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Evaluate safety and immunogenicity of three influenza vaccines in adults 18 years of age and above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QIVc | Experimental | Influenza vaccine |
|
| TIV1c | Active Comparator | Influenza vaccine |
|
| TIV2c | Active Comparator | Influenza vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QIVc | Biological | Novartis Investigational Quadrivalent Vaccine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c | Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of GMT in subjects measured by hemagglutination inhibition (HI) assay, three weeks after vaccination with one dose of either QIVc or TIV1c and TIV2c. Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5. | Three weeks post vaccination (Day 22) |
| 2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c | Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with one dose of either QIVc,TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer | Three weeks post vaccination (Day 22) |
| Measure | Description | Time Frame |
|---|---|---|
| 3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts | Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against each vaccine strains, three weeks (day 22) after vaccination with ether QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.The CBER criterion for 18 to <65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40% and that for the ≥ 65 years age group should meet or exceed 30% |
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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 |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | 35802 | United States | |||
All enrolled subjects were included in the trial
Subjects were enrolled from 40 centers in US
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| ID | Title | Description |
|---|---|---|
| FG000 | QIVc (≥18 Years) | Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc) |
| FG001 | TIV1c (≥18 Years) | Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| TIV1c |
| Biological |
Licensed Influenza Vaccine |
|
| TIV2c | Biological | Novartis Investigational Vaccine |
|
| Three weeks post vaccination (Day 22) |
| 4. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age-cohorts | Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c The CBER criterion for 18 to <65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥ 1:40 should meet or exceed 70% and that for the ≥ 65 years age group should meet or exceed 60% | Three weeks post vaccination (Day 22) |
| 5.Geometric Mean Ratios (GMR) in Subjects After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts | Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of post-vaccination to pre-vaccination HI GMTs, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Committee for Medicinal Products for Human Use (CHMP) criterion for 18 to ≤60 years age group is >2.5 and that for ≥ 61 years age group is >2.0 | Three weeks post vaccination (Day 22) |
| 6. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts | Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving seroconversion or significant increase in HI titer is >40% and that for ≥ 61 years age group is >30% | Three weeks post vaccination (Day 22) |
| 7. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts | Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c and TIV2c The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving an HI titer ≥1:40 is >70% and that for ≥ 61 years age group is >60% | Three weeks post vaccination (Day 22) |
| 8.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c Against B2 Strain | Immunogenicity of QIVc to TIV1c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV1c. Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1. | Three weeks post vaccination (Day 22) |
| 9.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c Against B2 Strain | Immunogenicity of QIVc to TIV1c was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks (day 22) after vaccination with QIVc or TIV1c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points | Three weeks post vaccination (Day 22) |
| 10.GMT in Subjects After Receiving One Dose of Either QIVc, TIV2c Against B1 Strain | Immunogenicity of QIVc to TIV2c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV2c. Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1 | Three weeks post vaccination (Day 22) |
| 11.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV2c Against B1 Strain | Immunogenicity of QIVc to TIV2c in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks (day 22) after vaccination with QIVc or TIV2c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points | Three weeks post vaccination (Day 22) |
| 12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group | Safety was assessed in terms of number (%) of subjects reporting solicited local and systemic reactions, day 1 to 7 after vaccination with one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c) | Day 1 to 7 post vaccination |
| 13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group | Safety was assessed in terms of number (%) of subjects reporting unsolicited AEs (day 1 to 22 after vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs), and concomitant medications (day 1 to day 181 post vaccination) after receiving one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c) | Day 1 to 181 post vaccination |
| Phoenix |
| Arizona |
| 85050 |
| United States |
| Anaheim | California | 92801 | United States |
| San Diego | California | 92108 | United States |
| Coral Gables | Florida | 33134 | United States |
| Hollywood | Florida | 33024 | United States |
| Melbourne | Florida | 32935 | United States |
| South Miami | Florida | 33143 | United States |
| West Palm Beach | Florida | 33409 | United States |
| Peoria | Illinois | 61602 | United States |
| Mishawaka | Indiana | 46545 | United States |
| Council Bluffs | Iowa | 51503 | United States |
| Newton | Kansas | 67114 | United States |
| Wichita | Kansas | 67205 | United States |
| Wichita | Kansas | 67207 | United States |
| Metairie | Louisiana | 70006 | United States |
| Rockville | Maryland | 20850 | United States |
| Edina | Minnesota | 55435 | United States |
| Bellevue | Nebraska | 68005 | United States |
| Omaha | Nebraska | 68134 | United States |
| Endwell | New York | 13760 | United States |
| Rochester | New York | 14609 | United States |
| Cary | North Carolina | 27518 | United States |
| Charlotte | North Carolina | 28209 | United States |
| Raleigh | North Carolina | 27609 | United States |
| Wilmington | North Carolina | 28401 | United States |
| Oklahoma City | Oklahoma | 73112 | United States |
| Warwick | Rhode Island | 02886 | United States |
| Anderson | South Carolina | 29621 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Dakota Dunes | South Dakota | 57049 | United States |
| Austin | Texas | 78705 | United States |
| Austin | Texas | 78745 | United States |
| Dallas | Texas | 75231 | United States |
| Fort Worth | Texas | 76135 | United States |
| San Angelo | Texas | 76904 | United States |
| Salt Lake City | Utah | 84109 | United States |
| Salt Lake City | Utah | 84121 | United States |
| Salt Lake City | Utah | 84124 | United States |
| South Jordan | Utah | 84095 | United States |
| FG002 | TIV2c (≥18 Years) | Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | QIVc (≥18 Years) | Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc) |
| BG001 | TIV1c (≥18 Years) | Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season |
| BG002 | TIV2c (≥18 Years) | Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
|
| 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 | 1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c | Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of GMT in subjects measured by hemagglutination inhibition (HI) assay, three weeks after vaccination with one dose of either QIVc or TIV1c and TIV2c. Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5. | Analysis was done on Per Protocol (PP) Population i.e. all subjects in the Full Analysis Set (FAS) efficacy/immunogenicity population correctly receive the vaccine, have no major protocol deviations leading to exclusion as defined prior to unblinding/analysis and are not excluded due to other reasons defined prior to unblinding or analysis | Posted | Geometric Mean | 95% Confidence Interval | Titer | Three weeks post vaccination (Day 22) |
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| Primary | 2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c | Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with one dose of either QIVc,TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer | Analysis was done on PP population | Posted | Number | 95% Confidence Interval | percentage of subjects | Three weeks post vaccination (Day 22) |
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| Secondary | 3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts | Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against each vaccine strains, three weeks (day 22) after vaccination with ether QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.The CBER criterion for 18 to <65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40% and that for the ≥ 65 years age group should meet or exceed 30% | Analysis was done on FAS immunogenicity set i.e. all subjects in the enrolled set who receive the study vaccination and provide immunogenicity data at visit 1 and visit 2 | Posted | Number | 95% Confidence Interval | percentages of subjects | Three weeks post vaccination (Day 22) |
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| Secondary | 4. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age-cohorts | Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c The CBER criterion for 18 to <65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥ 1:40 should meet or exceed 70% and that for the ≥ 65 years age group should meet or exceed 60% | Analysis was done on FAS immunogenicity set. | Posted | Number | 95% Confidence Interval | percentages of subjects | Three weeks post vaccination (Day 22) |
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| Secondary | 5.Geometric Mean Ratios (GMR) in Subjects After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts | Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of post-vaccination to pre-vaccination HI GMTs, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Committee for Medicinal Products for Human Use (CHMP) criterion for 18 to ≤60 years age group is >2.5 and that for ≥ 61 years age group is >2.0 | Analysis was done on FAS immunogenicity set. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Three weeks post vaccination (Day 22) |
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| Secondary | 6. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts | Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving seroconversion or significant increase in HI titer is >40% and that for ≥ 61 years age group is >30% | Analysis was done on FAS immunogenicity set. | Posted | Number | 95% Confidence Interval | percentages of subjects | Three weeks post vaccination (Day 22) |
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| Secondary | 7. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts | Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c and TIV2c The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving an HI titer ≥1:40 is >70% and that for ≥ 61 years age group is >60% | Analysis was done on FAS immunogenicity set. | Posted | Number | 95% Confidence Interval | percentages of subjects | Three weeks post vaccination (Day 22) |
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| Secondary | 8.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c Against B2 Strain | Immunogenicity of QIVc to TIV1c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV1c. Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1. | Analysis was done on FAS population | Posted | Geometric Mean | 95% Confidence Interval | Titers | Three weeks post vaccination (Day 22) |
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| Secondary | 9.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c Against B2 Strain | Immunogenicity of QIVc to TIV1c was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks (day 22) after vaccination with QIVc or TIV1c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points | Analysis was done on FAS population | Posted | Number | 95% Confidence Interval | percentages of subjects | Three weeks post vaccination (Day 22) |
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| Secondary | 10.GMT in Subjects After Receiving One Dose of Either QIVc, TIV2c Against B1 Strain | Immunogenicity of QIVc to TIV2c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV2c. Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1 | Analysis was done on FAS population | Posted | Geometric Mean | 95% Confidence Interval | Titers | Three weeks post vaccination (Day 22) |
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| Secondary | 11.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV2c Against B1 Strain | Immunogenicity of QIVc to TIV2c in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks (day 22) after vaccination with QIVc or TIV2c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points | Analysis was done on FAS population | Posted | Number | 95% Confidence Interval | percentages of subjects | Three weeks post vaccination (Day 22) |
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| Secondary | 12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group | Safety was assessed in terms of number (%) of subjects reporting solicited local and systemic reactions, day 1 to 7 after vaccination with one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c) | Analysis was done on solicited safety data set i.e. all subjects in the exposed set with solicited adverse event data | Posted | Number | Subjects | Day 1 to 7 post vaccination |
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| Secondary | 13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group | Safety was assessed in terms of number (%) of subjects reporting unsolicited AEs (day 1 to 22 after vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs), and concomitant medications (day 1 to day 181 post vaccination) after receiving one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c) | Analysis was done on unsolicited safety data set i.e. all subjects in the exposed set with unsolicited adverse event data | Posted | Number | Subjects | Day 1 to 181 post vaccination |
|
Solicited AEs were collected from day 1to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 22 post vaccination and SAEs were collected from day 1 to day 181
All the unsolicited AEs were reported by non-systematic assessment and the solicited AEs were reported by systemic assessment.
For SAEs- analysis was done on Unsolicited safety set. For Other Aes-analysis was done on overall safety set.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | QIVc (≥18 Years) | Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc) | 52 | 1,324 | 681 | 1,324 | ||
| EG001 | TIV1c (≥ 18 Years) | Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season | 22 | 673 | 332 | 673 | ||
| EG002 | TIV2c (≥18 Years) | Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 | 21 | 665 | 335 | 665 | ||
| EG003 | Total | Total Number of Subjects | 95 | 2,662 | 1,348 | 2,662 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HISTIOCYTOSIS HAEMATOPHAGIC | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| ARTERIOSCLEROSIS CORONARY ARTERY | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| CARDIAC ARREST | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| CARDIAC FAILURE ACUTE | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| MITRAL VALVE INCOMPETENCE | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| VENTRICULAR FIBRILLATION | Cardiac disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| LOWER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| CORONARY ARTERY RESTENOSIS | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| DEATH | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| STRANGULATED HERNIA | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| ESCHERICHIA SEPSIS | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| MENINGITIS VIRAL | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| PNEUMONIA LEGIONELLA | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 17.0 | Non-systematic Assessment |
| |
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 17.0 | Non-systematic Assessment |
| |
| POSTOPERATIVE ILEUS | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| TENDON RUPTURE | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| HYPOVOLAEMIA | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| MUSCLE HAEMORRHAGE | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| ACUTE MYELOID LEUKAEMIA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| CERVIX CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| ENDOMETRIAL ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| ENDOMETRIAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| METASTASES TO LUNG | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| OVARIAN ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| TRANSITIONAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
| |
| AMYOTROPHIC LATERAL SCLEROSIS | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| GENERALISED TONIC-CLONIC SEIZURE | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
| |
| ALCOHOLISM | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| BIPOLAR DISORDER | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
| |
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
| |
| ENDOMETRIOSIS | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| IMPLANTABLE DEFIBRILLATOR INSERTION | Surgical and medical procedures | MedDRA 17.0 | Systematic Assessment |
| |
| ARTERIOSCLEROSIS | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| INJECTION SITE ERYTHEMA | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| INJECTION SITE HAEMORRHAGE | General disorders | MedDRA 17.0 | Non-systematic Assessment |
| |
| INJECTION SITE INDURATION | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| INJECTION SITE PAIN | General disorders | MedDRA 17.0 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
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 |
Not provided
Not provided
| Male |
|
| H1N1: Day 22(N=1250,635,NA) |
|
| H3N2: Day 1(N=1250,635,NA) |
|
| H3N2: Day 22(N=1250,635,NA) |
|
| B1:Day 1(N=1250,635,NA) |
|
| B1:Day 22(N=1250,635,NA) |
|
| B2:Day 1(N=1250,NA,639) |
|
| B2:Day 22(N=1250,NA,639) |
|
|
Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain H3N2 |
| ANCOVA |
| Ratios of GMT |
| 1.0 |
| 2-Sided |
| 95 |
| 0.9 |
| 1.1 |
| Yes |
| Non-Inferiority or Equivalence |
Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5 |
| Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain B1 | ANCOVA | Ratios of GMT | 0.9 | 2-Sided | 95 | 0.8 | 1.0 | Yes | Non-Inferiority or Equivalence | Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5 |
| Non-inferiority of immune responses of QIVc to TIV2c, assessed in terms of ratios of GMT against influenza strain B2 | ANCOVA | Ratios of GMT | 0.9 | 2-Sided | 95 | 0.9 | 1.0 | Yes | Non-Inferiority or Equivalence | Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV2c/GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5 |
Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
|
|
|
| OG002 | TIV1c (18 to <65 Years) | Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013- 2014 season |
| OG003 | TIV1c (≥ 65 Years) | Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1)recommended for 2013-2014 season |
| OG004 | TIV2c (18 to <65 Years) | Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 |
| OG005 | TIV2c (≥ 65 Years) | Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 |
|
|
| OG003 |
| TIV1c (≥ 65 Years) |
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season |
| OG004 | TIV2c (18 to <65 Years) | Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 |
| OG005 | TIV2c (≥ 65 Years) | Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 |
|
|
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season |
| OG004 | TIV2c (18 to ≤60 Years) | Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 |
| OG005 | TIV2c (≥ 61 Years) | Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 |
|
|
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
| OG003 | TIV1c (≥ 61 Years) | Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season |
| OG004 | TIV2c (18 to ≤60 Years) | Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 |
| OG005 | TIV2c (≥ 61 Years) | Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 |
|
|
Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season |
| OG004 | TIV2c (18 to ≤60 Years) | Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 |
| OG005 | TIV2c (≥ 61 Years) | Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 |
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|