Trial Outcomes & Findings for Inactivated Split Virus Seasonal Influenza Vaccine (Vero Cell-Derived) (NCT NCT01773928)
NCT ID: NCT01773928
Last Updated: 2025-09-11
Results Overview
Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine Two co-primary analyses relating to this primary immunogenicity outcome measure were also performed: Outcome Measure 2 - Noninferiority Outcome Measure 3 - Lot Consistency
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1928 participants
Primary outcome timeframe
21 days post vaccination
Results posted on
2025-09-11
Participant Flow
Recruitment was conducted in the U.S. at 20 study sites. The first participant was enrolled in January 2013.
1,928 potential participants were enrolled at clinical study sites in the United States. 75 were screen failures; and 52 were not assigned to a treatment group once the randomization goals were reached. Therefore, 1,801 participants were randomized.
Participant milestones
| Measure |
Fluzone® (18-49 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
VCIV Current Process (18-49 Years Old)
Vero cell-derived trivalent influenza vaccine (VCIV)
VCIV manufactured with the current manufacturing process (VCIV current)
|
VCIV - Modified Process (18-49 Years Old) Lot 1
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Process (18-49 Years Old) Lot 2
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Process (18-49 Years Old) Lot 3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Fluzone® (≥50 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
VCIV - Modified Process (≥50 Years Old) Lot 1
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Process (≥50 Years Old) Lot 2
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Process (≥50 Years Old) Lot 3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
201
|
201
|
200
|
200
|
200
|
204
|
199
|
197
|
199
|
|
Overall Study
COMPLETED
|
196
|
196
|
196
|
194
|
192
|
202
|
199
|
196
|
197
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
4
|
6
|
8
|
2
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Fluzone® (18-49 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
VCIV Current Process (18-49 Years Old)
Vero cell-derived trivalent influenza vaccine (VCIV)
VCIV manufactured with the current manufacturing process (VCIV current)
|
VCIV - Modified Process (18-49 Years Old) Lot 1
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Process (18-49 Years Old) Lot 2
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Process (18-49 Years Old) Lot 3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Fluzone® (≥50 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
VCIV - Modified Process (≥50 Years Old) Lot 1
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Process (≥50 Years Old) Lot 2
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Process (≥50 Years Old) Lot 3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
4
|
4
|
7
|
1
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Subject misrepresented age
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Subject met exclusion criteria
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Randomized, had to leave, never returned
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Refused vaccine, withdrew consent
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Inactivated Split Virus Seasonal Influenza Vaccine (Vero Cell-Derived)
Baseline characteristics by cohort
| Measure |
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1
n=200 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2
n=199 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3
n=199 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV Manufactured With Current Process (18-49 Years Old)
n=201 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
VCIV manufactured with the current manufacturing process (VCIV current)
|
Fluzone® (18-49 Years Old)
n=201 Participants
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1
n=199 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2
n=197 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3
n=198 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Fluzone® (≥50 Years Old)
n=203 Participants
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
Total
n=1797 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
32.6 years
STANDARD_DEVIATION 9.09 • n=5 Participants
|
34.2 years
STANDARD_DEVIATION 9.26 • n=7 Participants
|
32.6 years
STANDARD_DEVIATION 9.05 • n=5 Participants
|
34.4 years
STANDARD_DEVIATION 9.28 • n=4 Participants
|
34.0 years
STANDARD_DEVIATION 9.28 • n=21 Participants
|
61.5 years
STANDARD_DEVIATION 8.44 • n=10 Participants
|
62.2 years
STANDARD_DEVIATION 8.55 • n=115 Participants
|
61.5 years
STANDARD_DEVIATION 7.91 • n=24 Participants
|
62.4 years
STANDARD_DEVIATION 8.71 • n=42 Participants
|
46.1 years
STANDARD_DEVIATION 16.63 • n=42 Participants
|
|
Sex: Female, Male
Female
|
121 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
117 Participants
n=21 Participants
|
116 Participants
n=10 Participants
|
92 Participants
n=115 Participants
|
103 Participants
n=24 Participants
|
115 Participants
n=42 Participants
|
998 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
84 Participants
n=21 Participants
|
83 Participants
n=10 Participants
|
105 Participants
n=115 Participants
|
95 Participants
n=24 Participants
|
88 Participants
n=42 Participants
|
799 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
200 participants
n=5 Participants
|
199 participants
n=7 Participants
|
199 participants
n=5 Participants
|
201 participants
n=4 Participants
|
201 participants
n=21 Participants
|
199 participants
n=10 Participants
|
197 participants
n=115 Participants
|
198 participants
n=24 Participants
|
203 participants
n=42 Participants
|
1797 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 21 days post vaccinationPopulation: Immunogenicity Analysis Set. The primary immunogenicity and safety analyses groups included the VCIV Modified lots separately. The secondary immunogenicity and safety analyses groups included all three of the VCIV Modified lots pooled.
Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine Two co-primary analyses relating to this primary immunogenicity outcome measure were also performed: Outcome Measure 2 - Noninferiority Outcome Measure 3 - Lot Consistency
Outcome measures
| Measure |
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1
n=196 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2
n=193 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3
n=192 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3
n=581 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV Manufactured With Current Process (18-49 Years Old)
n=195 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
VCIV manufactured with the current manufacturing process (VCIV current)
|
Fluzone® (18-49 Years Old)
n=196 Participants
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1
n=199 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2
n=196 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3
n=195 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (≥50 Years Old) Lots 1-3
n=590 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Fluzone® (≥50 Years Old)
n=200 Participants
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine
Strain A/H1N1
|
269.7 Titers
Interval 222.6 to 326.8
|
337.3 Titers
Interval 286.9 to 396.6
|
288.5 Titers
Interval 238.8 to 348.6
|
297.1 Titers
Interval 267.6 to 329.8
|
264.4 Titers
Interval 216.0 to 323.7
|
595.6 Titers
Interval 516.9 to 686.3
|
141.3 Titers
Interval 113.6 to 175.7
|
118.3 Titers
Interval 93.9 to 149.1
|
112.8 Titers
Interval 89.8 to 141.7
|
123.7 Titers
Interval 108.6 to 140.8
|
306.3 Titers
Interval 255.5 to 367.1
|
|
Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine
Strain A/H3N2
|
153.5 Titers
Interval 127.5 to 184.9
|
245.3 Titers
Interval 207.1 to 290.6
|
205.5 Titers
Interval 171.1 to 246.8
|
197.5 Titers
Interval 178.0 to 219.3
|
172.2 Titers
Interval 144.2 to 205.6
|
314.4 Titers
Interval 268.7 to 367.9
|
174.4 Titers
Interval 143.6 to 211.7
|
165.8 Titers
Interval 134.3 to 204.6
|
168.4 Titers
Interval 135.2 to 209.6
|
169.5 Titers
Interval 150.4 to 191.0
|
294.8 Titers
Interval 246.7 to 352.3
|
|
Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine
Strain B
|
86.8 Titers
Interval 74.5 to 101.0
|
83.5 Titers
Interval 70.7 to 98.6
|
83.6 Titers
Interval 70.3 to 99.5
|
84.6 Titers
Interval 77.0 to 93.0
|
60.7 Titers
Interval 51.2 to 72.0
|
97.3 Titers
Interval 84.3 to 112.2
|
40.5 Titers
Interval 33.4 to 49.0
|
35.9 Titers
Interval 29.7 to 43.4
|
30.4 Titers
Interval 25.3 to 36.4
|
35.4 Titers
Interval 31.7 to 39.4
|
37.1 Titers
Interval 31.4 to 44.0
|
PRIMARY outcome
Timeframe: 21 days post vaccinationPopulation: Subset of the per-protocol (PP) analysis dataset of Cohort 1 (18-49 years) comprising subjects from the VCIV modified and VCIV current treatment groups (because the aim of the analysis was to show non-inferiority between the two VCIV manufacturing processes), for all three strains separately.
Non-inferiority of modified manufacturing process compared to the current process. Co-primary analysis of HIA Titer for each of the three antigens (Outcome Measure 1) was performed on a subset of the Per Protocol analysis dataset for participants 18-49 Years Old treated with Vero cell-derived trivalent influenza vaccine (VCIV) from the modified manufacturing process and VCIV manufactured with the current process
Outcome measures
| Measure |
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1
n=774 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2
n=774 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3
n=774 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV Manufactured With Current Process (18-49 Years Old)
Vero cell-derived trivalent influenza vaccine (VCIV)
VCIV manufactured with the current manufacturing process (VCIV current)
|
Fluzone® (18-49 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (≥50 Years Old) Lots 1-3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Fluzone® (≥50 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Non-inferiority of Modified Manufacturing Process Compared to the Current Process
|
1.12 ratio of Geometric Mean- no units
Interval 0.93 to 1.35
|
1.16 ratio of Geometric Mean- no units
Interval 0.97 to 1.38
|
1.33 ratio of Geometric Mean- no units
Interval 1.11 to 1.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 21 days post vaccinationPopulation: Subset of the PP analysis dataset comprising the 3 VCIV modified lots (as the aim of the analysis was to show similarity between three different lots of the VCIV manufactured with the modified process), both cohort pooled, for all three strains separately.
Lot consistency of the three modified manufacturing process lots Co-primary analysis of HIA Titer for each of the three antigens (Outcome Measure 1) was performed on a subset of the Per Protocol Analysis Dataset for participants of all ages treated with three Vero cell-derived trivalent influenza vaccine (VCIV) lots manufactured from the modified process.
Outcome measures
| Measure |
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1
n=1163 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2
n=1163 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3
n=1163 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV Manufactured With Current Process (18-49 Years Old)
Vero cell-derived trivalent influenza vaccine (VCIV)
VCIV manufactured with the current manufacturing process (VCIV current)
|
Fluzone® (18-49 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (≥50 Years Old) Lots 1-3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Fluzone® (≥50 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Lot Consistency of the Three Modified Manufacturing Process Lots
Lot 2 vs. Lot 1
|
1.00 ratio of geometric mean- no units
Interval 0.84 to 1.19
|
1.15 ratio of geometric mean- no units
Interval 0.98 to 1.35
|
0.87 ratio of geometric mean- no units
Interval 0.74 to 1.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Lot Consistency of the Three Modified Manufacturing Process Lots
Lot 3 vs. Lot 1
|
0.90 ratio of geometric mean- no units
Interval 0.76 to 1.07
|
1.17 ratio of geometric mean- no units
Interval 1.0 to 1.38
|
0.84 ratio of geometric mean- no units
Interval 0.71 to 0.99
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Lot Consistency of the Three Modified Manufacturing Process Lots
Lot 3 vs. Lot 2
|
0.89 ratio of geometric mean- no units
Interval 0.75 to 1.06
|
1.02 ratio of geometric mean- no units
Interval 0.87 to 1.2
|
0.96 ratio of geometric mean- no units
Interval 0.81 to 1.13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: onset within 7 days post vaccinationPopulation: Safety Analysis Set. The primary immunogenicity and safety analyses groups included the VCIV Modified lots separately. The secondary immunogenicity and safety analyses groups included all three of the VCIV Modified lots pooled.
Percentage of participants with fever
Outcome measures
| Measure |
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1
n=200 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2
n=199 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3
n=199 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3
n=598 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV Manufactured With Current Process (18-49 Years Old)
n=201 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
VCIV manufactured with the current manufacturing process (VCIV current)
|
Fluzone® (18-49 Years Old)
n=201 Participants
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1
n=199 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2
n=197 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3
n=198 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (≥50 Years Old) Lots 1-3
n=594 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Fluzone® (≥50 Years Old)
n=203 Participants
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Fever
|
2.5 percentage of participants with fever
Interval 0.8 to 5.7
|
1.0 percentage of participants with fever
Interval 0.1 to 3.6
|
2.0 percentage of participants with fever
Interval 0.6 to 5.1
|
1.8 percentage of participants with fever
Interval 0.9 to 3.3
|
1.0 percentage of participants with fever
Interval 0.1 to 3.5
|
0.0 percentage of participants with fever
Interval 0.0 to 1.8
|
2.5 percentage of participants with fever
Interval 0.8 to 5.8
|
1.0 percentage of participants with fever
Interval 0.1 to 3.6
|
2.0 percentage of participants with fever
Interval 0.6 to 5.1
|
1.9 percentage of participants with fever
Interval 0.9 to 3.3
|
0.0 percentage of participants with fever
Interval 0.0 to 1.8
|
SECONDARY outcome
Timeframe: 21 days post vaccinationPopulation: Immunogenicity Analysis Set. The primary immunogenicity and safety analyses groups included the VCIV Modified lots separately. The secondary immunogenicity and safety analyses groups included all three of the VCIV Modified lots pooled.
Percentage of participants with seroprotective antibody titer \[reciprocal HIA titer ≥40\] for each of the three antigens contained in the vaccine
Outcome measures
| Measure |
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1
n=581 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2
n=590 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3
n=195 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3
n=196 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV Manufactured With Current Process (18-49 Years Old)
n=200 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
VCIV manufactured with the current manufacturing process (VCIV current)
|
Fluzone® (18-49 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (≥50 Years Old) Lots 1-3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Fluzone® (≥50 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens
Strain A/H1N1
|
94.7 percentage of participants
Interval 92.5 to 96.3
|
79.0 percentage of participants
Interval 75.5 to 82.2
|
90.8 percentage of participants
Interval 85.8 to 94.4
|
100.0 percentage of participants
Interval 98.1 to 100.0
|
95.5 percentage of participants
Interval 91.6 to 97.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens
Strain A/H3N2
|
91.6 percentage of participants
Interval 89.0 to 93.7
|
86.4 percentage of participants
Interval 83.4 to 89.1
|
90.8 percentage of participants
Interval 85.8 to 94.4
|
98.5 percentage of participants
Interval 95.6 to 99.7
|
94.0 percentage of participants
Interval 89.8 to 96.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens
Strain B
|
82.8 percentage of participants
Interval 79.5 to 85.8
|
53.6 percentage of participants
Interval 49.4 to 57.6
|
72.3 percentage of participants
Interval 65.5 to 78.5
|
88.8 percentage of participants
Interval 83.5 to 92.8
|
59.5 percentage of participants
Interval 52.3 to 66.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 21 days post vaccinationPopulation: Immunogenicity Analysis Set. The primary immunogenicity and safety analyses groups included the VCIV Modified lots separately. The secondary immunogenicity and safety analyses groups included all three of the VCIV Modified lots pooled.
Seroconversion is defined as a ≥ 4-fold increase in HIA titer from baseline OR a reciprocal HIA titer ≥ 40 when there is no detectable HIA titer (reciprocal HIA titer \< 10) at baseline
Outcome measures
| Measure |
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1
n=581 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2
n=590 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3
n=195 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3
n=196 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV Manufactured With Current Process (18-49 Years Old)
n=200 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
VCIV manufactured with the current manufacturing process (VCIV current)
|
Fluzone® (18-49 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (≥50 Years Old) Lots 1-3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Fluzone® (≥50 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine
Strain A/H1N1
|
70.9 percentage of participants
Interval 67.0 to 74.6
|
52.7 percentage of participants
Interval 48.6 to 56.8
|
64.6 percentage of participants
Interval 57.5 to 71.3
|
79.1 percentage of participants
Interval 72.7 to 84.6
|
70.5 percentage of participants
Interval 63.7 to 76.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine
Strain A/H3N2
|
57.5 percentage of participants
Interval 53.4 to 61.5
|
50.3 percentage of participants
Interval 46.2 to 54.4
|
51.3 percentage of participants
Interval 44.0 to 58.5
|
67.9 percentage of participants
Interval 60.8 to 74.3
|
63.5 percentage of participants
Interval 56.4 to 70.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine
Strain B
|
61.4 percentage of participants
Interval 57.4 to 65.4
|
40.3 percentage of participants
Interval 36.4 to 44.4
|
54.9 percentage of participants
Interval 47.6 to 62.0
|
70.9 percentage of participants
Interval 64.0 to 77.2
|
49.0 percentage of participants
Interval 41.9 to 56.1
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 21 days post vaccinationPopulation: Immunogenicity Analysis Set. The primary immunogenicity and safety analyses groups included the VCIV Modified lots separately. The secondary immunogenicity and safety analyses groups included all three of the VCIV Modified lots pooled.
Outcome measures
| Measure |
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1
n=581 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2
n=195 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3
n=196 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3
n=590 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV Manufactured With Current Process (18-49 Years Old)
n=200 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
VCIV manufactured with the current manufacturing process (VCIV current)
|
Fluzone® (18-49 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (≥50 Years Old) Lots 1-3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Fluzone® (≥50 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline
Strain A/H1N1
|
9.6 Titers
Interval 8.5 to 10.8
|
8.5 Titers
Interval 6.8 to 10.5
|
19.9 Titers
Interval 15.5 to 25.4
|
5.5 Titers
Interval 4.9 to 6.2
|
12.7 Titers
Interval 10.0 to 16.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline
Strain A/H3N2
|
5.6 Titers
Interval 5.0 to 6.3
|
4.8 Titers
Interval 4.0 to 5.8
|
9.5 Titers
Interval 7.6 to 12.0
|
5.1 Titers
Interval 4.6 to 5.8
|
8.5 Titers
Interval 6.8 to 10.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline
Strain B
|
6.7 Titers
Interval 6.0 to 7.5
|
5.6 Titers
Interval 4.7 to 6.8
|
9.1 Titers
Interval 7.6 to 10.8
|
3.9 Titers
Interval 3.5 to 4.3
|
4.8 Titers
Interval 4.0 to 5.6
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: within 7 days post vaccinationPopulation: Safety Analysis Set. The primary immunogenicity and safety analyses groups included the VCIV Modified lots separately. The secondary immunogenicity and safety analyses groups included all three of the VCIV Modified lots pooled.
Outcome measures
| Measure |
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1
n=598 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2
n=201 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3
n=201 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3
n=594 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV Manufactured With Current Process (18-49 Years Old)
n=203 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
VCIV manufactured with the current manufacturing process (VCIV current)
|
Fluzone® (18-49 Years Old)
n=1192 Participants
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1
n=404 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (≥50 Years Old) Lots 1-3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Fluzone® (≥50 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Solicited Systemic Reactions
|
37.0 percentage of participants
Interval 33.1 to 41.0
|
44.3 percentage of participants
Interval 37.3 to 51.4
|
39.8 percentage of participants
Interval 33.0 to 46.9
|
19.5 percentage of participants
Interval 16.4 to 22.9
|
27.1 percentage of participants
Interval 21.1 to 33.8
|
28.3 percentage of participants
Interval 25.7 to 30.9
|
33.4 percentage of participants
Interval 28.8 to 38.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: within 7 days post vaccinationPopulation: Safety Analysis Set. The primary immunogenicity and safety analyses groups included the VCIV Modified lots separately. The secondary immunogenicity and safety analyses groups included all three of the VCIV Modified lots pooled.
Outcome measures
| Measure |
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1
n=598 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2
n=201 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3
n=201 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3
n=594 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV Manufactured With Current Process (18-49 Years Old)
n=203 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
VCIV manufactured with the current manufacturing process (VCIV current)
|
Fluzone® (18-49 Years Old)
n=1192 Participants
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1
n=404 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (≥50 Years Old) Lots 1-3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Fluzone® (≥50 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Injection Site Reactions
|
50.7 percentage of participants
Interval 46.6 to 54.7
|
51.7 percentage of participants
Interval 44.6 to 58.8
|
44.3 percentage of participants
Interval 37.3 to 51.4
|
28.6 percentage of participants
Interval 25.0 to 32.4
|
30.5 percentage of participants
Interval 24.3 to 37.4
|
39.7 percentage of participants
Interval 36.9 to 42.5
|
37.4 percentage of participants
Interval 32.6 to 42.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: within 7 days post vaccinationPopulation: Safety Analysis Set. The primary immunogenicity and safety analyses groups included the VCIV Modified lots separately. The secondary immunogenicity and safety analyses groups included all three of the VCIV Modified lots pooled.
Outcome measures
| Measure |
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1
n=598 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2
n=201 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3
n=201 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3
n=594 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV Manufactured With Current Process (18-49 Years Old)
n=203 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
VCIV manufactured with the current manufacturing process (VCIV current)
|
Fluzone® (18-49 Years Old)
n=1192 Participants
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1
n=201 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2
n=404 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (≥50 Years Old) Lots 1-3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Fluzone® (≥50 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Injection site redness- Mild
|
5 number of adverse reactions
|
2 number of adverse reactions
|
1 number of adverse reactions
|
11 number of adverse reactions
|
3 number of adverse reactions
|
16 number of adverse reactions
|
2 number of adverse reactions
|
4 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Injection site redness-Moderate
|
2 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
2 number of adverse reactions
|
0 number of adverse reactions
|
4 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Injection site redness-Unknown
|
1 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
1 number of adverse reactions
|
2 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Injection site redness-Severe
|
1 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Injection site redness-Total
|
9 number of adverse reactions
|
2 number of adverse reactions
|
2 number of adverse reactions
|
14 number of adverse reactions
|
4 number of adverse reactions
|
23 number of adverse reactions
|
2 number of adverse reactions
|
6 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Injection site swelling-Mild
|
5 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
7 number of adverse reactions
|
1 number of adverse reactions
|
12 number of adverse reactions
|
0 number of adverse reactions
|
2 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Injection site swelling-Moderate
|
2 number of adverse reactions
|
1 number of adverse reactions
|
0 number of adverse reactions
|
3 number of adverse reactions
|
2 number of adverse reactions
|
5 number of adverse reactions
|
1 number of adverse reactions
|
2 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Injection site sweling-Unknown
|
1 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
2 number of adverse reactions
|
1 number of adverse reactions
|
3 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Injection site swelling-Total
|
8 number of adverse reactions
|
1 number of adverse reactions
|
1 number of adverse reactions
|
12 number of adverse reactions
|
4 number of adverse reactions
|
20 number of adverse reactions
|
1 number of adverse reactions
|
5 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Injection site induration-Mild
|
5 number of adverse reactions
|
3 number of adverse reactions
|
1 number of adverse reactions
|
8 number of adverse reactions
|
1 number of adverse reactions
|
13 number of adverse reactions
|
3 number of adverse reactions
|
1 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Injection site induration-Moderate
|
6 number of adverse reactions
|
1 number of adverse reactions
|
1 number of adverse reactions
|
3 number of adverse reactions
|
1 number of adverse reactions
|
9 number of adverse reactions
|
1 number of adverse reactions
|
2 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Injection site induration-Unknown
|
0 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
2 number of adverse reactions
|
2 number of adverse reactions
|
2 number of adverse reactions
|
0 number of adverse reactions
|
2 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Injection site induration-Total
|
11 number of adverse reactions
|
4 number of adverse reactions
|
3 number of adverse reactions
|
13 number of adverse reactions
|
2 number of adverse reactions
|
24 number of adverse reactions
|
4 number of adverse reactions
|
5 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Injection site pain-Mild
|
174 number of adverse reactions
|
67 number of adverse reactions
|
50 number of adverse reactions
|
67 number of adverse reactions
|
20 number of adverse reactions
|
241 number of adverse reactions
|
67 number of adverse reactions
|
70 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Injection site pain-Moderate
|
6 number of adverse reactions
|
1 number of adverse reactions
|
0 number of adverse reactions
|
6 number of adverse reactions
|
1 number of adverse reactions
|
12 number of adverse reactions
|
1 number of adverse reactions
|
1 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Injection site pain-Total
|
180 number of adverse reactions
|
68 number of adverse reactions
|
50 number of adverse reactions
|
73 number of adverse reactions
|
21 number of adverse reactions
|
253 number of adverse reactions
|
68 number of adverse reactions
|
71 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Injection site tenderness-Mild
|
230 number of adverse reactions
|
81 number of adverse reactions
|
68 number of adverse reactions
|
129 number of adverse reactions
|
47 number of adverse reactions
|
359 number of adverse reactions
|
81 number of adverse reactions
|
115 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Injection site tenderness-Moderate
|
4 number of adverse reactions
|
0 number of adverse reactions
|
2 number of adverse reactions
|
5 number of adverse reactions
|
2 number of adverse reactions
|
9 number of adverse reactions
|
0 number of adverse reactions
|
4 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Injection site tenderness-Total
|
234 number of adverse reactions
|
81 number of adverse reactions
|
70 number of adverse reactions
|
134 number of adverse reactions
|
49 number of adverse reactions
|
368 number of adverse reactions
|
81 number of adverse reactions
|
119 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Injection site ecchymosis-Mild
|
23 number of adverse reactions
|
6 number of adverse reactions
|
4 number of adverse reactions
|
8 number of adverse reactions
|
5 number of adverse reactions
|
31 number of adverse reactions
|
6 number of adverse reactions
|
9 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Injection site ecchymosis-Moderate
|
0 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
1 number of adverse reactions
|
1 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Injection site ecchymosis-Total
|
23 number of adverse reactions
|
6 number of adverse reactions
|
4 number of adverse reactions
|
9 number of adverse reactions
|
6 number of adverse reactions
|
32 number of adverse reactions
|
6 number of adverse reactions
|
10 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Malaise-Mild
|
86 number of adverse reactions
|
42 number of adverse reactions
|
32 number of adverse reactions
|
49 number of adverse reactions
|
16 number of adverse reactions
|
135 number of adverse reactions
|
42 number of adverse reactions
|
48 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Malaise-Moderate
|
22 number of adverse reactions
|
10 number of adverse reactions
|
8 number of adverse reactions
|
10 number of adverse reactions
|
3 number of adverse reactions
|
32 number of adverse reactions
|
10 number of adverse reactions
|
11 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Malaise-Severe
|
0 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Malaise-Total
|
108 number of adverse reactions
|
52 number of adverse reactions
|
40 number of adverse reactions
|
60 number of adverse reactions
|
19 number of adverse reactions
|
168 number of adverse reactions
|
52 number of adverse reactions
|
59 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Shivering-Mild
|
14 number of adverse reactions
|
7 number of adverse reactions
|
5 number of adverse reactions
|
3 number of adverse reactions
|
4 number of adverse reactions
|
17 number of adverse reactions
|
7 number of adverse reactions
|
9 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Shivering-Moderate
|
6 number of adverse reactions
|
5 number of adverse reactions
|
4 number of adverse reactions
|
2 number of adverse reactions
|
1 number of adverse reactions
|
8 number of adverse reactions
|
5 number of adverse reactions
|
5 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Shivering-Severe
|
0 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Shivering-Total
|
20 number of adverse reactions
|
12 number of adverse reactions
|
9 number of adverse reactions
|
6 number of adverse reactions
|
5 number of adverse reactions
|
26 number of adverse reactions
|
12 number of adverse reactions
|
14 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Fatigue-Mild
|
77 number of adverse reactions
|
33 number of adverse reactions
|
25 number of adverse reactions
|
37 number of adverse reactions
|
20 number of adverse reactions
|
114 number of adverse reactions
|
33 number of adverse reactions
|
45 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Fatigue-Moderate
|
28 number of adverse reactions
|
9 number of adverse reactions
|
10 number of adverse reactions
|
18 number of adverse reactions
|
5 number of adverse reactions
|
46 number of adverse reactions
|
9 number of adverse reactions
|
15 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Fatigue-Severe
|
0 number of adverse reactions
|
1 number of adverse reactions
|
1 number of adverse reactions
|
1 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
1 number of adverse reactions
|
1 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Fatigue-Total
|
105 number of adverse reactions
|
43 number of adverse reactions
|
36 number of adverse reactions
|
56 number of adverse reactions
|
25 number of adverse reactions
|
161 number of adverse reactions
|
43 number of adverse reactions
|
61 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Headache-Mild
|
92 number of adverse reactions
|
32 number of adverse reactions
|
24 number of adverse reactions
|
41 number of adverse reactions
|
19 number of adverse reactions
|
133 number of adverse reactions
|
32 number of adverse reactions
|
43 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Headache-Moderate
|
17 number of adverse reactions
|
7 number of adverse reactions
|
9 number of adverse reactions
|
8 number of adverse reactions
|
6 number of adverse reactions
|
25 number of adverse reactions
|
7 number of adverse reactions
|
15 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Headache-Severe
|
0 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Headache-Total
|
109 number of adverse reactions
|
39 number of adverse reactions
|
33 number of adverse reactions
|
50 number of adverse reactions
|
25 number of adverse reactions
|
159 number of adverse reactions
|
39 number of adverse reactions
|
58 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Sweating-Mild
|
15 number of adverse reactions
|
8 number of adverse reactions
|
4 number of adverse reactions
|
14 number of adverse reactions
|
7 number of adverse reactions
|
29 number of adverse reactions
|
8 number of adverse reactions
|
11 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Sweating-Moderate
|
8 number of adverse reactions
|
3 number of adverse reactions
|
3 number of adverse reactions
|
3 number of adverse reactions
|
1 number of adverse reactions
|
11 number of adverse reactions
|
3 number of adverse reactions
|
4 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Sweating-Severe
|
0 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Sweating-Total
|
23 number of adverse reactions
|
11 number of adverse reactions
|
7 number of adverse reactions
|
18 number of adverse reactions
|
8 number of adverse reactions
|
41 number of adverse reactions
|
11 number of adverse reactions
|
15 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Muscle pain-Mild
|
85 number of adverse reactions
|
34 number of adverse reactions
|
26 number of adverse reactions
|
53 number of adverse reactions
|
17 number of adverse reactions
|
138 number of adverse reactions
|
34 number of adverse reactions
|
43 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Muscle pain-Moderate
|
16 number of adverse reactions
|
6 number of adverse reactions
|
12 number of adverse reactions
|
8 number of adverse reactions
|
3 number of adverse reactions
|
24 number of adverse reactions
|
6 number of adverse reactions
|
15 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Muscle pain-Severe
|
0 number of adverse reactions
|
2 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
2 number of adverse reactions
|
0 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Muscle pain-Total
|
101 number of adverse reactions
|
42 number of adverse reactions
|
38 number of adverse reactions
|
62 number of adverse reactions
|
20 number of adverse reactions
|
163 number of adverse reactions
|
42 number of adverse reactions
|
58 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Arthralgia (joint pain)-Mild
|
30 number of adverse reactions
|
5 number of adverse reactions
|
4 number of adverse reactions
|
10 number of adverse reactions
|
6 number of adverse reactions
|
40 number of adverse reactions
|
5 number of adverse reactions
|
10 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Arthralgia (joint pain)-Moderate
|
6 number of adverse reactions
|
4 number of adverse reactions
|
3 number of adverse reactions
|
6 number of adverse reactions
|
1 number of adverse reactions
|
12 number of adverse reactions
|
4 number of adverse reactions
|
4 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Arthralgia (joint pain)-Severe
|
0 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
1 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Arthralgia (joint pain)-Total
|
36 number of adverse reactions
|
9 number of adverse reactions
|
8 number of adverse reactions
|
17 number of adverse reactions
|
7 number of adverse reactions
|
53 number of adverse reactions
|
9 number of adverse reactions
|
15 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Nausea-Mild
|
24 number of adverse reactions
|
10 number of adverse reactions
|
8 number of adverse reactions
|
14 number of adverse reactions
|
4 number of adverse reactions
|
38 number of adverse reactions
|
10 number of adverse reactions
|
12 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Nausea-Moderate
|
11 number of adverse reactions
|
4 number of adverse reactions
|
3 number of adverse reactions
|
2 number of adverse reactions
|
1 number of adverse reactions
|
13 number of adverse reactions
|
4 number of adverse reactions
|
4 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Nausea-Severe
|
1 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Nausea-Total
|
36 number of adverse reactions
|
14 number of adverse reactions
|
11 number of adverse reactions
|
16 number of adverse reactions
|
5 number of adverse reactions
|
52 number of adverse reactions
|
14 number of adverse reactions
|
16 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Vomiting-Mild
|
2 number of adverse reactions
|
0 number of adverse reactions
|
2 number of adverse reactions
|
1 number of adverse reactions
|
1 number of adverse reactions
|
3 number of adverse reactions
|
0 number of adverse reactions
|
3 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Vomiting-Moderate
|
6 number of adverse reactions
|
1 number of adverse reactions
|
2 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
6 number of adverse reactions
|
1 number of adverse reactions
|
2 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Vomiting-Severe
|
1 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
1 number of adverse reactions
|
0 number of adverse reactions
|
0 number of adverse reactions
|
—
|
—
|
—
|
|
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Vomiting-Total
|
9 number of adverse reactions
|
1 number of adverse reactions
|
4 number of adverse reactions
|
1 number of adverse reactions
|
1 number of adverse reactions
|
10 number of adverse reactions
|
1 number of adverse reactions
|
5 number of adverse reactions
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: within 21 days post vaccinationPopulation: Safety Analysis Set. The primary immunogenicity and safety analyses groups included the VCIV Modified lots separately. The secondary immunogenicity and safety analyses groups included all three of the VCIV Modified lots pooled.
Outcome measures
| Measure |
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1
n=598 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2
n=201 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3
n=201 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3
n=594 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV Manufactured With Current Process (18-49 Years Old)
n=203 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
VCIV manufactured with the current manufacturing process (VCIV current)
|
Fluzone® (18-49 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (≥50 Years Old) Lots 1-3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Fluzone® (≥50 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Adverse Events
Serious AEs
|
0.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0.7 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Adverse Events
Any non-serious systemic AEs
|
47.7 percentage of participants
|
53.2 percentage of participants
|
48.3 percentage of participants
|
35.4 percentage of participants
|
38.4 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Adverse Events
Treatment-related non-serious systemic AEs
|
38.5 percentage of participants
|
44.8 percentage of participants
|
40.3 percentage of participants
|
21.4 percentage of participants
|
27.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Adverse Events
Any non-serious local AEs
|
50.8 percentage of participants
|
51.7 percentage of participants
|
44.3 percentage of participants
|
28.8 percentage of participants
|
31.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: within 21 days post vaccinationPopulation: Safety Analysis Set. The primary immunogenicity and safety analyses groups included the VCIV Modified lots separately. The secondary immunogenicity and safety analyses groups included all three of the VCIV Modified lots pooled.
Frequency and severity of adverse events considered related to the vaccination (possibly related, probably related, unknown) according to System Organ Class (SOC) and Preferred Term (PT) SOCs are abbreviated as follows:- BLD- Blood and lymphatic system disorders EAR- Ear and labyrinth disorders EYE- Eye disorders GID- Gastrointestinal disorders GEN- General disorders and administration site conditions IMM- Immune system disorders INF- Infections and infestations MET- Metabolism and nutrition disorders MSK- Musculoskeletal and connective tissue disorders NER- Nervous system disorders RES- Respiratory, thoracic and mediastinal disorders SKN- Skin and subcutaneous tissue disorders VAS- Vascular disorders SYS-Systemic LOC-Local
Outcome measures
| Measure |
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1
n=598 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2
n=201 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3
n=201 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3
n=594 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV Manufactured With Current Process (18-49 Years Old)
n=203 Participants
Vero cell-derived trivalent influenza vaccine (VCIV)
VCIV manufactured with the current manufacturing process (VCIV current)
|
Fluzone® (18-49 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Total VCIV - Modified Process (≥50 Years Old) Lots 1-3
Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Fluzone® (≥50 Years Old)
Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV)
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Feeling cold-Total
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Injection site pain-Mild
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Injection site pain-Total
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Injection site reaction-Mild
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Injection site reaction-Total
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-SKN-Pruritus-Mild
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-SKN-Pruritus-Total
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-SKN-Rash-Mild
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-SKN-Rash-Total
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-SKN-Skin mass-Mild
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-SKN-Skin mass-Total
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-SKN-MILD-TOTAL
|
3.3 percentage of related adverse events
|
4.5 percentage of related adverse events
|
2.0 percentage of related adverse events
|
2.4 percentage of related adverse events
|
3.0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-SKN-MODERATE-TOTAL
|
1.3 percentage of related adverse events
|
1.5 percentage of related adverse events
|
1.5 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-SKN-SEVERE-TOTAL
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-SKN-TOTAL
|
4.7 percentage of related adverse events
|
6.0 percentage of related adverse events
|
3.5 percentage of related adverse events
|
3.0 percentage of related adverse events
|
3.4 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-VAS-Pallor-Mild
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-VAS-Pallor-Total
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-VAS-MILD-TOTAL
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-VAS-TOTAL
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-TOTAL
|
17.4 percentage of related adverse events
|
21.4 percentage of related adverse events
|
18.4 percentage of related adverse events
|
10.8 percentage of related adverse events
|
12.3 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-MODERATE-TOTAL
|
2.7 percentage of related adverse events
|
3.5 percentage of related adverse events
|
5.5 percentage of related adverse events
|
1.3 percentage of related adverse events
|
1.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-SEVERE-TOTAL
|
0 percentage of related adverse events
|
1.0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Malaise-Mild
|
14.4 percentage of related adverse events
|
20.9 percentage of related adverse events
|
15.9 percentage of related adverse events
|
7.7 percentage of related adverse events
|
7.4 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Pain in jaw-Mild
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Pain in jaw-Total
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-MILD-TOTAL
|
14.7 percentage of related adverse events
|
16.9 percentage of related adverse events
|
12.4 percentage of related adverse events
|
9.3 percentage of related adverse events
|
10.8 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-NER-Burning sensation-Mild
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-NER-Burning sensation-Total
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-NER-Dizziness-Mild
|
0.3 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-NER-Dizziness-Total
|
0.3 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-NER-Dysgeusia-Mild
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-NER-Dysgeusia-Moderate
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-NER-Dysgeusia-Total
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-NER-Headache-Mild
|
13.4 percentage of related adverse events
|
13.4 percentage of related adverse events
|
10.9 percentage of related adverse events
|
6.1 percentage of related adverse events
|
7.9 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-NER-Headache-Moderate
|
3.0 percentage of related adverse events
|
3.5 percentage of related adverse events
|
4.5 percentage of related adverse events
|
1.2 percentage of related adverse events
|
3.0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SSYS-NER-Headache-Severe
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-NER-Headache-Total
|
16.4 percentage of related adverse events
|
16.9 percentage of related adverse events
|
15.4 percentage of related adverse events
|
7.4 percentage of related adverse events
|
10.8 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-NER-Hypoaesthesia-Mild
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-NER-Hypoaesthesia-Total
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-NER-Lethargy-Mild
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-NER-Lethargy-Total
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-NER-Paraesthesia-Mild
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-NER-Paraesthesia-Total
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-NER-Sinus headache-Mild
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-NER-Sinus headache-Moderate
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-NER-Sinus headache-Total
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-NER-MILD-TOTAL
|
13.4 percentage of related adverse events
|
13.9 percentage of related adverse events
|
10.9 percentage of related adverse events
|
6.4 percentage of related adverse events
|
7.9 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-NER-MODERATE-TOTAL
|
3.2 percentage of related adverse events
|
3.5 percentage of related adverse events
|
4.5 percentage of related adverse events
|
1.2 percentage of related adverse events
|
3.0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-NER-SEVERE-TOTAL
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-NER-TOTAL
|
16.6 percentage of related adverse events
|
17.4 percentage of related adverse events
|
15.4 percentage of related adverse events
|
7.7 percentage of related adverse events
|
10.8 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Cough-Mild
|
0.7 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Cough-Moderate
|
0.7 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Cough-Total
|
1.3 percentage of related adverse events
|
1.0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.3 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Increased upper airway secretion-Mild
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Increased upper airway secretion-Moderate
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Increased upper airway secretion-Total
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Nasal congestion-Mild
|
0.3 percentage of related adverse events
|
0.5 percentage of related adverse events
|
1.5 percentage of related adverse events
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Nasal congestion-Moderate
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Nasal congestion-Total
|
0.5 percentage of related adverse events
|
0.5 percentage of related adverse events
|
1.5 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Oropharyngeal pain-Mild
|
0.5 percentage of related adverse events
|
2.0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.3 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Oropharyngeal pain-Moderate
|
0.8 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Oropharyngeal pain-Total
|
1.3 percentage of related adverse events
|
2.0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.3 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Paranasal sinus hypersecretion-Moderate
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Paranasal sinus hypersecretion-Total
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Productive cough-Moderate
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Productive cough-Total
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Respiratory tract congestion-Mild
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Respiratory tract congestion-Moderate
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Respiratory tract congestion-Total
|
0.7 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Rhinorrhoea-Mild
|
1.0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Rhinorrhoea-Moderate
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Rhinorrhoea-Total
|
1.3 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Sinus congestion-Mild
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Sinus congestion-Moderate
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Sinus congestion-Total
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Sneezing-Mild
|
0.7 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Sneezing-Total
|
0.7 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Throat irritation-Mild
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-Throat irritation-Total
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-MILD-TOTAL
|
1.8 percentage of related adverse events
|
2.5 percentage of related adverse events
|
2.0 percentage of related adverse events
|
0.8 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-MODERATE-TOTAL
|
1.5 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0.3 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-RES-TOTAL
|
3.3 percentage of related adverse events
|
3.0 percentage of related adverse events
|
2.0 percentage of related adverse events
|
1.2 percentage of related adverse events
|
1.0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-SKN-Dermatitis allergic-Mild
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-SKN-Dermatitis allergic-Total
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-SKN-Dermatitis contact-Mild
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-SKN-Dermatitis contact-Total
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-SKN-Erythema-Mild
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-SKN-Erythema-Total
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-SKN-Hyperhidrosis-Mild
|
2.5 percentage of related adverse events
|
4.0 percentage of related adverse events
|
2.0 percentage of related adverse events
|
1.9 percentage of related adverse events
|
3.0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-SKN-Hyperhidrosis-Moderate
|
1.3 percentage of related adverse events
|
1.5 percentage of related adverse events
|
1.5 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-SKN-Hyperhidrosis-Severe
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-SKN-Hyperhidrosis-Total
|
3.8 percentage of related adverse events
|
5.5 percentage of related adverse events
|
3.5 percentage of related adverse events
|
2.5 percentage of related adverse events
|
3.4 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-SKN-Night sweats-Mild
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-SKN-Night sweats-Total
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Anaesthesia-Mild
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Anaesthesia-Total
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Bruising-Mild
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Bruising-Total
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Discolouration-Mild
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Discolouration-Total
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Erythema-Mild
|
0.8 percentage of related adverse events
|
1.0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
1.9 percentage of related adverse events
|
1.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Erythema-Moderate
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Erythema-Severe
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Erythema-Unknown
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Erythema-Total
|
1.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Exfoliation-Mild
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Exfoliation-Total
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Haemorrhage-Mild
|
3.8 percentage of related adverse events
|
3.0 percentage of related adverse events
|
2.0 percentage of related adverse events
|
1.3 percentage of related adverse events
|
2.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Haemorrhage-Moderate
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Haemorrhage-Total
|
3.8 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Induration-Mild
|
0.8 percentage of related adverse events
|
1.5 percentage of related adverse events
|
0.5 percentage of related adverse events
|
1.3 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Induration-Moderate
|
1.0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Induration-Unknown
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.3 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Induration-Total
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
2.2 percentage of related adverse events
|
1.0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Pain-Mild
|
47.5 percentage of related adverse events
|
50.2 percentage of related adverse events
|
42.3 percentage of related adverse events
|
25.1 percentage of related adverse events
|
26.6 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Pain-Moderate
|
1.3 percentage of related adverse events
|
0.5 percentage of related adverse events
|
1.0 percentage of related adverse events
|
1.2 percentage of related adverse events
|
1.0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Pain-Total
|
48.8 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Pruritus-Mild
|
1.0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.7 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Pruritus-Moderate
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Pruritus-Total
|
1.0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Rash-Mild
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Rash-Total
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Reaction-Mild
|
0.7 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Reaction-Total
|
0.7 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Scab-Mild
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Scab-Total
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Swelling-Mild
|
0.8 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
1.2 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Swelling-Moderate
|
0.3 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
1.0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Swelling-Unknown
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.3 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Chills-Mild
|
2.5 percentage of related adverse events
|
3.5 percentage of related adverse events
|
2.0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
2.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Swelling-Total
|
1.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
2.0 percentage of related adverse events
|
2.0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Warmth-Mild
|
0.2 percentage of related adverse events
|
1.0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-Injection Site Warmth-Total
|
0.2 percentage of related adverse events
|
1.0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-MILD-TOTAL
|
48.5 percentage of related adverse events
|
50.7 percentage of related adverse events
|
41.8 percentage of related adverse events
|
25.9 percentage of related adverse events
|
29.1 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-MODERATE-TOTAL
|
1.8 percentage of related adverse events
|
1.0 percentage of related adverse events
|
2.0 percentage of related adverse events
|
2.2 percentage of related adverse events
|
2.0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-SEVERE-TOTAL
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-UNKNOWN-TOTAL
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.7 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
LOC-GEN-TOTAL
|
50.8 percentage of related adverse events
|
51.7 percentage of related adverse events
|
44.3 percentage of related adverse events
|
28.8 percentage of related adverse events
|
31.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-BLD-Lymph node pain-Mild
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-BLD-Lymph node pain-Total
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-BLD-Lymphadenopathy-Mild
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-BLD-Lymphadenopathy-Moderate
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-BLD-Lymphadenopathy-Total
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-BLD-MILD-TOTAL
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-BLD-MODERATE-TOTAL
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-BLD-TOTAL
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-EAR-Ear pain-Mild
|
0.2 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-EAR-Ear pain-Total
|
0.2 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-EAR-MILD-TOTAL
|
0.2 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-EAR-TOTAL
|
0.2 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-EYE-Dark circles under eyes-Mild
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-EYE-Dark circles under eyes-Total
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-EYE-Eye pruritus-Mild
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-EYE-Eye pruritus-Total
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-EYE-MILD-TOTAL
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-EYE-TOTAL
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GID-Abdominal pain upper-Moderate
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Chills-Moderate
|
1.0 percentage of related adverse events
|
2.5 percentage of related adverse events
|
2.0 percentage of related adverse events
|
0.3 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GID-Abdominal pain upper-Total
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GID-Apthous stomatitis-Mild
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GID-Apthous stomatitis-Total
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GID-Diarrhoea-Mild
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GID-Diarrhoea-Moderate
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GID-Diarrhoea-Total
|
0.8 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GID-Hypoaesthesia oral-Mild
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GID-Hypoaesthesia oral-Total
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GID-Nausea-Mild
|
3.8 percentage of related adverse events
|
5.0 percentage of related adverse events
|
3.0 percentage of related adverse events
|
2.2 percentage of related adverse events
|
2.0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Chills-Severe
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GID-Nausea-Moderate
|
1.8 percentage of related adverse events
|
2.0 percentage of related adverse events
|
1.5 percentage of related adverse events
|
0.3 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GID-Nausea-Severe
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GID-Nausea-Total
|
5.9 percentage of related adverse events
|
7.0 percentage of related adverse events
|
4.5 percentage of related adverse events
|
2.5 percentage of related adverse events
|
2.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GID-Oedema mouth-Mild
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GID-Oedema mouth-Total
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GID-Vomiting-Mild
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
1.0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GID-Vomiting-Moderate
|
1.0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
1.0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GID-Vomiting-Severe
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GID-Vomiting-Total
|
1.5 percentage of related adverse events
|
0.5 percentage of related adverse events
|
2.0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GID-MILD-TOTAL
|
4.0 percentage of related adverse events
|
5.0 percentage of related adverse events
|
3.0 percentage of related adverse events
|
2.4 percentage of related adverse events
|
2.0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GID-MODERATE-TOTAL
|
2.2 percentage of related adverse events
|
2.0 percentage of related adverse events
|
2.0 percentage of related adverse events
|
0.3 percentage of related adverse events
|
1.0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GID-SEVERE-TOTAL
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GID-TOTAL
|
6.4 percentage of related adverse events
|
7.0 percentage of related adverse events
|
5.0 percentage of related adverse events
|
2.7 percentage of related adverse events
|
3.0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Chest discomfort-Mild
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Chest discomfort-Total
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Chest pain-Mild
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Chest pain-Total
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Chills-Total
|
3.5 percentage of related adverse events
|
6.0 percentage of related adverse events
|
4.0 percentage of related adverse events
|
1.0 percentage of related adverse events
|
3.0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Discomfort-Mild
|
0.2 percentage of related adverse events
|
1.0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Discomfort-Total
|
0.2 percentage of related adverse events
|
1.0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Fatigue-Mild
|
12 percentage of related adverse events
|
14.9 percentage of related adverse events
|
10.9 percentage of related adverse events
|
5.6 percentage of related adverse events
|
9.4 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Fatigue-Moderate
|
4.5 percentage of related adverse events
|
4.5 percentage of related adverse events
|
5.0 percentage of related adverse events
|
2.9 percentage of related adverse events
|
2.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Fatigue-Severe
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Fatigue-Total
|
16.6 percentage of related adverse events
|
19.9 percentage of related adverse events
|
16.4 percentage of related adverse events
|
8.6 percentage of related adverse events
|
11.8 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Feeling abnormal-Mild
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Feeling abnormal-Total
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Feeling cold-Mild
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Malaise-Moderate
|
3.5 percentage of related adverse events
|
5.0 percentage of related adverse events
|
4.0 percentage of related adverse events
|
1.7 percentage of related adverse events
|
1.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Malaise-Severe
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Malaise-Total
|
17.9 percentage of related adverse events
|
25.9 percentage of related adverse events
|
19.9 percentage of related adverse events
|
9.6 percentage of related adverse events
|
8.9 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Nodule-Mild
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Nodule-Total
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Non-cardiac chest pain-Mild
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Non-cardiac chest pain-Total
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Oedema peripheral-Moderate
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Oedema peripheral-Total
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Pain-Mild
|
0.3 percentage of related adverse events
|
1.0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Pain-Moderate
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Pain-Total
|
0.5 percentage of related adverse events
|
1.0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.7 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Pyrexia-Mild
|
1.3 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
1.0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Pyrexia-Moderate
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Pyrexia-Severe
|
0.2 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-Pyrexia-Total
|
1.8 percentage of related adverse events
|
1.0 percentage of related adverse events
|
0 percentage of related adverse events
|
1.3 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-MILD-TOTAL
|
20.6 percentage of related adverse events
|
26.4 percentage of related adverse events
|
22.9 percentage of related adverse events
|
10.4 percentage of related adverse events
|
13.8 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-MODERATE-TOTAL
|
6.7 percentage of related adverse events
|
8.5 percentage of related adverse events
|
6.5 percentage of related adverse events
|
3.5 percentage of related adverse events
|
3.9 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-SEVERE-TOTAL
|
0.2 percentage of related adverse events
|
1.0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-GEN-TOTAL
|
27.4 percentage of related adverse events
|
35.8 percentage of related adverse events
|
29.9 percentage of related adverse events
|
14.3 percentage of related adverse events
|
17.7 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-INF-Acute sinusitis-Moderate
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-INF-Acute sinusitis-Total
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-INF-Herpes simplex-Moderate
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-INF-Herpes simplex-Total
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-INF-Nasopharyngitis-Mild
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-INF-Nasopharyngitis-Total
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-INF-Oral herpes-Mild
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-INF-Oral herpes-Total
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-INF-Otitis media-Mild
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-INF-Otitis media-Total
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-INF-Sinusitis-Mild
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-INF-Sinusitis-Total
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-INF-Upper respiratory tract infection-Mild
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-INF-Upper respiratory tract infection-Moderate
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-INF-Upper respiratory tract infection-Total
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-INF-MILD-TOTAL
|
0.7 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-INF-MODERATE-TOTAL
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-INF-TOTAL
|
1.0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MET-Decreased appetite-Mild
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MET-Decreased appetite-Total
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MET-MILD-TOTAL
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MET-TOTAL
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Arthralgia-Mild
|
4.5 percentage of related adverse events
|
2.5 percentage of related adverse events
|
2.0 percentage of related adverse events
|
1.5 percentage of related adverse events
|
3.0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Arthralgia-Moderate
|
1.0 percentage of related adverse events
|
2.0 percentage of related adverse events
|
1.5 percentage of related adverse events
|
1.0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Arthralgia-Severe
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Arthralgia-Total
|
5.5 percentage of related adverse events
|
4.5 percentage of related adverse events
|
4.0 percentage of related adverse events
|
2.7 percentage of related adverse events
|
3.4 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Back pain-Mild
|
0.2 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Back pain-Moderate
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Back pain-Total
|
0.2 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Joint swelling-Mild
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Joint swelling-Total
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Muscle spasms-Mild
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Muscle spasms-Moderate
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Muscle spasms-Total
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0 percentage of related adverse events
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Muscle tightness-Mild
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Muscle tightness-Total
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Musculoskeletal pain-Mild
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Musculoskeletal pain-Moderate
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Musculoskeletal pain-Total
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Musculoskeletal stiffness-Mild
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Musculoskeletal stiffness-Total
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Myalgia-Mild
|
13.7 percentage of related adverse events
|
15.9 percentage of related adverse events
|
11.9 percentage of related adverse events
|
8.6 percentage of related adverse events
|
8.4 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Myalgia-Moderate
|
2.5 percentage of related adverse events
|
3.0 percentage of related adverse events
|
6.0 percentage of related adverse events
|
1.3 percentage of related adverse events
|
1.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Myalgia-Severe
|
0 percentage of related adverse events
|
1.0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.2 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Myalgia-Total
|
16.2 percentage of related adverse events
|
19.9 percentage of related adverse events
|
17.9 percentage of related adverse events
|
10.1 percentage of related adverse events
|
9.9 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Neck pain-Mild
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Neck pain-Total
|
0.3 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Pain in extremity-Mild
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.3 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency and Severity of Related Adverse Events
SYS-MSK-Pain in extremity-Total
|
0 percentage of related adverse events
|
0 percentage of related adverse events
|
0.5 percentage of related adverse events
|
0.3 percentage of related adverse events
|
0.5 percentage of related adverse events
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1
Serious events: 1 serious events
Other events: 133 other events
Deaths: 0 deaths
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2
Serious events: 0 serious events
Other events: 124 other events
Deaths: 0 deaths
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3
Serious events: 0 serious events
Other events: 120 other events
Deaths: 0 deaths
VCIV Manufactured With Current Process
Serious events: 0 serious events
Other events: 132 other events
Deaths: 0 deaths
Fluzone® (18-49 Years Old)
Serious events: 0 serious events
Other events: 125 other events
Deaths: 0 deaths
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1
Serious events: 1 serious events
Other events: 97 other events
Deaths: 0 deaths
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2
Serious events: 1 serious events
Other events: 84 other events
Deaths: 0 deaths
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3
Serious events: 2 serious events
Other events: 96 other events
Deaths: 0 deaths
Fluzone® (≥50 Years Old)
Serious events: 0 serious events
Other events: 100 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1
n=200 participants at risk
Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2
n=199 participants at risk
Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3
n=199 participants at risk
Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV Manufactured With Current Process
n=201 participants at risk
Vero cell-derived trivalent influenza vaccine (VCIV)
VCIV manufactured with the current manufacturing process (VCIV current)
|
Fluzone® (18-49 Years Old)
n=201 participants at risk
Fluzone®, licensed trivalent influenza vaccine (TIV) Fluzone®, licensed trivalent influenza vaccine (TIV)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1
n=199 participants at risk
Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2
n=197 participants at risk
Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3
n=198 participants at risk
Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Fluzone® (≥50 Years Old)
n=203 participants at risk
Fluzone®, licensed trivalent influenza vaccine (TIV) Fluzone®, licensed trivalent influenza vaccine (TIV)
|
|---|---|---|---|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/200 • Throughout the study period of approximately 2.5 months
|
0.00%
0/199 • Throughout the study period of approximately 2.5 months
|
0.00%
0/199 • Throughout the study period of approximately 2.5 months
|
0.00%
0/201 • Throughout the study period of approximately 2.5 months
|
0.00%
0/201 • Throughout the study period of approximately 2.5 months
|
0.00%
0/199 • Throughout the study period of approximately 2.5 months
|
0.51%
1/197 • Throughout the study period of approximately 2.5 months
|
0.00%
0/198 • Throughout the study period of approximately 2.5 months
|
0.00%
0/203 • Throughout the study period of approximately 2.5 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/200 • Throughout the study period of approximately 2.5 months
|
0.00%
0/199 • Throughout the study period of approximately 2.5 months
|
0.00%
0/199 • Throughout the study period of approximately 2.5 months
|
0.00%
0/201 • Throughout the study period of approximately 2.5 months
|
0.00%
0/201 • Throughout the study period of approximately 2.5 months
|
0.00%
0/199 • Throughout the study period of approximately 2.5 months
|
0.00%
0/197 • Throughout the study period of approximately 2.5 months
|
0.51%
1/198 • Throughout the study period of approximately 2.5 months
|
0.00%
0/203 • Throughout the study period of approximately 2.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/200 • Throughout the study period of approximately 2.5 months
|
0.00%
0/199 • Throughout the study period of approximately 2.5 months
|
0.00%
0/199 • Throughout the study period of approximately 2.5 months
|
0.00%
0/201 • Throughout the study period of approximately 2.5 months
|
0.00%
0/201 • Throughout the study period of approximately 2.5 months
|
0.00%
0/199 • Throughout the study period of approximately 2.5 months
|
0.00%
0/197 • Throughout the study period of approximately 2.5 months
|
0.51%
1/198 • Throughout the study period of approximately 2.5 months
|
0.00%
0/203 • Throughout the study period of approximately 2.5 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/200 • Throughout the study period of approximately 2.5 months
|
0.00%
0/199 • Throughout the study period of approximately 2.5 months
|
0.00%
0/199 • Throughout the study period of approximately 2.5 months
|
0.00%
0/201 • Throughout the study period of approximately 2.5 months
|
0.00%
0/201 • Throughout the study period of approximately 2.5 months
|
0.50%
1/199 • Throughout the study period of approximately 2.5 months
|
0.00%
0/197 • Throughout the study period of approximately 2.5 months
|
0.00%
0/198 • Throughout the study period of approximately 2.5 months
|
0.00%
0/203 • Throughout the study period of approximately 2.5 months
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.50%
1/200 • Throughout the study period of approximately 2.5 months
|
0.00%
0/199 • Throughout the study period of approximately 2.5 months
|
0.00%
0/199 • Throughout the study period of approximately 2.5 months
|
0.00%
0/201 • Throughout the study period of approximately 2.5 months
|
0.00%
0/201 • Throughout the study period of approximately 2.5 months
|
0.00%
0/199 • Throughout the study period of approximately 2.5 months
|
0.00%
0/197 • Throughout the study period of approximately 2.5 months
|
0.00%
0/198 • Throughout the study period of approximately 2.5 months
|
0.00%
0/203 • Throughout the study period of approximately 2.5 months
|
Other adverse events
| Measure |
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1
n=200 participants at risk
Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2
n=199 participants at risk
Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3
n=199 participants at risk
Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV Manufactured With Current Process
n=201 participants at risk
Vero cell-derived trivalent influenza vaccine (VCIV)
VCIV manufactured with the current manufacturing process (VCIV current)
|
Fluzone® (18-49 Years Old)
n=201 participants at risk
Fluzone®, licensed trivalent influenza vaccine (TIV) Fluzone®, licensed trivalent influenza vaccine (TIV)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1
n=199 participants at risk
Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2
n=197 participants at risk
Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3
n=198 participants at risk
Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
|
Fluzone® (≥50 Years Old)
n=203 participants at risk
Fluzone®, licensed trivalent influenza vaccine (TIV) Fluzone®, licensed trivalent influenza vaccine (TIV)
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
11.5%
23/200 • Throughout the study period of approximately 2.5 months
|
7.0%
14/199 • Throughout the study period of approximately 2.5 months
|
6.0%
12/199 • Throughout the study period of approximately 2.5 months
|
8.5%
17/201 • Throughout the study period of approximately 2.5 months
|
6.5%
13/201 • Throughout the study period of approximately 2.5 months
|
2.5%
5/199 • Throughout the study period of approximately 2.5 months
|
4.1%
8/197 • Throughout the study period of approximately 2.5 months
|
5.1%
10/198 • Throughout the study period of approximately 2.5 months
|
3.4%
7/203 • Throughout the study period of approximately 2.5 months
|
|
General disorders
Chills
|
6.5%
13/200 • Throughout the study period of approximately 2.5 months
|
2.0%
4/199 • Throughout the study period of approximately 2.5 months
|
3.5%
7/199 • Throughout the study period of approximately 2.5 months
|
7.0%
14/201 • Throughout the study period of approximately 2.5 months
|
5.5%
11/201 • Throughout the study period of approximately 2.5 months
|
2.0%
4/199 • Throughout the study period of approximately 2.5 months
|
3.6%
7/197 • Throughout the study period of approximately 2.5 months
|
2.0%
4/198 • Throughout the study period of approximately 2.5 months
|
3.0%
6/203 • Throughout the study period of approximately 2.5 months
|
|
General disorders
Fatigue
|
16.5%
33/200 • Throughout the study period of approximately 2.5 months
|
19.1%
38/199 • Throughout the study period of approximately 2.5 months
|
19.1%
38/199 • Throughout the study period of approximately 2.5 months
|
21.9%
44/201 • Throughout the study period of approximately 2.5 months
|
18.4%
37/201 • Throughout the study period of approximately 2.5 months
|
12.1%
24/199 • Throughout the study period of approximately 2.5 months
|
9.1%
18/197 • Throughout the study period of approximately 2.5 months
|
11.1%
22/198 • Throughout the study period of approximately 2.5 months
|
13.8%
28/203 • Throughout the study period of approximately 2.5 months
|
|
General disorders
Malaise
|
20.0%
40/200 • Throughout the study period of approximately 2.5 months
|
21.1%
42/199 • Throughout the study period of approximately 2.5 months
|
19.1%
38/199 • Throughout the study period of approximately 2.5 months
|
27.4%
55/201 • Throughout the study period of approximately 2.5 months
|
21.9%
44/201 • Throughout the study period of approximately 2.5 months
|
13.1%
26/199 • Throughout the study period of approximately 2.5 months
|
9.6%
19/197 • Throughout the study period of approximately 2.5 months
|
12.1%
24/198 • Throughout the study period of approximately 2.5 months
|
9.9%
20/203 • Throughout the study period of approximately 2.5 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.5%
17/200 • Throughout the study period of approximately 2.5 months
|
5.5%
11/199 • Throughout the study period of approximately 2.5 months
|
5.5%
11/199 • Throughout the study period of approximately 2.5 months
|
6.5%
13/201 • Throughout the study period of approximately 2.5 months
|
4.5%
9/201 • Throughout the study period of approximately 2.5 months
|
4.5%
9/199 • Throughout the study period of approximately 2.5 months
|
3.6%
7/197 • Throughout the study period of approximately 2.5 months
|
3.0%
6/198 • Throughout the study period of approximately 2.5 months
|
6.4%
13/203 • Throughout the study period of approximately 2.5 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.5%
37/200 • Throughout the study period of approximately 2.5 months
|
14.6%
29/199 • Throughout the study period of approximately 2.5 months
|
18.1%
36/199 • Throughout the study period of approximately 2.5 months
|
20.4%
41/201 • Throughout the study period of approximately 2.5 months
|
19.4%
39/201 • Throughout the study period of approximately 2.5 months
|
11.1%
22/199 • Throughout the study period of approximately 2.5 months
|
12.7%
25/197 • Throughout the study period of approximately 2.5 months
|
11.1%
22/198 • Throughout the study period of approximately 2.5 months
|
11.3%
23/203 • Throughout the study period of approximately 2.5 months
|
|
Nervous system disorders
Headache
|
25.0%
50/200 • Throughout the study period of approximately 2.5 months
|
21.6%
43/199 • Throughout the study period of approximately 2.5 months
|
19.6%
39/199 • Throughout the study period of approximately 2.5 months
|
21.9%
44/201 • Throughout the study period of approximately 2.5 months
|
20.4%
41/201 • Throughout the study period of approximately 2.5 months
|
12.6%
25/199 • Throughout the study period of approximately 2.5 months
|
10.7%
21/197 • Throughout the study period of approximately 2.5 months
|
9.1%
18/198 • Throughout the study period of approximately 2.5 months
|
13.3%
27/203 • Throughout the study period of approximately 2.5 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.0%
8/200 • Throughout the study period of approximately 2.5 months
|
4.5%
9/199 • Throughout the study period of approximately 2.5 months
|
2.0%
4/199 • Throughout the study period of approximately 2.5 months
|
6.0%
12/201 • Throughout the study period of approximately 2.5 months
|
2.0%
4/201 • Throughout the study period of approximately 2.5 months
|
1.5%
3/199 • Throughout the study period of approximately 2.5 months
|
1.0%
2/197 • Throughout the study period of approximately 2.5 months
|
1.5%
3/198 • Throughout the study period of approximately 2.5 months
|
0.99%
2/203 • Throughout the study period of approximately 2.5 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.5%
11/200 • Throughout the study period of approximately 2.5 months
|
4.0%
8/199 • Throughout the study period of approximately 2.5 months
|
5.5%
11/199 • Throughout the study period of approximately 2.5 months
|
6.0%
12/201 • Throughout the study period of approximately 2.5 months
|
5.0%
10/201 • Throughout the study period of approximately 2.5 months
|
3.0%
6/199 • Throughout the study period of approximately 2.5 months
|
4.1%
8/197 • Throughout the study period of approximately 2.5 months
|
2.5%
5/198 • Throughout the study period of approximately 2.5 months
|
3.4%
7/203 • Throughout the study period of approximately 2.5 months
|
|
General disorders
Injection site pain
|
51.0%
102/200 • Throughout the study period of approximately 2.5 months
|
50.3%
100/199 • Throughout the study period of approximately 2.5 months
|
45.2%
90/199 • Throughout the study period of approximately 2.5 months
|
50.7%
102/201 • Throughout the study period of approximately 2.5 months
|
43.3%
87/201 • Throughout the study period of approximately 2.5 months
|
29.6%
59/199 • Throughout the study period of approximately 2.5 months
|
19.8%
39/197 • Throughout the study period of approximately 2.5 months
|
29.3%
58/198 • Throughout the study period of approximately 2.5 months
|
27.6%
56/203 • Throughout the study period of approximately 2.5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Agreements may vary with individual PIs, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication or up to 18 months after study completion. Baxter requires a review of results communications (eg for confidential information) ≥60 days prior to submission/communication. Baxter may request additional delay of ≤60 days(e.g. for intellectual property protection). Prior authorization may be required.
- Publication restrictions are in place
Restriction type: OTHER