Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2022/23

Study Overview
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Brief Summary
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This is an enhanced passive safety surveillance conducted in routine clinical care setting. Spontaneously reported ADRs will be collected by study staff following routine vaccination. The primary objective of this surveillance is to estimate the vaccinee reporting rate (RR) 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 2022/23. The secondary objectives of the study are: To estimate the vaccinee reporting rate of suspected ADRs occurring within 7 days following routine vaccination with VaxigripTetra® and Efluelda®, respectively, according to the pre-defined age groups (not applicable for Efluelda®) To estimate the vaccinee reporting rate of serious suspected ADRs after vaccination with VaxigripTetra® and Efluelda®, respectively, at any time following vaccination, within the EPSS

Detailed Description
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Study duration per participant 2 months (including 6 weeks for VC distribution + 2 weeks for vaccinee reporting) following the first vaccination

Official Title
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Enhanced Passive Safety Surveillance of VaxigripTetra® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) and Efluelda® (High-dose Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) Vaccines in Europe During the Influenza Season 2022/23.

Conditions
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Influenza (Healthy Volunteers)

Intervention / Treatment
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* Biological: Quadrivalent Influenza Vaccine
* Biological: High-Dose Quadrivalent Influenza Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: There are no formal inclusion criteria. Individuals who approach the site for vaccination and agree to receive a vaccination card will be included and vaccinated with the respective vaccine brand according to the country of their location, recommendations for the individual vaccines as well as national recommendations Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VaxigripTetra®<br>Participant vaccinated with VaxigripTetra® as per routine clinical practice | Biological: Quadrivalent Influenza Vaccine<br>* Intramuscular or subcutaneous administration<br>* Other names: VaxigripTetra®;|
| Efluelda®<br>Participant vaccinated with Efluelda® as per routine clinical practice | Biological: High-Dose Quadrivalent Influenza Vaccine<br>* Intramuscular administration<br>* Other names: Efluelda®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccinee reporting rate of suspected adverse drug reactions (ADRs) following routine vaccination with VaxigripTetra® and Efluelda® | Number of vaccinees who reported at least 1 suspected ADR divided by the total number of vaccination cards (VCs) distributed | Within 7 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccinees' reporting rate of ADRs according to age group |  | Within 7 days after vaccination | 
| Vaccinees' reporting rate of serious suspected ADRs at any time following vaccination within the EPSS period | Serious suspected ADRs will be collected from vaccination up to the end of data collection. Data collection ends when 1000 vaccination cards have been distributed (per vaccine brand) plus 2 weeks or 2 months following the first vaccination, whichever comes first. | From vaccination to end of data collection (maximum 2 months following first vaccination) | 
| Vaccinees' reporting rate of suspected ADR at any time following vaccination within the EPSS period | Suspected ADRs will be collected from vaccination up to the end of data collection. Data collection ends when 1000 vaccination cards have been distributed (per vaccine brand) plus 2 weeks or 2 months following the first vaccination, whichever comes first | From vaccination to end of data collection (maximum 2 months following first vaccination |