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This study will evaluate the safety of an influenza (flu) vaccine in Korean men and women aged 65 years and older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluad | Experimental | Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV). |
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| Vantaflu_aTIV | Experimental | Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluad_MF59-adjuvanted trivalent influenza subunit vaccine | Biological |
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| Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KeeTaek Kim internal medicine Clinic | Gimpo-si | Gyeonggi-do | 415-040 | South Korea | ||
| Jiguchon internal medicine Clinic |
All subjects were included in the trial.
Subjects were recruited from 24 study sites in Korea.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluad_aTIV | Subjects aged >65 years received one dose of Fluad_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine. |
| FG001 | Vantaflu_aTIV | Subjects aged >65 years received one dose of Vantaflu_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Biological |
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| Jeongeup |
| Jeonrabuk-do |
| 580-060 |
| South Korea |
| 21th Century hana internal medicine clinic | Mokpo | Jeonranam-do | 530-390 | South Korea |
| JoongAng family medicine Clinic | Suncheon | Jeonranam-do | 540-150 | South Korea |
| Yonsei Universtity College of Medicine | Sinchon-dong | Seoul | 120-752 | South Korea |
| Hangajok internal medicine clinic | Daejeon | 300-110 | South Korea |
| Ju Saengmyeong internal medicine Clinic | Daejeon | 305-313 | South Korea |
| Daejeon hospital | Daejeon | 306-010 | South Korea |
| SaeSeoul internal medicine and radiology Clinic | Daejeon | 770-160 | South Korea |
| SeoIncheon catholic clinic | Incheon | 404-190 | South Korea |
| TaeIl Jang internal medicine Clinic | Incheon | 405-224 | South Korea |
| SeokYeon Kim internal medicine clinic | Incheon | 407-806 | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| Yonsei University Severance Hospital | Seoul | 120-752 | South Korea |
| Seoul medical center | Seoul | 131-865 | South Korea |
| Global care internal medicine clinic | Seoul | 135-271 | South Korea |
| Yeonsei Koum internal medicine Clinic | Seoul | 138-201 | South Korea |
| Soon Chun Hyang University Hospital | Seoul | 140-887 | South Korea |
| Gikim internal medicine clinic | Seoul | 143-203 | South Korea |
| Lee internal medicine clinic | Seoul | 143-210 | South Korea |
| Kangnam Sacred Heart Hospital | Seoul | 150-950 | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Yonsei University Severance Hospital | Seoul | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluad_aTIV | Subjects aged >65 years received one dose of Fluad_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine. |
| BG001 | Vantaflu_aTIV | Subjects aged >65 years received one dose of Vantaflu_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis was done on safety population ie. all subjects in the exposed set who provided postvaccination safety data. | Posted | Number | participants | Day 1 through Day 4 after vaccination |
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| 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. | Analysis was done on safety population. | Posted | Number | participants | Day 1 through Day 28 post vaccination |
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| 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. | Analysis was done on safety population. | Posted | Number | participants | Day 1 through Day 28 post vaccination |
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Throughout the study (Day 1 through Day 28).
All solicited AEs and unsolicited AEs were collected from Day 1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 28.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fluad_aTIV | Subjects aged >65 years received one dose of Fluad_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine. | 0 | 386 | 163 | 386 | ||
| EG001 | Vantaflu_aTIV | Subjects aged >65 years received one dose of Vantaflu_aTIV: investigational MF59-adjuvanted trivalent influenza vaccine. | 0 | 379 | 155 | 379 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Chills | General disorders | MedDRA (17.1) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| Male |
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| Erythema (Type I) |
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| Erythema (Type II) |
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| Induration (Type I) |
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| Induration (Type II) |
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| Swelling (Type I) |
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| Swelling (Type II) |
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| Pain at injection site |
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| Tenderness at injection site |
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| Chills |
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| Myalgia |
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| Arthralgia |
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| Headache |
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| Sweating |
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| Fatigue |
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