Trial Outcomes & Findings for Safety and Immunogenicity of GPO Seasonal Trivalent Inactivated Influenza Vaccine in Healthy Thai Adults (NCT NCT02894840)
NCT ID: NCT02894840
Last Updated: 2020-03-17
Results Overview
All Adverse Events during 90 days will be analysed in terms of percentage and relationship to study vaccine
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
340 participants
Primary outcome timeframe
90 days
Results posted on
2020-03-17
Participant Flow
A total of 340 participants (40 in phase I and 300 in phase II) who met all inclusion criteria and not of the exclusion criteria were enrolled in the study.
Participant milestones
| Measure |
Inactivated Influenza Vaccine Phase I
A single dose of a seasonal trivalent inactivated split virion influenza vaccine \[A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains\] 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
|
Placebo Phase I
A single dose of placebo (0.9% normal saline solution) 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
|
Inactivated Influenza Vaccine Phase II
A single dose of a seasonal trivalent inactivated split virion influenza vaccine \[A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains\] 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
|
Placebo Phase II
A single dose of placebo (0.9% normal saline solution) was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
200
|
100
|
|
Overall Study
COMPLETED
|
19
|
20
|
197
|
100
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
3
|
0
|
Reasons for withdrawal
| Measure |
Inactivated Influenza Vaccine Phase I
A single dose of a seasonal trivalent inactivated split virion influenza vaccine \[A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains\] 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
|
Placebo Phase I
A single dose of placebo (0.9% normal saline solution) 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
|
Inactivated Influenza Vaccine Phase II
A single dose of a seasonal trivalent inactivated split virion influenza vaccine \[A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains\] 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
|
Placebo Phase II
A single dose of placebo (0.9% normal saline solution) was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
3
|
0
|
Baseline Characteristics
Phase I and phase II was analyzed separately Phase I=40 (20 received vaccine, 20 received placebo).Phase II=300(ITT analysis). 200 received vaccine,100 received placebo).
Baseline characteristics by cohort
| Measure |
Inactivated Influenza Vaccine Phase I
n=20 Participants
A single dose of a seasonal trivalent inactivated split virion influenza vaccine \[A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains\] 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
|
Placebo Phase I
n=20 Participants
A single dose of placebo (0.9% normal saline solution) 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
|
Inactivated Influenza Vaccine Phase II
n=200 Participants
A single dose of a seasonal trivalent inactivated split virion influenza vaccine \[A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains\] 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
|
Placebo Phase II
n=100 Participants
A single dose of placebo (0.9% normal saline solution) 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays.
|
Total
n=340 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
200 Participants
n=27 Participants
|
100 Participants
n=483 Participants
|
340 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
|
32.25 years
STANDARD_DEVIATION 9.45 • n=93 Participants • Phase I and phase II was analyzed separately Phase I=40 (20 received vaccine, 20 received placebo).Phase II=300(ITT analysis). 200 received vaccine,100 received placebo).
|
28.15 years
STANDARD_DEVIATION 6.72 • n=4 Participants • Phase I and phase II was analyzed separately Phase I=40 (20 received vaccine, 20 received placebo).Phase II=300(ITT analysis). 200 received vaccine,100 received placebo).
|
32.28 years
STANDARD_DEVIATION 8.19 • n=27 Participants • Phase I and phase II was analyzed separately Phase I=40 (20 received vaccine, 20 received placebo).Phase II=300(ITT analysis). 200 received vaccine,100 received placebo).
|
32.2 years
STANDARD_DEVIATION 7.96 • n=483 Participants • Phase I and phase II was analyzed separately Phase I=40 (20 received vaccine, 20 received placebo).Phase II=300(ITT analysis). 200 received vaccine,100 received placebo).
|
31.22 years
STANDARD_DEVIATION 8.43 • n=36 Participants • Phase I and phase II was analyzed separately Phase I=40 (20 received vaccine, 20 received placebo).Phase II=300(ITT analysis). 200 received vaccine,100 received placebo).
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants • Phase I and phase II was analyzed separately. Numbers in phase I = 40, Phase II = 300 (Intent to treat analysis).
|
5 Participants
n=4 Participants • Phase I and phase II was analyzed separately. Numbers in phase I = 40, Phase II = 300 (Intent to treat analysis).
|
112 Participants
n=27 Participants • Phase I and phase II was analyzed separately. Numbers in phase I = 40, Phase II = 300 (Intent to treat analysis).
|
65 Participants
n=483 Participants • Phase I and phase II was analyzed separately. Numbers in phase I = 40, Phase II = 300 (Intent to treat analysis).
|
192 Participants
n=36 Participants • Phase I and phase II was analyzed separately. Numbers in phase I = 40, Phase II = 300 (Intent to treat analysis).
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants • Phase I and phase II was analyzed separately. Numbers in phase I = 40, Phase II = 300 (Intent to treat analysis).
|
15 Participants
n=4 Participants • Phase I and phase II was analyzed separately. Numbers in phase I = 40, Phase II = 300 (Intent to treat analysis).
|
88 Participants
n=27 Participants • Phase I and phase II was analyzed separately. Numbers in phase I = 40, Phase II = 300 (Intent to treat analysis).
|
35 Participants
n=483 Participants • Phase I and phase II was analyzed separately. Numbers in phase I = 40, Phase II = 300 (Intent to treat analysis).
|
148 Participants
n=36 Participants • Phase I and phase II was analyzed separately. Numbers in phase I = 40, Phase II = 300 (Intent to treat analysis).
|
|
Region of Enrollment
Thailand
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
200 Participants
n=27 Participants
|
100 Participants
n=483 Participants
|
340 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: All participants who receive at least one vaccination would be included in the safety population. The analysis will be conducted based on intent-to-treat (ITT) analysis. The population for the ITT analysis is defined as all individuals in the trial. The ITT analysis would include individuals who may not complete follow-up.
All Adverse Events during 90 days will be analysed in terms of percentage and relationship to study vaccine
Outcome measures
| Measure |
Inactivated Influenza Vaccine Phase I
n=20 Participants
Number of Participants With Adverse Events Phase I: AE/SAE Vaccine group (N=20)
|
Placebo Phase I
n=20 Participants
Number of Participants With Adverse Events Phase I: AE/SAE Placebo group (N = 20)
|
Inactivated Influenza Vaccine Phase II
n=200 Participants
Number of Participants With Adverse Events Phase II: AE/SAE Vaccine group (N=200)
|
Placebo Phase II
n=100 Participants
Number of Participants With Adverse Events Phase II: AE/SAE placebo group (N=100)
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
5 Participants
|
8 Participants
|
69 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Seroconversion against the hemagglutinin antigens contained in the vaccine were assessed in all studied participants both phase I and phase II. The analysis was performed as intention-to-treat (ITT).
Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (\<1:10), attainment of a post-immunization titer of ≥1:40.
Outcome measures
| Measure |
Inactivated Influenza Vaccine Phase I
n=20 Participants
Number of Participants With Adverse Events Phase I: AE/SAE Vaccine group (N=20)
|
Placebo Phase I
n=20 Participants
Number of Participants With Adverse Events Phase I: AE/SAE Placebo group (N = 20)
|
Inactivated Influenza Vaccine Phase II
n=200 Participants
Number of Participants With Adverse Events Phase II: AE/SAE Vaccine group (N=200)
|
Placebo Phase II
n=100 Participants
Number of Participants With Adverse Events Phase II: AE/SAE placebo group (N=100)
|
|---|---|---|---|---|
|
Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer.
A/H3N2 Day 90
|
7 Participants
|
1 Participants
|
92 Participants
|
2 Participants
|
|
Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer.
B/Brisbane/60/2008 Day 21
|
19 Participants
|
0 Participants
|
173 Participants
|
1 Participants
|
|
Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer.
B/Brisbane/60/2008 Day 60
|
19 Participants
|
2 Participants
|
153 Participants
|
1 Participants
|
|
Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer.
B/Brisbane/60/2008 Day 90
|
18 Participants
|
1 Participants
|
146 Participants
|
1 Participants
|
|
Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer.
A/H1N1 Day 21
|
17 Participants
|
0 Participants
|
176 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer.
A/H1N1 Day 60
|
14 Participants
|
0 Participants
|
166 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer.
A/H1N1 Day 90
|
13 Participants
|
0 Participants
|
163 Participants
|
1 Participants
|
|
Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer.
A/H3N2 day 21
|
9 Participants
|
1 Participants
|
107 Participants
|
0 Participants
|
|
Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer.
A/H3N2 Day 60
|
8 Participants
|
1 Participants
|
93 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0,21, 60 and 90) were assessed in all studied participants both phase I and phase II. The analysis was performed as intention-to-treat (ITT).
The analysis was performed only as intention-to-treat (ITT). The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0,21, 60 and 90)
Outcome measures
| Measure |
Inactivated Influenza Vaccine Phase I
n=20 Participants
Number of Participants With Adverse Events Phase I: AE/SAE Vaccine group (N=20)
|
Placebo Phase I
n=20 Participants
Number of Participants With Adverse Events Phase I: AE/SAE Placebo group (N = 20)
|
Inactivated Influenza Vaccine Phase II
n=200 Participants
Number of Participants With Adverse Events Phase II: AE/SAE Vaccine group (N=200)
|
Placebo Phase II
n=100 Participants
Number of Participants With Adverse Events Phase II: AE/SAE placebo group (N=100)
|
|---|---|---|---|---|
|
Geometric Mean of Immune Response at Every Time of Assessment
A/H1N1 Day 0
|
21.44 titer
Interval 11.12 to 41.33
|
24.62 titer
Interval 14.09 to 43.02
|
19.39 titer
Interval 16.4 to 22.92
|
20.14 titer
Interval 15.9 to 25.52
|
|
Geometric Mean of Immune Response at Every Time of Assessment
A/H1N1 Day 21
|
380.55 titer
Interval 246.97 to 586.38
|
24.62 titer
Interval 14.09 to 43.02
|
392.60 titer
Interval 337.59 to 456.59
|
20.00 titer
Interval 15.79 to 25.33
|
|
Geometric Mean of Immune Response at Every Time of Assessment
A/H1N1 Day 60
|
226.27 titer
Interval 149.51 to 342.45
|
24.62 titer
Interval 14.09 to 43.02
|
253.10 titer
Interval 218.31 to 293.42
|
20.00 titer
Interval 15.82 to 25.29
|
|
Geometric Mean of Immune Response at Every Time of Assessment
A/H1N1 Day 90
|
206.55 titer
Interval 133.78 to 318.9
|
24.62 titer
Interval 14.09 to 43.02
|
221.21 titer
Interval 189.48 to 258.25
|
20.85 titer
Interval 16.45 to 26.42
|
|
Geometric Mean of Immune Response at Every Time of Assessment
A/H3N2 Day 0
|
62.77 titer
Interval 40.53 to 97.21
|
64.98 titer
Interval 40.54 to 104.16
|
51.16 titer
Interval 43.43 to 60.27
|
44.38 titer
Interval 35.03 to 56.22
|
|
Geometric Mean of Immune Response at Every Time of Assessment
A/H3N2 Day 21
|
177.53 titer
Interval 128.84 to 244.61
|
72.10 titer
Interval 43.87 to 118.49
|
214.81 titer
Interval 183.77 to 251.09
|
43.17 titer
Interval 34.2 to 54.49
|
|
Geometric Mean of Immune Response at Every Time of Assessment
A/H3N2 Day 60
|
149.29 titer
Interval 109.06 to 204.35
|
72.10 titer
Interval 43.87 to 118.49
|
165.12 titer
Interval 143.17 to 190.43
|
43.17 titer
Interval 34.2 to 54.49
|
|
Geometric Mean of Immune Response at Every Time of Assessment
A/H3N2 Day 90
|
148.74 titer
Interval 111.03 to 199.26
|
69.64 titer
Interval 43.19 to 112.29
|
155.06 titer
Interval 135.47 to 177.48
|
45.00 titer
Interval 35.77 to 56.62
|
|
Geometric Mean of Immune Response at Every Time of Assessment
B/Brisbane/60/2008 Day 0
|
9.01 titer
Interval 6.54 to 12.42
|
14.14 titer
Interval 9.34 to 21.4
|
9.97 titer
Interval 8.72 to 11.39
|
9.20 titer
Interval 7.77 to 10.9
|
|
Geometric Mean of Immune Response at Every Time of Assessment
B/Brisbane/60/2008 Day 21
|
190.27 titer
Interval 110.26 to 328.35
|
13.66 titer
Interval 9.03 to 20.67
|
115.92 titer
Interval 97.6 to 137.66
|
9.40 titer
Interval 7.83 to 11.28
|
|
Geometric Mean of Immune Response at Every Time of Assessment
B/Brisbane/60/2008 Day 60
|
134.54 titer
Interval 79.6 to 227.43
|
16.82 titer
Interval 10.28 to 27.51
|
83.72 titer
Interval 70.39 to 99.58
|
9.33 titer
Interval 7.82 to 11.13
|
|
Geometric Mean of Immune Response at Every Time of Assessment
B/Brisbane/60/2008 Day 90
|
107.11 titer
Interval 61.16 to 187.58
|
15.69 titer
Interval 10.13 to 24.3
|
73.33 titer
Interval 61.15 to 87.94
|
9.40 titer
Interval 7.89 to 11.19
|
SECONDARY outcome
Timeframe: 90 daysPopulation: The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0,21, 60 and 90) were assessed in all studied participants both phase I and phase II. The analysis was performed as intention-to-treat (ITT).
The analysis was performed only as intention-to-treat (ITT). The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0, 21, 60 and 90). Proportion of increased in GMT Titer \> 2.5 at each time of assessment compared with baseline (Day 0) was reported both phase I and phase II
Outcome measures
| Measure |
Inactivated Influenza Vaccine Phase I
n=20 Participants
Number of Participants With Adverse Events Phase I: AE/SAE Vaccine group (N=20)
|
Placebo Phase I
n=20 Participants
Number of Participants With Adverse Events Phase I: AE/SAE Placebo group (N = 20)
|
Inactivated Influenza Vaccine Phase II
n=200 Participants
Number of Participants With Adverse Events Phase II: AE/SAE Vaccine group (N=200)
|
Placebo Phase II
n=100 Participants
Number of Participants With Adverse Events Phase II: AE/SAE placebo group (N=100)
|
|---|---|---|---|---|
|
Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer
A/H1N1 Day 21
|
17.75 titer
Interval 8.18 to 38.55
|
1.00 titer
Interval 1.0 to 1.0
|
20.25 titer
Interval 16.54 to 24.79
|
0.99 titer
Interval 0.97 to 1.02
|
|
Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer
A/H1N1 Day 60
|
10.56 titer
Interval 5.08 to 21.95
|
1.00 titer
Interval 1.0 to 1.0
|
13.06 titer
Interval 10.82 to 15.76
|
0.99 titer
Interval 0.97 to 1.02
|
|
Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer
A/H1N1 Day 90
|
9.26 titer
Interval 4.4 to 19.47
|
1.00 titer
Interval 1.0 to 1.0
|
11.45 titer
Interval 9.51 to 13.8
|
1.04 titer
Interval 0.96 to 1.11
|
|
Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer
A/H3N2 day 21
|
2.83 titer
Interval 1.7 to 4.71
|
1.11 titer
Interval 0.89 to 1.38
|
4.20 titer
Interval 3.47 to 5.07
|
0.97 titer
Interval 0.94 to 1.01
|
|
Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer
A/H3N2 Day 60
|
2.38 titer
Interval 1.52 to 3.71
|
1.11 titer
Interval 0.89 to 1.38
|
3.19 titer
Interval 2.71 to 3.75
|
0.97 titer
Interval 0.92 to 1.02
|
|
Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer
A/H3N2 Day 90
|
2.31 titer
Interval 1.43 to 3.74
|
1.07 titer
Interval 0.85 to 1.35
|
3.03 titer
Interval 2.6 to 3.53
|
1.01 titer
Interval 0.96 to 1.08
|
|
Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer
B/Brisbane/60/2008 Day 21
|
21.11 titer
Interval 12.97 to 34.35
|
0.97 titer
Interval 0.9 to 1.04
|
11.63 titer
Interval 9.68 to 13.98
|
1.02 titer
Interval 0.95 to 1.1
|
|
Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer
B/Brisbane/60/2008 Day 60
|
14.93 titer
Interval 9.23 to 24.15
|
1.19 titer
Interval 0.92 to 1.53
|
8.40 titer
Interval 6.99 to 10.1
|
1.01 titer
Interval 0.95 to 1.09
|
|
Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer
B/Brisbane/60/2008 Day 90
|
12.85 titer
Interval 8.23 to 20.08
|
1.11 titer
Interval 0.92 to 1.34
|
7.33 titer
Interval 6.08 to 8.84
|
1.02 titer
Interval 0.95 to 1.1
|
Adverse Events
Inactivated Influenza Vaccine Phase I
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Phase I
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Inactivated Influenza Vaccine Phase II
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Phase II
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place