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

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ClinicalTrials.gov Identifier: NCT01222403
Recruitment Status : Completed
First Posted : October 18, 2010
Results First Posted : October 12, 2015
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Influenza Biological: MF59-adjuvanted trivalent influenza subunit vaccine Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 767 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : October 2010
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Hangajok internal medicine clinic
Daejeon, Korea, Republic of, 300-110
Ju Saengmyeong internal medicine Clinic
Daejeon, Korea, Republic of, 305-313
Daejeon hospital
Daejeon, Korea, Republic of, 306-010
SaeSeoul internal medicine and radiology Clinic
Daejeon, Korea, Republic of, 770-160
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

Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01222403     History of Changes
Other Study ID Numbers: V70_26
First Posted: October 18, 2010    Key Record Dates
Results First Posted: October 12, 2015
Last Update Posted: October 12, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
MF59 oil emulsion
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic