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 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
NCT ID:
NCT00980850
Eligibility Criteria:
Inclusion Criteria:
* baby or child aged between 6 months to 12 years of age (i.e., to day before 13th birthday)
* for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained
* available for all the visits scheduled in the study
* willingness to complete all study procedures
Exclusion Criteria:
* History of any vaccine against novel influenza A strain H1N1 (based on verbal confirmation from parent/guardian)
* Previous laboratory confirmed case of novel influenza A strain H1N1 or treatment with oseltamivir or zanamivir for novel influenza A strain H1N1 (n.b. a child commenced on treatment with oseltamivir or zanamivir for novel influenza A strain H1N1 whose treatment was stopped following negative microbiological tests for H1N1 on nasal swabs would be allowed to enrol in the study\]
* History of severe allergic reaction after previous vaccinations or hypersensitivity to any H1N1 vaccine component
* Current egg allergy
* Known or suspected impairment/alteration of the immune system
* Disorders of coagulation
* Immunosuppressive therapy, use of systemic corticosteroids for more than 1 week within the 3 months prior to enrollment
* Receipt of blood, blood products and/or plasma derivatives or any immunoglobulin preparation within 3 months prior to enrollment
* Intent to immunize with any other vaccine(s) against novel influenza A strain H1N1 throughout the study period
* Participation in another clinical trial of an investigational medical product
* Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. Children with chronic, stable medical illnesses that do not result in immunosuppression (e.g., cerebral palsy, epilepsy, cystic fibrosis, congenital heart disease) will be allowed to participate in the study, unless these conditions will in some way interfere with the completion of study procedures. Children with conditions that may alter the immune response to vaccines (e.g., Trisomy 21) or will affect the ability to accurately describe adverse events (e.g., children over 5 years of age but with severe learning difficulties) will be excluded
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
12 Years
Study:
NCT00980850
Study Brief:
Protocol Section:
NCT00980850