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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01222403
First received: October 12, 2010
Last updated: September 9, 2015
Last verified: September 2015
  Purpose
This study will evaluate the safety of an influenza (flu) vaccine in Korean men and women aged 65 years and older.

Condition Intervention Phase
Influenza
Biological: MF59-adjuvanted trivalent influenza subunit vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official 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.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. [ Time Frame: Day 1 through Day 4 after vaccination ] [ Designated as safety issue: No ]
    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. [ Time Frame: Day 1 through Day 28 post vaccination ] [ Designated as safety issue: No ]
    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. [ Time Frame: Day 1 through Day 28 post vaccination ] [ Designated as safety issue: No ]
    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.


Enrollment: 767
Study Start Date: October 2010
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluad
Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
Biological: MF59-adjuvanted trivalent influenza subunit vaccine
Experimental: Vantaflu_aTIV
Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
Biological: MF59-adjuvanted trivalent influenza subunit vaccine

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01222403

Locations
Korea, Republic of
KeeTaek Kim internal medicine Clinic
Gimpo, Gyeonggi-do, Korea, Republic of, 415-040
Jiguchon internal medicine Clinic
Jeongeup, Jeonrabuk-do, Korea, Republic of, 580-060
21th Century hana internal medicine clinic
Mokpo, Jeonranam-do, Korea, Republic of, 530-390
JoongAng family medicine Clinic
Suncheon, Jeonranam-do, Korea, Republic of, 540-150
Yonsei Universtity College of Medicine
Seodaemun-gu, Seoul, Korea, Republic of, 120-752
SaeSeoul internal medicine and radiology Clinic
Daejeon, Korea, Republic of, 770-160
Hangajok internal medicine clinic
Daejeon, Korea, Republic of, 300-110
Daejeon hospital
Daejeon, Korea, Republic of, 306-010
Ju Saengmyeong internal medicine Clinic
Daejeon, Korea, Republic of, 305-313
SeoIncheon catholic clinic
Incheon, Korea, Republic of, 404-190
TaeIl Jang internal medicine Clinic
Incheon, Korea, Republic of, 405-224
SeokYeon Kim internal medicine clinic
Incheon, Korea, Republic of, 407-806
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Yonsei University Severance Hospital
Seoul, Korea, Republic of, 120-752
Seoul medical center
Seoul, Korea, Republic of, 131-865
Global care internal medicine clinic
Seoul, Korea, Republic of, 135-271
Yeonsei Koum internal medicine Clinic
Seoul, Korea, Republic of, 138-201
Soon Chun Hyang University Hospital
Seoul, Korea, Republic of, 140-887
Gikim internal medicine clinic
Seoul, Korea, Republic of, 143-203
Lee internal medicine clinic
Seoul, Korea, Republic of, 143-210
Kangnam Sacred Heart Hospital
Seoul, Korea, Republic of, 150-950
Korea University Guro Hospital
Seoul, Korea, Republic of
Yonsei University Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01222403     History of Changes
Other Study ID Numbers: V70_26 
Study First Received: October 12, 2010
Results First Received: September 9, 2015
Last Updated: September 9, 2015
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on February 04, 2016