Trial Outcomes & Findings for Immunogenicity and Safety of Vaccine GSK2340272A (H1N1) and GSK Biologicals Fluarix™ Vaccine When Co-administered in Elderly (NCT NCT00968890)
NCT ID: NCT00968890
Last Updated: 2018-08-20
Results Overview
A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer \< 10 and a postvaccination reciprocal titer \>= 40, or a pre-vaccination reciprocal HI titer \>= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
168 participants
Primary outcome timeframe
21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
Results posted on
2018-08-20
Participant Flow
Participant milestones
| Measure |
Pandemrix+Fluarix and Pandemrix+Placebo
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
Pandemrix+Placebo and Pandemrix+Fluarix
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
84
|
|
Overall Study
COMPLETED
|
84
|
84
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunogenicity and Safety of Vaccine GSK2340272A (H1N1) and GSK Biologicals Fluarix™ Vaccine When Co-administered in Elderly
Baseline characteristics by cohort
| Measure |
Pandemrix+Fluarix and Pandemrix+Placebo
n=84 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
Pandemrix+Placebo and Pandemrix+Fluarix
n=84 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.9 Years
STANDARD_DEVIATION 4.63 • n=99 Participants
|
69.1 Years
STANDARD_DEVIATION 4.70 • n=107 Participants
|
69.0 Years
STANDARD_DEVIATION 4.65 • n=206 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)Population: The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.
A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer \< 10 and a postvaccination reciprocal titer \>= 40, or a pre-vaccination reciprocal HI titer \>= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Outcome measures
| Measure |
Pandemrix+Fluarix and Pandemrix+Placebo
n=83 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
Pandemrix+Placebo and Pandemrix+Fluarix
n=84 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
|---|---|---|
|
Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
A/Cal/09
|
79 subjects
|
82 subjects
|
|
Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
B/Bri/08
|
40 subjects
|
22 subjects
|
|
Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
A/Uru/07
|
36 subjects
|
23 subjects
|
|
Number of Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
A/Bri/07
|
31 subjects
|
23 subjects
|
PRIMARY outcome
Timeframe: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)Population: The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.
A seroprotected subject was a subject with reciprocal HI titers \>= 40 against the vaccine homologous virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Outcome measures
| Measure |
Pandemrix+Fluarix and Pandemrix+Placebo
n=83 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
Pandemrix+Placebo and Pandemrix+Fluarix
n=84 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
|---|---|---|
|
Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
A/Cal/09
|
82 subjects
|
84 subjects
|
|
Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
A/Bri/07
|
57 subjects
|
52 subjects
|
|
Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
A/Uru/07
|
65 subjects
|
54 subjects
|
|
Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
B/Bri/08
|
83 subjects
|
84 subjects
|
PRIMARY outcome
Timeframe: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)Population: The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.
The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Outcome measures
| Measure |
Pandemrix+Fluarix and Pandemrix+Placebo
n=83 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
Pandemrix+Placebo and Pandemrix+Fluarix
n=84 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix
A/Uru/07
|
4.2 ratio
Interval 3.3 to 5.4
|
3.0 ratio
Interval 2.4 to 3.9
|
|
Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix
A/Bri/07
|
3.5 ratio
Interval 2.9 to 4.3
|
2.7 ratio
Interval 2.2 to 3.3
|
|
Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix
A/Cal/09
|
33.1 ratio
Interval 26.0 to 42.1
|
32.2 ratio
Interval 25.6 to 40.4
|
|
Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix
B/Bri/08
|
4.7 ratio
Interval 3.6 to 6.1
|
2.1 ratio
Interval 1.8 to 2.5
|
SECONDARY outcome
Timeframe: Days 0, 21, 42, 182, 364Population: The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.
Titers are expressed as GMTs. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Outcome measures
| Measure |
Pandemrix+Fluarix and Pandemrix+Placebo
n=84 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
Pandemrix+Placebo and Pandemrix+Fluarix
n=84 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
|---|---|---|
|
Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
A/Cal/09 Day 0 (N=83;84)
|
7.4 titer
Interval 6.1 to 9.0
|
8.5 titer
Interval 7.1 to 10.2
|
|
Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
A/Cal/09 Day 21 (N=83;84)
|
138.8 titer
Interval 107.7 to 178.9
|
168.2 titer
Interval 137.5 to 205.7
|
|
Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
A/Cal/09 Day 42 (N=83;84)
|
246.1 titer
Interval 201.3 to 300.8
|
273.6 titer
Interval 231.4 to 323.4
|
|
Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
A/Cal/09 Day 182 (N=84;84)
|
71.2 titer
Interval 57.4 to 88.4
|
84.0 titer
Interval 69.8 to 101.2
|
|
Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
A/Cal/09 Day 364 (N=84;84)
|
29.1 titer
Interval 22.8 to 37.0
|
34.4 titer
Interval 28.0 to 42.4
|
|
Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
A/Bri/07 Day 0 (N=83;84)
|
15.2 titer
Interval 12.4 to 18.7
|
16.0 titer
Interval 13.3 to 19.2
|
|
Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
A/Bri/07 Day 21/Day 42 (N=83;84)
|
53.6 titer
Interval 43.1 to 66.5
|
42.5 titer
Interval 34.5 to 52.4
|
|
Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
A/Bri/07 Day 182 (N=84;84)
|
37.9 titer
Interval 31.6 to 45.4
|
36.8 titer
Interval 30.5 to 44.4
|
|
Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
A/Bri/07 Day 364 (N=84;84)
|
29.4 titer
Interval 24.9 to 34.7
|
28.8 titer
Interval 24.4 to 34.0
|
|
Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
A/Uru/07 Day 0 (N=83;84)
|
17.9 titer
Interval 14.0 to 22.8
|
19.7 titer
Interval 15.0 to 25.8
|
|
Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
A/Uru/07 Day 21/Day 42 (N=83;84)
|
74.8 titer
Interval 57.6 to 97.1
|
59.7 titer
Interval 44.5 to 80.0
|
|
Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
A/Uru/07 Day 182 (N=84;84)
|
35.9 titer
Interval 28.0 to 46.0
|
35.0 titer
Interval 26.2 to 46.9
|
|
Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
A/Uru/07 Day 364 (N=84;84)
|
28.7 titer
Interval 22.8 to 36.3
|
27.7 titer
Interval 20.6 to 37.2
|
|
Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
B/Bri/08 Day 0 (N=83;84)
|
49.9 titer
Interval 38.8 to 64.1
|
115.5 titer
Interval 96.3 to 138.5
|
|
Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
B/Bri/08 Day 21/Day 42 (N=83;84)
|
235.0 titer
Interval 199.5 to 276.8
|
246.7 titer
Interval 208.5 to 292.0
|
|
Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
B/Bri/08 Day 182 (N=84;84)
|
220.7 titer
Interval 187.9 to 259.3
|
222.5 titer
Interval 188.6 to 262.6
|
|
Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
B/Bri/08 Day 364 (N=84;84)
|
104.6 titer
Interval 88.5 to 123.7
|
112.7 titer
Interval 92.4 to 137.4
|
SECONDARY outcome
Timeframe: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364Population: The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.
A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer \< 10 and a postvaccination reciprocal titer \>= 40, or a pre-vaccination reciprocal HI titer \>= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Outcome measures
| Measure |
Pandemrix+Fluarix and Pandemrix+Placebo
n=84 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
Pandemrix+Placebo and Pandemrix+Fluarix
n=84 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
|---|---|---|
|
Number of Seroconverted Subjects
A/Cal/09 Day 21 (N=83;84)
|
73 subjects
|
78 subjects
|
|
Number of Seroconverted Subjects
A/Cal/09 Day 182 (N=84;84)
|
64 subjects
|
69 subjects
|
|
Number of Seroconverted Subjects
A/Cal/09 Day 364 (N=84;84)
|
25 subjects
|
30 subjects
|
|
Number of Seroconverted Subjects
A/Bri/07 Day 182 (N=84;84)
|
18 subjects
|
13 subjects
|
|
Number of Seroconverted Subjects
A/Bri/07 Day 364 (N=84;84)
|
5 subjects
|
8 subjects
|
|
Number of Seroconverted Subjects
A/Uru/07 Day 182 (N=84;84)
|
13 subjects
|
9 subjects
|
|
Number of Seroconverted Subjects
A/Uru/07 Day 364 (N=84;84)
|
7 subjects
|
6 subjects
|
|
Number of Seroconverted Subjects
B/Bri/08 Day 182 (N=84;84)
|
40 subjects
|
13 subjects
|
|
Number of Seroconverted Subjects
B/Bri/08 Day 364 (N=84;84)
|
19 subjects
|
3 subjects
|
SECONDARY outcome
Timeframe: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364Population: The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.
A seroprotected subject is a subject with reciprocal HI titers \>= 40 against the vaccine homologous virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Outcome measures
| Measure |
Pandemrix+Fluarix and Pandemrix+Placebo
n=84 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
Pandemrix+Placebo and Pandemrix+Fluarix
n=84 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
|---|---|---|
|
Number of Seroprotected Subjects
A/Cal/09 Day 0 (N=83;84)
|
6 subjects
|
7 subjects
|
|
Number of Seroprotected Subjects
A/Cal/09 Day 21 (N=83;84)
|
74 subjects
|
81 subjects
|
|
Number of Seroprotected Subjects
A/Cal/09 Day 182 (N=84;84)
|
67 subjects
|
75 subjects
|
|
Number of Seroprotected Subjects
A/Cal/09 Day 364 (N=84;84)
|
32 subjects
|
40 subjects
|
|
Number of Seroprotected Subjects
A/Bri/07 Day 0 (N=83;84)
|
22 subjects
|
17 subjects
|
|
Number of Seroprotected Subjects
A/Bri/07 Day 182 (N=84;84)
|
48 subjects
|
44 subjects
|
|
Number of Seroprotected Subjects
A/Bri/07 Day 364 (N=84;84)
|
36 subjects
|
34 subjects
|
|
Number of Seroprotected Subjects
A/Uru/07 Day 0 (N=83;84)
|
29 subjects
|
31 subjects
|
|
Number of Seroprotected Subjects
A/Uru/07 Day 182 (N=84;84)
|
44 subjects
|
43 subjects
|
|
Number of Seroprotected Subjects
A/Uru/07 Day 364 (N=84;84)
|
36 subjects
|
40 subjects
|
|
Number of Seroprotected Subjects
B/Bri/08 Day 182 (N=84;84)
|
84 subjects
|
84 subjects
|
|
Number of Seroprotected Subjects
B/Bri/08 Day 364 (N=84;84)
|
78 subjects
|
77 subjects
|
|
Number of Seroprotected Subjects
B/Bri/08 Day 0 (N=83;84)
|
56 subjects
|
78 subjects
|
SECONDARY outcome
Timeframe: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364Population: The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.
The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Outcome measures
| Measure |
Pandemrix+Fluarix and Pandemrix+Placebo
n=84 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
Pandemrix+Placebo and Pandemrix+Fluarix
n=84 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR)
A/Cal/09 Day 21 (N=83;84)
|
18.7 ratio
Interval 14.6 to 23.8
|
19.8 ratio
Interval 15.7 to 25.0
|
|
Geometric Mean Fold Rise (GMFR)
A/Cal/09 Day 182 (N=84;84)
|
9.6 ratio
Interval 7.8 to 11.9
|
9.9 ratio
Interval 8.1 to 12.0
|
|
Geometric Mean Fold Rise (GMFR)
A/Cal/09 Day 364 (N=84;84)
|
3.9 ratio
Interval 3.2 to 4.8
|
4.0 ratio
Interval 3.3 to 4.9
|
|
Geometric Mean Fold Rise (GMFR)
A/Bri/07 Day 182 (N=84;84)
|
2.5 ratio
Interval 2.1 to 2.9
|
2.3 ratio
Interval 2.0 to 2.7
|
|
Geometric Mean Fold Rise (GMFR)
A/Bri/07 Day 364 (N=84;84)
|
1.9 ratio
Interval 1.7 to 2.2
|
1.8 ratio
Interval 1.6 to 2.1
|
|
Geometric Mean Fold Rise (GMFR)
A/Uru/07 Day 182 (N=84;84)
|
2.0 ratio
Interval 1.6 to 2.4
|
1.8 ratio
Interval 1.5 to 2.1
|
|
Geometric Mean Fold Rise (GMFR)
A/Uru/07 Day 364 (N=84;84)
|
1.6 ratio
Interval 1.4 to 1.9
|
1.4 ratio
Interval 1.2 to 1.7
|
|
Geometric Mean Fold Rise (GMFR)
B/Bri/08 Day 182 (N=84;84)
|
4.4 ratio
Interval 3.6 to 5.5
|
1.9 ratio
Interval 1.7 to 2.2
|
|
Geometric Mean Fold Rise (GMFR)
B/Bri/08 Day 364 (N=84;84)
|
2.1 ratio
Interval 1.7 to 2.6
|
1.0 ratio
Interval 0.9 to 1.0
|
SECONDARY outcome
Timeframe: Days 0, 21, 42, 182, 364Population: The analysis was performed on the according-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom blood samples were taken and immunogenicity data were available.
The cut-off 1:10 was considered as seropositivity. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
Outcome measures
| Measure |
Pandemrix+Fluarix and Pandemrix+Placebo
n=84 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
Pandemrix+Placebo and Pandemrix+Fluarix
n=84 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
|---|---|---|
|
Number of Subjects With Titers Equal to or Above Titer 1:10
A/Cal/09 Day 0 (N=83;84)
|
20 subjects
|
32 subjects
|
|
Number of Subjects With Titers Equal to or Above Titer 1:10
A/Cal/09 Day 21 (N=83;84)
|
82 subjects
|
84 subjects
|
|
Number of Subjects With Titers Equal to or Above Titer 1:10
A/Cal/09 Day 42 (N=83;84)
|
83 subjects
|
84 subjects
|
|
Number of Subjects With Titers Equal to or Above Titer 1:10
A/Cal/09 Day 182 (N=84;84)
|
84 subjects
|
84 subjects
|
|
Number of Subjects With Titers Equal to or Above Titer 1:10
A/Cal/09 Day 364 (N=84;84)
|
78 subjects
|
81 subjects
|
|
Number of Subjects With Titers Equal to or Above Titer 1:10
A/Bri/07 Day 0 (N=83;84)
|
59 subjects
|
68 subjects
|
|
Number of Subjects With Titers Equal to or Above Titer 1:10
A/Bri/07 Day 21/Day 42 (N=83;84)
|
82 subjects
|
82 subjects
|
|
Number of Subjects With Titers Equal to or Above Titer 1:10
A/Bri/07 Day 182 (N=84;84)
|
83 subjects
|
83 subjects
|
|
Number of Subjects With Titers Equal to or Above Titer 1:10
A/Bri/07 Day 364 (N=84;84)
|
82 subjects
|
83 subjects
|
|
Number of Subjects With Titers Equal to or Above Titer 1:10
A/Uru/07 Day 0 (N=83;84)
|
58 subjects
|
57 subjects
|
|
Number of Subjects With Titers Equal to or Above Titer 1:10
A/Uru/07 Day 21/Day 42 (N=83;84)
|
79 subjects
|
80 subjects
|
|
Number of Subjects With Titers Equal to or Above Titer 1:10
A/Uru/07 Day 182 (N=84;84)
|
77 subjects
|
73 subjects
|
|
Number of Subjects With Titers Equal to or Above Titer 1:10
A/Uru/07 Day 364 (N=84;84)
|
76 subjects
|
65 subjects
|
|
Number of Subjects With Titers Equal to or Above Titer 1:10
B/Bri/08 Day 0 (N=83;84)
|
76 subjects
|
84 subjects
|
|
Number of Subjects With Titers Equal to or Above Titer 1:10
B/Bri/08 Day 21/Day 42 (N=83;84)
|
83 subjects
|
84 subjects
|
|
Number of Subjects With Titers Equal to or Above Titer 1:10
B/Bri/08 Day 182 (N=84;84)
|
84 subjects
|
84 subjects
|
|
Number of Subjects With Titers Equal to or Above Titer 1:10
B/Bri/08 Day 364 (N=84;84)
|
84 subjects
|
84 subjects
|
SECONDARY outcome
Timeframe: Within 7 days (Day 0-Day 6) after each vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort.
Solicited local symptoms are pain, redness and swelling at the injection site. They are divided between solicited local symptoms occurring after administration of Pandemrix, Fluarix or Placebo. Solicited general symptoms are fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (defined as axillary temperature \>= 38.0 degrees Celsius).
Outcome measures
| Measure |
Pandemrix+Fluarix and Pandemrix+Placebo
n=84 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
Pandemrix+Placebo and Pandemrix+Fluarix
n=84 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
|---|---|---|
|
Number of Subjects With Solicited Local and General Symptoms
Pain after Pandemrix
|
64 subjects
|
74 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms
Pain after Fluarix
|
18 subjects
|
26 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms
Pain after Placebo
|
0 subjects
|
8 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms
Redness after Pandemrix
|
15 subjects
|
19 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms
Redness after Fluarix
|
0 subjects
|
1 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms
Redness after Placebo
|
0 subjects
|
0 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms
Swelling after Pandemrix
|
22 subjects
|
27 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms
Swelling after Fluarix
|
3 subjects
|
4 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms
Swelling after Placebo
|
0 subjects
|
2 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms
Fatigue
|
25 subjects
|
27 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms
Headache
|
23 subjects
|
23 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms
Joint pain at other location
|
13 subjects
|
17 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms
Muscle aches
|
18 subjects
|
26 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms
Shivering
|
12 subjects
|
16 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms
Sweating
|
2 subjects
|
8 subjects
|
|
Number of Subjects With Solicited Local and General Symptoms
Temperature
|
3 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: From Day 0 to Day 83Population: The analysis was performed on the Total Vaccinated cohort.
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms
Outcome measures
| Measure |
Pandemrix+Fluarix and Pandemrix+Placebo
n=84 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
Pandemrix+Placebo and Pandemrix+Fluarix
n=84 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
|
41 subjects
|
41 subjects
|
SECONDARY outcome
Timeframe: From Day 0 to Day 364Population: The analysis was performed on the Total Vaccinated cohort.
Adverse events of specific interest include autoimmune diseases and other immune mediated inflammatory disorders.
Outcome measures
| Measure |
Pandemrix+Fluarix and Pandemrix+Placebo
n=84 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
Pandemrix+Placebo and Pandemrix+Fluarix
n=84 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
|---|---|---|
|
Number of Subjects With Adverse Events of Specific Interest
|
0 subjects
|
0 subjects
|
SECONDARY outcome
Timeframe: From Day 0 to Day 364Population: The analysis was performed on the Total Vaccinated cohort.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Pandemrix+Fluarix and Pandemrix+Placebo
n=84 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
Pandemrix+Placebo and Pandemrix+Fluarix
n=84 Participants
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
2 subjects
|
3 subjects
|
Adverse Events
Pandemrix+Fluarix and Pandemrix+Placebo
Serious events: 2 serious events
Other events: 71 other events
Deaths: 0 deaths
Pandemrix+Placebo and Pandemrix+Fluarix
Serious events: 3 serious events
Other events: 78 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pandemrix+Fluarix and Pandemrix+Placebo
n=84 participants at risk
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
Pandemrix+Placebo and Pandemrix+Fluarix
n=84 participants at risk
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
|---|---|---|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/84
|
1.2%
1/84
|
|
Vascular disorders
Hypertension
|
1.2%
1/84
|
0.00%
0/84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
1.2%
1/84
|
0.00%
0/84
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/84
|
1.2%
1/84
|
|
Eye disorders
Retinal detachment
|
0.00%
0/84
|
1.2%
1/84
|
Other adverse events
| Measure |
Pandemrix+Fluarix and Pandemrix+Placebo
n=84 participants at risk
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
Pandemrix+Placebo and Pandemrix+Fluarix
n=84 participants at risk
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
|
|---|---|---|
|
General disorders
Pain after Pandemrix
|
76.2%
64/84
|
88.1%
74/84
|
|
General disorders
Pain after Fluarix
|
21.4%
18/84
|
31.0%
26/84
|
|
General disorders
Pain after Placebo
|
0.00%
0/84
|
9.5%
8/84
|
|
General disorders
Redness after Pandemrix
|
17.9%
15/84
|
22.6%
19/84
|
|
General disorders
Swelling after Pandemrix
|
26.2%
22/84
|
32.1%
27/84
|
|
General disorders
Fatigue
|
29.8%
25/84
|
32.1%
27/84
|
|
General disorders
Headache
|
27.4%
23/84
|
27.4%
23/84
|
|
General disorders
Joint pain at other location
|
15.5%
13/84
|
20.2%
17/84
|
|
General disorders
Muscle aches
|
21.4%
18/84
|
31.0%
26/84
|
|
General disorders
Shivering
|
14.3%
12/84
|
19.0%
16/84
|
|
General disorders
Sweating
|
2.4%
2/84
|
9.5%
8/84
|
|
Infections and infestations
Nasopharyngitis
|
17.9%
15/84
|
16.7%
14/84
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.4%
2/84
|
7.1%
6/84
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.0%
5/84
|
2.4%
2/84
|
|
Gastrointestinal disorders
Nausea
|
2.4%
2/84
|
6.0%
5/84
|
|
Nervous system disorders
Dizziness
|
6.0%
5/84
|
0.00%
0/84
|
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