Healthy Volunteers, Influenza Immunization
Conditions
Keywords
Flu, Efluelda®
Brief summary
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.
Interventions
BIOLOGICALEfluelda® Pre-filled syringe
Pharmaceutical Form: Suspension for injection in a pre-filled syringe Route of Administration: Intramuscular administration
Sponsors
Sanofi
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 65 years or older on the day of enrollment * The informed consent form has been signed and dated * Receipt of 1 dose of Efluelda® on the day of enrollment according to the approved local product label
Exclusion criteria
* Previous history of enrollment in this study * Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device or medical procedure The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of solicited injected site reactions. | Up to 7 days after vaccination | Number of participants experiencing solicited injection site reactions |
| Occurrence of solicited systemic reactions | Up to 7 days after vaccination | Number of participants experiencing solicited systemic reactions |
| Occurrence of unsolicited Adverse Events (AE) | From vaccination to Visit 2 (up to approximately 42 days) | Number of participants experiencing AEs |
| Occurrence of unsolicited Adverse Drug Reactions (ADR) | From vaccination to Visit 2 (up to approximately 42 days) | Number of participants experiencing ADRs |
| Occurrence of unexpected Adverse Events (AE) | From vaccination to participant's last contact (up to approximately 42 days) | Number of participants experiencing unexpected AEs |
| Occurrence of unexpected Adverse Drug Reactions (ADR) | From vaccination to participant's last contact (up to approximately 42 days) | Number of participants experiencing unexpected ADRs |
| Occurrence of Serious Adverse Events (SAE) | From vaccination to participant's last contact (up to approximately 42 days) | Number of participants experiencing SAEs |
| Occurrence of unexpected Serious Adverse Drug Reactions (SADR) | From vaccination to participant's last contact (up to approximately 42 days) | Number of participants experiencing unexpected SADRs |
| Occurrence of Adverse Event of Special Interest (AESI) | From vaccination to participant's last contact (up to approximately 42 days) | Number of participants experiencing AESIs |
Contacts
CONTACTTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed