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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023791-63 | EudraCT Number |
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This study aims to evaluate the immunogenicity, by means of cell mediated immunity (CMI) and hemagglutination inhibition (HI) assay, and also the safety of a MF59C.1-adjuvanted subunit influenza vaccine compared with a conventional subunit vaccine in previously unvaccinated children aged 6 to <36 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
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| Arm 2 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MF59C.1-adjuvanted subunit influenza vaccine | Biological | 2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm |
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| Measure | Description | Time Frame |
|---|---|---|
| Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | The CMI responses were determined by intracellular staining/Fluorescence-Activated Cell Sorting(ICS/FACS) after in-vitro restimulation of PBMC with vaccine antigens on day 0 and day 50. | Day 1, Day 50 |
| Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV | The number of subjects reporting unsolicited AEs between Day 1 and the study termination i.e., Day 50, after receiving two doses of aTIV and TIV. Data are reported based on the Safety Set. | Day 1 to Day 50 post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer | To evaluate the immune responses by seroconversion of aTIV or TIV according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test on plasma from previously unvaccinated healthy children aged 6 to < 36 months for all three strains. Criteron: The proportion of subjects achieving seroconversion or significant increase in HI titer should be > 40%. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 21: GZA campus Sint Vincentius | Antwerp | 2018 | Belgium | |||
| Site 22: Kinderartsenpraktijk |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25037034 | Derived | Zedda L, Forleo-Neto E, Vertruyen A, Raes M, Marchant A, Jansen W, Clouting H, Arora A, Beatty ME, Galli G, Del Giudice G, Castellino F. Dissecting the immune response to MF59-adjuvanted and nonadjuvanted seasonal influenza vaccines in children less than three years of age. Pediatr Infect Dis J. 2015 Jan;34(1):73-8. doi: 10.1097/INF.0000000000000465. |
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All enrolled subjects were included in the trial.
Subjects were recruited from two sites in Belgium.
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| ID | Title | Description |
|---|---|---|
| FG000 | aTIV Group | Subjects received two doses (0.25mL) of MF59C.1-adjuvanted subunit influenza vaccine administered four weeks apart. |
| FG001 | TIV Group | Subjects received two doses (0.25mL) of inactivated, subunit influenza vaccine administered four weeks apart. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Sub unit, Inactivated, Influenza vaccine | Biological | 2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm |
|
| Day 50 |
| Geometric Mean Ratios (GMR) | To evaluate the immune responses by mean geometric increase (GMR) of aTIV or TIV according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test on plasma from previously unvaccinated healthy children aged 6 to < 36 months for all three strains. Criterion: Mean geometric increase (GMR) should be > 2.5. | Day 50/Day 1 |
| Percentage of Subjects With HI Titers >1:40 | To evaluate the immune responses by proportion of subjects with HI titers >1:40 of aTIV or TIV according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test on plasma from previously unvaccinated healthy children aged 6 to < 36 months for all three strains. Criterion: The proportion of subjects with HI titers >1:40 should be > 70% | Day 50 |
| Hasselt |
| 3500 |
| Belgium |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | aTIV Group | Subjects received two doses (0.25mL) of MF59C.1-adjuvanted subunit influenza vaccine administered four weeks apart. |
| BG001 | TIV Group | Subjects received two doses (0.25mL) of inactivated, subunit influenza vaccine administered four weeks apart. |
| 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 | Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. | The CMI responses were determined by intracellular staining/Fluorescence-Activated Cell Sorting(ICS/FACS) after in-vitro restimulation of PBMC with vaccine antigens on day 0 and day 50. | Per Protocol Set | Posted | Mean | 95% Confidence Interval | Cells per Million Total Cells | Day 1, Day 50 |
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| Primary | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV | The number of subjects reporting unsolicited AEs between Day 1 and the study termination i.e., Day 50, after receiving two doses of aTIV and TIV. Data are reported based on the Safety Set. | All subjects in the Exposed Set (all enrolled subjects who actually received a study vaccine) who provided post-baseline safety data. | Posted | Count of Participants | Participants | Day 1 to Day 50 post vaccination |
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| Secondary | Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer | To evaluate the immune responses by seroconversion of aTIV or TIV according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test on plasma from previously unvaccinated healthy children aged 6 to < 36 months for all three strains. Criteron: The proportion of subjects achieving seroconversion or significant increase in HI titer should be > 40%. | Per Protocol Set | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 50 |
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| Secondary | Geometric Mean Ratios (GMR) | To evaluate the immune responses by mean geometric increase (GMR) of aTIV or TIV according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test on plasma from previously unvaccinated healthy children aged 6 to < 36 months for all three strains. Criterion: Mean geometric increase (GMR) should be > 2.5. | Per Protocol Set | Posted | Geometric Mean | 95% Confidence Interval | titer ratio | Day 50/Day 1 |
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| Secondary | Percentage of Subjects With HI Titers >1:40 | To evaluate the immune responses by proportion of subjects with HI titers >1:40 of aTIV or TIV according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test on plasma from previously unvaccinated healthy children aged 6 to < 36 months for all three strains. Criterion: The proportion of subjects with HI titers >1:40 should be > 70% | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 50 |
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All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.
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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 | aTIV (6 to <36 Months) | 0 | 43 | 37 | 43 | |||
| EG001 | TIV (6 to <36 Months) | 2 | 41 | 29 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Varicella | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Crying | General disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Injection site haemorrhage | General disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Injection site induration | General disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Nasopharyngitis | General disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Bronchitis | General disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Eating Disorder | Psychiatric disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Irratability | Psychiatric disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | Novartis.email@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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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Male |
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| Any Cytokine - A/H1N1, Day 50 |
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| Any Cytokine - A/H3N2, Day 1 |
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| Any Cytokine - A/H3N2, Day 50 |
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| Any Cytokine - B/Brisbane, (N=19, 24), Day 1 |
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| Any Cytokine - B/Brisbane, Day 50 |
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| Any cytokine - B/Florida, Day 1 |
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| Any cytokine - B/Florida, Day 50 |
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| Any Cytokine - SEB, Day 1 |
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| Any Cytokine - SEB, Day 50 |
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| Any cytokine -Tetanus toxoid, Day 1 |
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| Any cytokine -Tetanus toxoid, Day 50 |
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| IL-2- A/H1N1, Day 1 |
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| IL-2- A/H1N1, Day 50 |
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| IL-2 - A/H3N2, Day 1 |
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| IL-2 - A/H3N2, Day 50 |
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| IL-2- B/Brisbane, Day 1 |
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| IL-2- B/Brisbane, Day 50 |
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| IL-2 - B/Florida, Day 1 |
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| IL-2 - B/Florida, Day 50 |
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| IL-2 - SEB, Day 1 |
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| IL-2 - SEB, Day 50 |
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| IL-2 - Tetanus toxoid, Day 1 |
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| IL-2 - Tetanus toxoid, Day 50 |
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| IFN-γ - A/H1N1, Day 1 |
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| IFN-γ - A/H1N1, Day 50 |
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| IFN-γ - A/H3N2, Day 1 |
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| IFN-γ - A/H3N2, Day 50 |
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| IFN-γ -B/Brisbane, Day 1 |
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| IFN-γ -B/Brisbane, Day 50 |
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| IFN-γ - B/Florida, Day 1 |
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| IFN-γ - B/Florida, Day 50 |
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| IFN-γ - SEB, Day 1 |
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| IFN-γ - SEB, Day 50 |
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| IFN-γ - Tetanus toxoid, Day 1 |
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| IFN-γ - Tetanus toxoid, Day 50 |
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| TNF-α- A/H1N1, Day 1 |
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| TNF-α- A/H1N1, Day 50 |
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| TNF-α - A/H3N2, Day 1 |
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| TNF-α - A/H3N2, Day 50 |
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| TNF-α - B/Brisbane, Day 1 |
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| TNF-α - B/Brisbane, Day 50 |
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| TNF-α - B/Florida, Day 1 |
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| TNF-α - B/Florida, Day 50 |
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| TNF-α-SEB, Day 1 |
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| TNF-α-SEB, Day 50 |
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| TNF-α-Tetanus toxoid, Day 1 |
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| TNF-α-Tetanus toxoid, Day 50 |
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| IL-13 - A/H1N1, Day 1 |
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| IL-13 - A/H1N1, Day 50 |
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| IL-13 - A/H3N2, Day 1 |
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| IL-13 - A/H3N2, Day 50 |
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| IL-13 - B/Brisbane, Day 1 |
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| IL-13 - B/Brisbane, Day 50 |
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| IL-13 - B/Florida, Day 1 |
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| IL-13 - B/Florida, Day 50 |
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| IL-13 -SEB, Day 1 |
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| IL-13 -SEB, Day 50 |
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| IL-13 -Tetanus toxoid, Day 1 |
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| IL-13 -Tetanus toxoid, Day 50 |
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