Safety Surveillance of VaxigripTetra® and Efluelda® Influenza Vaccines in Europe During the Influenza Season 2021/22

Study Overview
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Brief Summary
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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
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Study duration per participant is maximum 2 months.

Official Title
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Enhanced Passive Safety Surveillance of VaxigripTetra® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) and Efluelda® (Quadrivalent Inactivated Split Virion Influenza Vaccine, Intramuscular Route) Vaccines in Europe During the Influenza Season 2021/22.

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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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.

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 |
| --- | --- | --- |
| Vaccinees' reporting rate following routine vaccination with VaxigripTetra® and Efluelda® | The vaccinees' reporting rate is expressed as the percentage of vaccinees who reported at least one suspected ADR among the distributed vaccination cards | Within 7 days after vaccination | 
| ADR reporting rate following routine vaccination with VaxigripTetra® and Efluelda® | The ADR reporting rate is expressed as the percentage of suspected ADRs among the distributed vaccination cards | Within 7 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADR reporting rate according to age group |  | Within 7 days after vaccination | 
| Vaccinees' reporting rate 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) | 
| Serious suspected ADR reporting rate 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) |