Trial Outcomes & Findings for Immunogenicity and Safety of Quadrivalent Influenza Vaccine (NBP607-QIV) in Adults and Elderly Subjects (NCT NCT02467842)
NCT ID: NCT02467842
Last Updated: 2020-05-08
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1503 participants
Primary outcome timeframe
At Day 21 post vaccination.
Results posted on
2020-05-08
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
752
|
373
|
378
|
|
Overall Study
COMPLETED
|
752
|
373
|
378
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunogenicity and Safety of Quadrivalent Influenza Vaccine (NBP607-QIV) in Adults and Elderly Subjects
Baseline characteristics by cohort
| Measure |
NBP607-QIV
n=752 Participants
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
|
NBP607-Y
n=373 Participants
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
|
NBP607-V
n=378 Participants
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
|
Total
n=1503 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
19 to 59 years old
|
599 Participants
n=5 Participants
|
299 Participants
n=7 Participants
|
305 Participants
n=5 Participants
|
1203 Participants
n=4 Participants
|
|
Age, Customized
60 years old and older
|
153 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
300 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
476 Participants
n=5 Participants
|
238 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
947 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
276 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
556 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Day 21 post vaccination.Population: Per Protocol Set.
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).
Outcome measures
| Measure |
NBP607-QIV
n=748 Participants
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
|
NBP607-Y
n=371 Participants
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
|
NBP607-V
n=376 Participants
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
|
|---|---|---|---|
|
Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects
A/H1N1
|
329.76 titers
Interval 309.17 to 351.71
|
334.98 titers
Interval 313.91 to 357.47
|
334.98 titers
Interval 313.91 to 357.47
|
|
Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects
A/H3N2
|
401.21 titers
Interval 378.87 to 424.87
|
377.34 titers
Interval 356.47 to 399.44
|
377.34 titers
Interval 356.47 to 399.44
|
|
Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects
B/Yamagata
|
163.74 titers
Interval 156.11 to 171.73
|
144.65 titers
Interval 135.54 to 154.37
|
123.08 titers
Interval 115.39 to 131.28
|
|
Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects
B/Victoria
|
124.82 titers
Interval 119.16 to 130.75
|
93.29 titers
Interval 87.43 to 99.53
|
112.20 titers
Interval 105.2 to 119.66
|
PRIMARY outcome
Timeframe: At Day 21 post vaccination.Population: Per protocol set
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).
Outcome measures
| Measure |
NBP607-QIV
n=748 Participants
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
|
NBP607-Y
n=371 Participants
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
|
NBP607-V
n=376 Participants
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
|
|---|---|---|---|
|
Seroconversion Rate (SCR) After Vaccination in All Subjects
A/H1N1
|
52.41 percentage of participants
Interval 48.83 to 55.99
|
52.56 percentage of participants
Interval 47.48 to 57.64
|
50.27 percentage of participants
Interval 45.21 to 55.32
|
|
Seroconversion Rate (SCR) After Vaccination in All Subjects
A/H3N2
|
51.20 percentage of participants
Interval 47.62 to 54.79
|
46.09 percentage of participants
Interval 41.02 to 51.16
|
46.28 percentage of participants
Interval 41.24 to 51.32
|
|
Seroconversion Rate (SCR) After Vaccination in All Subjects
B/Yamagata
|
43.72 percentage of participants
Interval 40.16 to 47.27
|
36.66 percentage of participants
Interval 31.75 to 41.56
|
24.73 percentage of participants
Interval 20.37 to 29.1
|
|
Seroconversion Rate (SCR) After Vaccination in All Subjects
B/Victoria
|
55.75 percentage of participants
Interval 52.19 to 59.31
|
43.13 percentage of participants
Interval 38.09 to 48.17
|
52.66 percentage of participants
Interval 47.61 to 57.71
|
PRIMARY outcome
Timeframe: At Day 21 post vaccination.Population: Per protocol set.
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.
Outcome measures
| Measure |
NBP607-QIV
n=152 Participants
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
|
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
|
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
|
|---|---|---|---|
|
Seroprotection Rate (SPR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
A/H1N1
|
92.76 percentage of participants
Interval 88.64 to 96.88
|
—
|
—
|
|
Seroprotection Rate (SPR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
A/H3N2
|
98.68 percentage of participants
Interval 96.87 to 100.0
|
—
|
—
|
|
Seroprotection Rate (SPR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
B/Yamagata
|
94.08 percentage of participants
Interval 90.33 to 97.83
|
—
|
—
|
|
Seroprotection Rate (SPR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
B/Victoria
|
96.05 percentage of participants
Interval 92.96 to 99.15
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 21 post vaccination.Population: Per protocol set.
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
Outcome measures
| Measure |
NBP607-QIV
n=152 Participants
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
|
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
|
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
|
|---|---|---|---|
|
Seroconversion Rate (SCR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
A/H1N1
|
52.63 percentage of participants
Interval 44.69 to 60.57
|
—
|
—
|
|
Seroconversion Rate (SCR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
A/H3N2
|
42.11 percentage of participants
Interval 34.26 to 49.95
|
—
|
—
|
|
Seroconversion Rate (SCR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
B/Yamagata
|
43.42 percentage of participants
Interval 35.54 to 51.3
|
—
|
—
|
|
Seroconversion Rate (SCR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
B/Victoria
|
59.87 percentage of participants
Interval 52.08 to 67.66
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 21 post vaccination.Population: Per protocol set
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.
Outcome measures
| Measure |
NBP607-QIV
n=152 Participants
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
|
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
|
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
|
|---|---|---|---|
|
Geometric Mean Ratio (GMR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
A/H1N1
|
4.07 ratio
Interval 3.39 to 4.9
|
—
|
—
|
|
Geometric Mean Ratio (GMR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
A/H3N2
|
3.27 ratio
Interval 2.69 to 3.97
|
—
|
—
|
|
Geometric Mean Ratio (GMR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
B/Yamagata
|
2.99 ratio
Interval 2.59 to 3.44
|
—
|
—
|
|
Geometric Mean Ratio (GMR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years
B/Victoria
|
4.61 ratio
Interval 3.91 to 5.42
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 21 post vaccination.Population: Per protocol set.
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).
Outcome measures
| Measure |
NBP607-QIV
n=748 Participants
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
|
NBP607-Y
n=371 Participants
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
|
NBP607-V
n=376 Participants
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
|
|---|---|---|---|
|
Geometric Mean HI Titers (GMTs) of Each B Strain After Vaccination in All Subjects
B/Victoria
|
124.82 titer
Interval 119.16 to 130.75
|
93.29 titer
Interval 87.43 to 99.53
|
112.20 titer
Interval 105.2 to 119.66
|
|
Geometric Mean HI Titers (GMTs) of Each B Strain After Vaccination in All Subjects
B/Yamagata
|
163.74 titer
Interval 156.11 to 171.73
|
144.65 titer
Interval 135.54 to 154.37
|
123.08 titer
Interval 115.39 to 131.28
|
SECONDARY outcome
Timeframe: At Day 21 post vaccination.Population: Per protocol set
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
Outcome measures
| Measure |
NBP607-QIV
n=748 Participants
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
|
NBP607-Y
n=371 Participants
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
|
NBP607-V
n=376 Participants
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
|
|---|---|---|---|
|
Seroconversion Rate (SCR) of B Strain After Vaccination in All Subjects
B/Yamagata
|
43.72 percentage of participants
Interval 40.16 to 47.27
|
36.66 percentage of participants
Interval 31.75 to 41.56
|
24.73 percentage of participants
Interval 20.37 to 29.1
|
|
Seroconversion Rate (SCR) of B Strain After Vaccination in All Subjects
B/Victoria
|
55.75 percentage of participants
Interval 52.19 to 59.31
|
43.13 percentage of participants
Interval 38.09 to 48.17
|
52.66 percentage of participants
Interval 47.61 to 57.71
|
SECONDARY outcome
Timeframe: At Day 21 post vaccination.Population: Per protocol set
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.
Outcome measures
| Measure |
NBP607-QIV
n=596 Participants
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
|
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
|
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
|
|---|---|---|---|
|
Seroprotection Rate (SPR) of NBP607-QIV in the Adults Aged 19 to 59 Years
A/H1N1
|
98.32 percentage of participants
Interval 97.29 to 99.35
|
—
|
—
|
|
Seroprotection Rate (SPR) of NBP607-QIV in the Adults Aged 19 to 59 Years
A/H3N2
|
99.50 percentage of participants
Interval 98.93 to 100.0
|
—
|
—
|
|
Seroprotection Rate (SPR) of NBP607-QIV in the Adults Aged 19 to 59 Years
B/Yamagata
|
98.49 percentage of participants
Interval 97.51 to 99.47
|
—
|
—
|
|
Seroprotection Rate (SPR) of NBP607-QIV in the Adults Aged 19 to 59 Years
B/Victoria
|
99.16 percentage of participants
Interval 98.43 to 99.89
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 21 post vaccination.Population: Per protocol set
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
Outcome measures
| Measure |
NBP607-QIV
n=596 Participants
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
|
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
|
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
|
|---|---|---|---|
|
Seroconversion Rate (SCR) of NBP607-QIV in the Adults Aged 19 to 59 Years
A/H1N1
|
52.35 percentage of participants
Interval 48.34 to 56.36
|
—
|
—
|
|
Seroconversion Rate (SCR) of NBP607-QIV in the Adults Aged 19 to 59 Years
A/H3N2
|
53.52 percentage of participants
Interval 49.52 to 57.53
|
—
|
—
|
|
Seroconversion Rate (SCR) of NBP607-QIV in the Adults Aged 19 to 59 Years
B/Yamagata
|
43.79 percentage of participants
Interval 39.81 to 47.78
|
—
|
—
|
|
Seroconversion Rate (SCR) of NBP607-QIV in the Adults Aged 19 to 59 Years
B/Victoria
|
54.70 percentage of participants
Interval 50.7 to 58.69
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 21 post vaccination.Population: Per protocol set
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
Outcome measures
| Measure |
NBP607-QIV
n=596 Participants
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
|
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
|
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
|
|---|---|---|---|
|
Geometric Mean Ratio (GMR) of NBP607-QIV in the Subjects Aged 19 to 59 Years
A/H1N1
|
4.83 ratio
Interval 4.29 to 5.43
|
—
|
—
|
|
Geometric Mean Ratio (GMR) of NBP607-QIV in the Subjects Aged 19 to 59 Years
A/H3N2
|
3.80 ratio
Interval 3.45 to 4.18
|
—
|
—
|
|
Geometric Mean Ratio (GMR) of NBP607-QIV in the Subjects Aged 19 to 59 Years
B/Yamagata
|
3.21 ratio
Interval 2.95 to 3.5
|
—
|
—
|
|
Geometric Mean Ratio (GMR) of NBP607-QIV in the Subjects Aged 19 to 59 Years
B/Victoria
|
4.08 ratio
Interval 3.73 to 4.46
|
—
|
—
|
Adverse Events
NBP607-QIV
Serious events: 9 serious events
Other events: 364 other events
Deaths: 0 deaths
NBP607-Y
Serious events: 3 serious events
Other events: 154 other events
Deaths: 0 deaths
NBP607-V
Serious events: 3 serious events
Other events: 151 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NBP607-QIV
n=752 participants at risk
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
|
NBP607-Y
n=373 participants at risk
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
|
NBP607-V
n=378 participants at risk
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
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.13%
1/752 • Number of events 1 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/373 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/378 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
Infections and infestations
Diverticulitis
|
0.13%
1/752 • Number of events 1 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/373 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/378 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.13%
1/752 • Number of events 1 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/373 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/378 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
Infections and infestations
Tooth abscess
|
0.13%
1/752 • Number of events 1 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/373 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/378 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.13%
1/752 • Number of events 1 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/373 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/378 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.13%
1/752 • Number of events 1 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/373 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/378 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
Nervous system disorders
cerebral haemorrhage
|
0.13%
1/752 • Number of events 1 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/373 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/378 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
Gastrointestinal disorders
acute abdomen
|
0.13%
1/752 • Number of events 1 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/373 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/378 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
Infections and infestations
pneumonia bacterial
|
0.13%
1/752 • Number of events 1 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/373 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/378 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
Gastrointestinal disorders
gastric ulcer haemorrhage
|
0.00%
0/752 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.27%
1/373 • Number of events 1 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/378 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
Infections and infestations
otitis externa
|
0.00%
0/752 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.27%
1/373 • Number of events 1 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/378 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
Injury, poisoning and procedural complications
concussion
|
0.00%
0/752 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.27%
1/373 • Number of events 1 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/378 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
Surgical and medical procedures
colon operation
|
0.00%
0/752 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/373 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.26%
1/378 • Number of events 1 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
Investigations
prostatic specific antigen increased
|
0.00%
0/752 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/373 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.26%
1/378 • Number of events 1 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
Infections and infestations
gastroenteritis
|
0.00%
0/752 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/373 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.26%
1/378 • Number of events 1 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
Gastrointestinal disorders
colitis
|
0.00%
0/752 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.00%
0/373 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.26%
1/378 • Number of events 1 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
Other adverse events
| Measure |
NBP607-QIV
n=752 participants at risk
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
|
NBP607-Y
n=373 participants at risk
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
|
NBP607-V
n=378 participants at risk
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
|
|---|---|---|---|
|
General disorders
Tenderness
|
27.5%
207/752 • Number of events 207 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
22.5%
84/373 • Number of events 84 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
21.4%
81/378 • Number of events 81 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
General disorders
Pain
|
26.3%
198/752 • Number of events 198 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
18.8%
70/373 • Number of events 70 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
18.8%
71/378 • Number of events 71 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
Skin and subcutaneous tissue disorders
Redness/erythema
|
5.9%
44/752 • Number of events 44 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
4.8%
18/373 • Number of events 18 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
3.7%
14/378 • Number of events 14 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
General disorders
Induration/swelling
|
1.9%
14/752 • Number of events 14 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
2.1%
8/373 • Number of events 8 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.26%
1/378 • Number of events 1 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.3%
130/752 • Number of events 130 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
15.5%
58/373 • Number of events 58 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
14.6%
55/378 • Number of events 55 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
General disorders
Fatigue/Malaise
|
13.4%
101/752 • Number of events 101 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
19.0%
71/373 • Number of events 71 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
15.9%
60/378 • Number of events 60 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
Nervous system disorders
Headache
|
9.4%
71/752 • Number of events 71 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
9.4%
35/373 • Number of events 35 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
10.1%
38/378 • Number of events 38 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
25/752 • Number of events 25 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
2.4%
9/373 • Number of events 9 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
3.2%
12/378 • Number of events 12 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
9/752 • Number of events 9 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.27%
1/373 • Number of events 1 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.53%
2/378 • Number of events 2 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
|
General disorders
Fever
|
0.40%
3/752 • Number of events 3 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.27%
1/373 • Number of events 1 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
0.26%
1/378 • Number of events 1 • 1) Incidence rate of solicited adverse events (AEs) occured within 7 days after test drug or comparator vaccination 2) Incidence rate of unsolicited AEs occured within 21 days after test drug or comparator vaccination 3) Incidence rate of serious adverse events (SAEs) occured within 6 months after test drug or comparator vaccination
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place