Status:
COMPLETED
A Post-marketing Study to Monitor the Safety of a MF59-adjuvanted Influenza Vaccine Administered in Korean Subjects Aged 65 Years or Older
Lead Sponsor:
Novartis Vaccines
Conditions:
Influenza
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
This study will evaluate the safety of an influenza (flu) vaccine in Korean men and women aged 65 years and older.
Eligibility Criteria
Inclusion
- Males and females aged 65 years and above on the day of enrollment, who were eligible for seasonal influenza vaccination.
- In the judgement of the study doctor are determined to be in reasonable health considering their age and able to comply with all study procedures.
Exclusion
- History of any serious reaction to flu vaccine, or any materials in the vaccine, and to eggs (including ovalbumin) and chicken protein.
- Receipt of another (inactivated) vaccine within 2 weeks, or receipt of a live vaccine within 4 weeks prior to Study Day 1, or planning to receive some other vaccination before the final study visit (about Day 29 after vaccination).
- Any condition, which in the opinion of the study doctor, might interfere with the evaluation of the study objective.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
767 Patients enrolled
Trial Details
Trial ID
NCT01222403
Start Date
October 1 2010
End Date
October 1 2014
Last Update
June 12 2019
Active Locations (23)
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1
KeeTaek Kim internal medicine Clinic
Gimpo-si, Gyeonggi-do, South Korea, 415-040
2
Jiguchon internal medicine Clinic
Jeongeup, Jeonrabuk-do, South Korea, 580-060
3
21th Century hana internal medicine clinic
Mokpo, Jeonranam-do, South Korea, 530-390
4
JoongAng family medicine Clinic
Suncheon, Jeonranam-do, South Korea, 540-150