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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002081-39 | EudraCT Number |
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| Name | Class |
|---|---|
| Novartis Vaccines | INDUSTRY |
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To evaluate the safety and immunogenicity of four influenza vaccines in children 6 months to < 48 months of age
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIVc-High Dose | Experimental | Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine |
|
| TIVc-Full Dose | Experimental | Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine |
|
| TIVc- Half Dose | Experimental | Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine |
|
| TIVe | Active Comparator | Subjects (6 to <48 months old) received two doses of TIVe vaccine(IM/0.25mL -for ages 6 to <36 months and IM/ 0.5 mL -for ages 36 to <48 months) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trivalent influenza vaccine (TIVc) | Biological |
| ||
| Trivalent influenza vaccine-licensed |
| Measure | Description | Time Frame |
|---|---|---|
| Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | Immunogenicity was assessed in terms of ratios of GMTs in subjects (6 to <48 months old), measured by hemagglutination inhibition (HI) assay, day 1 to day 50 after vaccination with two doses of either TIVc or TIVe vaccine | Day 50/Day 1 |
| Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | Immunogenicity was assessed in terms number (%) of subjects (6 to <48 months old) achieving seroconversion as measured by HI antibody titer, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer < 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer | Day 50 post vaccination |
| Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine | Differences in percentages of subjects (6 to <48 months old) with severe local solicited AEs and severe solicited systemic AEs, 3 days after vaccination with either TIVc or TIVe vaccine was assessed in terms of an individual desirability index score (High dose, Full dose, Half dose TIVc vs. TIVe vaccine). An individual desirability index score was assigned to each (non-transformed) safety value based on predefined functions. Each desirability index score is assigned a value between 0 and 1, wherein 0 is an undesirable response and 1 is a highly desirable response. | Day 1 to Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving seroconversion as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer < 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer The Center for Biologics Evaluation, Research, and Review (CBER) criterion for pediatric population is that the lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40% The Committee for Medicinal Products for Human Use (CHMP) criterion for pediatric population is that the percentage of subjects achieving seroconversion or significant increase in HI antibody titers >40% |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 116 | Phoenix | Arizona | United States | |||
| Site 119 |
All enrolled Subjects were included in the trial
6 centers in the United States, 1 center in Finland, 2 centers in Thailand, 2 centers in Philippines
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| ID | Title | Description |
|---|---|---|
| FG000 | TIVc-High Dose | Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine |
| FG001 | TIVc-Full Dose | Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Biological |
Licensed influenza vaccine |
|
| Day 50 post vaccination |
| Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving HI titer ≥1:40 as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine The CBER criterion for pediatric population 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% The CHMP criterion for pediatric population is that the percentage of subjects achieving HI antibody titers ≥1:40 should be >70% | Day 1, Day 50 post vaccination |
| Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | Immunogenicity was assessed in terms of GMR in subjects (6 to <48 months old) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine The CHMP criterion is mean geometric ratio (GMR) >2.5 | Day 50 post vaccination over day 1 |
| Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | Immunogenicity was assessed in terms of GMR in subjects (6 to <48 months old) as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine | Day 50 post vaccination over day 1 |
| Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving post vaccination HI titers (i.e. HI titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine | Day 1 and Day 50 post vaccination |
| Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine | Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving MN titer ≥1:20 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Post-vaccination MN titer ≥1:20 was defined as for subjects with baseline (day 1) MN titer <1:10, or a minimum 2-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI | Day 1 and Day 50 post vaccination |
| Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving MN titer ≥1:40 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Post-vaccination MN titer ≥1:40 was defined as for subjects with baseline (day 1) MN titer <1:10, or a minimum 4-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI | Day 1 and Day 50 post vaccination |
| Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Safety was assessed in terms of number of subjects (6 to <48 months old) reporting solicited local and systemic reactions, day 1 to day 7 after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination) | Day 1 to Day 7 |
| Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Safety was assessed in terms of number of subjects (6 to <48 months old) reporting unsolicited reactions after Each /any Vaccination from Day 1 [Post Vaccination] to Day 29 [Pre Clinic Visit] and Day 29 [Post Vaccination] to Day 50 [Pre Clinic Visit] , Serious Adverse Events (SAEs), AEs leading to New Onset of Chronic Diseases (NOCD), AEs leading to withdrawal from the study and concomitant medications (day 1 to day 209) after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination) | Unsolicited AEs after Each/any Vaccination from Day 1 to Day 29 and Day 29 to Day 50 , Day 1 to Day 209 |
| Tucson |
| Arizona |
| United States |
| Site 109 | Little Rock | Arkansas | United States |
| Site 112 | Long Beach | California | United States |
| Site 113 | Ontario | California | United States |
| Site 117 | San Diego | California | United States |
| Site 114 | West Covina | California | United States |
| Site 107 | Thornton | Colorado | United States |
| Site 111 | Miami | Florida | United States |
| Site 108 | Miami Beach | Florida | United States |
| Site 121 | Gainesville | Georgia | United States |
| Site 101 | Omaha | Nebraska | United States |
| Site 104 | Omaha | Nebraska | United States |
| Site 105 | Omaha | Nebraska | United States |
| Site 106 | Omaha | Nebraska | United States |
| Site 103 | Youngstown | Ohio | United States |
| Site 102 | Charleston | South Carolina | United States |
| Site 115 | Houston | Texas | United States |
| Site 110 | Salt Lake City | Utah | United States |
| Site 118 | St. George | Utah | United States |
| Site 120 | Spokane | Washington | United States |
| Site 502 | Kuopio | Finland |
| Site 506 | Tampere | Finland |
| Site 302 | City of Muntinlupa | Philippines |
| Site 301 | Manila | Philippines |
| Site 201 | Bangkok | Thailand |
| Site 202 | Bangkok | Thailand |
| FG002 | TIVc- Half Dose | Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine |
| FG003 | TIVe | Subjects (6 to <48 months old) received two doses of TIVe vaccine |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TIVc-High Dose | Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine |
| BG001 | TIVc-Full Dose | Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine |
| BG002 | TIVc- Half Dose | Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine |
| BG003 | TIVe | Subjects (6 to <48 months old) received two doses of TIVe vaccine |
| BG004 | 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 | Months |
| |||||||||||||||
| 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 | Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | Immunogenicity was assessed in terms of ratios of GMTs in subjects (6 to <48 months old), measured by hemagglutination inhibition (HI) assay, day 1 to day 50 after vaccination with two doses of either TIVc or TIVe vaccine | Analysis was done on Per Protocol (PP) population i.e. all subjects in the FAS Efficacy/Immunogenicity Set who are not excluded due to reasons defined prior to unblinding or analysis | Posted | Number | 95% Confidence Interval | Ratios | Day 50/Day 1 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | Immunogenicity was assessed in terms number (%) of subjects (6 to <48 months old) achieving seroconversion as measured by HI antibody titer, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer < 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer | Analysis was done on PP population | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 50 post vaccination |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine | Differences in percentages of subjects (6 to <48 months old) with severe local solicited AEs and severe solicited systemic AEs, 3 days after vaccination with either TIVc or TIVe vaccine was assessed in terms of an individual desirability index score (High dose, Full dose, Half dose TIVc vs. TIVe vaccine). An individual desirability index score was assigned to each (non-transformed) safety value based on predefined functions. Each desirability index score is assigned a value between 0 and 1, wherein 0 is an undesirable response and 1 is a highly desirable response. | Analysis was done on PPSd-All subjects in the FASd who:Correctly received the vaccine (i.e., received the vaccine to which the subjects is randomized and at the scheduled time points). | Posted | Number | percentage of participants | Day 1 to Day 3 |
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| Secondary | Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine | Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving seroconversion as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer < 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer The Center for Biologics Evaluation, Research, and Review (CBER) criterion for pediatric population is that the lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40% The Committee for Medicinal Products for Human Use (CHMP) criterion for pediatric population is that the percentage of subjects achieving seroconversion or significant increase in HI antibody titers >40% | Analysis was done on Full analysis set | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 50 post vaccination |
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| Secondary | Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving HI titer ≥1:40 as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine The CBER criterion for pediatric population 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% The CHMP criterion for pediatric population is that the percentage of subjects achieving HI antibody titers ≥1:40 should be >70% | Analysis was done on FAS | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 1, Day 50 post vaccination |
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| Secondary | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | Immunogenicity was assessed in terms of GMR in subjects (6 to <48 months old) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine The CHMP criterion is mean geometric ratio (GMR) >2.5 | Analysis was done on FAS | Posted | Number | 95% Confidence Interval | Ratios | Day 50 post vaccination over day 1 |
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| Secondary | Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine | Immunogenicity was assessed in terms of GMR in subjects (6 to <48 months old) as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine | Analysis was done on PPS | Posted | Number | 95% Confidence Interval | Ratios | Day 50 post vaccination over day 1 |
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| Secondary | Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine | Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving post vaccination HI titers (i.e. HI titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine | Analysis was done on PPS | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 1 and Day 50 post vaccination |
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| Secondary | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine | Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving MN titer ≥1:20 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Post-vaccination MN titer ≥1:20 was defined as for subjects with baseline (day 1) MN titer <1:10, or a minimum 2-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI | Analysis was done on PPS | Posted | Number | 95% Confidence Interval | Percentage of subjects | Day 1 and Day 50 post vaccination |
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| Secondary | Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine | Immunogenicity was assessed in terms of number (%) of subjects (6 to <48 months old) achieving MN titer ≥1:40 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Post-vaccination MN titer ≥1:40 was defined as for subjects with baseline (day 1) MN titer <1:10, or a minimum 4-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI | Analysis was done on PPS | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 1 and Day 50 post vaccination |
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| Secondary | Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Safety was assessed in terms of number of subjects (6 to <48 months old) reporting solicited local and systemic reactions, day 1 to day 7 after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination) | Analyses was done on solicited safety data set. 4 subjects (3 subjects from the TIVe group, and 1 subject from the full dose TIVc group, were excluded from the solicited safety set analyses (6h -day3, day4-day7 and 6h - day 7) as these subjects did not provide any post vaccination solicited safety data | Posted | Number | Subjects | Day 1 to Day 7 |
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| Secondary | Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine | Safety was assessed in terms of number of subjects (6 to <48 months old) reporting unsolicited reactions after Each /any Vaccination from Day 1 [Post Vaccination] to Day 29 [Pre Clinic Visit] and Day 29 [Post Vaccination] to Day 50 [Pre Clinic Visit] , Serious Adverse Events (SAEs), AEs leading to New Onset of Chronic Diseases (NOCD), AEs leading to withdrawal from the study and concomitant medications (day 1 to day 209) after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination) | Analyses was done on unsolicited safety data set i.e. all subjects in the exposed set who have post-vaccination unsolicited AE data | Posted | Number | Subjects | Unsolicited AEs after Each/any Vaccination from Day 1 to Day 29 and Day 29 to Day 50 , Day 1 to Day 209 |
|
Throughout the study period, up to day 209 post vaccination.
Solicited AEs were collected from day 1 to day 7 post vaccination, unsolicited AEs were collected from day 1 to day 50 post vaccination and SAEs -collected from day 1 to day 209 post vaccination.
A systematic adverse event is equivalent to an event that was solicited by the diary card, whereas a non-systematic event is an unsolicited adverse event
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 | TIVc-High Dose | Subjects (6 to <48 months old) received two doses of 0.75 mL of TIVc vaccine | 4 | 174 | 142 | 174 | ||
| EG001 | TIVc-Full Dose | Subjects(6 to <48 months old) received two doses of 0.50 mL of TIVc vaccine | 8 | 166 | 133 | 166 | ||
| EG002 | TIVc- Half Dose | Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine | 10 | 167 | 141 | 167 | ||
| EG003 | TIVe | Subjects (6 to <48 months old) received two doses of TIVe vaccine | 6 | 164 | 127 | 164 | ||
| EG004 | Total | Total number of subjects | 28 | 671 | 543 | 671 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PYREXIA | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| VARICELLA | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| ANIMAL BITE | Injury, poisoning and procedural complications | MedDRA (18.0) | Non-systematic Assessment |
| |
| FEBRILE CONVULSION | Nervous system disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| ABSCESS | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| AMOEBIASIS | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| HAND-FOOT-AND-MOUTH DISEASE | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| PERIORBITAL CELLULITIS | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| PHARYNGOTONSILLITIS | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| PSEUDOMONAL SEPSIS | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIARRHOEA | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| INJECTION SITE ERYTHEMA | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| INJECTION SITE HAEMORRHAGE | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| INJECTION SITE INDURATION | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| INJECTION SITE PAIN | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (18.0) | Non-systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| RHINITIS | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| EATING DISORDER | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| IRRITABILITY | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA (18.0) | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA (18.0) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure Manager | Seqirus | Seqirus.ClinicalTrials@Seqirus.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
| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| MALE |
|
| A/H3N2 |
|
| B |
|
Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50 |
| Vaccine Group ratios at Day 50 |
| 2.11 |
| 2-Sided |
| 95 |
| 1.5 |
| 2.98 |
| Non-Inferiority or Equivalence |
Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 |
| Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1 | Vaccine Group ratios at Day 1 | 0.68 | 2-Sided | 95 | 0.43 | 1.06 | Non-Inferiority or Equivalence | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 |
| Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50 | Vaccine Group Ratios at Day 50 | 0.71 | 2-Sided | 95 | 0.58 | 0.87 | Non-Inferiority or Equivalence | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 |
| Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1 | Vaccine Group Ratios at Day 1 | 1 | 2-Sided | 95 | 0.92 | 1.08 | Non-Inferiority or Equivalence | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 |
| Non-inferiority of immune responses of a TIVc-High Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50 | Vaccine Group ratios at Day 50 | 0.78 | 2-Sided | 95 | 0.6 | 1.01 | Non-Inferiority or Equivalence | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 |
| Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1 | Vaccine Group Ratios at Day 1 | 1.27 | 2-Sided | 95 | 0.83 | 1.96 | Non-Inferiority or Equivalence | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 |
| Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50 | Vaccine Group Ratios at Day 50 | 1.6 | 2-Sided | 95 | 1.13 | 2.28 | Non-Inferiority or Equivalence | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 |
| Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1 | Vaccine Group Ratios at Day 1 | 0.52 | 2-Sided | 95 | 0.33 | 0.81 | Non-Inferiority or Equivalence | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 |
| Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50 | Vaccine Group Ratios at Day 50 | 0.64 | 2-Sided | 95 | 0.52 | 0.78 | Non-Inferiority or Equivalence | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 |
| Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1 | Vaccine Group ratios at Day 1 | 0.96 | 2-Sided | 95 | 0.89 | 1.04 | Non-Inferiority or Equivalence | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 |
| Non-inferiority of immune responses of a TIVc-Full Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50 | Vaccine Group Ratios at Day 50 | 0.64 | 2-Sided | 95 | 0.49 | 0.84 | Non-Inferiority or Equivalence | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 |
| Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 1 | Vaccine Group Ratios at Day 1 | 1.02 | 2-Sided | 95 | 0.66 | 1.58 | Non-Inferiority or Equivalence | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 |
| Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H1N1 at Day 50 | Vaccine Group ratios at Day 50 | 1.62 | 2-Sided | 95 | 1.14 | 2.3 | Non-Inferiority or Equivalence | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 |
| Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 1 | Vaccine Group Ratios at Day 1 | 0.74 | 2-Sided | 95 | 0.47 | 1.17 | Non-Inferiority or Equivalence | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 |
| Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain A/H3N2 at Day 50 | Vaccine Group ratios at Day 50 | 0.46 | 2-Sided | 95 | 0.38 | 0.57 | Non-Inferiority or Equivalence | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 |
| Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 1 | Vaccine Group Ratios at Day 1 | 0.94 | 2-Sided | 95 | 0.87 | 1.02 | Non-Inferiority or Equivalence | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 |
| Non-inferiority of immune responses of a TIVc- Half Dose to TIVe, assessed in terms of vaccine group GMT ratios against influenza strain B at Day 50 | Vaccine Group Ratios at Day 50 | 0.57 | 2-Sided | 95 | 0.44 | 0.75 | Non-Inferiority or Equivalence | Non-inferiority was established if the Lower limit of the 2-sided 95% CI of the vaccine group GMT ratio ≥ 0.67 |
| TIVe |
Subjects (6 to <48 months old) received two doses of TIVe vaccine |
|
|
|
| TIVc- Half Dose-TIVe |
Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine vs Subjects (6 to <48 months old) received two doses of TIVe vaccine |
|
|
|
| OG002 | TIVc- Half Dose | Subjects (6 to <48 months old)received two doses of 0.25 mL of TIVc vaccine |
| OG003 | TIVe | Subjects (6 to <48 months old) received two doses of TIVe vaccine |
|
|
| OG003 |
| TIVe |
Subjects (6 to <48 months old) received two doses of TIVe vaccine |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
Subjects (6 to <48 months old) received two doses of TIVe vaccine |
|
|
Subjects (6 to <48 months old) received two doses of TIVe vaccine |
|
|
| TIVe |
Subjects (6 to <48 months old) received two doses of TIVe vaccine |
|
|
| OG003 | TIVe | Subjects (6 to <48 months old) received two doses of TIVe vaccine |
|
|