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

Novartis

Status and phase

Completed

Phase 4

Conditions

Influenza

Treatments

Biological: Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccine

Biological: Fluad_MF59-adjuvanted trivalent influenza subunit vaccine

Study type

Interventional

Funder types

Industry

Identifiers

V70_26

Details and patient eligibility

About

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

Enrollment

767 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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.