A Post-marketing Study to Monitor the Safety of a MF59-adjuvanted Influenza Vaccine Administered in Korean Subjects Aged 65 Years or Older
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.
1 other identifier
interventional
767
1 country
23
Brief Summary
This study will evaluate the safety of an influenza (flu) vaccine in Korean men and women aged 65 years and older.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2010
Longer than P75 for phase_4
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 12, 2010
CompletedFirst Posted
Study publicly available on registry
October 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedResults Posted
Study results publicly available
October 12, 2015
CompletedJune 12, 2019
May 1, 2019
4 years
October 12, 2010
September 9, 2015
May 31, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination.
The number of subjects reporting any solicited local and systemic AEs, following vaccination with Fluad\_aTIV and Vantaflu\_aTIV.
Day 1 through Day 4 after vaccination
Number of Subjects Reporting Unsolicited AEs After Vaccination.
The number of subjects reporting any unsolicited AEs following vaccination with Fluad\_aTIV and Vantaflu\_aTIV.
Day 1 through Day 28 post vaccination
Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After 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.
Day 1 through Day 28 post vaccination
Study Arms (2)
Fluad
EXPERIMENTALSubjects aged \>65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
Vantaflu_aTIV
EXPERIMENTALSubjects aged \>65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
KeeTaek Kim internal medicine Clinic
Gimpo-si, Gyeonggi-do, 415-040, South Korea
Jiguchon internal medicine Clinic
Jeongeup, Jeonrabuk-do, 580-060, South Korea
21th Century hana internal medicine clinic
Mokpo, Jeonranam-do, 530-390, South Korea
JoongAng family medicine Clinic
Suncheon, Jeonranam-do, 540-150, South Korea
Yonsei Universtity College of Medicine
Sinchon-dong, Seoul, 120-752, South Korea
Hangajok internal medicine clinic
Daejeon, 300-110, South Korea
Ju Saengmyeong internal medicine Clinic
Daejeon, 305-313, South Korea
Daejeon hospital
Daejeon, 306-010, South Korea
SaeSeoul internal medicine and radiology Clinic
Daejeon, 770-160, South Korea
SeoIncheon catholic clinic
Incheon, 404-190, South Korea
TaeIl Jang internal medicine Clinic
Incheon, 405-224, South Korea
SeokYeon Kim internal medicine clinic
Incheon, 407-806, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Yonsei University Severance Hospital
Seoul, 120-752, South Korea
Seoul medical center
Seoul, 131-865, South Korea
Global care internal medicine clinic
Seoul, 135-271, South Korea
Yeonsei Koum internal medicine Clinic
Seoul, 138-201, South Korea
Soon Chun Hyang University Hospital
Seoul, 140-887, South Korea
Gikim internal medicine clinic
Seoul, 143-203, South Korea
Lee internal medicine clinic
Seoul, 143-210, South Korea
Kangnam Sacred Heart Hospital
Seoul, 150-950, South Korea
Korea University Guro Hospital
Seoul, South Korea
Yonsei University Severance Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Posting Director
- Organization
- Novartis Vaccines and Diagnostics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2010
First Posted
October 18, 2010
Study Start
October 1, 2010
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
June 12, 2019
Results First Posted
October 12, 2015
Record last verified: 2019-05