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All participants received a single dose of their assigned vaccine on Day 0. They were followed up for immunogenicity and safety through Day 21 post-vaccination. Serious adverse events were collected for 6 months post-vaccination.
In a randomized controlled phase III trial undertaken in 10 university hospitals of South Korea, adults and elderly subjects were randomly assigned in a 2:1:1 ratio to NBP607-QIV versus cell culture-based trivalent inactivated influenza vaccine (TIV), NBP607-Y and NBP607-V. Immunogenicity was assessed 3 weeks after vaccination by hemagglutination inhibition (HI) assay. Safety was assessed for 6 months post-vaccination: solicited adverse events for 7 days, unsolicited adverse events (AEs) for 21 days and serious adverse events (SAE) for 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBP607-QIV | Experimental | Participants aged 19 years and older received a 0.5mL single intramuscular dose of Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria on Day 0 |
|
| NBP607-Y | Active Comparator | Participants aged 19 years and older received a 0.5mL single intramuscular dose of Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata on Day 0 |
|
| NBP607-V | Active Comparator | Participants aged 19 years and older received a 0.5mL single intramuscular dose of Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria on Day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBP607-QIV | Biological | Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects | GMTs of anti-influenza antibodies were measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. For each A strain, the titers were made with the pooled TIV group (NBP60-Y and NBP607-V). For each A strain, the comparion was made with the pooled TIV groups (Y+V/QIV). For each B strain, the comparison was made with the corresponding TIV group(i.e. for B/Yamagata, Geometric Mean Titer Ratio (GMR) is Y/QIV). | At Day 21 post vaccination. |
| Seroconversion Rate (SCR) After Vaccination in All Subjects | SCR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10 For each A strain, the comparion was made with the pooled TIV groups (Y+V minus QIV). For each B strain, the comparison was made with the corresponding TIV group(i.e. for B/Yamagata, Difference of SCR (Diff.SCR) is Y minus QIV). | At Day 21 post vaccination. |
| Seroprotection Rate (SPR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years | SPR of NBP607-QIV was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroprotection was defined as the proportion of subjects whose post-vaccination HI titer increased to ≥1:40. | At Day 21 post vaccination. |
| Seroconversion Rate (SCR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years | SCR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10 | At Day 21 post vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean HI Titers (GMTs) of Each B Strain After Vaccination in All Subjects | GMTs of anti-influenza antibodies were measured for B strains: B/Victoria, and B/Yamagata. For each B strain, the comparison was made with the TIV group which did not contain the correponding B strain (i.e. for B/Yamagata, Geometric Mean Titer Ratio (GMR) is V/QIV). | At Day 21 post vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Woo Joo Kim, MD, PhD | Korea University Guro Hospital | Study Chair |
| Won Suk Choi, MD, PhD | Korea University | Principal Investigator |
| Seong-Heon Wie, MD, PhD | Catholic University St. Vincent's Hospital | Principal Investigator |
| Jin Soo Lee, MD, PhD | Inha University Hospital | Principal Investigator |
| Jacob Lee, MD, PhD | Hallym University Kangnam Sacred Heart Hospital | Principal Investigator |
| Shin Woo Kim, MD, PhD | Kyungpook University Hospital | Principal Investigator |
| Hye Won Jeong, MD | Chungbuk University Hospital | Principal Investigator |
| Sook-In Jung, MD | Chonnam University Hospital | Principal Investigator |
| Yeon-Sook Kim, MD, PhD | Chungnam University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28406746 | Result | Choi WS, Noh JY, Song JY, Cheong HJ, Wie SH, Lee JS, Lee J, Kim SW, Jeong HW, Jung SI, Kim YS, Woo HJ, Kim KH, Kim H, Kim WJ. Immunogenicity and safety of a cell culture-derived inactivated quadrivalent influenza vaccine (NBP607-QIV): A randomized, double-blind, multi-center, phase III clinical trial in adults and elderly subjects. Hum Vaccin Immunother. 2017 Jul 3;13(7):1653-1660. doi: 10.1080/21645515.2017.1297351. Epub 2017 Apr 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NBP607-QIV | Participants received a 0.5mL single intramuscular dose on Day 0 NBP607-QIV: Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria |
| FG001 | NBP607-Y | Participants received a 0.5mL single intramuscular dose on Day 0 NBP607-Y: Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata |
| FG002 | NBP607-V | Participants received a 0.5mL single intramuscular dose on Day 0 NBP607-V: Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NBP607-QIV | Participants aged 19 years and older received a 0.5mL single intramuscular dose on Day 0 NBP607-QIV: Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria |
| BG001 | NBP607-Y |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of 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 HI Titers (GMTs) After Vaccination in All Subjects | GMTs of anti-influenza antibodies were measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. For each A strain, the titers were made with the pooled TIV group (NBP60-Y and NBP607-V). For each A strain, the comparion was made with the pooled TIV groups (Y+V/QIV). For each B strain, the comparison was made with the corresponding TIV group(i.e. for B/Yamagata, Geometric Mean Titer Ratio (GMR) is Y/QIV). | Per Protocol Set. | Posted | Geometric Mean | 95% Confidence Interval | titers | At Day 21 post vaccination. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NBP607-QIV | Participants aged 19 years and older received a 0.5mL single intramuscular dose on Day 0 NBP607-QIV: Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Mild Severity, recovered, unrelated to NBP607-QIV |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tenderness | General disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hayoung Lee | SK bioscience | +82-2-2008-2552 | haylee@sk.com |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| NBP607-Y | Biological | Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata |
|
| NBP607-V | Biological | Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria |
|
| Geometric Mean Ratio (GMR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years | GMR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMR was defined as the fold-rise of the geometric mean HI titer from pre- to post-vaccination. | At Day 21 post vaccination. |
| Seroconversion Rate (SCR) of B Strain After Vaccination in All Subjects | SCR was measured for each B strain: B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10 | At Day 21 post vaccination. |
| Seroprotection Rate (SPR) of NBP607-QIV in the Adults Aged 19 to 59 Years | SPR of NBP607-QIV was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroprotection was defined as the proportion of subjects whose post-vaccination HI titer increased to ≥1:40. | At Day 21 post vaccination. |
| Seroconversion Rate (SCR) of NBP607-QIV in the Adults Aged 19 to 59 Years | SCR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10 | At Day 21 post vaccination. |
| Geometric Mean Ratio (GMR) of NBP607-QIV in the Subjects Aged 19 to 59 Years | GMR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMR was defined as the fold-rise of the geometric mean HI titer from pre- to post-vaccination | At Day 21 post vaccination. |
| Heung Jeong Woo, MD, PhD |
| Hallym University Dongtan Sacred Heart Hospital |
| Principal Investigator |
Participants aged 19 years and older received a 0.5mL single intramuscular dose on Day 0 NBP607-Y: Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata |
| BG002 | NBP607-V | Participants aged 19 years and older received a 0.5mL single intramuscular dose on Day 0 NBP607-V: Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | NBP607-Y | Participants aged 19 years and older received a 0.5mL single intramuscular dose on Day 0 NBP607-Y: Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata |
| OG002 | NBP607-V | Participants aged 19 years and older received a 0.5mL single intramuscular dose on Day 0 NBP607-V: Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria |
|
|
|
| Primary | Seroconversion Rate (SCR) After Vaccination in All Subjects | SCR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10 For each A strain, the comparion was made with the pooled TIV groups (Y+V minus QIV). For each B strain, the comparison was made with the corresponding TIV group(i.e. for B/Yamagata, Difference of SCR (Diff.SCR) is Y minus QIV). | Per protocol set | Posted | Number | 95% Confidence Interval | percentage of participants | At Day 21 post vaccination. |
|
|
|
|
| Primary | Seroprotection Rate (SPR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years | SPR of NBP607-QIV was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroprotection was defined as the proportion of subjects whose post-vaccination HI titer increased to ≥1:40. | Per protocol set. | Posted | Number | 95% Confidence Interval | percentage of participants | At Day 21 post vaccination. |
|
|
|
| Primary | Seroconversion Rate (SCR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years | SCR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10 | Per protocol set. | Posted | Number | 95% Confidence Interval | percentage of participants | At Day 21 post vaccination. |
|
|
|
| Primary | Geometric Mean Ratio (GMR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years | GMR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMR was defined as the fold-rise of the geometric mean HI titer from pre- to post-vaccination. | Per protocol set | Posted | Geometric Mean | 95% Confidence Interval | ratio | At Day 21 post vaccination. |
|
|
|
| Secondary | Geometric Mean HI Titers (GMTs) of Each B Strain After Vaccination in All Subjects | GMTs of anti-influenza antibodies were measured for B strains: B/Victoria, and B/Yamagata. For each B strain, the comparison was made with the TIV group which did not contain the correponding B strain (i.e. for B/Yamagata, Geometric Mean Titer Ratio (GMR) is V/QIV). | Per protocol set. | Posted | Geometric Mean | 95% Confidence Interval | titer | At Day 21 post vaccination. |
|
|
|
|
| Secondary | Seroconversion Rate (SCR) of B Strain After Vaccination in All Subjects | SCR was measured for each B strain: B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10 | Per protocol set | Posted | Number | 95% Confidence Interval | percentage of participants | At Day 21 post vaccination. |
|
|
|
|
| Secondary | Seroprotection Rate (SPR) of NBP607-QIV in the Adults Aged 19 to 59 Years | SPR of NBP607-QIV was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroprotection was defined as the proportion of subjects whose post-vaccination HI titer increased to ≥1:40. | Per protocol set | Posted | Number | 95% Confidence Interval | percentage of participants | At Day 21 post vaccination. |
|
|
|
| Secondary | Seroconversion Rate (SCR) of NBP607-QIV in the Adults Aged 19 to 59 Years | SCR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10 | Per protocol set | Posted | Number | 95% Confidence Interval | percentage of participants | At Day 21 post vaccination. |
|
|
|
| Secondary | Geometric Mean Ratio (GMR) of NBP607-QIV in the Subjects Aged 19 to 59 Years | GMR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMR was defined as the fold-rise of the geometric mean HI titer from pre- to post-vaccination | Per protocol set | Posted | Geometric Mean | 95% Confidence Interval | ratio | At Day 21 post vaccination. |
|
|
|
| 0 |
| 752 |
| 9 |
| 752 |
| 364 |
| 752 |
| EG001 | NBP607-Y | Participants aged 19 years and older received a 0.5mL single intramuscular dose on Day 0 NBP607-Y: Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata | 0 | 373 | 3 | 373 | 154 | 373 |
| EG002 | NBP607-V | Participants aged 19 years and older received a 0.5mL single intramuscular dose on Day 0 NBP607-V: Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria | 0 | 378 | 3 | 378 | 151 | 378 |
|
| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| cerebral haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
|
| acute abdomen | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| pneumonia bacterial | Infections and infestations | MedDRA | Systematic Assessment |
|
| gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| otitis externa | Infections and infestations | MedDRA | Systematic Assessment |
|
| concussion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| colon operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| prostatic specific antigen increased | Investigations | MedDRA | Systematic Assessment |
|
| gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| colitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Redness/erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Induration/swelling | General disorders | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Fatigue/Malaise | General disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Fever | General disorders | MedDRA | Systematic Assessment |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
|
| B/Yamagata |
|
| B/Victoria |
|
Diff. SCR of A/H3N2 strain (SCR of pooled TIV minus QIV) |
| Difference in percentage |
| -5.02 |
| 2-Sided |
| 95 |
| -10.08 |
| 0.04 |
| Non-Inferiority |
Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain. |
| Diff. SCR of B/Yamaga strain (SCR of TIV minus QIV) | Difference in percentage | -7.06 | 2-Sided | 95 | -13.12 | -1.00 | Non-Inferiority | Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain. |
| Diff. SCR of B/Victoria (SCR of TIV minus QIV) | Difference in percentage | -3.09 | 2-Sided | 95 | -9.26 | 3.09 | Non-Inferiority | Non-inferiority of SCR was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator minus experimental) ≤10% for each strain. |
| Title | Measurements |
|---|---|
|
| B/Victoria |
|
| Title | Measurements |
|---|---|
|
| B/Victoria |
|
| Title | Measurements |
|---|---|
|
| B/Victoria |
|
|
GMR of B/Victoria (GMTs of TIV/QIV) |
| GMR (TIV/QIV) |
| 0.75 |
| 2-Sided |
| 95 |
| 0.69 |
| 0.81 |
| Superiority |
Superiority of GMTs was concluded if the upper limit of 95% confidence interval for GMR (active comparator/experimental) was ≤1.0 for each B strain. |
|
Diff. SCR of B/Victoria strain (SCR of TIV minus QIV) |
| Difference in percentage |
| -12.62 |
| 2-Sided |
| 95 |
| -18.79 |
| -6.45 |
| Superiority |
Superiority was concluded if the upper limit of 95% confidence interval for Diff. SCR (active comparator-experimental) was ≤0% in each B strain. |
| Title | Measurements |
|---|---|
|
| B/Victoria |
|
| Title | Measurements |
|---|---|
|
| B/Victoria |
|
| Title | Measurements |
|---|---|
|
| B/Victoria |
|