Trial Outcomes & Findings for A Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™ / Influsplit SSW® 2008/2009 in Adults (NCT NCT00706563)
NCT ID: NCT00706563
Last Updated: 2018-08-17
Results Overview
Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
120 participants
Primary outcome timeframe
At Day 0 and 21
Results posted on
2018-08-17
Participant Flow
Participant milestones
| Measure |
Fluarix Adult Group
Subjects who are 18-40 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
|
59
|
|
Overall Study
COMPLETED
|
61
|
59
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix™ / Influsplit SSW® 2008/2009 in Adults
Baseline characteristics by cohort
| Measure |
Fluarix Adult Group
n=61 Participants
Subjects who are 18-40 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=59 Participants
Subjects who are ≥ 60 years of age received one dose of Fluarix™
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 13.26 • n=5 Participants
|
68.8 years
STANDARD_DEVIATION 5.25 • n=7 Participants
|
53.7 years
STANDARD_DEVIATION 18.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Day 0 and 21Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains
Outcome measures
| Measure |
Fluarix Adult Group
n=61 Participants
Subjects who are 18-40 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=59 Participants
Subjects who are ≥ 60 years of age received one dose of Fluarix™
|
|---|---|---|
|
Hemagglutination Inhibition (HI) Antibody Titer
A/Brisbane (Day 0)
|
13.6 titer
Interval 10.1 to 18.2
|
11.6 titer
Interval 9.1 to 14.9
|
|
Hemagglutination Inhibition (HI) Antibody Titer
A/Brisbane (Day 21)
|
165.5 titer
Interval 119.2 to 229.7
|
68.2 titer
Interval 48.4 to 96.3
|
|
Hemagglutination Inhibition (HI) Antibody Titer
A/Uruguay (Day 0)
|
7.6 titer
Interval 6.2 to 9.3
|
9.7 titer
Interval 7.3 to 12.9
|
|
Hemagglutination Inhibition (HI) Antibody Titer
A/Uruguay (Day 21)
|
90.7 titer
Interval 60.2 to 136.5
|
120.6 titer
Interval 76.1 to 191.0
|
|
Hemagglutination Inhibition (HI) Antibody Titer
B/Brisbane (Day 0)
|
102.1 titer
Interval 74.4 to 140.0
|
108.0 titer
Interval 76.9 to 151.8
|
|
Hemagglutination Inhibition (HI) Antibody Titer
B/Brisbane (Day 21)
|
785.3 titer
Interval 634.0 to 972.7
|
524.0 titer
Interval 404.9 to 678.2
|
PRIMARY outcome
Timeframe: At Day 0 and 21The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains
Outcome measures
| Measure |
Fluarix Adult Group
n=61 Participants
Subjects who are 18-40 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=59 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)
|
36 subjects
|
35 subjects
|
|
Number of Subjects With HI Antibody Titer Above the Cut-off Value
A/Brisbane (Day 21)
|
61 subjects
|
58 subjects
|
|
Number of Subjects With HI Antibody Titer Above the Cut-off Value
A/Uruguay (Day 0)
|
19 subjects
|
23 subjects
|
|
Number of Subjects With HI Antibody Titer Above the Cut-off Value
A/Uruguay (Day 21)
|
57 subjects
|
58 subjects
|
|
Number of Subjects With HI Antibody Titer Above the Cut-off Value
B/Brisbane (Day 0)
|
60 subjects
|
58 subjects
|
|
Number of Subjects With HI Antibody Titer Above the Cut-off Value
B/Brisbane (Day 21)
|
61 subjects
|
59 subjects
|
PRIMARY outcome
Timeframe: At Day 0 and 21A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40
Outcome measures
| Measure |
Fluarix Adult Group
n=61 Participants
Subjects who are 18-40 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=59 Participants
Subjects who are ≥ 60 years of age received one dose of Fluarix™
|
|---|---|---|
|
Number of Seroprotected Subjects
A/Brisbane (Day 0)
|
15 subjects
|
9 subjects
|
|
Number of Seroprotected Subjects
A/Brisbane (Day 21)
|
55 subjects
|
40 subjects
|
|
Number of Seroprotected Subjects
A/Uruguay (Day 0)
|
5 subjects
|
8 subjects
|
|
Number of Seroprotected Subjects
A/Uruguay (Day 21)
|
47 subjects
|
43 subjects
|
|
Number of Seroprotected Subjects
B/Brisbane (Day 0)
|
48 subjects
|
50 subjects
|
|
Number of Seroprotected Subjects
B/Brisbane (Day 21)
|
61 subjects
|
59 subjects
|
PRIMARY outcome
Timeframe: At Day 21A 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=61 Participants
Subjects who are 18-40 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=59 Participants
Subjects who are ≥ 60 years of age received one dose of Fluarix™
|
|---|---|---|
|
Number of Serconverted Subjects
B/Brisbane
|
39 subjects
|
30 subjects
|
|
Number of Serconverted Subjects
A/Brisbane
|
44 subjects
|
30 subjects
|
|
Number of Serconverted Subjects
A/Uruguay
|
44 subjects
|
39 subjects
|
PRIMARY outcome
Timeframe: At Day 21Seroconversion 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=61 Participants
Subjects who are 18-40 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=59 Participants
Subjects who are ≥ 60 years of age received one dose of Fluarix™
|
|---|---|---|
|
Serconversion Factor
A/Brisbane
|
12.2 factor
|
5.9 factor
|
|
Serconversion Factor
A/Uruguay
|
12.0 factor
|
12.4 factor
|
|
Serconversion Factor
B/Brisbane
|
7.7 factor
|
4.9 factor
|
PRIMARY outcome
Timeframe: At Day 21Population: Analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects unprotected at pre-vaccination and with available results
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=56 Participants
Subjects who are 18-40 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=51 Participants
Subjects who are ≥ 60 years of age received one dose of Fluarix™
|
|---|---|---|
|
Seroprotection Power
A/Brisbane (N=46; 50)
|
40 subjects
|
32 subjects
|
|
Seroprotection Power
A/Uruguay (N=56; 51)
|
42 subjects
|
35 subjects
|
|
Seroprotection Power
B/Brisbane (N=13; 9)
|
13 subjects
|
9 subjects
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0-3) post-vaccination periodSolicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever
Outcome measures
| Measure |
Fluarix Adult Group
n=61 Participants
Subjects who are 18-40 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=59 Participants
Subjects who are ≥ 60 years of age received one dose of Fluarix™
|
|---|---|---|
|
Number of Subjects Reporting Solicited Symptoms
Ecchymosis
|
3 subjects
|
0 subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Induration
|
19 subjects
|
7 subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Pain
|
36 subjects
|
22 subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Redness
|
24 subjects
|
11 subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Swelling
|
16 subjects
|
6 subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Arthralgia
|
6 subjects
|
2 subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Fatigue
|
10 subjects
|
8 subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Headache
|
8 subjects
|
8 subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Myalgia
|
15 subjects
|
7 subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Shivering
|
4 subjects
|
5 subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Sweating
|
5 subjects
|
4 subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Fever
|
0 subjects
|
0 subjects
|
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 18-40 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=59 Participants
Subjects who are ≥ 60 years of age received one dose of Fluarix™
|
|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AE)
|
7 subjects
|
6 subjects
|
SECONDARY outcome
Timeframe: During the 21-day (Day 0-20) post-vaccination periodAn SAE is any untoward medical occurrence that: results in death, is life-threatening, 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 18-40 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=59 Participants
Subjects who are ≥ 60 years of age received one dose of Fluarix™
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAE)
|
1 subjects
|
0 subjects
|
Adverse Events
Fluarix Adult Group
Serious events: 1 serious events
Other events: 44 other events
Deaths: 0 deaths
Fluarix Elderly Group
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluarix Adult Group
n=61 participants at risk
Subjects who are 18-40 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=59 participants at risk
Subjects who are ≥ 60 years of age received one dose of Fluarix™
|
|---|---|---|
|
General disorders
Chest pain
|
1.6%
1/61
|
0.00%
0/59
|
Other adverse events
| Measure |
Fluarix Adult Group
n=61 participants at risk
Subjects who are 18-40 years of age received one dose of Fluarix™
|
Fluarix Elderly Group
n=59 participants at risk
Subjects who are ≥ 60 years of age received one dose of Fluarix™
|
|---|---|---|
|
General disorders
Induration
|
31.1%
19/61
|
11.9%
7/59
|
|
General disorders
Pain
|
59.0%
36/61
|
37.3%
22/59
|
|
General disorders
Redness
|
39.3%
24/61
|
18.6%
11/59
|
|
General disorders
Swelling
|
26.2%
16/61
|
10.2%
6/59
|
|
General disorders
Arthralgia
|
9.8%
6/61
|
3.4%
2/59
|
|
General disorders
Fatigue
|
16.4%
10/61
|
13.6%
8/59
|
|
General disorders
Headache
|
13.1%
8/61
|
13.6%
8/59
|
|
General disorders
Myalgia
|
24.6%
15/61
|
11.9%
7/59
|
|
General disorders
Shivering
|
6.6%
4/61
|
8.5%
5/59
|
|
General disorders
Sweating
|
8.2%
5/61
|
6.8%
4/59
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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