Status:
UNKNOWN
Clinical Investigation on Allergic-like Reactions and Oculo-respiratory Syndrome After the H1N1 Pandemic Vaccine
Lead Sponsor:
PHAC/CIHR Influenza Research Network
Collaborating Sponsors:
Institut National en Santé Publique du Québec
Laval University
Conditions:
Anaphylaxis
Allergy
Eligibility:
All Genders
10-64 years
Brief 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...
Eligibility Criteria
Inclusion
- case:
- There will be three groups of cases. For all groups of cases, patients will be included if the time of onset of their first symptoms has been within 24 hours after vaccination and if they are between 10 and 64 years of age.
- 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
- Pregnant women cannot participate in this study.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT01247415
Start Date
January 1 2011
End Date
November 1 2012
Last Update
July 4 2012
Active Locations (7)
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1
Centre Hospitalier Charles Lemoyne
Greenfield Park, Quebec, Canada, J4V2H1
2
Centre Hospitalier Universitaire de Montréal
Montreal, Quebec, Canada, H2L4M1
3
Montreal General Hospital
Montreal, Quebec, Canada, H3G1A4
4
Montreal Children's Hospital
Montreal, Quebec, Canada, H3H1P3