Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT00569894
Brief Summary:
To assess the safety of FluMist vaccination
Detailed Description:
* To assess the safety of FluMist vaccination Rates of medically attended events in FluMist recipients, including serious adverse events (SAEs), anaphylaxis , urticaria, asthma, wheezing, pre-specified grouped diagnoses, and rare events potentially related to wild-type influenza, will be compared to rates in multiple non-randomized control groups.
* To assess the safety of annual FluMist re-vaccination \[Rates of MAEs in the subset of children who receive FluMist in ≥2 consecutive years will be compared to rates in first-time vaccinees during the same season.\]
* To assess the safety of FluMist vaccination in children previously vaccinated with trivalent inactivated influenza vaccine (TIV) \[Rates of MAEs in the subset of children who received one or more prior TIV vaccinations will be compared to rates in children who did not receive prior TIV.\]
Study:
NCT00569894
Study Brief:
Protocol Section:
NCT00569894