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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

767 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-10-31

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.

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Fluad

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

Group Type EXPERIMENTAL

Fluad_MF59-adjuvanted trivalent influenza subunit vaccine

Intervention Type BIOLOGICAL

Vantaflu_aTIV

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

Group Type EXPERIMENTAL

Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccine

Intervention Type BIOLOGICAL

Interventions

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Fluad_MF59-adjuvanted trivalent influenza subunit vaccine

Intervention Type BIOLOGICAL

Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes