Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1271-1492 | Registry Identifier | ICTRP | |
| FLU00171 | Other Identifier | Sanofi Identifier |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Study duration per participant 2 months (including 6 weeks for VC distribution + 2 weeks for vaccinee reporting) following the first vaccination
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VaxigripTetra® | Participant vaccinated with VaxigripTetra® as per routine clinical practice |
| |
| Efluelda® | Participant vaccinated with Efluelda® as per routine clinical practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent Influenza Vaccine | Biological | Intramuscular or subcutaneous administration |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
VaxigripTetra® will be given to adults (including pregnant women) and children aged 6 months and older in Finland. Efluelda® will be given to adults 60 years of age and older in Germany.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number : 2-2-002 | Helsinki | 00180 | Finland | |||
| Investigational Site Number : 2-2-005 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38448394 | Result | Machado MAA, Gandhi-Banga S, Gallo S, Cousseau TG, Byrareddy RM, Nissila M, Schelling J, Monfredo C. Enhanced passive safety surveillance of high-dose and standard-dose quadrivalent inactivated split-virion influenza vaccines in Germany and Finland during the 2022/23 influenza season. Hum Vaccin Immunother. 2024 Dec 31;20(1):2322196. doi: 10.1080/21645515.2024.2322196. Epub 2024 Mar 6. |
Not provided
Not provided
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| High-Dose Quadrivalent Influenza Vaccine | Biological | Intramuscular administration |
|
|
| 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 |
| Jyväskylä |
| 40100 |
| Finland |
| Investigational Site Number : 2-2-004 | Kuopio | 70100 | Finland |
| Investigational Site Number : 2-2-006 | Rauma | 26100 | Finland |
| Investigational Site Number : 2-2-003 | Tampere | 33100 | Finland |
| Investigational Site Number : 2-2-001 | Turku | 20100 | Finland |
| Investigational Site Number : 2760011 | Berlin | 10117 | Germany |
| Investigational Site Number : 2760005 | Blankenhain | 99444 | Germany |
| Investigational Site Number : 2760001 | Donaueschingen | 78166 | Germany |
| Investigational Site Number : 2760004 | Düsseldorf | 40470 | Germany |
| Investigational Site Number : 2760007 | Frankfurt am Main | 60329 | Germany |
| Investigational Site Number : 2760002 | Fulda | 36037 | Germany |
| Investigational Site Number : 2760003 | Grafenrheinfeld | 97506 | Germany |
| Investigational Site Number : 2760009 | Martinsried | 82152 | Germany |
| Investigational Site Number : 2760008 | Wendelstein | 90530 | Germany |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided