Clinical Investigation on Allergic-like Reactions and Oculo-respiratory Syndrome After the H1N1 Pandemic Vaccine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01247415|
Recruitment Status : Unknown
Verified July 2012 by Gaston De Serres, PHAC/CIHR Influenza Research Network.
Recruitment status was: Active, not recruiting
First Posted : November 24, 2010
Last Update Posted : July 4, 2012
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.
|Condition or disease|
|Anaphylaxis Allergy Oculorespiratory Syndrome Allergic-like Reactions|
|Study Type :||Observational|
|Actual Enrollment :||138 participants|
|Observational Model:||Case Control|
|Official Title:||Clinical Investigation of Anaphylaxis, Allergic-like Reactions and Oculo-Respiratory Syndrome (ORS) Following Administration of an Adjuvanted Vaccine Against H1N1 Pandemic Influenza|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||March 2011|
|Estimated Study Completion Date :||November 2012|
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
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
Controls will be individuals who received the pH1N1 vaccine but did not present any of the above mentioned adverse events after their vaccine.
- proportion of individuals with IgE mediated allergic reaction [ Time Frame: one year ]The overall objective of this clinical investigation is to estimate the proportion of individuals with IgE mediated allergic reaction to Arepanrix or its components among patients with anaphylaxis/allergic reaction after pH1N1 vaccination, and the proportion that are allergic to the 2010-2011 trivalent inactivated seasonal influenza vaccine (TIV).
- Biomarkers that may allow differentiation between ORS and type I hypersensitivity [ Time Frame: two year ]We will try to identify biomarkers that may allow differentiation of patients with ORS and those with type I hypersensitivity to the vaccine.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247415
|Centre Hospitalier Charles Lemoyne|
|Greenfield-Park, Quebec, Canada, J4V2H1|
|Centre Hospitalier Universitaire de Montréal|
|Montréal, Quebec, Canada, H2L4M1|
|Montreal General Hospital|
|Montréal, Quebec, Canada, H3G1A4|
|Montreal Children's Hospital|
|Montréal, Quebec, Canada, H3H1P3|
|Montréal, Quebec, Canada, H3T 1C5|
|Centre Hospitalier Universitaire de Québec|
|Québec, Quebec, Canada, G1V 4V2|
|Centre Hospitalier et Universitaire de Sherbrooke|
|Sherbrooke, Quebec, Canada, J1H5N4|