Influenza (Healthy Volunteers)
Conditions
Brief summary
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
Study duration per participant 2 months (including 6 weeks for VC distribution + 2 weeks for vaccinee reporting) following the first vaccination
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaccinee reporting rate of suspected adverse drug reactions (ADRs) following routine vaccination with VaxigripTetra® and Efluelda® | Within 7 days after vaccination | Number of vaccinees who reported at least 1 suspected ADR divided by the total number of vaccination cards (VCs) distributed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Vaccinees' reporting rate of suspected ADR at any time following vaccination within the EPSS period | From vaccination to end of data collection (maximum 2 months following first vaccination | 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