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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT05078060
Brief Summary:
The primary objective of the study is to estimate the reporting rate of suspected Adverse Drug Reactions (ADRs) occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, during the Northern Hemisphere (NH) influenza season 2021/22.
The secondary objectives of the study are:
* To estimate the reporting rates of suspected ADRs occurring within 7 days following routine vaccination with VaxigripTetra® according to the pre-defined age groups.
* To estimate the reporting rates of serious suspected ADRs after vaccination with VaxigripTetra®, and Efluelda®, respectively, at any time following vaccination, within the Enhanced Passive Safety Surveillance (EPSS) period.
* To compare vaccinees' reporting rates of suspected ADRs observed during the NH influenza season 2021/22.
Detailed Description:
Study duration per participant is maximum 2 months.
Study:
NCT05078060
Study Brief:
Protocol Section:
NCT05078060