Influenza
Conditions
Keywords
Influenza vaccine, Quadrivalent, Inactivated cell culture-derived
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALNBP607-QIV
Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria
BIOLOGICALNBP607-Y
Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata
BIOLOGICALNBP607-V
Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria
Sponsors
SK Chemicals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 19 years and older * Those who are able to comply with the requirements for the study * If women, a negative pregnancy test and willingness to use birth control measures for the entire study duration
Exclusion criteria
* Disorders in immune function * Any malignancy or lymphoproliferative disorder * History of Guillain-Barré syndrome * Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time * Experience of fever (\>38.0 ℃) within 24 hours following vaccination * Body temperature \>38.0 ℃ at the vaccination day * Concomitant medications/therapy such as immunosuppressants or immune modifying drugs, systemic corticosteroids, immunoglobulins, blood or blood- derived products within 3 months * Influenza vaccination within 6 months * Subjects who have participated in other interventional study within 4 weeks * Any vaccination within 1 month * Those who are planning to receive any vaccine within 1 month from the study vaccine * Individuals with any serious chronic or progressive disease * Pregnant or breast-feeding women * Any other reason that in the opinion of the investigator might interfere with the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Ratio (GMR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years | At Day 21 post vaccination. | 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. |
| Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects | At Day 21 post vaccination. | 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). |
| Seroconversion Rate (SCR) After Vaccination in All Subjects | At Day 21 post vaccination. | 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). |
| Seroprotection Rate (SPR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years | At Day 21 post vaccination. | 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. |
| Seroconversion Rate (SCR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years | At Day 21 post vaccination. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean HI Titers (GMTs) of Each B Strain After Vaccination in All Subjects | At Day 21 post vaccination. | 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). |
| Seroconversion Rate (SCR) of B Strain After Vaccination in All Subjects | At Day 21 post vaccination. | 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 |
| Seroprotection Rate (SPR) of NBP607-QIV in the Adults Aged 19 to 59 Years | At Day 21 post vaccination. | 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. |
| Seroconversion Rate (SCR) of NBP607-QIV in the Adults Aged 19 to 59 Years | At Day 21 post vaccination. | 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 |
| Geometric Mean Ratio (GMR) of NBP607-QIV in the Subjects Aged 19 to 59 Years | At Day 21 post vaccination. | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 752 |
| 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 | 373 |
| 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 | 378 |
| Total | 1,503 |
Baseline characteristics
| Characteristic | NBP607-QIV | NBP607-Y | NBP607-V | Total |
|---|---|---|---|---|
| Age, Customized 19 to 59 years old | 599 Participants | 299 Participants | 305 Participants | 1203 Participants |
| Age, Customized 60 years old and older | 153 Participants | 74 Participants | 73 Participants | 300 Participants |
| Sex: Female, Male Female | 476 Participants | 238 Participants | 233 Participants | 947 Participants |
| Sex: Female, Male Male | 276 Participants | 135 Participants | 145 Participants | 556 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 752 | 0 / 373 | 0 / 378 |
| other Total, other adverse events | 364 / 752 | 154 / 373 | 151 / 378 |
| serious Total, serious adverse events | 9 / 752 | 3 / 373 | 3 / 378 |
Outcome results
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).
Time frame: At Day 21 post vaccination.
Population: Per Protocol Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| NBP607-QIV | Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects | A/H1N1 | 329.76 titers |
| NBP607-QIV | Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects | A/H3N2 | 401.21 titers |
| NBP607-QIV | Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects | B/Yamagata | 163.74 titers |
| NBP607-QIV | Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects | B/Victoria | 124.82 titers |
| NBP607-Y | Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects | B/Victoria | 93.29 titers |
| NBP607-Y | Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects | A/H1N1 | 334.98 titers |
| NBP607-Y | Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects | B/Yamagata | 144.65 titers |
| NBP607-Y | Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects | A/H3N2 | 377.34 titers |
| NBP607-V | Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects | B/Victoria | 112.20 titers |
| NBP607-V | Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects | A/H3N2 | 377.34 titers |
| NBP607-V | Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects | B/Yamagata | 123.08 titers |
| NBP607-V | Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects | A/H1N1 | 334.98 titers |
Comparison: GMR of A/H1N1 strain (GMTs of pooled TIV/QIV)95% CI: [0.94, 1.1]
Comparison: GMR of A/H3N2 strain (GMTs of pooled TIV/QIV)95% CI: [0.87, 1.01]
Comparison: GMR of B/Yamagata strain (GMTs of TIV/QIV)95% CI: [0.82, 0.95]
Comparison: GMR of A/H1N1 strain (GMTs of TIV/QIV)95% CI: [0.83, 0.97]
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.
Time frame: At Day 21 post vaccination.
Population: Per protocol set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| NBP607-QIV | Geometric Mean Ratio (GMR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years | A/H1N1 | 4.07 ratio |
| NBP607-QIV | Geometric Mean Ratio (GMR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years | A/H3N2 | 3.27 ratio |
| NBP607-QIV | Geometric Mean Ratio (GMR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years | B/Yamagata | 2.99 ratio |
| NBP607-QIV | Geometric Mean Ratio (GMR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years | B/Victoria | 4.61 ratio |
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).
Time frame: At Day 21 post vaccination.
Population: Per protocol set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NBP607-QIV | Seroconversion Rate (SCR) After Vaccination in All Subjects | A/H1N1 | 52.41 percentage of participants |
| NBP607-QIV | Seroconversion Rate (SCR) After Vaccination in All Subjects | A/H3N2 | 51.20 percentage of participants |
| NBP607-QIV | Seroconversion Rate (SCR) After Vaccination in All Subjects | B/Yamagata | 43.72 percentage of participants |
| NBP607-QIV | Seroconversion Rate (SCR) After Vaccination in All Subjects | B/Victoria | 55.75 percentage of participants |
| NBP607-Y | Seroconversion Rate (SCR) After Vaccination in All Subjects | B/Victoria | 43.13 percentage of participants |
| NBP607-Y | Seroconversion Rate (SCR) After Vaccination in All Subjects | A/H1N1 | 52.56 percentage of participants |
| NBP607-Y | Seroconversion Rate (SCR) After Vaccination in All Subjects | B/Yamagata | 36.66 percentage of participants |
| NBP607-Y | Seroconversion Rate (SCR) After Vaccination in All Subjects | A/H3N2 | 46.09 percentage of participants |
| NBP607-V | Seroconversion Rate (SCR) After Vaccination in All Subjects | B/Victoria | 52.66 percentage of participants |
| NBP607-V | Seroconversion Rate (SCR) After Vaccination in All Subjects | A/H3N2 | 46.28 percentage of participants |
| NBP607-V | Seroconversion Rate (SCR) After Vaccination in All Subjects | B/Yamagata | 24.73 percentage of participants |
| NBP607-V | Seroconversion Rate (SCR) After Vaccination in All Subjects | A/H1N1 | 50.27 percentage of participants |
Comparison: Diff. SCR of A/H1N1 strain (SCR of pooled TIV minus QIV)95% CI: [-6.07, 4.06]
Comparison: Diff. SCR of A/H3N2 strain (SCR of pooled TIV minus QIV)95% CI: [-10.08, 0.04]
Comparison: Diff. SCR of B/Yamaga strain (SCR of TIV minus QIV)95% CI: [-13.12, -1]
Comparison: Diff. SCR of B/Victoria (SCR of TIV minus QIV)95% CI: [-9.26, 3.09]
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
Time frame: At Day 21 post vaccination.
Population: Per protocol set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NBP607-QIV | Seroconversion Rate (SCR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years | A/H1N1 | 52.63 percentage of participants |
| NBP607-QIV | Seroconversion Rate (SCR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years | A/H3N2 | 42.11 percentage of participants |
| NBP607-QIV | Seroconversion Rate (SCR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years | B/Yamagata | 43.42 percentage of participants |
| NBP607-QIV | Seroconversion Rate (SCR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years | B/Victoria | 59.87 percentage of participants |
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.
Time frame: At Day 21 post vaccination.
Population: Per protocol set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NBP607-QIV | Seroprotection Rate (SPR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years | A/H1N1 | 92.76 percentage of participants |
| NBP607-QIV | Seroprotection Rate (SPR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years | A/H3N2 | 98.68 percentage of participants |
| NBP607-QIV | Seroprotection Rate (SPR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years | B/Yamagata | 94.08 percentage of participants |
| NBP607-QIV | Seroprotection Rate (SPR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years | B/Victoria | 96.05 percentage of participants |
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).
Time frame: At Day 21 post vaccination.
Population: Per protocol set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| NBP607-QIV | Geometric Mean HI Titers (GMTs) of Each B Strain After Vaccination in All Subjects | B/Yamagata | 163.74 titer |
| NBP607-QIV | Geometric Mean HI Titers (GMTs) of Each B Strain After Vaccination in All Subjects | B/Victoria | 124.82 titer |
| NBP607-Y | Geometric Mean HI Titers (GMTs) of Each B Strain After Vaccination in All Subjects | B/Yamagata | 144.65 titer |
| NBP607-Y | Geometric Mean HI Titers (GMTs) of Each B Strain After Vaccination in All Subjects | B/Victoria | 93.29 titer |
| NBP607-V | Geometric Mean HI Titers (GMTs) of Each B Strain After Vaccination in All Subjects | B/Yamagata | 123.08 titer |
| NBP607-V | Geometric Mean HI Titers (GMTs) of Each B Strain After Vaccination in All Subjects | B/Victoria | 112.20 titer |
Comparison: GMR of B/Yamagata strain (GMTs of TIV/QIV)95% CI: [0.7, 0.81]
Comparison: GMR of B/Victoria (GMTs of TIV/QIV)95% CI: [0.69, 0.81]
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
Time frame: At Day 21 post vaccination.
Population: Per protocol set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| NBP607-QIV | Geometric Mean Ratio (GMR) of NBP607-QIV in the Subjects Aged 19 to 59 Years | A/H1N1 | 4.83 ratio |
| NBP607-QIV | Geometric Mean Ratio (GMR) of NBP607-QIV in the Subjects Aged 19 to 59 Years | A/H3N2 | 3.80 ratio |
| NBP607-QIV | Geometric Mean Ratio (GMR) of NBP607-QIV in the Subjects Aged 19 to 59 Years | B/Yamagata | 3.21 ratio |
| NBP607-QIV | Geometric Mean Ratio (GMR) of NBP607-QIV in the Subjects Aged 19 to 59 Years | B/Victoria | 4.08 ratio |
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
Time frame: At Day 21 post vaccination.
Population: Per protocol set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NBP607-QIV | Seroconversion Rate (SCR) of B Strain After Vaccination in All Subjects | B/Yamagata | 43.72 percentage of participants |
| NBP607-QIV | Seroconversion Rate (SCR) of B Strain After Vaccination in All Subjects | B/Victoria | 55.75 percentage of participants |
| NBP607-Y | Seroconversion Rate (SCR) of B Strain After Vaccination in All Subjects | B/Yamagata | 36.66 percentage of participants |
| NBP607-Y | Seroconversion Rate (SCR) of B Strain After Vaccination in All Subjects | B/Victoria | 43.13 percentage of participants |
| NBP607-V | Seroconversion Rate (SCR) of B Strain After Vaccination in All Subjects | B/Yamagata | 24.73 percentage of participants |
| NBP607-V | Seroconversion Rate (SCR) of B Strain After Vaccination in All Subjects | B/Victoria | 52.66 percentage of participants |
Comparison: Diff. SCR of B/Yamaga strain (SCR of TIV minus QIV)95% CI: [-24.61, -13.36]
Comparison: Diff. SCR of B/Victoria strain (SCR of TIV minus QIV)95% CI: [-18.79, -6.45]
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
Time frame: At Day 21 post vaccination.
Population: Per protocol set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NBP607-QIV | Seroconversion Rate (SCR) of NBP607-QIV in the Adults Aged 19 to 59 Years | A/H1N1 | 52.35 percentage of participants |
| NBP607-QIV | Seroconversion Rate (SCR) of NBP607-QIV in the Adults Aged 19 to 59 Years | A/H3N2 | 53.52 percentage of participants |
| NBP607-QIV | Seroconversion Rate (SCR) of NBP607-QIV in the Adults Aged 19 to 59 Years | B/Yamagata | 43.79 percentage of participants |
| NBP607-QIV | Seroconversion Rate (SCR) of NBP607-QIV in the Adults Aged 19 to 59 Years | B/Victoria | 54.70 percentage of participants |
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.
Time frame: At Day 21 post vaccination.
Population: Per protocol set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NBP607-QIV | Seroprotection Rate (SPR) of NBP607-QIV in the Adults Aged 19 to 59 Years | B/Yamagata | 98.49 percentage of participants |
| NBP607-QIV | Seroprotection Rate (SPR) of NBP607-QIV in the Adults Aged 19 to 59 Years | B/Victoria | 99.16 percentage of participants |
| NBP607-QIV | Seroprotection Rate (SPR) of NBP607-QIV in the Adults Aged 19 to 59 Years | A/H1N1 | 98.32 percentage of participants |
| NBP607-QIV | Seroprotection Rate (SPR) of NBP607-QIV in the Adults Aged 19 to 59 Years | A/H3N2 | 99.50 percentage of participants |