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: November 27, 2014
Last verified: November 2014
  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 influenza subunit vaccine
Phase 4

Study Type: Interventional
Study Design: 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 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:
  • Occurrence of solicited local (tenderness, erythema, induration, swelling and pain at the injection site) and systemic reactions (chills, myalgia, arthralgia, headache, sweating, fatigue and fever) [ Time Frame: For 4 days following vaccine dose ] [ Designated as safety issue: Yes ]
  • Occurrence of unsolicited adverse events [ Time Frame: Upto 28 days follow-up period after vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence of serious adverse events [ Time Frame: During the entire period of study ] [ Designated as safety issue: Yes ]

Enrollment: 770
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
65 and above
Biological: MF59- adjuvanted influenza subunit vaccine
immunization

  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 are 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
29 KeeTaek Kim internal medicine Clinic
Gimpo, Gyeonggi-do, Korea, Republic of, 415-040
28 Jiguchon internal medicine Clinic
Jeongeup, Jeonrabuk-do, Korea, Republic of, 580-060
10 21th Century hana internal medicine clinic
Mokpo, Jeonranam-do, Korea, Republic of, 530-390
27 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
23 SaeSeoul internal medicine and radiology Clinic
Daejeon, Korea, Republic of, 770-160
16 Daejeon hospital
Daejeon, Korea, Republic of, 306-010
17 Ju Saengmyeong internal medicine Clinic
Daejeon, Korea, Republic of, 305-313
18 Ju Saengmyeong internal medicine Clinic
Daejeon, Korea, Republic of, 305-313
19 SaeSeoul internal medicine and radiology Clinic
Daejeon, Korea, Republic of, 770-160
20 SaeSeoul internal medicine and radiology Clinic
Daejeon, Korea, Republic of, 770-160
21 SaeSeoul internal medicine and radiology Clinic
Daejeon, Korea, Republic of, 770-160
22 SaeSeoul internal medicine and radiology Clinic
Daejeon, Korea, Republic of, 770-160
15 Hangajok internal medicine clinic
Daejeon, Korea, Republic of, 300-110
24 TaeIl Jang internal medicine Clinic
Incheon, Korea, Republic of, 405-224
25 SeoIncheon catholic clinic
Incheon, Korea, Republic of, 404-190
26 SeokYeon Kim internal medicine clinic
Incheon, Korea, Republic of, 407-806
Yonsei University Severance Hospital
Seoul, Korea, Republic of
05 Yonsei University Severance Hospital
Seoul, Korea, Republic of, 120-752
06 Kangnam Sacred Heart Hospital
Seoul, Korea, Republic of, 150-950
12 Gikim internal medicine clinic
Seoul, Korea, Republic of, 143-203
13 Lee internal medicine clinic
Seoul, Korea, Republic of, 143-210
14 Global care internal medicine clinic
Seoul, Korea, Republic of, 135-271
30 Yeonsei Koum internal medicine Clinic
Seoul, Korea, Republic of, 138-201
31 Soon Chun Hyang University Hospital
Seoul, Korea, Republic of, 140-887
32 Seoul medical center
Seoul, Korea, Republic of, 131-865
33 Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Korea University Guro Hospital
Seoul, Korea, Republic of
04 Soon Chun Hyang University Hospital
Seoul, Korea, Republic of, 140-887
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
Last Updated: November 27, 2014
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 May 27, 2015