Ignite Creation Date:
2024-05-05 @ 11:04 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01247415
Status:
UNKNOWN
Last Update Posted:
2012-07-04
First Post:
2010-11-22
Brief Title:
Clinical Investigation on Allergic-like Reactions and Oculo-respiratory Syndrome After the H1N1 Pandemic Vaccine
Sponsor:
PHACCIHR Influenza Research Network
Organization:
PHACCIHR Influenza Research Network
Study Overview
Official Title:
Clinical Investigation of Anaphylaxis Allergic-like Reactions and Oculo-Respiratory Syndrome ORS Following Administration of an Adjuvanted Vaccine Against H1N1 Pandemic Influenza
Status:
UNKNOWN
Status Verified Date:
2012-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
During the 2009-2010 immunization campaign against pandemic H1N1 some people reported having allergic-like reactions anaphylaxisa 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None