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NCT01222403 Clinical Trial

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

Influenza Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01222403
Other study ID # V70_26
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 2010
Est. completion date October 2014

Study information
Verified date May 2019
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 767
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Fluad_MF59-adjuvanted trivalent influenza subunit vaccine

• Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccine

Locations
Country Name City State
Korea, Republic of Daejeon hospital Daejeon
Korea, Republic of Hangajok internal medicine clinic Daejeon
Korea, Republic of Ju Saengmyeong internal medicine Clinic Daejeon
Korea, Republic of SaeSeoul internal medicine and radiology Clinic Daejeon
Korea, Republic of KeeTaek Kim internal medicine Clinic Gimpo-si Gyeonggi-do
Korea, Republic of SeoIncheon catholic clinic Incheon
Korea, Republic of SeokYeon Kim internal medicine clinic Incheon
Korea, Republic of TaeIl Jang internal medicine Clinic Incheon
Korea, Republic of Jiguchon internal medicine Clinic Jeongeup Jeonrabuk-do
Korea, Republic of 21th Century hana internal medicine clinic Mokpo Jeonranam-do
Korea, Republic of Gikim internal medicine clinic Seoul
Korea, Republic of Global care internal medicine clinic Seoul
Korea, Republic of Kangnam Sacred Heart Hospital Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Lee internal medicine clinic Seoul
Korea, Republic of Seoul medical center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Soon Chun Hyang University Hospital Seoul
Korea, Republic of Yeonsei Koum internal medicine Clinic Seoul
Korea, Republic of Yonsei University Severance Hospital Seoul
Korea, Republic of Yonsei University Severance Hospital Seoul
Korea, Republic of Yonsei Universtity College of Medicine Sinchon-dong Seoul
Korea, Republic of JoongAng family medicine Clinic Suncheon Jeonranam-do

Sponsors (1)
Lead Sponsor Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. The number of subjects reporting any solicited local and systemic AEs, following vaccination with Fluad_aTIV and Vantaflu_aTIV. Day 1 through Day 4 after vaccination
Primary Number of Subjects Reporting Unsolicited AEs After Vaccination. The number of subjects reporting any unsolicited AEs following vaccination with Fluad_aTIV and Vantaflu_aTIV. Day 1 through Day 28 post vaccination
Primary Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After 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. Day 1 through Day 28 post vaccination
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