Trial Outcomes & Findings for Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects (NCT NCT02256488)
NCT ID: NCT02256488
Last Updated: 2019-06-11
Results Overview
Hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, for each three vaccine strains, three weeks after one vaccination of one lot of TIVc vaccine (Day 22), evaluated using HI antigen assay.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1561 participants
Primary outcome timeframe
Day 22
Results posted on
2019-06-11
Participant Flow
Subjects were enrolled at Twenty five study centers in the United States of America.
All enrolled subjects were included in the trial.
Participant milestones
| Measure |
TIVc_LOT A
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
|
TIVc_LOT B
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
|
TIVc_LOT C
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
|
TIVf
Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
387
|
392
|
392
|
390
|
|
Overall Study
COMPLETED
|
379
|
386
|
382
|
384
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
10
|
6
|
Reasons for withdrawal
| Measure |
TIVc_LOT A
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
|
TIVc_LOT B
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
|
TIVc_LOT C
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
|
TIVf
Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
6
|
9
|
3
|
|
Overall Study
OTHER
|
1
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
2
|
Baseline Characteristics
Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects
Baseline characteristics by cohort
| Measure |
TIVc_LOT A
n=387 Participants
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
|
TIVc_LOT B
n=392 Participants
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
|
TIVc_LOT C
n=392 Participants
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
|
TIVf
n=390 Participants
Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
|
Total
n=1561 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
33.1 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
33.8 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
33.2 years
STANDARD_DEVIATION 9.0 • n=4 Participants
|
33.1 years
STANDARD_DEVIATION 8.9 • n=21 Participants
|
|
Sex: Female, Male
FEMALE
|
221 Participants
n=5 Participants
|
227 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
250 Participants
n=4 Participants
|
941 Participants
n=21 Participants
|
|
Sex: Female, Male
MALE
|
166 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
140 Participants
n=4 Participants
|
620 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 22Population: Per Protocol Set(PPS) All subjects in the FAS (Full Analysis Set) Immunogenicity Population who were not excluded due to reasons defined prior to unblinding or analysis.
Hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, for each three vaccine strains, three weeks after one vaccination of one lot of TIVc vaccine (Day 22), evaluated using HI antigen assay.
Outcome measures
| Measure |
TIVc_LOT A
n=363 Participants
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
|
TIVc_LOT B
n=375 Participants
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
|
TIVc_LOT C
n=374 Participants
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
|
|---|---|---|---|
|
Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots.
A/Brisbane/10/2010 (H1N1)
|
667 Titers
Interval 595.0 to 747.0
|
738 Titers
Interval 660.0 to 824.0
|
655 Titers
Interval 586.0 to 733.0
|
|
Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots.
A/Texas/50/2012 (H3N2)
|
466 Titers
Interval 417.0 to 519.0
|
472 Titers
Interval 424.0 to 525.0
|
437 Titers
Interval 392.0 to 486.0
|
|
Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots.
B Massachusetts/2/2012 (B)
|
178 Titers
Interval 161.0 to 196.0
|
175 Titers
Interval 159.0 to 192.0
|
172 Titers
Interval 156.0 to 189.0
|
SECONDARY outcome
Timeframe: Day 22Population: FAS(Full Analysis Set) All subjects in the Enrolled Population who: ▫ receive a study vaccination and provide immunogenicity data at Day 1 and at Day 22 FAS populations was analyzed "as randomized" (i.e., according to the vaccine a subject was designated to receive, which may be different from the vaccine the subject actually received).
Percentages of subjects achieving HI seroconversion after each of three vaccine strains were measured three weeks after vaccination of TIVc or TIVf vaccine (day 22). Percentages of subjects who achieved HI titer ≥1:40 against each of three vaccine strains were measured three weeks after one vaccination of TIVc or TIVf vaccine. HI assay analysis for TIVc vaccine was based on cell-based antigen and for TIVf vaccine was based on egg based antigen. According to Center for Biologics Evaluation and Research recommendations (CBER 2007), CBER criteria are met when the lower limit of the 2-sided 95% CI for seroconversion/significant increase is ≥ 40%, and the lower limit of the 2-sided 95% CI for HI titers ≥ 1:40 is ≥ 70%.
Outcome measures
| Measure |
TIVc_LOT A
n=1144 Participants
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
|
TIVc_LOT B
n=379 Participants
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
|
TIVc_LOT C
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
|
|---|---|---|---|
|
Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine.
Influenza A H1N1 Brisbane/2010 CC Ab-SC(1143,379 )
|
60 percentages of subjects
Interval 57.0 to 62.0
|
69 percentages of subjects
Interval 64.0 to 74.0
|
—
|
|
Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine.
A/Texas/50/2012 (H3N2)- Seroconversion
|
49 percentages of subjects
Interval 46.0 to 52.0
|
63 percentages of subjects
Interval 58.0 to 68.0
|
—
|
|
Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine.
B Massachusetts/2/2012 (B) - Seroconversion
|
39 percentages of subjects
Interval 36.0 to 42.0
|
45 percentages of subjects
Interval 40.0 to 50.0
|
—
|
|
Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine.
Influenza A H1N1 Brisbane/2010 CC Ab-HI ≥1:40Day22
|
99 percentages of subjects
Interval 99.0 to 100.0
|
99 percentages of subjects
Interval 98.0 to 100.0
|
—
|
|
Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine.
A/Texas/50/2012 (H3N2)- HI ≥1:40(Day 22)
|
100 percentages of subjects
Interval 99.0 to 100.0
|
100 percentages of subjects
Interval 99.0 to 100.0
|
—
|
|
Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine.
B Massachusetts/2/2012 (B) - HI ≥1:40 (Day 22)
|
98 percentages of subjects
Interval 97.0 to 99.0
|
92 percentages of subjects
Interval 89.0 to 95.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 through day 7 (without 30 min)Population: Solicited Safety Set-All subjects in the exposed set with any solicited AE data postvaccination or indicators of solicited AEs postvaccination
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIVc and control vaccines.
Outcome measures
| Measure |
TIVc_LOT A
n=1169 Participants
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
|
TIVc_LOT B
n=391 Participants
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
|
TIVc_LOT C
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
|
|---|---|---|---|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf
Induration
|
168 Subjects
|
62 Subjects
|
—
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf
Erythema
|
208 Subjects
|
77 Subjects
|
—
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf
Ecchymosis
|
76 Subjects
|
30 Subjects
|
—
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf
Pain
|
481 Subjects
|
135 Subjects
|
—
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf
Nausea
|
91 Subjects
|
30 Subjects
|
—
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf
Myalgia
|
109 Subjects
|
28 Subjects
|
—
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf
Arthralgia
|
84 Subjects
|
28 Subjects
|
—
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf
Headache
|
259 Subjects
|
80 Subjects
|
—
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf
Fatigue
|
221 Subjects
|
77 Subjects
|
—
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf
Diarrhea
|
85 Subjects
|
47 Subjects
|
—
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf
Chills
|
45 Subjects
|
11 Subjects
|
—
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf
Loss of appetite
|
66 Subjects
|
39 Subjects
|
—
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf
Vomiting
|
18 Subjects
|
9 Subjects
|
—
|
|
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf
Fever (≥38°C)
|
7 Subjects
|
2 Subjects
|
—
|
SECONDARY outcome
Timeframe: Day 1 through day 22Population: Unsolicited Safety Set-All subjects in the exposed set with unsolicited AE data postvaccination.
Safety was assessed as the number of subjects who reported Unsolicited Adverse Events after vaccination of TIVc and control vaccine.
Outcome measures
| Measure |
TIVc_LOT A
n=1169 Participants
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
|
TIVc_LOT B
n=391 Participants
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
|
TIVc_LOT C
Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
|
|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events
Any AE
|
139 Subjects
|
38 Subjects
|
—
|
|
Number of Subjects With Unsolicited Adverse Events
Possibly or probably related AE
|
50 Subjects
|
14 Subjects
|
—
|
|
Number of Subjects With Unsolicited Adverse Events
SAE
|
0 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects With Unsolicited Adverse Events
Possibly or probably related SAE
|
0 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects With Unsolicited Adverse Events
AE leading to withdrawal
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects With Unsolicited Adverse Events
Medically attended AE
|
28 Subjects
|
9 Subjects
|
—
|
|
Number of Subjects With Unsolicited Adverse Events
New Onset of Chronic Disease
|
2 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects With Unsolicited Adverse Events
Death
|
0 Subjects
|
0 Subjects
|
—
|
Adverse Events
TIVc Pooled
Serious events: 0 serious events
Other events: 709 other events
Deaths: 0 deaths
TIVf
Serious events: 2 serious events
Other events: 237 other events
Deaths: 0 deaths
Total
Serious events: 2 serious events
Other events: 946 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TIVc Pooled
n=1169 participants at risk
Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc
|
TIVf
n=391 participants at risk
Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf;
|
Total
n=1560 participants at risk
Total number of subjects
|
|---|---|---|---|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/1169 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
0.26%
1/391 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
0.06%
1/1560 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.00%
0/1169 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
0.26%
1/391 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
0.06%
1/1560 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
Other adverse events
| Measure |
TIVc Pooled
n=1169 participants at risk
Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc
|
TIVf
n=391 participants at risk
Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf;
|
Total
n=1560 participants at risk
Total number of subjects
|
|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
7.4%
86/1169 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
12.0%
47/391 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
8.5%
133/1560 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
|
Gastrointestinal disorders
NAUSEA
|
7.8%
91/1169 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
7.7%
30/391 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
7.8%
121/1560 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
|
General disorders
FATIGUE
|
19.0%
222/1169 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
19.7%
77/391 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
19.2%
299/1560 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
17.8%
208/1169 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
19.7%
77/391 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
18.3%
285/1560 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
|
General disorders
INJECTION SITE HAEMORRHAGE
|
6.5%
76/1169 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
7.7%
30/391 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
6.8%
106/1560 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
|
General disorders
INJECTION SITE INDURATION
|
14.4%
168/1169 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
15.9%
62/391 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
14.7%
230/1560 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
|
General disorders
INJECTION SITE PAIN
|
41.1%
481/1169 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
34.5%
135/391 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
39.5%
616/1560 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
5.6%
66/1169 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
10.0%
39/391 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
6.7%
105/1560 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.2%
84/1169 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
7.4%
29/391 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
7.2%
113/1560 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
9.4%
110/1169 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
7.2%
28/391 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
8.8%
138/1560 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
|
Nervous system disorders
HEADACHE
|
22.4%
262/1169 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
21.0%
82/391 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
22.1%
344/1560 • Throughout the study period, (Day 1 through Day 22)
SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22. 1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site was postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER