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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018603-29 | EudraCT Number |
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This study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted influenza vaccine administered to elderly subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | No comparator is administered, only one IM single dose of trivalent subunit inactivated influenza vaccine is administered during the vaccination visit |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seasonal flu vaccine | Biological | This phase II is performed as a multicenters study site in elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated adjuvanted flu vaccine during the vaccination visit, according to the study protocol (follow-up period: till day 22) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD | Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay. Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase. The European (Committee for Medicinal Products for Human Use [CHMP]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years). | day 22 |
| Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD | Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 22). The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.0 (≥65 years). | day 22 |
| Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD | Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 1) and three weeks after FLUAD vaccination (day 22). This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years). | day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Reported Solicited Local and Systemic Reactions | Safety was assessed for all participants who reported solicited local and systemic reactions from Day 1 up to and including Day 4 after the FLUAD vaccination in accordance with available safety data on influenza vaccines. | 1 to 4 days post-vaccination |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio, Via dei Vestini | Chieti | 66100 | Italy | |||
Blood samples for the determination of antibody titers were obtained prior to vaccination.
Overall, 64 participants ≥65 years of age were enrolled at 5 sites in Italy.
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| ID | Title | Description |
|---|---|---|
| FG000 | FLUAD | Participants received a single intramuscular (IM) dose of 0.5 milliliter (mL) of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Dipartimento di Medicina Clinica e Sperimentale - Sezione di Igiene e Medicina Preventiva, Via Fossato di Mortara, 64/b |
| Ferrara |
| 44100 |
| Italy |
| Dipartimento di Scienze della Salute Università di Genova Via Pastore, 1 | Genova | 16132 | Italy |
| Centro Satellite. ASL Lanciano - Vasto, sede legale Via S. Spaventa, 37 | Lanciano | 66034 | Italy |
| Centro Satellite. Distretto Sanitario di Base di Fossacesia in Via Polidoro-Vasto | Lanciano | Italy |
| Vaccine and Immunotherapy Research Center Department of Infectious and Tropical Diseases San Raffaele Scientific Institute Via Stamira d'Ancona, 20 | Milan | 20127 | Italy |
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| NOT COMPLETED |
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Baseline analysis population included all participants who were enrolled and randomized into the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | FLUAD | Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22. |
| 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 | Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD | Immunogenicity was measured as the percentage of participants who achieved seroconversion or significant increase in single radial hemolysis (SRH) area, against each of the three vaccine strains, three weeks after vaccination (day 22), evaluated using SRH assay. Seroconversion: proportion of participants with negative pre-vaccination serum and a post-vaccination serum area ≥ 25 mm2. Significant increase: proportion of participants with at least a 50% increase in area from positive pre-vaccination serum. Seroconversion or significant increase: proportion of participants with either seroconversion or significant increase. The European (Committee for Medicinal Products for Human Use [CHMP]) criterion is met, if percentage of participants achieving seroconversion or significant increase in SRH area is 30% (≥65 years). | Per protocol (PP) analysis set included all enrolled participants who had received the vaccine, provided evaluable serum samples before and after vaccination, and had no major protocol violation. | Posted | Number | 95% Confidence Interval | Percentage of participants | day 22 |
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| Secondary | Number of Participants Who Reported Solicited Local and Systemic Reactions | Safety was assessed for all participants who reported solicited local and systemic reactions from Day 1 up to and including Day 4 after the FLUAD vaccination in accordance with available safety data on influenza vaccines. | Analysis was done using the safety dataset; all participants exposed and who had post-baseline safety data were included in the safety analysis. | Posted | Number | Number of participants | 1 to 4 days post-vaccination |
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| Primary | Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD | Geometric mean ratio (GMR) of participants was calculated as the ratio of post-vaccination to pre-vaccination SRH geometric mean areas (GMAs), directed against each of the three vaccine strains, three weeks after FLUAD vaccination (day 22). The CHMP criterion was met if the geometric mean increase (GMR, day 22/day 1) in SRH antibody area is >2.0 (≥65 years). | Analysis was done using the PP dataset. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | day 22 |
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| Primary | Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD | Immunogenicity was measured as the percentage of participants achieving SRH area ≥25 mm2 against each of the three vaccine strains at baseline (day 1) and three weeks after FLUAD vaccination (day 22). This criterion is met according to CHMP guideline if percentage of participants achieving SRH area ≥25 mm2 is 60% (≥65 years). | Analysis was done using the PP dataset. | Posted | Number | 95% Confidence Interval | Percentage of participants | day 22 |
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From Day 1 through Day 22.
Adverse events other than local and systemic reactions or solicited reactions lasting longer than 4 days after vaccination were documented during the study period. Analysis was done using the safety dataset; all participants exposed and who had post-baseline safety data were included in the safety analysis.
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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 | Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22. | 0 | 64 | 4 | 64 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
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The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications 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 |
| Title | Measurements |
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