AnaphylaxisNCT01247415
Clinical Investigation on Allergic-like Reactions and Oculo-respiratory Syndrome After the H1N1 Pandemic Vaccine
An observational study of Anaphylaxis and Allergy, run by PHAC/CIHR Influenza Research Network at 7 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 64 years
- Conditions the study is for
- Anaphylaxis, Allergy, Oculorespiratory Syndrome
- Type of treatment
- Vaccines
- How many people
- 138 participants
- Where
- 7 sitesCanada
- Study dates
- Jan 2011to Nov 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: During the 2009-2010 immunization campaign against pandemic H1N1, the Canada has immunized most of its population with a dose-sparing adjuvanted vaccine produced by GlaxoSmithKline (GSK). Following the vaccination, some people reported having allergic-like reactions (anaphylaxis, oculo-respiratory syndrome and allergy). This study will compare three groups of patients (cases): those who had allergic-like reactions, those who had anaphylaxis and those who had ORS post vaccination to vaccinated individuals who had no such adverse events (controls).
Who may be able to join
- 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).
Who cannot join
- -Pregnant women cannot participate in this study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Centre Hospitalier Charles Lemoyne
Greenfield Park, Quebec, J4V2H1
Centre Hospitalier Universitaire de Montréal
Montreal, Quebec, H2L4M1
Montreal General Hospital
Montreal, Quebec, H3G1A4
Montreal Children's Hospital
Montreal, Quebec, H3H1P3
Hôpitale Ste-Justine
Montreal, Quebec, H3T 1C5
Centre Hospitalier Universitaire de Québec
Québec, Quebec, G1V 4V2
Centre Hospitalier et Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H5N4
About this study
Official title: Clinical Investigation of Anaphylaxis, Allergic-like Reactions and Oculo-Respiratory Syndrome (ORS) Following Administration of an Adjuvanted Vaccine Against H1N1 Pandemic Influenza
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.
- Keywords
- anaphylaxis, allergy, IgE mediated, ORS, oculorespiratory syndrome, Allergic-like reactions, H1N1, Arepanrix
- Medical subject headings
- Anaphylaxis, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anaphylaxis | 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 | 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 | 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 | Controls will be individuals who received the pH1N1 vaccine but did not present any of the above mentioned adverse events after their vaccine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of individuals with IgE mediated allergic reaction
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).
Measured: one year
Secondary outcomes (1)
Biomarkers that may allow differentiation between ORS and type I hypersensitivity
We will try to identify biomarkers that may allow differentiation of patients with ORS and those with type I hypersensitivity to the vaccine.
Measured: two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionMar 2011
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnaphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- PHAC/CIHR Influenza Research Network
- Sponsor type
- Other government
- Collaborators
- Institut National en Santé Publique du Québec, Laval University, University of British Columbia, Stollery Children's Hospital, University of Manitoba, University of Toronto, CHU de Quebec-Universite Laval, St. Justine's Hospital, Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Centre hospitalier de l'Université de Montréal (CHUM), Montreal Children's Hospital of the MUHC, Montreal General Hospital, Hopital Charles Lemoyne, IWK Health Centre, Université de Montréal, University of Cincinnati, McMaster University, Public Health Agency of Canada (PHAC), British Columbia Centre for Disease Control
- Responsible party
- Principal investigator, Gaston De Serres, PHAC/CIHR Influenza Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247415
- Sponsor's protocol ID
- pcirn-clin-invest-aller-1011
- Status last verified
- Jul 2012
- First submitted
- 22 Nov 2010
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of Anaphylaxis, Allergic-like Reactions and Oculo-Respiratory Syndrome (ORS) Following Administration of an Adjuvanted Vaccine Against H1N1 Pandemic Influenza
- ClinicalTrials.gov ID
- NCT01247415
- Acronym / sponsor ID
- pcirn-clin-invest-aller-1011
- Keywords
- anaphylaxis, allergy, IgE mediated, ORS, oculorespiratory syndrome, Allergic-like reactions, H1N1, Arepanrix
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (actual)
- Lead sponsor
- PHAC/CIHR Influenza Research NetworkOther government
- Collaborators
- Institut National en Santé Publique du Québec, Laval University, University of British Columbia, Stollery Children's Hospital, University of Manitoba, University of Toronto, CHU de Quebec-Universite Laval, St. Justine's Hospital, Centre de recherche du Centre hospitalier universitaire de Sherbrooke, Centre hospitalier de l'Université de Montréal (CHUM), Montreal Children's Hospital of the MUHC, Montreal General Hospital, Hopital Charles Lemoyne, IWK Health Centre, Université de Montréal, University of Cincinnati, McMaster University, Public Health Agency of Canada (PHAC), British Columbia Centre for Disease Control
- Study start
- Jan 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Nov 2012 (estimated)
- First posted
- 24 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Anaphylaxis | – | –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 | – | –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 | – | –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 | – | –Controls will be individuals who received the pH1N1 vaccine but did not present any of the above mentioned adverse events after their vaccine. |
Who may qualify
- Ages
- 10 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- During the 2009-2010 immunization campaign against pandemic H1N1, the Canada has immunized most of its population with a dose-sparing adjuvanted vaccine produced by GlaxoSmithKline (GSK). Following the vaccination, some people reported having allergic-like reactions (anaphylaxis, oculo-respiratory syndrome and allergy). This study will compare three groups of patients (cases): those who had allergic-like reactions, those who had anaphylaxis and those who had ORS post vaccination to vaccinated individuals who had no such adverse events (controls).
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- -Pregnant women cannot participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
Biomarkers that may allow differentiation between ORS and type I hypersensitivity
Time frame: two year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaphylaxis and Allergy, run by PHAC/CIHR Influenza Research Network at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of individuals with IgE mediated allergic reaction (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2012.