Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT00950456
Eligibility Criteria:
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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Months
Study:
NCT00950456
Study Brief:
Protocol Section:
NCT00950456