) that started within 24 hrs of vaccination, with or without facial oedema (no restriction for duration)
* Controls will be individuals between 10 and 64 years of age who received the pH1N1 vaccine but did not present any of the above mentioned adverse events after their vaccine (anaphylaxis, allergic like reactions and SOR).
Exclusion Criteria
10 Years
64 Years
ALL
No
Sponsors
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Institut National en Santé Publique du Québec
OTHER
Laval University
OTHER
University of British Columbia
OTHER
Stollery Children's Hospital
OTHER
University of Manitoba
OTHER
University of Toronto
OTHER
CHU de Quebec-Universite Laval
OTHER
St. Justine's Hospital
OTHER
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
OTHER
Centre hospitalier de l'Université de Montréal (CHUM)
OTHER
Montreal Children's Hospital of the MUHC
OTHER
Montreal General Hospital
OTHER
Hopital Charles Lemoyne
OTHER
IWK Health Centre
OTHER
Université de Montréal
OTHER
University of Cincinnati
OTHER
McMaster University
OTHER
Public Health Agency of Canada (PHAC)
OTHER_GOV
British Columbia Centre for Disease Control
OTHER_GOV
PHAC/CIHR Influenza Research Network
OTHER_GOV
Responsible Party
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Gaston De Serres
Epidemiologist at the National Institute of Public Health of Quebec and professor of epidemiology at the University Laval
Locations
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Centre Hospitalier Charles Lemoyne
Greenfield Park, Quebec, Canada
Centre Hospitalier Universitaire de Montréal
Montreal, Quebec, Canada
Montreal General Hospital
Montreal, Quebec, Canada
Montreal Children's Hospital
Montreal, Quebec, Canada
Hôpitale Ste-Justine
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Québec
Québec, Quebec, Canada
Centre Hospitalier et Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Countries
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Other Identifiers
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pcirn-clin-invest-aller-1011
Identifier Type: -
Identifier Source: org_study_id