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A Post-marketing Study to Monitor the Safety of a MF59-adjuvanted Influenza Vaccine Administered in Korean Subjects Aged 65 Years or Older

Primary Purpose

Influenza

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fluad_MF59-adjuvanted trivalent influenza subunit vaccine
Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccine
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • KeeTaek Kim internal medicine Clinic
  • Jiguchon internal medicine Clinic
  • 21th Century hana internal medicine clinic
  • JoongAng family medicine Clinic
  • Yonsei Universtity College of Medicine
  • Hangajok internal medicine clinic
  • Ju Saengmyeong internal medicine Clinic
  • Daejeon hospital
  • SaeSeoul internal medicine and radiology Clinic
  • SeoIncheon catholic clinic
  • TaeIl Jang internal medicine Clinic
  • SeokYeon Kim internal medicine clinic
  • Seoul National University Hospital
  • Yonsei University Severance Hospital
  • Seoul medical center
  • Global care internal medicine clinic
  • Yeonsei Koum internal medicine Clinic
  • Soon Chun Hyang University Hospital
  • Gikim internal medicine clinic
  • Lee internal medicine clinic
  • Kangnam Sacred Heart Hospital
  • Korea University Guro Hospital
  • Yonsei University Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Fluad

Vantaflu_aTIV

Arm Description

Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).

Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).

Outcomes

Primary Outcome Measures

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.
Number of Subjects Reporting Unsolicited AEs After 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.
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

Full Information

First Posted
October 12, 2010
Last Updated
May 31, 2019
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT01222403
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

5. Study Description

Brief Summary
This study will evaluate the safety of an influenza (flu) vaccine in Korean men and women aged 65 years and older.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
767 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluad
Arm Type
Experimental
Arm Description
Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
Arm Title
Vantaflu_aTIV
Arm Type
Experimental
Arm Description
Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
Intervention Type
Biological
Intervention Name(s)
Fluad_MF59-adjuvanted trivalent influenza subunit vaccine
Intervention Type
Biological
Intervention Name(s)
Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccine
Primary Outcome Measure Information:
Title
Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination.
Description
The number of subjects reporting any solicited local and systemic AEs, following vaccination with Fluad_aTIV and Vantaflu_aTIV.
Time Frame
Day 1 through Day 4 after vaccination
Title
Number of Subjects Reporting Unsolicited AEs After Vaccination.
Description
The number of subjects reporting any unsolicited AEs following vaccination with Fluad_aTIV and Vantaflu_aTIV.
Time Frame
Day 1 through Day 28 post vaccination
Title
Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination.
Description
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.
Time Frame
Day 1 through Day 28 post vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Facility Information:
Facility Name
KeeTaek Kim internal medicine Clinic
City
Gimpo-si
State/Province
Gyeonggi-do
ZIP/Postal Code
415-040
Country
Korea, Republic of
Facility Name
Jiguchon internal medicine Clinic
City
Jeongeup
State/Province
Jeonrabuk-do
ZIP/Postal Code
580-060
Country
Korea, Republic of
Facility Name
21th Century hana internal medicine clinic
City
Mokpo
State/Province
Jeonranam-do
ZIP/Postal Code
530-390
Country
Korea, Republic of
Facility Name
JoongAng family medicine Clinic
City
Suncheon
State/Province
Jeonranam-do
ZIP/Postal Code
540-150
Country
Korea, Republic of
Facility Name
Yonsei Universtity College of Medicine
City
Sinchon-dong
State/Province
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Hangajok internal medicine clinic
City
Daejeon
ZIP/Postal Code
300-110
Country
Korea, Republic of
Facility Name
Ju Saengmyeong internal medicine Clinic
City
Daejeon
ZIP/Postal Code
305-313
Country
Korea, Republic of
Facility Name
Daejeon hospital
City
Daejeon
ZIP/Postal Code
306-010
Country
Korea, Republic of
Facility Name
SaeSeoul internal medicine and radiology Clinic
City
Daejeon
ZIP/Postal Code
770-160
Country
Korea, Republic of
Facility Name
SeoIncheon catholic clinic
City
Incheon
ZIP/Postal Code
404-190
Country
Korea, Republic of
Facility Name
TaeIl Jang internal medicine Clinic
City
Incheon
ZIP/Postal Code
405-224
Country
Korea, Republic of
Facility Name
SeokYeon Kim internal medicine clinic
City
Incheon
ZIP/Postal Code
407-806
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Yonsei University Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Seoul medical center
City
Seoul
ZIP/Postal Code
131-865
Country
Korea, Republic of
Facility Name
Global care internal medicine clinic
City
Seoul
ZIP/Postal Code
135-271
Country
Korea, Republic of
Facility Name
Yeonsei Koum internal medicine Clinic
City
Seoul
ZIP/Postal Code
138-201
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Hospital
City
Seoul
ZIP/Postal Code
140-887
Country
Korea, Republic of
Facility Name
Gikim internal medicine clinic
City
Seoul
ZIP/Postal Code
143-203
Country
Korea, Republic of
Facility Name
Lee internal medicine clinic
City
Seoul
ZIP/Postal Code
143-210
Country
Korea, Republic of
Facility Name
Kangnam Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
150-950
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Severance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

A Post-marketing Study to Monitor the Safety of a MF59-adjuvanted Influenza Vaccine Administered in Korean Subjects Aged 65 Years or Older

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