Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluate safety and immunogenicity of three influenza vaccines in children ages greater than 4 years old to less than 18 years old.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QIVc (≥4 to <18 years) | Experimental | Subjects received one or two doses of QIVc-Quadrivalent Cell-based Influenza Vaccine recommended for 2013-2014 season |
|
| TIV1c (≥4 to <18 years) | Active Comparator | Subjects received one or two doses of TIV1c (Trivalent Inactivated Cell-based Influenza Vaccine containing one strain from B lineage ("B1" strain) recommended for 2013-2014 season |
|
| TIV2c (≥4 to <18 years) | Active Comparator | Subjects received one or two doses of TIV2c (Trivalent Inactivated Cell-based Influenza Vaccine containing B strain from the alternate lineage ("B2" strain) recommended for 2013-2014 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QIVc | Biological | Novartis Investigational Quadrivalent Vaccine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | Immunogenicity of QIVc to comparator TIV1c (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by hemagglutination inhibition (HI) assay, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or 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. | Day 1,Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) |
| Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c | Immunogenicity of QIVc to comparator TIVc (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase (at least a 4-fold increase in HI titer in subjects seropositive at baseline [i.e., HI titer ≥1:10 at Day 1] ) in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive 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 for previously vaccinated and Day 50 for Not previously vaccinated subjects) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive 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 Center for Biologics Evaluation, Research, and Review (CBER) criterion for an adult population 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% |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | 35802 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26585940 | Derived | Hartvickson R, Cruz M, Ervin J, Brandon D, Forleo-Neto E, Dagnew AF, Chandra R, Lindert K, Mateen AA. Non-inferiority of mammalian cell-derived quadrivalent subunit influenza virus vaccines compared to trivalent subunit influenza virus vaccines in healthy children: a phase III randomized, multicenter, double-blind clinical trial. Int J Infect Dis. 2015 Dec;41:65-72. doi: 10.1016/j.ijid.2015.11.004. Epub 2015 Nov 14. |
Not provided
Not provided
All enrolled subjects were included in the trial
Subjects were recruited from 90 centers in the United States (US)
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | QIVc | Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season |
| FG001 | TIV1c | Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| TIV1c |
| Biological |
Licensed Influenza Vaccine |
|
| TIV2c | Biological | Novartis Investigational Vaccine |
|
| Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) |
| Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing HI titer ≥1:40, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c. The CBER criterion for adult population was 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% | Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) |
| Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive 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 for previously vaccinated and Day 50 for Not previously vaccinated subjects) |
| Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing HI titer ≥1:40, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c The Committee for Medicinal Products for Human Use (CHMP) criterion for an adult population was that the percentage of subjects achieving an HI titer ≥1:40 is >70% | Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) |
| Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age | Immunogenicity was measured in subjects (Previously vaccinated and Not previously vaccinated) as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c .For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c The CHMP criterion for GMR in adult population is >2.5 | Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) |
| GMT in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c Against B2 Strain | Immunogenicity of QIVc to comparator TIV1c was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by HI assay, three weeks after last vaccination with one or two doses 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 did not exceed the superiority margin of 1 | Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) |
| Percentages of Subjects Achieving Seroconversion Against B2 Strain After One or Two Doses of Either QIVc or TIV1c | Immunogenicity of QIVc to comparator TIV1c in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks after last vaccination with QIVc or TIV1c. Superiority criterion 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 does not exceed the margin of 0 points | Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) |
| GMT in Subjects After Receiving One or Two Doses of Either QIVc,TIV2c Against B1 Strain | Immunogenicity of QIVc to comparator TIV2c was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by HI assay, three weeks after last vaccination with one or two doses 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 | Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) |
| Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc or TIV2c | Immunogenicity of QIVc to comparator TIV2c in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks after last 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 does not exceed the margin of 0 points | Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) |
| Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Safety was assessed in terms of number of subjects (Previously vaccinated and Not previously vaccinated) reporting solicited local and systemic reactions, day 1 to 7 after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c.For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c. | Day 1 to 7 after last vaccination |
| Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | Safety was assessed in terms of number of subjects (Previously vaccinated and Not previously vaccinated) reporting unsolicited AEs (day 1 to 22 for Previously vaccinated and day 1 to day 50 for Not previously vaccinated subjects), 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 for Previously vaccinated and day 1 to day 210 for Not previously vaccinated subjects) after receiving one or two doses of either QIVc, TIV1c or TIV2c. For A/H1N1, A/H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c. | Day 1 to 210 post vaccination |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Chandler | Arizona | 85224 | United States |
| Mesa | Arizona | 85206 | United States |
| Mesa | Arizona | 85213 | United States |
| Harrisburg | Arkansas | 72452 | United States |
| Jonesboro | Arkansas | 72401 | United States |
| Anaheim | California | 92801 | United States |
| Anaheim | California | 92804 | United States |
| Downey | California | 90241 | United States |
| Garden Grove | California | 92844 | United States |
| Modesto | California | 95350 | United States |
| Paramount | California | 90723 | United States |
| Sacramento | California | 95816 | United States |
| San Diego | California | 92103-6204 | United States |
| San Francisco | California | 94102 | United States |
| Santa Rosa | California | 95405 | United States |
| West Covina | California | 91790 | United States |
| Colorado Springs | Colorado | 80907 | United States |
| Denver | Colorado | 80246 | United States |
| Denver | Colorado | 80249 | United States |
| Thornton | Colorado | 80233 | United States |
| Boca Raton | Florida | 33432 | United States |
| Lake Mary | Florida | 32746 | United States |
| Melbourne | Florida | 32935 | United States |
| Miami Beach | Florida | 33141 | United States |
| Opa-locka | Florida | 33055 | United States |
| Pinellas Park | Florida | 33781 | United States |
| Atlanta | Georgia | 30338 | United States |
| Marietta | Georgia | 30062 | United States |
| Woodstock | Georgia | 30189 | United States |
| Boise | Idaho | 83642 | 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 | 67010 | United States |
| Wichita | Kansas | 67207 | United States |
| Lexington | Kentucky | 40509 | United States |
| Louisville | Kentucky | 40291 | United States |
| Metairie | Louisiana | 70006 | United States |
| Kansas City | Missouri | 64114 | United States |
| St Louis | Missouri | 63141 | United States |
| Bellevue | Nebraska | 68005 | United States |
| Fremont | Nebraska | 68025 | United States |
| Omaha | Nebraska | 68114 | United States |
| Omaha | Nebraska | 68134 | United States |
| Las Vegas | Nevada | 89104 | United States |
| Binghamton | New York | 13901 | United States |
| Wilmington | North Carolina | 28401 | United States |
| Akron | Ohio | 44311 | United States |
| Cincinnati | Ohio | 45249 | United States |
| Cleveland | Ohio | 44106 | United States |
| Cleveland | Ohio | 44122 | United States |
| Dayton | Ohio | 45406 | United States |
| Dayton | Ohio | 45414 | United States |
| Kettering | Ohio | 45429 | United States |
| Oklahoma City | Oklahoma | 73103 | United States |
| Oklahoma City | Oklahoma | 73112 | United States |
| Tulsa | Oklahoma | 74127 | United States |
| Erie | Pennsylvania | 16505 | United States |
| Erie | Pennsylvania | 16508 | United States |
| Hermitage | Pennsylvania | 16148 | United States |
| Sellersville | Pennsylvania | 18960 | United States |
| Upper Saint Clair | Pennsylvania | 15241 | United States |
| Anderson | South Carolina | 29621 | United States |
| Charleston | South Carolina | 29403 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Bristol | Tennessee | 37620 | United States |
| Jefferson City | Tennessee | 37760 | United States |
| Lebanon | Tennessee | 37087 | United States |
| Nashville | Tennessee | 37203 | United States |
| Austin | Texas | 78705 | United States |
| Dallas | Texas | 75231 | United States |
| Fort Worth | Texas | 76107 | United States |
| Fort Worth | Texas | 76135 | United States |
| Round Rock | Texas | 78681 | United States |
| San Angelo | Texas | 76904 | United States |
| San Antonio | Texas | 78229 | United States |
| Draper | Utah | 84020 | United States |
| Layton | Utah | 84041 | 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 |
| West Jordan | Utah | 84088 | United States |
| Burke | Virginia | 22015 | United States |
| Charlottesville | Virginia | 22902 | United States |
| FG002 | TIV2c | Subjects received one or two doses 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 | Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season |
| BG001 | TIV1c | Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season |
| BG002 | TIV2c | Subjects received one or two doses 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 | Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c | Immunogenicity of QIVc to comparator TIV1c (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by hemagglutination inhibition (HI) assay, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or 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 received the vaccine, had 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 | Titers | Day 1,Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c | Immunogenicity of QIVc to comparator TIVc (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase (at least a 4-fold increase in HI titer in subjects seropositive at baseline [i.e., HI titer ≥1:10 at Day 1] ) in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive 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 | percentages of subjects | Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive 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 Center for Biologics Evaluation, Research, and Review (CBER) criterion for an adult population 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% | Analysis was done on Full Analysis Set (FAS) immunogenicity set i.e. all subjects in the enrolled set who received ▫ Received at least one study vaccination and provided immunogenicity data at day 1 and day 22 (day 50 for not previously vaccinated subjects) | Posted | Number | 95% Confidence Interval | percentages of subjects | Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing HI titer ≥1:40, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c. The CBER criterion for adult population was 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% | Analysis was done on FAS immunogenicity set (FAS) i.e. all subjects in the enrolled set who received at least one study vaccination and provided immunogenicity data at day 22 (day 50 for not previously vaccinated subjects) | Posted | Number | 95% Confidence Interval | percentages of subjects | Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive 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 FAS immunogenicity set | Posted | Number | 95% Confidence Interval | percentages of subjects | Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years | Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing HI titer ≥1:40, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c The Committee for Medicinal Products for Human Use (CHMP) criterion for an adult population was that the percentage of subjects achieving an HI titer ≥1:40 is >70% | Analysis was done on FAS immunogenicity set | Posted | Number | 95% Confidence Interval | percentages of subjects | Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age | Immunogenicity was measured in subjects (Previously vaccinated and Not previously vaccinated) as the geometric mean ratio (GMR). The ratio of postvaccination to prevaccination HI GMTs, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c .For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c The CHMP criterion for GMR in adult population is >2.5 | Analysis was done on FAS immunogenicity set | Posted | Geometric Mean | 95% Confidence Interval | Ratios | Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | GMT in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c Against B2 Strain | Immunogenicity of QIVc to comparator TIV1c was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by HI assay, three weeks after last vaccination with one or two doses 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 did not exceed the superiority margin of 1 | Analysis was done on FAS population | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentages of Subjects Achieving Seroconversion Against B2 Strain After One or Two Doses of Either QIVc or TIV1c | Immunogenicity of QIVc to comparator TIV1c in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks after last vaccination with QIVc or TIV1c. Superiority criterion 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 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 for previously vaccinated and Day 50 for Not previously vaccinated subjects) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | GMT in Subjects After Receiving One or Two Doses of Either QIVc,TIV2c Against B1 Strain | Immunogenicity of QIVc to comparator TIV2c was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by HI assay, three weeks after last vaccination with one or two doses 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 | Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc or TIV2c | Immunogenicity of QIVc to comparator TIV2c in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks after last 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 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 for previously vaccinated and Day 50 for Not previously vaccinated subjects) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata | Safety was assessed in terms of number of subjects (Previously vaccinated and Not previously vaccinated) reporting solicited local and systemic reactions, day 1 to 7 after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c.For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and 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 after last vaccination |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group | Safety was assessed in terms of number of subjects (Previously vaccinated and Not previously vaccinated) reporting unsolicited AEs (day 1 to 22 for Previously vaccinated and day 1 to day 50 for Not previously vaccinated subjects), 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 for Previously vaccinated and day 1 to day 210 for Not previously vaccinated subjects) after receiving one or two doses of either QIVc, TIV1c or TIV2c. For A/H1N1, A/H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and 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 210 post vaccination |
|
Throughout the study period.
Solicited AEs -collected from day 1 to day 7 after last vaccination, unsolicited AEs - collected from day 1 to day 22 for previously vaccinated subjects and day 1 to day 50 for not previously vaccinated subjects.SAEs were collected from day 1 to day 181 for previously vaccinated subjects and day 1 to day 210 for not previously vaccinated subjects
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 | Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season | 6 | 1,149 | 840 | 1,149 | ||
| EG001 | TIV1c | Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season | 7 | 579 | 417 | 579 | ||
| EG002 | TIV2c | Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 | 2 | 570 | 392 | 570 | ||
| EG003 | Total | Total number of Subjects | 15 | 2,298 | 1,649 | 2,298 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAPHYLACTIC REACTION | Immune system disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| ABSCESS OF EYELID | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| PERIORBITAL CELLULITIS | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| CRANIOCEREBRAL INJURY | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
| |
| FOREARM FRACTURE | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 17.1 | Non-systematic Assessment |
| |
| HIPPOCAMPAL SCLEROSIS | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| PARTIAL SEIZURES | Nervous system disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| BIPOLAR DISORDER | Psychiatric disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| INTENTIONAL SELF-INJURY | Psychiatric disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| MAJOR DEPRESSION | Psychiatric disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| OPPOSITIONAL DEFIANT DISORDER | Psychiatric disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| SLEEP APNOEA SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| HENOCH-SCHONLEIN PURPURA | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHEA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| INJECTION SITE ERYTHEMA | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| INJECTION SITE HEMORRHAGE | General disorders | MedDRA 17.1 | Non-systematic Assessment |
| |
| INJECTION SITE INDURATION | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| INJECTION SITE PAIN | General disorders | MedDRA 17.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 17.1 | Non-systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Non-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 |
|
| A/H1N1: Day 22/Day 50 (N=1014, 510) |
|
| A/H3N2: Day 1 (N=1013, 510) |
|
| A/H3N2: Day 22/Day 50 (N=1013, 510) |
|
| B1: Day 1 (N=1013, 510) |
|
| B1: Day 22/Day 50 (N=1013, 510) |
|
| B2: Day 1(N=1009, 501) |
|
| B2: Day 22/Day 50 (N=1009, 501) |
|
| Non-inferiority of immune responses of QIVc to TIV1c, assessed in terms of ratios of GMT against influenza strain A/H3N2 | ANCOVA | Ratios of GMT (Day 22/Day 50) | 1.05 | 2-Sided | 95 | 0.97 | 1.14 | 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 (Day 22/Day 50) | 0.99 | 2-Sided | 95 | 0.89 | 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 TIV2c, assessed in terms of ratios of GMT against influenza strain B2 | ANCOVA | Ratios of GMT (Day 22/Day 50) | 1 | 2-Sided | 95 | 0.87 | 1.14 | 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 |
| OG002 | TIV2c (≥4 to <18 Years) | Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 |
|
|
|
| OG001 | TIV1c (≥4 to <18 Years) | Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season |
| OG002 | TIV2c (≥4 to <18 Years) | Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 |
|
|
| OG002 | TIV2c (≥4 to <18 Years) | Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 |
|
|
| OG002 | TIV2c (≥4 to <18 Years) | Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 |
|
|
Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 |
|
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
| OG003 | QIVc _Second Vaccine (≥4 to <6 Years) | Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season |
| OG004 | TIV1c_Second Vaccine (≥4 to <6 Years) | Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season |
| OG005 | TIV2c _Second Vaccine (≥4 to <6 Years) | Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 |
| OG006 | QIVc _First Vaccine (≥6 to <9 Years) | Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season |
| OG007 | TIV1c_First Vaccine (≥6 to <9 Years) | Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2,B1) recommended for 2013-2014 season |
| OG008 | TIV2c _First Vaccine (≥6 to <9 Years) | Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 |
| OG009 | QIVc _Second Vaccine (≥6 to <9 Years) | Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season |
| OG010 | TIV1c_Second Vaccine (≥6 to <9 Years) | Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season |
| OG011 | TIV2c _Second Vaccine (≥6 to <9 Years) | Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 |
| OG012 | QIVc (≥9 to <18 Years) | Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season |
| OG013 | TIV1c (≥9 to <18 Years) | Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season |
| OG014 | TIV2c (≥9 to <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 |
|
|
| OG002 |
| TIV2c (≥4 to <18 Years) |
Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014 |
|
|