Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe.

Launched by SANOFI · Nov 15, 2024

Keywords

ClinConnect Summary

This clinical trial is looking into the safety of a flu vaccine called Efluelda Tetra for adults aged 65 and older. Researchers want to find out if there are any side effects or reactions after people receive this vaccine in a regular healthcare setting. If you decide to participate, you’ll need to agree to take the vaccine on the day you enroll and provide your consent by signing a form.

To be eligible for this study, you must be at least 65 years old and cannot have participated in this study before or be involved in any other clinical research about vaccines or medications at the same time. If you join, you’ll be involved for about 28 to 35 days, with a chance for it to extend if you miss a follow-up visit. This study is currently recruiting participants, and both men and women can take part. Your experience will help researchers understand how safe this vaccine is for older adults.

Gender

ALL

Eligibility criteria

• 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 Tetra 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