InfluenzaPhase 4NCT01222403

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

A Phase 4 study testing Fluad_MF59-adjuvanted trivalent influenza subunit vaccine and Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccine in people with Influenza, run by Novartis Vaccines at 23 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Fluad_MF59-adjuvanted trivalent influenza subunit vaccine and Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 767 participants
Where: 23 sitesSouth Korea
Study dates: Oct 2010to Oct 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

South Korea23 sites

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

Other trials in South Korea

About this study

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.

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

Conditions: Influenza
Being tested: Fluad_MF59-adjuvanted trivalent influenza subunit vaccine, Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccine
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fluad_MF59-adjuvanted trivalent influenza subunit vaccineBiological
Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccineBiological

Study groups in NCT01222403
Study group	Role	What they receive
Fluad	Experimental	Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV). Receives: Biological: Fluad_MF59-adjuvanted trivalent influenza subunit vaccine
Vantaflu_aTIV	Experimental	Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV). Receives: Biological: Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 1 through Day 4 after vaccination
Number of Subjects Reporting Unsolicited AEs After Vaccination.
The number of subjects reporting any unsolicited AEs following vaccination with Fluad_aTIV and Vantaflu_aTIV.
Measured: Day 1 through Day 28 post vaccination
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.
Measured: Day 1 through Day 28 post vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010Oct 2014

First posted18 Oct 2010 (estimated)
Study startOct 2010
Primary completionOct 2014
Study completionOct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InfluenzaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 767 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01222403
Sponsor's protocol ID: V70_26
Status last verified: May 2019
First submitted: 12 Oct 2010
Last updated: 12 Jun 2019
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT01222403
Acronym / sponsor ID: V70_26
Conditions: Influenza
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 767 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 18 Oct 2010 (estimated)
Results: Posted 12 Oct 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fluad	Experimental	Biological: Fluad_MF59-adjuvanted trivalent influenza subunit vaccineSubjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
Vantaflu_aTIV	Experimental	Biological: Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccineSubjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fluad_MF59-adjuvanted trivalent influenza subunit vaccine	Biological	Fluad
Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccine	Biological	Vantaflu_aTIV

Primary outcome

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.
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.
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.

Results and safety

Results posted to the registry on 12 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fluad_aTIV	386	386
Vantaflu_aTIV	381	379

Primary outcome: Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination.

Time frame: Day 1 through Day 4 after vaccination. Number. Unit: participants

Measure	Fluad_aTIV n = 386	Vantaflu_aTIV n = 379
Any Local	134	122
Any Systemic	74	72
Erythema (Type I)	14	21
Erythema (Type II)	9	3
Induration (Type I)	8	14
Induration (Type II)	5	0
Swelling (Type I)	17	25
Swelling (Type II)	5	3

Population analysed: Analysis was done on safety population ie. all subjects in the exposed set who provided postvaccination safety data.

Primary outcome: Number of Subjects Reporting Unsolicited AEs After Vaccination.

Time frame: Day 1 through Day 28 post vaccination. Number. Unit: participants

Measure	Fluad_aTIV n = 386	Vantaflu_aTIV n = 379
Any AEs	15	18
Possibly/probably related AEs	3	1

Population analysed: Analysis was done on safety population.

Primary outcome: Number of Subjects Reporting Unsolicited Serious Adverse Events (SAEs) After Vaccination.

Time frame: Day 1 through Day 28 post vaccination. Number. Unit: participants

Measure	Fluad_aTIV n = 386	Vantaflu_aTIV n = 379
SAEs	0	0
At least possibly related SAEs	0	0
AEs leading to hospitalization	0	0
AEs leading to interruption or delay	0	0
AEs resulting in premature withdrawal	0	0
Deaths	0	0

Population analysed: Analysis was done on safety population.

Adverse events

Time frame: Throughout the study (Day 1 through Day 28).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluad_aTIV	0 of 386 (0%)	163 of 386 (42.2%)	Not reported
Vantaflu_aTIV	0 of 379 (0%)	155 of 379 (40.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

23 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects Reporting Solicited Adverse Events (AEs) After Vaccination. (time frame: Day 1 through Day 4 after vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01222403.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2019.