Trial Outcomes & Findings for Study of the Safety and Immunogenicity of an Influenza Vaccine Administered to Healthy Adults (NCT NCT00264576)
NCT ID: NCT00264576
Last Updated: 2017-03-24
Results Overview
Non-inferiority was measured by the ratio of postvaccination geometric mean titers (cTIV vs. eTIV\_f) against all three vaccine strains as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
613 participants
Primary outcome timeframe
3 weeks postvaccination (Day 22)
Results posted on
2017-03-24
Participant Flow
Participant milestones
| Measure |
cTIV
Adults 18 to \< 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
|
eTIV_f
Adults 18 to \< 50 years of age received one dose of egg-derived trivalent vaccine (eTIV\_f).
|
|---|---|---|
|
Overall Study
STARTED
|
308
|
305
|
|
Overall Study
COMPLETED
|
307
|
304
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
cTIV
Adults 18 to \< 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
|
eTIV_f
Adults 18 to \< 50 years of age received one dose of egg-derived trivalent vaccine (eTIV\_f).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Study of the Safety and Immunogenicity of an Influenza Vaccine Administered to Healthy Adults
Baseline characteristics by cohort
| Measure |
cTIV
n=308 Participants
Adults 18 to \< 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
|
eTIV_f
n=305 Participants
Adults 18 to \< 50 years of age received one dose of egg-derived trivalent vaccine (eTIV\_f).
|
Total
n=613 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.8 years
STANDARD_DEVIATION 8.8 • n=99 Participants
|
34.2 years
STANDARD_DEVIATION 9.3 • n=107 Participants
|
34 years
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
196 Participants
n=99 Participants
|
205 Participants
n=107 Participants
|
401 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=99 Participants
|
100 Participants
n=107 Participants
|
212 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 weeks postvaccination (Day 22)Population: Analysis was done on per protocol set
Non-inferiority was measured by the ratio of postvaccination geometric mean titers (cTIV vs. eTIV\_f) against all three vaccine strains as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.
Outcome measures
| Measure |
cTIV
n=307 Participants
Adults 18 to \< 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
|
eTIV_f
n=303 Participants
Adults 18 to \< 50 years of age received one dose of egg-derived trivalent vaccine (eTIV\_f).
|
|---|---|---|
|
Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.
A/H1N1 (egg-derived assay)
|
259 Titer
Interval 225.0 to 298.0
|
306 Titer
Interval 265.0 to 352.0
|
|
Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.
A/H3N2 (egg-derived assay)
|
181 Titer
Interval 157.0 to 210.0
|
320 Titer
Interval 276.0 to 370.0
|
|
Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.
B (egg-derived assay)
|
179 Titer
Interval 157.0 to 203.0
|
157 Titer
Interval 138.0 to 179.0
|
|
Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.
A/H1N1 (cell-culture-derived assay)
|
468 Titer
Interval 407.0 to 538.0
|
508 Titer
Interval 441.0 to 585.0
|
|
Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.
A/H3N2 (cell-culture-derived assay)
|
287 Titer
Interval 250.0 to 331.0
|
468 Titer
Interval 406.0 to 539.0
|
|
Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.
B (cell-culture-derived assay)
|
176 Titer
Interval 155.0 to 199.0
|
134 Titer
Interval 118.0 to 153.0
|
PRIMARY outcome
Timeframe: 3 weeks postvaccination (Day 22)Population: Analysis was done on per protocol set
Non-inferiority was measured by the ratio of postvaccination geometric mean titers (cTIV vs. eTIV\_f) against all three vaccine strains as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.
Outcome measures
| Measure |
cTIV
n=307 Participants
Adults 18 to \< 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
|
eTIV_f
n=303 Participants
Adults 18 to \< 50 years of age received one dose of egg-derived trivalent vaccine (eTIV\_f).
|
|---|---|---|
|
Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.
B (cell-culture-derived assay)
|
180 Titer
Interval 160.0 to 203.0
|
135 Titer
Interval 120.0 to 153.0
|
|
Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.
A/H1N1 (egg-derived assay)
|
263 Titer
Interval 229.0 to 302.0
|
310 Titer
Interval 270.0 to 355.0
|
|
Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.
A/H3N2 (egg-derived assay)
|
199 Titer
Interval 173.0 to 229.0
|
316 Titer
Interval 275.0 to 364.0
|
|
Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.
B (egg-derived assay)
|
185 Titer
Interval 163.0 to 210.0
|
159 Titer
Interval 141.0 to 181.0
|
|
Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.
A/H1N1 (cell-culture-derived assay)
|
478 Titer
Interval 417.0 to 549.0
|
518 Titer
Interval 451.0 to 595.0
|
|
Geometric Mean Titers (GMT) After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.
A/H3N2 (cell-culture-derived assay)
|
306 Titer
Interval 267.0 to 350.0
|
444 Titer
Interval 388.0 to 508.0
|
SECONDARY outcome
Timeframe: 3 weeks postvaccination (Day 22)Population: Analysis was done on per protocol set
Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay. The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22/Day1) in HI antibody titer is \> 2.5.
Outcome measures
| Measure |
cTIV
n=307 Participants
Adults 18 to \< 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
|
eTIV_f
n=303 Participants
Adults 18 to \< 50 years of age received one dose of egg-derived trivalent vaccine (eTIV\_f).
|
|---|---|---|
|
Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.
A/H1N1 (egg-derived assay)
|
8.06 Ratio
Interval 6.64 to 9.8
|
9.65 Ratio
Interval 7.93 to 12.0
|
|
Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.
A/H3N2 (egg-derived assay)
|
18 Ratio
Interval 15.0 to 20.0
|
25 Ratio
Interval 21.0 to 29.0
|
|
Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.
B (egg-derived assay)
|
11 Ratio
Interval 9.49 to 13.0
|
9.15 Ratio
Interval 7.83 to 11.0
|
|
Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.
A/H1N1 (cell-culture-derived assay)
|
9.21 Ratio
Interval 7.48 to 11.0
|
10 Ratio
Interval 8.19 to 12.0
|
|
Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.
A/H3N2 (cell-culture-derived assay)
|
18 Ratio
Interval 15.0 to 21.0
|
22 Ratio
Interval 18.0 to 26.0
|
|
Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method.
B (cell-culture-derived assay)
|
10 Ratio
Interval 8.92 to 12.0
|
7.6 Ratio
Interval 6.54 to 8.83
|
SECONDARY outcome
Timeframe: 3 weeks postvaccination (Day 22)Population: Analysis was done on per protocol set
Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay. The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22/Day1) in HI antibody titer is \> 2.5.
Outcome measures
| Measure |
cTIV
n=307 Participants
Adults 18 to \< 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
|
eTIV_f
n=303 Participants
Adults 18 to \< 50 years of age received one dose of egg-derived trivalent vaccine (eTIV\_f).
|
|---|---|---|
|
Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.
A/H1N1 (egg-derived assay)
|
7.76 Ratio
Interval 6.36 to 9.47
|
9.32 Ratio
Interval 7.64 to 11.0
|
|
Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.
A/H3N2 (egg-derived assay)
|
18 Ratio
Interval 15.0 to 21.0
|
25 Ratio
Interval 22.0 to 30.0
|
|
Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.
B (egg-derived assay)
|
11 Ratio
Interval 9.14 to 13.0
|
8.86 Ratio
Interval 7.57 to 10.0
|
|
Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.
A/H1N1 (cell-culture-derived assay)
|
8.76 Ratio
Interval 7.08 to 11.0
|
9.64 Ratio
Interval 7.8 to 12.0
|
|
Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.
A/H3N2 (cell-culture-derived assay)
|
18 Ratio
Interval 15.0 to 21.0
|
22 Ratio
Interval 19.0 to 26.0
|
|
Geometric Mean Ratio After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANCOVA Method.
B (cell-culture-derived assay)
|
10 Ratio
Interval 8.76 to 12.0
|
7.46 Ratio
Interval 6.41 to 8.68
|
SECONDARY outcome
Timeframe: 3 weeks postvaccination (Day 22)Population: Analysis was done on per protocol set
Antibody titers as assessed by egg-derived antigen and cell-derived antigen haemagglutination inhibition (HI) assay.
Outcome measures
| Measure |
cTIV
n=307 Participants
Adults 18 to \< 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
|
eTIV_f
n=303 Participants
Adults 18 to \< 50 years of age received one dose of egg-derived trivalent vaccine (eTIV\_f).
|
|---|---|---|
|
Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method
A/H1N1 (Day 1) (egg-derived assay)
|
32 Titer
Interval 27.0 to 39.0
|
32 Titer
Interval 26.0 to 38.0
|
|
Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method
A/H1N1 (Day 22) (egg-derived assay)
|
259 Titer
Interval 225.0 to 298.0
|
306 Titer
Interval 265.0 to 352.0
|
|
Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method
A/H1N1 (Day 1) (cell-culture-derived assay)
|
51 Titer
Interval 42.0 to 62.0
|
50 Titer
Interval 41.0 to 61.0
|
|
Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method
A/H1N1 (Day 22) (cell-culture-derived assay)
|
468 Titer
Interval 407.0 to 538.0
|
508 Titer
Interval 441.0 to 585.0
|
|
Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method
A/H3N2 (Day 1) (egg derived assay)
|
10 Titer
Interval 9.22 to 12.0
|
13 Titer
Interval 12.0 to 15.0
|
|
Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method
A/H3N2 (Day 22) (egg-derived assay)
|
181 Titer
Interval 157.0 to 210.0
|
320 Titer
Interval 276.0 to 370.0
|
|
Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method
A/H3N2 (Day 1) (cell-culture-derived assay)
|
16 Titer
Interval 14.0 to 18.0
|
21 Titer
Interval 19.0 to 24.0
|
|
Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method
A/H3N2 (Day 22) (cell-culture-derived assay)
|
287 Titer
Interval 250.0 to 331.0
|
468 Titer
Interval 406.0 to 539.0
|
|
Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method
B (Day 1) (egg-derived assay)
|
16 Titer
Interval 14.0 to 18.0
|
17 Titer
Interval 15.0 to 20.0
|
|
Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method
B (Day 22) (egg-derived assay)
|
179 Titer
Interval 157.0 to 203.0
|
157 Titer
Interval 138.0 to 179.0
|
|
Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method
B (Day 1) (cell-culture-derived assay)
|
17 Titer
Interval 15.0 to 19.0
|
18 Titer
Interval 15.0 to 20.0
|
|
Geometric Mean Titers (GMT) Before and After 1 Dose of Cell-culture-derived Vaccine (cTIV) or Egg-derived Vaccine (eTIV_f), Using the ANOVA Method
B (Day 22) (cell-culture-derived assay)
|
176 Titer
Interval 155.0 to 199.0
|
134 Titer
Interval 118.0 to 153.0
|
SECONDARY outcome
Timeframe: 3 weeks postvaccination (Day 22)Population: Analysis was done on per protocol set
Antibody titers as assessed by egg-derived antigen and cell-derived antigen HI assay. This criterion is met according to European (CHMP) guideline if the percentages of subjects achieving HI titers ≥40 is \>70%. According to the US Center for Biologics Evaluation and Research (CBER) guideline, the criterion is also met if the lower limit of the 95% CI for percentages of subjects achieving seroprotection (HI antibody titer ≥1:40) is ≥70%.
Outcome measures
| Measure |
cTIV
n=307 Participants
Adults 18 to \< 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
|
eTIV_f
n=303 Participants
Adults 18 to \< 50 years of age received one dose of egg-derived trivalent vaccine (eTIV\_f).
|
|---|---|---|
|
Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40.
B(cell-culture-derived assay)
|
97 Percentages
Interval 94.0 to 98.0
|
91 Percentages
Interval 88.0 to 94.0
|
|
Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40.
A/H1N1 (egg-derived assay)
|
96 Percentages
Interval 94.0 to 98.0
|
98 Percentages
Interval 96.0 to 99.0
|
|
Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40.
A/H3N2 (egg-derived assay)
|
91 Percentages
Interval 87.0 to 94.0
|
96 Percentages
Interval 93.0 to 98.0
|
|
Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40.
B (egg-derived assay)
|
94 Percentages
Interval 91.0 to 96.0
|
93 Percentages
Interval 89.0 to 95.0
|
|
Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40.
A/H1N1 (cell-culture-derived assay)
|
99 Percentages
Interval 98.0 to 100.0
|
99 Percentages
Interval 97.0 to 100.0
|
|
Percentages of Subjects With Haemagglutination Inhibition (HI) Antibody Titer ≥ 40.
A/H3N2 (cell-culture-derived assay)
|
98 Percentages
Interval 95.0 to 99.0
|
99 Percentages
Interval 97.0 to 100.0
|
SECONDARY outcome
Timeframe: 3 weeks postvaccination (Day 22)Population: Analysis was done on per protocol set
As the definition for seroconversion/significant increase from CHMP guideline CPMP/BWP/214/96 corresponds to that of seroconversion from the May 2007 CBER guidance, the analysis of this immunogenicity endpoint is presented as seroconversion. Seroconversion is defined as prevaccination HI titer \<10 and postvaccination HI titer ≥40, or prevaccination HI titer ≥10 and a ≥4-fold increase in postvaccination HI antibody titer, on day 22. CBER criterion is met if the lower limit of the 95% CI for percentages of subjects achieving seroconversion for HI antibody (at least a 4-fold rise in HI antibody titer) postvaccination is ≥40%. CHMP criterion is also met if the percentages of subjects achieving seroconversion is \>40%.
Outcome measures
| Measure |
cTIV
n=307 Participants
Adults 18 to \< 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
|
eTIV_f
n=303 Participants
Adults 18 to \< 50 years of age received one dose of egg-derived trivalent vaccine (eTIV\_f).
|
|---|---|---|
|
Percentages of Subjects With Seroconversion.
A/H1N1 (egg-derived assay)
|
62 Percentages
Interval 57.0 to 68.0
|
65 Percentages
Interval 59.0 to 70.0
|
|
Percentages of Subjects With Seroconversion.
A/H3N2 (egg-derived assay)
|
85 Percentages
Interval 81.0 to 89.0
|
92 Percentages
Interval 88.0 to 95.0
|
|
Percentages of Subjects With Seroconversion.
B (egg-derived assay)
|
77 Percentages
Interval 72.0 to 81.0
|
76 Percentages
Interval 70.0 to 80.0
|
|
Percentages of Subjects With Seroconversion.
A/H1N1 (cell-culture-derived assay)
|
62 Percentages
Interval 56.0 to 67.0
|
64 Percentages
Interval 58.0 to 69.0
|
|
Percentages of Subjects With Seroconversion.
A/H3N2 (cell-culture-derived assay)
|
89 Percentages
Interval 85.0 to 92.0
|
90 Percentages
Interval 87.0 to 93.0
|
|
Percentages of Subjects With Seroconversion.
B(cell-culture-derived assay)
|
78 Percentages
Interval 73.0 to 83.0
|
72 Percentages
Interval 66.0 to 77.0
|
SECONDARY outcome
Timeframe: 7 days postvaccinationPopulation: Analysis was done on safety set
Safety and tolerability of cTIV and eTIV\_f postvaccination. Difference between demography and safety numbers was due to one misrandomization.
Outcome measures
| Measure |
cTIV
n=309 Participants
Adults 18 to \< 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
|
eTIV_f
n=304 Participants
Adults 18 to \< 50 years of age received one dose of egg-derived trivalent vaccine (eTIV\_f).
|
|---|---|---|
|
Number of Subjects Reporting Local and Systemic Reactions
Ecchymosis
|
12 Subjects
|
26 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Injection site erythema
|
34 Subjects
|
48 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Injection site induration
|
27 Subjects
|
19 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Sweating
|
15 Subjects
|
23 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Fatigue
|
59 Subjects
|
67 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Red Eye
|
3 Subjects
|
6 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Fever (>=38°C))
|
3 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Injection site swelling
|
13 Subjects
|
16 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Injection site pain
|
155 Subjects
|
169 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Chills
|
14 Subjects
|
26 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Malaise
|
76 Subjects
|
72 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Myalgia
|
68 Subjects
|
73 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Arthralgia
|
26 Subjects
|
28 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Headache
|
109 Subjects
|
121 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Nausea
|
31 Subjects
|
35 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Cough
|
26 Subjects
|
35 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Wheezing
|
7 Subjects
|
9 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Chest tightness
|
14 Subjects
|
11 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Difficulty breathing
|
10 Subjects
|
6 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Sore Throat
|
53 Subjects
|
45 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Facial Edema
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Stayed at home due to reaction
|
7 Subjects
|
9 Subjects
|
|
Number of Subjects Reporting Local and Systemic Reactions
Analgesic medicine used
|
102 Subjects
|
109 Subjects
|
Adverse Events
cTIV
Serious events: 3 serious events
Other events: 236 other events
Deaths: 0 deaths
eTIV_f
Serious events: 5 serious events
Other events: 237 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
cTIV
n=309 participants at risk
Adults 18 to \< 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
|
eTIV_f
n=304 participants at risk
Adults 18 to \< 50 years of age received one dose of egg-derived trivalent vaccine (eTIV\_f).
|
|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/309 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
0.33%
1/304 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
|
Infections and infestations
Cellulitis
|
0.32%
1/309 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
0.00%
0/304 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
|
Infections and infestations
Influenza
|
0.32%
1/309 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
0.66%
2/304 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/309 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
0.33%
1/304 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
|
Surgical and medical procedures
Nasal septal operation
|
0.00%
0/309 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
0.33%
1/304 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
|
Vascular disorders
Hypertension
|
0.32%
1/309 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
0.00%
0/304 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
Other adverse events
| Measure |
cTIV
n=309 participants at risk
Adults 18 to \< 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
|
eTIV_f
n=304 participants at risk
Adults 18 to \< 50 years of age received one dose of egg-derived trivalent vaccine (eTIV\_f).
|
|---|---|---|
|
Nervous system disorders
Headache
|
35.3%
109/309 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
39.8%
121/304 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
|
General disorders
Malaise
|
24.6%
76/309 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
23.7%
72/304 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
22.0%
68/309 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
24.0%
73/304 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
|
General disorders
Fatigue
|
19.4%
60/309 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
22.0%
67/304 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
17.2%
53/309 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
14.8%
45/304 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
|
General disorders
Injection site erythema
|
11.0%
34/309 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
15.8%
48/304 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.4%
26/309 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
11.5%
35/304 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
31/309 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
11.5%
35/304 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.4%
26/309 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
9.5%
29/304 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
|
General disorders
Injection site induration
|
8.7%
27/309 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
6.2%
19/304 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
|
General disorders
Chills
|
4.5%
14/309 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
8.6%
26/304 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
|
General disorders
Injection site haemorrhage
|
3.9%
12/309 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
8.6%
26/304 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.9%
15/309 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
7.6%
23/304 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
|
General disorders
Injection site swelling
|
4.2%
13/309 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
5.3%
16/304 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
|
General disorders
Injection site pain
|
50.2%
155/309 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
55.6%
169/304 • All Serious adverse events were collected throughout the study period (Day 1 - Day 180). All solicited adverse reactions were collected from Day 1 - Day 7. All unsolicited reactions were collected from Day 8 - Day 180.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60