NCT01222403

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

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 767 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Fluad_MF59-adjuvanted trivalent influenza subunit vaccine
BIOLOGICAL	Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccine

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2010-10-18
• Last updated: 2019-06-12
• Results posted: 2015-10-12

Locations

23 sites across 1 country: South Korea