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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002080-26 | EudraCT Number |
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The study is designed to evaluate the safety of TIVc or TIV vaccine in children 3 to < 18 years of age who are at risk of complications of influenza disease due to underlying diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIVc | Experimental | flu vaccine |
|
| TIV | Active Comparator | flu vaccine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIVc | Biological | Madin Darby Canine Kidney (MDCK) cell culture derived subunit influenza vaccine TIVc contained the purified viral envelope glycoproteins, hemagglutinin (HA) and neuraminidase (NA) derived from 3 strains (including HA for each strain [A/H1N1-like, A/H3N2-like, and B-like]) intramuscular (IM) injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group | Safety was assessed in terms of number of the subjects (3 to < 18 years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV | Day 1 through Day 7 post injection 1 and Day 29 through Day 35 post injection 2 |
| Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata | Safety was assessed in terms of number of the subjects (3 to <6 years,(≥ 6 to < 9 years and 9 to <18 Years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV | Day 1 through Day 7 after any vaccination |
| Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata | Safety was assessed in terms of number of subjects who reported any unsolicited AEs (four weeks after 1st vaccination and up to three weeks after 2nd vaccination), serious adverse events (SAEs), new onset of chronic diseases (NOCD), medically attended AEs and AEs leading to vaccine/study withdrawal after receiving one or two doses of either TIVc or TIV by overall age group (3 to <18 years) and age sub-strata (3 to <9 years and 9 to <18 years) | Day 1 -Day 181(one dose group) Day 1 -Day 209(two dose group) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigational Site 022 | Florence | 50139 | Italy | |||
| Novartis Investigational Site 020 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27343983 | Derived | Diez-Domingo J, de Martino M, Lopez JG, Zuccotti GV, Icardi G, Villani A, Moreno-Perez D, Hernandez MM, Aldean JA, Mateen AA, Enweonye I, de Rooij R, Chandra R. Safety and tolerability of cell culture-derived and egg-derived trivalent influenza vaccines in 3 to <18-year-old children and adolescents at risk of influenza-related complications. Int J Infect Dis. 2016 Aug;49:171-8. doi: 10.1016/j.ijid.2016.06.018. Epub 2016 Jun 23. |
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All enrolled subjects were included in the trial.
Subjects were recruited from 12 centers in Spain and 4 centers from Italy.
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| ID | Title | Description |
|---|---|---|
| FG000 | TIVc (3 to <18 Years) | Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc) |
| FG001 | TIV (3 to <18 Years) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| TIV | Biological | A conventional egg derived subunit influenza vaccine (TIV) contained the purified viral envelope-glycoproteins, HA and NA derived from 3 strains (including HA for each strain [A/ H1N1-like, A/H3N2-like, and B-like]) IM injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere. |
|
| Genova |
| 16132 |
| Italy |
| Novartis Investigational Site 021 | Milan | 20157 | Italy |
| Novartis Investigational Site 023 | Roma | 165 | Italy |
| Novartis Investigational Site 031 | Badalona | Barcelona | 8916 | Spain |
| Novartis Investigational Site 017 | Burriana | Castellon | 12530 | Spain |
| Novartis Investigational Site 016 | Castellon | Castellon | 12004 | Spain |
| Novartis Investigational Site 010 | Marbella | Malaga | 29603 | Spain |
| Novartis Investigational Site 015 | L'Eliana | Valencia | 46183 | Spain |
| Novartis Investigational Site 013 | Paiporta | Valencia | 46200 | Spain |
| Novartis Investigational Site 018 | Quart de Poblet | Valencia | 46930 | Spain |
| Novartis Investigational Site 030 | Madrid | 28050 | Spain |
| Novartis Investigational Site 011 | Málaga | 29011 | Spain |
| Novartis Investigational Site 019 | Valencia | 46017 | Spain |
| Novartis Investigational Site 014 | Valencia | 46020 | Spain |
| Novartis Investigational Site 012 | Valencia | 46024 | Spain |
Vaccine naive and non-naïve subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | TIVc (3 to <18 Years) | Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc) |
| BG001 | TIV (3 to <18 Years) | Vaccine naive and non-naïve subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV) |
| 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 | year |
| |||||||||||||||
| 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) Following Vaccination With Either TIVc or TIV by Overall Age Group | Safety was assessed in terms of number of the subjects (3 to < 18 years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV | Analysis was done on safety dataset, i.e. the subjects in the Exposed Set who provided post-vaccination solicited AE data | Posted | Number | Subjects | Day 1 through Day 7 post injection 1 and Day 29 through Day 35 post injection 2 |
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| |||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata | Safety was assessed in terms of number of the subjects (3 to <6 years,(≥ 6 to < 9 years and 9 to <18 Years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV | Analysis was done on safety dataset | Posted | Number | Subjects | Day 1 through Day 7 after any vaccination |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata | Safety was assessed in terms of number of subjects who reported any unsolicited AEs (four weeks after 1st vaccination and up to three weeks after 2nd vaccination), serious adverse events (SAEs), new onset of chronic diseases (NOCD), medically attended AEs and AEs leading to vaccine/study withdrawal after receiving one or two doses of either TIVc or TIV by overall age group (3 to <18 years) and age sub-strata (3 to <9 years and 9 to <18 years) | Analysis was done on unsolicited safety dataset, i.e. all subjects in the Exposed Set who have post-vaccination unsolicited AE records (even if no AEs have occurred) | Posted | Number | Subjects | Day 1 -Day 181(one dose group) Day 1 -Day 209(two dose group) |
|
Solicited local,systemic AEs collected -day 1 through Day 7 post injection 1 and Day 29 through Day 35 post injection 2, unsolicited AEs -Day 1 through Day 29 post 1st vaccination and Day 29 to Day 57 post 2nd vaccination. SAEs Day 1 through end of study
Subjects 9 to <18 years of age were determined to be "previously vaccinated (vaccine non-naive)" by default. Analysis was done on unsolicited safety set-All subjects in the exposed set who had postvaccination unsolicited AE records (even if no AEs were reported).
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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 | TIVc (3 to <18 Years) | Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc). | 12 | 278 | 246 | 278 | ||
| EG001 | TIV (3 to <18 Years) | Vaccine naive and non-naïve subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV) | 4 | 148 | 126 | 148 | ||
| EG002 | Total | Total Number of subjects | 16 | 426 | 372 | 426 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LYMPHADENITIS | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
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| SICKLE CELL ANAEMIA WITH CRISIS | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
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| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
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| MASTOIDITIS | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
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| PHARYNGOTONSILLITIS | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
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| POST PROCEDURAL COMPLICATION | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
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| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
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| COMPLEX PARTIAL SEIZURES | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
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| TOXIC ENCEPHALOPATHY | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
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| ANXIETY DISORDER | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
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| ASTHMATIC CRISIS | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| BRONCHOPNEUMOPATHY | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| BRONCHOSPASM | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 17.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| CHILLS | General disorders | MedDRA 17.0 | Non-systematic Assessment |
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| FATIGUE | General disorders | MedDRA 17.0 | Non-systematic Assessment |
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| INJECTION SITE ERYTHEMA | General disorders | MedDRA 17.0 | Systematic Assessment |
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| INJECTION SITE HAEMORRHAGE | General disorders | MedDRA 17.0 | Systematic Assessment |
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| INJECTION SITE INDURATION | General disorders | MedDRA 17.0 | Systematic Assessment |
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| INJECTION SITE PAIN | General disorders | MedDRA 17.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 17.0 | Non-systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
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| OTITIS MEDIA ACUTE | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
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| PHARYNGITIS | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
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| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
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| TONSILLITIS | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| VIRAL INFECTION | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 17.0 | Non-systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Non-systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
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| SOMNOLENCE | Nervous system disorders | MedDRA 17.0 | Non-systematic Assessment |
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| EATING DISORDER | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
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| IRRITABILITY | Psychiatric disorders | MedDRA 17.0 | Non-systematic Assessment |
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| ASTHMATIC CRISIS | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| BRONCHOSPASM | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Non-systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| 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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| Injection Site Tenderness |
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| Injection Site Pain |
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| Injection site erythema ,< 6 years |
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| Injection site induration < 6 years |
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| Injection site ecchymosis < 6 years |
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| Injection site erythema >=6 years |
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| Injection site induration >=6years |
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| Injection site ecchymosis >= 6 years |
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| Any Systemic |
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| Change in eating habits |
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| Chills |
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| Diarrhea |
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| Irritability |
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| Sleepiness |
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| Vomiting |
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| Arthralgia |
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| Fatigue |
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| Headache |
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| Loss of appetite |
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| Myalgia |
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| Nausea |
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| Body Temp. ( >= 38C ) |
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| Treatment of pain and or fever |
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| Prevention of pain and or fever |
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Vaccine nonnaïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV) |
| OG004 | TIV_naive_inj 1 (3 to <6 Years) | Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV) |
| OG005 | TIV_naive_inj 2 (3 to <6 Years) | Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV) |
| OG006 | TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years) | Vaccine non-naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc) |
| OG007 | TIVc_Naive_inj 1 (≥ 6 to < 9 Years) | Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc) |
| OG008 | TIVc_Naive_inj 2 (≥ 6 to < 9 Years) | Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc) |
| OG009 | TIV_Non Naive_inj 1 (≥ 6 to < 9 Years) | Vaccine non-naïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV) |
| OG010 | TIV_Naive_inj 1 (≥ 6 to < 9 Years) | Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV) |
| OG011 | TIV_Naive_inj 2 (≥ 6 to < 9 Years) | Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV) |
| OG012 | TIVc_Non Naive (9 to <18 Years) | Vaccine nonnaïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc) |
| OG013 | TIV_Non Naive (9 to <18 Years) | Vaccine nonnaïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV) |
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|
Vaccine naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
| OG003 | TIVc_Non Naive (3 to <9 Years) | Vaccine non naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc) |
| OG004 | TIVc_Non Naive (9 to <18 Years) | Vaccine nonnaïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc) |
| OG005 | TIV_Naive (3 to <9 Years) | Vaccine naïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV) |
| OG006 | TIV_Non Naive (3 to <9 Years) | Vaccine non naïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV) |
| OG007 | TIV_Non Naive (9 to <18 Years) | Vaccine nonnaïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV) |
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