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

May 31, 2019 updated by: Novartis Vaccines

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

767

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daejeon, Korea, Republic of, 300-110
        • Hangajok internal medicine clinic
      • Daejeon, Korea, Republic of, 305-313
        • Ju Saengmyeong internal medicine Clinic
      • Daejeon, Korea, Republic of, 306-010
        • Daejeon hospital
      • Daejeon, Korea, Republic of, 770-160
        • SaeSeoul internal medicine and radiology Clinic
      • Incheon, Korea, Republic of, 404-190
        • SeoIncheon catholic clinic
      • Incheon, Korea, Republic of, 405-224
        • TaeIl Jang internal medicine Clinic
      • Incheon, Korea, Republic of, 407-806
        • SeokYeon Kim internal medicine clinic
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Yonsei University Severance Hospital
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 120-752
        • Yonsei University Severance Hospital
      • Seoul, Korea, Republic of, 140-887
        • Soon Chun Hyang University Hospital
      • Seoul, Korea, Republic of, 131-865
        • Seoul Medical Center
      • Seoul, Korea, Republic of, 135-271
        • Global care internal medicine clinic
      • Seoul, Korea, Republic of, 138-201
        • Yeonsei Koum internal medicine Clinic
      • Seoul, Korea, Republic of, 143-203
        • Gikim internal medicine clinic
      • Seoul, Korea, Republic of, 143-210
        • Lee internal medicine clinic
      • Seoul, Korea, Republic of, 150-950
        • KangNam Sacred Heart Hospital
    • Gyeonggi-do
      • Gimpo-si, Gyeonggi-do, Korea, Republic of, 415-040
        • KeeTaek Kim internal medicine Clinic
    • Jeonrabuk-do
      • Jeongeup, Jeonrabuk-do, Korea, Republic of, 580-060
        • Jiguchon internal medicine Clinic
    • Jeonranam-do
      • Mokpo, Jeonranam-do, Korea, Republic of, 530-390
        • 21th Century hana internal medicine clinic
      • Suncheon, Jeonranam-do, Korea, Republic of, 540-150
        • JoongAng family medicine Clinic
    • Seoul
      • Sinchon-dong, Seoul, Korea, Republic of, 120-752
        • Yonsei Universtity College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluad
Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
Biological: Fluad_MF59-adjuvanted trivalent influenza subunit vaccine
Experimental: Vantaflu_aTIV
Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
Biological: Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination.
Time Frame: 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.
Day 1 through Day 4 after vaccination
Number of Subjects Reporting Unsolicited AEs After Vaccination.
Time Frame: Day 1 through Day 28 post 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.
Time Frame: 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.
Day 1 through Day 28 post vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Vaccines

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

October 12, 2010

First Submitted That Met QC Criteria

October 14, 2010

First Posted (Estimate)

October 18, 2010

Study Record Updates

Last Update Posted (Actual)

June 12, 2019

Last Update Submitted That Met QC Criteria

May 31, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V70_26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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