Clinical trial NCT01222403: A Post-marketing Study to Monitor the Safety of a MF59-adjuvanted Influenza Vaccine Administered in Korean Subjects Aged 65 Years or Older
Official title: A Multicenter, Post-marketing Surveillance Study to Monitor the Safety of Novartis Vaccine MF59-adjuvanted Influenza Subunit Vaccine FLUAD® and Sandoz Korea Vaccine MF59-adjuvanted Influenza Subunit Vaccine VANTAFLU® Administered According to the Prescribing Information in Korean Subjects Aged 65 Years or Older at the Time of Vaccination.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-10-18
Enrollment: 767
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 Criteria:

1. Males and females aged 65 years and above on the day of enrollment, who were eligible for seasonal influenza vaccination.
2. 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 Criteria:

1. History of any serious reaction to flu vaccine, or any materials in the vaccine, and to eggs (including ovalbumin) and chicken protein.
2. 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).
3. Any condition, which in the opinion of the study doctor, might interfere with the evaluation of the study objective.

Primary outcomes:
measure: Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination.
timeFrame: Day 1 through Day 4 after vaccination
measure: Number of Subjects Reporting Unsolicited AEs After Vaccination.
timeFrame: Day 1 through Day 28 post vaccination
measure: Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination.
timeFrame: Day 1 through Day 28 post vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Gimpo-si
country: Korea, Republic of
facility: KeeTaek Kim internal medicine Clinic
state: Gyeonggi-do
city: Jeongeup
country: Korea, Republic of
facility: Jiguchon internal medicine Clinic
state: Jeonrabuk-do
city: Mokpo
country: Korea, Republic of
facility: 21th Century hana internal medicine clinic
state: Jeonranam-do
city: Suncheon
country: Korea, Republic of
facility: JoongAng family medicine Clinic
state: Jeonranam-do
city: Sinchon-dong
country: Korea, Republic of
facility: Yonsei Universtity College of Medicine
state: Seoul
city: Daejeon
country: Korea, Republic of
facility: Hangajok internal medicine clinic
city: Daejeon
country: Korea, Republic of
facility: Ju Saengmyeong internal medicine Clinic
city: Daejeon
country: Korea, Republic of
facility: Daejeon hospital
city: Daejeon
country: Korea, Republic of
facility: SaeSeoul internal medicine and radiology Clinic
city: Incheon
country: Korea, Republic of
facility: SeoIncheon catholic clinic
city: Incheon
country: Korea, Republic of
facility: TaeIl Jang internal medicine Clinic
city: Incheon
country: Korea, Republic of
facility: SeokYeon Kim internal medicine clinic
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul medical center
city: Seoul
country: Korea, Republic of
facility: Global care internal medicine clinic
city: Seoul
country: Korea, Republic of
facility: Yeonsei Koum internal medicine Clinic
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Gikim internal medicine clinic
city: Seoul
country: Korea, Republic of
facility: Lee internal medicine clinic
city: Seoul
country: Korea, Republic of
facility: Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
Study officials:
References: