A Post-marketing Study to Monitor the Safety of a MF59-adjuvanted Influenza Vaccine Administered in Korean Subjects Aged 65 Years or Older
- Conditions
- Influenza
- Registration Number
- NCT01222403
- Lead Sponsor
- Novartis Vaccines
- Brief Summary
This study will evaluate the safety of an influenza (flu) vaccine in Korean men and women aged 65 years and older.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 767
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. Day 1 through Day 4 after vaccination The number of subjects reporting any solicited local and systemic AEs, following vaccination with Fluad_aTIV and Vantaflu_aTIV.
Number of Subjects Reporting Unsolicited AEs After Vaccination. Day 1 through Day 28 post vaccination The number of subjects reporting any unsolicited AEs following vaccination with Fluad_aTIV and Vantaflu_aTIV.
Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination. Day 1 through Day 28 post vaccination The number of subjects reporting any unsolicited AEs, SAEs, AEs leading to withdrawal (WD), AEs of special interest (AESI) following vaccination with Fluad_aTIV and Vantaflu_aTIV.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (22)
KeeTaek Kim internal medicine Clinic
🇰🇷Gimpo-si, Gyeonggi-do, Korea, Republic of
Jiguchon internal medicine Clinic
🇰🇷Jeongeup, Jeonrabuk-do, Korea, Republic of
21th Century hana internal medicine clinic
🇰🇷Mokpo, Jeonranam-do, Korea, Republic of
JoongAng family medicine Clinic
🇰🇷Suncheon, Jeonranam-do, Korea, Republic of
Yonsei Universtity College of Medicine
🇰🇷Sinchon-dong, Seoul, Korea, Republic of
Hangajok internal medicine clinic
🇰🇷Daejeon, Korea, Republic of
Ju Saengmyeong internal medicine Clinic
🇰🇷Daejeon, Korea, Republic of
Daejeon hospital
🇰🇷Daejeon, Korea, Republic of
SaeSeoul internal medicine and radiology Clinic
🇰🇷Daejeon, Korea, Republic of
SeoIncheon catholic clinic
🇰🇷Incheon, Korea, Republic of
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