Influenza (Healthy Volunteers)
Conditions
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.
Interventions
BIOLOGICALQuadrivalent Influenza Vaccine
Intramuscular or subcutaneous administration
BIOLOGICALHigh-Dose Quadrivalent Influenza Vaccine
Intramuscular administration
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaccinees' reporting rate following routine vaccination with VaxigripTetra® and Efluelda® | Within 7 days after vaccination | The vaccinees' reporting rate is expressed as the percentage of vaccinees who reported at least one suspected ADR among the distributed vaccination cards |
| ADR reporting rate following routine vaccination with VaxigripTetra® and Efluelda® | Within 7 days after vaccination | The ADR reporting rate is expressed as the percentage of suspected ADRs among the distributed vaccination cards |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From vaccination to end of data collection (maximum 2 months following first vaccination) | 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. |
| Serious suspected ADR reporting rate at any time following vaccination within the EPSS period | From vaccination to end of data collection (maximum 2 months following first vaccination) | 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. |
Countries
Finland, Germany
Outcome results
None listed