Observational Study to Assess Safety of H1N1 Pandemic Influenza Vaccine (NCT00950456) | Clinical Trial Compass
CompletedNot Applicable
Observational Study to Assess Safety of H1N1 Pandemic Influenza Vaccine
Austria3,216 participantsStarted 2009-11
Plain-language summary
The purpose of this observational study, which will be initiated as soon as the licensed H1N1 Pandemic Influenza Vaccine is used in a mass vaccination campaign, is to estimate the incidence of any medically-attended adverse events in all vaccinated subjects.
Who can participate
Age range2 Months
SexALL
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Inclusion Criteria:
Male and female subjects, per indication on license or per official vaccine recommendations, will be eligible for participation in this study if:
* They will be administered CELVAPAN (= Baxter´s H1N1 pandemic influenza vaccine)
* They are 2 months of age or older at the time of first vaccine administration
* Their medical history is available
* The investigator believes they will comply with the foreseen vaccination schedule and will reliably observe signs or symptoms of adverse events during the observational period
* They and/or their parent(s)/legal guardian(s) provide written informed consent, and assent where appropriate, prior to study entry according to national law
Exclusion Criteria:
Male and female subjects will be excluded from participation in this study if:
* They have already been administered another H1N1 pandemic vaccine
* They have any contraindication to vaccination (as per the Summary of Product Characteristics and/or relevant national immunization guidelines)