Trial Outcomes & Findings for A Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in Adults (NCT NCT00920374)
NCT ID: NCT00920374
Last Updated: 2018-09-21
Results Overview
Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains
COMPLETED
PHASE3
118 participants
Day 0 and Day 21
2018-09-21
Participant Flow
Participant milestones
| Measure |
Fluarix Adult Group
Subjects who are 18-60 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
Subjects who are \> 60 years of age received one dose of Fluarix™
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
57
|
|
Overall Study
COMPLETED
|
61
|
57
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in Adults
Baseline characteristics by cohort
| Measure |
Fluarix Adult Group
n=61 Participants
Subjects who are 18-60 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=57 Participants
Subjects who are \> 60 years of age received one dose of Fluarix™
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.3 years
STANDARD_DEVIATION 12.18 • n=5 Participants
|
68.9 years
STANDARD_DEVIATION 6.57 • n=7 Participants
|
53.6 years
STANDARD_DEVIATION 17.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 21Population: Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data
Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains
Outcome measures
| Measure |
Fluarix Adult Group
n=59 Participants
Subjects who are 18-60 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=56 Participants
Subjects who are \> 60 years of age received one dose of Fluarix™
|
|---|---|---|
|
Hemagglutination Inhibition (HI) Antibody Titer
A/Brisbane (Day 0)
|
15.5 titer
Interval 11.7 to 20.6
|
11.4 titer
Interval 9.2 to 14.0
|
|
Hemagglutination Inhibition (HI) Antibody Titer
A/Brisbane (Day 21)
|
139.7 titer
Interval 100.6 to 194.0
|
55.8 titer
Interval 39.2 to 79.5
|
|
Hemagglutination Inhibition (HI) Antibody Titer
A/Uruguay (Day 0)
|
18.2 titer
Interval 13.7 to 24.1
|
13.2 titer
Interval 10.1 to 17.2
|
|
Hemagglutination Inhibition (HI) Antibody Titer
A/Uruguay (Day 21)
|
151.7 titer
Interval 111.6 to 206.2
|
112.4 titer
Interval 76.3 to 165.5
|
|
Hemagglutination Inhibition (HI) Antibody Titer
B/Brisbane (Day 0)
|
62.8 titer
Interval 45.4 to 86.8
|
77.6 titer
Interval 57.3 to 105.0
|
|
Hemagglutination Inhibition (HI) Antibody Titer
B/Brisbane (Day 21)
|
393.0 titer
Interval 319.3 to 483.7
|
371.3 titer
Interval 274.9 to 501.6
|
PRIMARY outcome
Timeframe: Day 0 and Day 21Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data
The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains
Outcome measures
| Measure |
Fluarix Adult Group
n=59 Participants
Subjects who are 18-60 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=56 Participants
Subjects who are \> 60 years of age received one dose of Fluarix™
|
|---|---|---|
|
Number of Subjects With HI Antibody Titer Above the Cut-off Value
A/Brisbane (Day 0)
|
39 Participants
|
36 Participants
|
|
Number of Subjects With HI Antibody Titer Above the Cut-off Value
A/Brisbane (Day 21)
|
58 Participants
|
56 Participants
|
|
Number of Subjects With HI Antibody Titer Above the Cut-off Value
A/Uruguay (Day 0)
|
44 Participants
|
37 Participants
|
|
Number of Subjects With HI Antibody Titer Above the Cut-off Value
A/Uruguay (Day 21)
|
59 Participants
|
56 Participants
|
|
Number of Subjects With HI Antibody Titer Above the Cut-off Value
B/Brisbane (Day 0)
|
56 Participants
|
54 Participants
|
|
Number of Subjects With HI Antibody Titer Above the Cut-off Value
B/Brisbane (Day 21)
|
59 Participants
|
56 Participants
|
PRIMARY outcome
Timeframe: Day 0 and Day 21Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data
A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40
Outcome measures
| Measure |
Fluarix Adult Group
n=59 Participants
Subjects who are 18-60 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=56 Participants
Subjects who are \> 60 years of age received one dose of Fluarix™
|
|---|---|---|
|
Number of Seroprotected Subjects
A/Brisbane (Day 0)
|
18 Participants
|
6 Participants
|
|
Number of Seroprotected Subjects
A/Brisbane (Day 21)
|
53 Participants
|
35 Participants
|
|
Number of Seroprotected Subjects
A/Uruguay (Day 0)
|
17 Participants
|
10 Participants
|
|
Number of Seroprotected Subjects
A/Uruguay (Day 21)
|
52 Participants
|
46 Participants
|
|
Number of Seroprotected Subjects
B/Brisbane (Day 0)
|
38 Participants
|
45 Participants
|
|
Number of Seroprotected Subjects
B/Brisbane (Day 21)
|
59 Participants
|
56 Participants
|
PRIMARY outcome
Timeframe: Day 21Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data
A seroconverted subject is a subject with a pre-vaccination serum HI titer \< 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4
Outcome measures
| Measure |
Fluarix Adult Group
n=59 Participants
Subjects who are 18-60 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=56 Participants
Subjects who are \> 60 years of age received one dose of Fluarix™
|
|---|---|---|
|
Number of Seroconverted Subjects
A/Brisbane
|
41 Participants
|
24 Participants
|
|
Number of Seroconverted Subjects
A/Uruguay
|
40 Participants
|
41 Participants
|
|
Number of Seroconverted Subjects
B/Brisbane
|
34 Participants
|
30 Participants
|
PRIMARY outcome
Timeframe: Day 21Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data
Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains
Outcome measures
| Measure |
Fluarix Adult Group
n=59 Participants
Subjects who are 18-60 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=56 Participants
Subjects who are \> 60 years of age received one dose of Fluarix™
|
|---|---|---|
|
Seroconversion Factor
A/Brisbane
|
9.0 fold change
Interval 6.2 to 13.1
|
4.9 fold change
Interval 3.5 to 6.9
|
|
Seroconversion Factor
A/Uruguay
|
8.3 fold change
Interval 6.0 to 11.6
|
8.5 fold change
Interval 6.2 to 11.7
|
|
Seroconversion Factor
B/Brisbane
|
6.3 fold change
Interval 4.5 to 8.7
|
4.8 fold change
Interval 3.6 to 6.4
|
PRIMARY outcome
Timeframe: Day 21Population: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available data
Seroprotection power is defined as the number of subject who had a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40
Outcome measures
| Measure |
Fluarix Adult Group
n=42 Participants
Subjects who are 18-60 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=50 Participants
Subjects who are \> 60 years of age received one dose of Fluarix™
|
|---|---|---|
|
Seroprotection Power
A/Brisbane
|
35 Participants
|
29 Participants
|
|
Seroprotection Power
A/Uruguay
|
35 Participants
|
36 Participants
|
|
Seroprotection Power
B/Brisbane
|
21 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0-3) post-vaccination periodSolicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.
Outcome measures
| Measure |
Fluarix Adult Group
n=61 Participants
Subjects who are 18-60 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=57 Participants
Subjects who are \> 60 years of age received one dose of Fluarix™
|
|---|---|---|
|
Number of Subjects Reporting Solicited Local Symptoms
Ecchymosis
|
3 Participants
|
2 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Induration
|
14 Participants
|
13 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Pain
|
41 Participants
|
21 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Redness
|
22 Participants
|
16 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Swelling
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0-3) post-vaccination periodSolicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever
Outcome measures
| Measure |
Fluarix Adult Group
n=61 Participants
Subjects who are 18-60 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=57 Participants
Subjects who are \> 60 years of age received one dose of Fluarix™
|
|---|---|---|
|
Number of Subjects Reporting Solicited General Symptoms
Arthralgia
|
5 Participants
|
8 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Fatigue
|
13 Participants
|
6 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Headache
|
12 Participants
|
3 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Myalgia
|
14 Participants
|
7 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Shivering
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Sweating
|
6 Participants
|
5 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Fever
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 21-day (Day 0-20) post-vaccination periodAn AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
Fluarix Adult Group
n=61 Participants
Subjects who are 18-60 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=57 Participants
Subjects who are \> 60 years of age received one dose of Fluarix™
|
|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AE)
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: During the entire study periodAn SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Outcome measures
| Measure |
Fluarix Adult Group
n=61 Participants
Subjects who are 18-60 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=57 Participants
Subjects who are \> 60 years of age received one dose of Fluarix™
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAE)
|
0 Participants
|
0 Participants
|
Adverse Events
Fluarix Adult Group
Fluarix Elderly Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fluarix Adult Group
n=61 participants at risk
Subjects who are 18-60 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=57 participants at risk
Subjects who are \> 60 years of age received one dose of Fluarix™
|
|---|---|---|
|
General disorders
Arthralgia
|
8.2%
5/61
|
14.0%
8/57
|
|
General disorders
Fatigue
|
21.3%
13/61
|
10.5%
6/57
|
|
General disorders
Headache
|
19.7%
12/61
|
5.3%
3/57
|
|
General disorders
Myalgia
|
23.0%
14/61
|
12.3%
7/57
|
|
General disorders
Sweating
|
9.8%
6/61
|
8.8%
5/57
|
|
General disorders
Induration
|
23.0%
14/61
|
22.8%
13/57
|
|
General disorders
Pain
|
67.2%
41/61
|
36.8%
21/57
|
|
General disorders
Redness
|
36.1%
22/61
|
28.1%
16/57
|
|
General disorders
Swelling
|
14.8%
9/61
|
15.8%
9/57
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER