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

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

Official Title
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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.

Conditions
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Influenza

Intervention / Treatment
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* Biological: Fluad_MF59-adjuvanted trivalent influenza subunit vaccine
* Biological: Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |