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

Influenza research study

What is the primary objective of this study?

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

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Influenza

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Biological:MF59-adjuvanted trivalent influenza subunit vaccine

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Completed

Start Date: October 2010

Completed Date: October 2014

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination.

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Novartis Vaccines

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01222403

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