Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1331-8205 | Registry Identifier | ICTRP |
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
To objective of this study is to investigate the incidence of adverse events (AEs) and adverse drug reactions (ADRs) occurred following administration of Efluelda® in adults aged 65 years or older under routine clinical practice, as per approved indications This is an open-label, multi-center, observational active safety surveillance study, designed to be conducted under standard healthcare setting of the Republic of Korea, in accordance with "Regulation on the Operation of Risk Management Plans".
The study duration of each participation will be approximately 28 to 35 days. In the event that Visit 2 is not made, the study duration would be extended to 36 to 42 days.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efluelda® Vaccination Group | Adults aged 65 years of age or older will receive 1 dose of Efluelda® vaccination intramuscularly on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efluelda® Pre-filled syringe | Biological | Pharmaceutical Form: Suspension for injection in a pre-filled syringe Route of Administration: Intramuscular administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of solicited injected site reactions. | Number of participants experiencing solicited injection site reactions | Up to 7 days after vaccination |
| Occurrence of solicited systemic reactions | Number of participants experiencing solicited systemic reactions | Up to 7 days after vaccination |
| Occurrence of unsolicited Adverse Events (AE) | Number of participants experiencing AEs | From vaccination to Visit 2 (up to approximately 42 days) |
| Occurrence of unsolicited Adverse Drug Reactions (ADR) | Number of participants experiencing ADRs | From vaccination to Visit 2 (up to approximately 42 days) |
| Occurrence of unexpected Adverse Events (AE) | Number of participants experiencing unexpected AEs | From vaccination to participant's last contact (up to approximately 42 days) |
| Occurrence of unexpected Adverse Drug Reactions (ADR) | Number of participants experiencing unexpected ADRs | From vaccination to participant's last contact (up to approximately 42 days) |
| Occurrence of Serious Adverse Events (SAE) | Number of participants experiencing SAEs | From vaccination to participant's last contact (up to approximately 42 days) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Not provided
Not provided
Not provided
Investigators will recruit participants after vaccination with Efluelda® as per routine healthcare visits and according to approved local product labeling, at study centers (general hospitals or clinics located in South Korea).
600 evaluable participants will be included and will include male and female adults aged 65 years and older.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended (Toll free for US & Canada) | Contact | 800-633-1610 | option 6 | Contact-US@sanofi.com |
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
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
| Occurrence of unexpected Serious Adverse Drug Reactions (SADR) | Number of participants experiencing unexpected SADRs | From vaccination to participant's last contact (up to approximately 42 days) |
| Occurrence of Adverse Event of Special Interest (AESI) | Number of participants experiencing AESIs | From vaccination to participant's last contact (up to approximately 42 days) |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |