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.

NCT01222403 Phase 4 COMPLETED Results posted

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

Details

Lead sponsor	Novartis Vaccines
Phase	Phase 4
Status	COMPLETED
Enrolment	767
Start date	2010-10
Completion	2014-10

Conditions

• Influenza

Interventions

• Fluad_MF59-adjuvanted trivalent influenza subunit vaccine
• Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccine

Primary outcomes

• Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. — Day 1 through Day 4 after vaccination
  The number of subjects reporting any solicited local and systemic AEs, following vaccination with Fluad\_aTIV and Vantaflu\_aTIV.
• Number of Subjects Reporting Unsolicited AEs After Vaccination. — Day 1 through Day 28 post vaccination
  The number of subjects reporting any unsolicited AEs following vaccination with Fluad\_aTIV and Vantaflu\_aTIV.
• Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination. — Day 1 through Day 28 post 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.

Countries

South Korea