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Completed

NCT Number: NCT01222403

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

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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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

KeeTaek Kim internal medicine Clinic, Gimpo-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluad_MF59-adjuvanted trivalent influenza subunit vaccine

Biological

Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccine

Biological

Primary outcomes

  1. Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination.

    Time frame: 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.

  2. Number of Subjects Reporting Unsolicited AEs After Vaccination.

    Time frame: Day 1 through Day 28 post vaccination

    The number of subjects reporting any unsolicited AEs following vaccination with Fluad_aTIV and Vantaflu_aTIV.

  3. Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

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.

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 18, 2010
Registry last updated
Jun 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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