Trial Outcomes & Findings for Immunogenicity and Safety Study of a GlaxoSmithKline Biologicals' Candidate Influenza Vaccine in Healthy Children (NCT NCT00985790)
NCT ID: NCT00985790
Last Updated: 2018-09-21
Results Overview
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 3 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2) and Flu B/Brisbane/60/08 Victoria (VICT).The POST results were the primary outcome variables.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
599 participants
Primary outcome timeframe
At Day 0 [PRE] and at 28 days post last vaccination (Day 28 or Day 56) [POST]
Results posted on
2018-09-21
Participant Flow
A total of 599 subjects were enrolled in the study, and assigned to either the GSK2321138A Group (298 subjects) or the Fluarix Group (301 subjects). Duration of study was of approximately 6 months for each subject.
For demography and safety, results are presented as per the main study groups. For some outcome measures and where relevant, subjects as in these 2 main groups are split according to their priming status at study entry.
Participant milestones
| Measure |
GSK2321138A Group
Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
|
Fluarix Group
Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
|
|---|---|---|
|
Overall Study
STARTED
|
298
|
301
|
|
Overall Study
COMPLETED
|
291
|
293
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
| Measure |
GSK2321138A Group
Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
|
Fluarix Group
Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
7
|
Baseline Characteristics
Immunogenicity and Safety Study of a GlaxoSmithKline Biologicals' Candidate Influenza Vaccine in Healthy Children
Baseline characteristics by cohort
| Measure |
GSK2321138A Group
n=298 Participants
Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
|
Fluarix Group
n=301 Participants
Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
|
Total
n=599 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.4 months
STANDARD_DEVIATION 8.46 • n=5 Participants
|
31.6 months
STANDARD_DEVIATION 8.29 • n=7 Participants
|
31.5 months
STANDARD_DEVIATION 8.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
285 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
160 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
314 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Day 0 [PRE] and at 28 days post last vaccination (Day 28 or Day 56) [POST]Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 3 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2) and Flu B/Brisbane/60/08 Victoria (VICT).The POST results were the primary outcome variables.
Outcome measures
| Measure |
GSK2321138A Group
n=193 Participants
Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
|
Fluarix Group
n=193 Participants
Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
|
|---|---|---|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains.
H1N1, PRE
|
22.2 titers
Interval 17.2 to 28.7
|
21.6 titers
Interval 16.7 to 28.0
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains.
H1N1, POST
|
173.8 titers
Interval 141.4 to 213.5
|
176.9 titers
Interval 143.3 to 218.5
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains.
H3N2, PRE
|
18.6 titers
Interval 14.9 to 23.2
|
20.8 titers
Interval 16.5 to 26.2
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains.
H3N2, POST
|
120.7 titers
Interval 101.2 to 143.9
|
130.4 titers
Interval 108.0 to 157.5
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains.
VICT, PRE
|
8.7 titers
Interval 7.3 to 10.2
|
9.0 titers
Interval 7.7 to 10.6
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains.
VICT, POST
|
61.9 titers
Interval 48.7 to 78.6
|
66.6 titers
Interval 52.4 to 84.7
|
SECONDARY outcome
Timeframe: At Days 0 and 28.Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.
Outcome measures
| Measure |
GSK2321138A Group
n=94 Participants
Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
|
Fluarix Group
n=95 Participants
Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
|
|---|---|---|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
H1N1. Day 0
|
40.3 titers
Interval 27.0 to 60.2
|
36.5 titers
Interval 24.3 to 54.9
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
H1N1. Day 28
|
117.0 titers
Interval 83.2 to 164.5
|
124.4 titers
Interval 89.8 to 172.4
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
H3N2, Day 0
|
22.8 titers
Interval 16.7 to 31.2
|
21.7 titers
Interval 16.0 to 29.5
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
H3N2, Day 28
|
85.2 titers
Interval 64.8 to 112.0
|
83.0 titers
Interval 63.6 to 108.2
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
VICT, Day 0
|
8.9 titers
Interval 7.2 to 11.0
|
9.7 titers
Interval 7.7 to 12.4
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
VICT, Day 28
|
38.7 titers
Interval 26.2 to 57.1
|
44.0 titers
Interval 29.6 to 65.2
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
YAMA, Day 0
|
29.3 titers
Interval 23.0 to 37.4
|
37.7 titers
Interval 29.8 to 47.8
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
YAMA, Day 28
|
243.6 titers
Interval 198.1 to 299.6
|
127.2 titers
Interval 106.1 to 152.3
|
SECONDARY outcome
Timeframe: At Days 0, 28 and Day 56Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.
Outcome measures
| Measure |
GSK2321138A Group
n=192 Participants
Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
|
Fluarix Group
n=198 Participants
Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
|
|---|---|---|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
H1N1, Day 0
|
14.7 titers
Interval 11.8 to 18.4
|
12.8 titers
Interval 10.5 to 15.7
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
H1N1, Day 28
|
173.1 titers
Interval 113.1 to 264.8
|
161.6 titers
Interval 103.9 to 251.4
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
H1N1, Day 56
|
253.1 titers
Interval 203.4 to 314.8
|
249.0 titers
Interval 192.5 to 321.9
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
H3N2, Day 0
|
17.7 titers
Interval 14.1 to 22.1
|
17.9 titers
Interval 14.1 to 22.6
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
H3N2, Day 28
|
99.3 titers
Interval 64.8 to 152.2
|
84.2 titers
Interval 54.1 to 131.2
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
H3N2, Day 56
|
168.1 titers
Interval 136.6 to 206.7
|
202.1 titers
Interval 158.6 to 257.5
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
VICT, Day 0
|
7.8 titers
Interval 6.7 to 9.2
|
8.7 titers
Interval 7.5 to 10.3
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
VICT, Day 28
|
26.5 titers
Interval 17.7 to 39.7
|
34.6 titers
Interval 22.4 to 53.6
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
VICT, Day 56
|
97.2 titers
Interval 74.9 to 126.1
|
99.6 titers
Interval 76.7 to 129.4
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
YAMA, Day 0
|
9.1 titers
Interval 7.7 to 10.7
|
9.9 titers
Interval 8.4 to 11.8
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
YAMA, Day 28
|
97.0 titers
Interval 64.7 to 145.4
|
30.0 titers
Interval 21.3 to 42.1
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
YAMA, Day 56
|
311.1 titers
Interval 255.4 to 379.1
|
42.2 titers
Interval 30.6 to 58.1
|
SECONDARY outcome
Timeframe: At Days 0 and 28Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.
Outcome measures
| Measure |
GSK2321138A Group
n=94 Participants
Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
|
Fluarix Group
n=95 Participants
Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
|
|---|---|---|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
H1N1, Day 0
|
58 Participants
|
54 Participants
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
H1N1, Day 28
|
83 Participants
|
87 Participants
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
H3N2, Day 0
|
60 Participants
|
59 Participants
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
H3N2, Day 28
|
88 Participants
|
87 Participants
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
VICT, Day 0
|
26 Participants
|
28 Participants
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
VICT, Day 28
|
62 Participants
|
66 Participants
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
YAMA, Day 0
|
73 Participants
|
80 Participants
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
YAMA, Day 28
|
93 Participants
|
94 Participants
|
SECONDARY outcome
Timeframe: At Days 0, 28 and 56Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.
Outcome measures
| Measure |
GSK2321138A Group
n=192 Participants
Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
|
Fluarix Group
n=198 Participants
Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
|
|---|---|---|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
H1N1, Day 0
|
75 Participants
|
71 Participants
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
H1N1, Day 28
|
83 Participants
|
84 Participants
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
H1N1, Day 56
|
99 Participants
|
96 Participants
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
H3N2, Day 0
|
85 Participants
|
82 Participants
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
H3N2, Day 28
|
74 Participants
|
78 Participants
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
H3N2, Day 56
|
99 Participants
|
98 Participants
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
VICT, Day 0
|
30 Participants
|
42 Participants
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
VICT, Day 28
|
51 Participants
|
61 Participants
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
VICT, Day 56
|
96 Participants
|
94 Participants
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
YAMA, Day 0
|
45 Participants
|
57 Participants
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
YAMA, Day 28
|
75 Participants
|
57 Participants
|
|
Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
YAMA, Day 56
|
98 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: At Day 28Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.
Outcome measures
| Measure |
GSK2321138A Group
n=94 Participants
Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
|
Fluarix Group
n=95 Participants
Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
|
|---|---|---|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
H1N1, Day 28
|
30 Participants
|
39 Participants
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
H3N2, Day 28
|
48 Participants
|
46 Participants
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
VICT, Day 28
|
46 Participants
|
42 Participants
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
YAMA, Day 28
|
82 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: At Days 28 and 56Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.
Outcome measures
| Measure |
GSK2321138A Group
n=96 Participants
Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
|
Fluarix Group
n=101 Participants
Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
|
|---|---|---|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
H1N1, Day 28
|
63 Participants
|
74 Participants
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
H1N1, Day 56
|
81 Participants
|
89 Participants
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
H3N2, Day 28
|
55 Participants
|
54 Participants
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
H3N2, Day 56
|
79 Participants
|
75 Participants
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
VICT, Day 28
|
34 Participants
|
40 Participants
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
VICT, Day 56
|
77 Participants
|
85 Participants
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
YAMA, Day 28
|
59 Participants
|
40 Participants
|
|
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
YAMA, Day 56
|
90 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: At Day 28Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.
Outcome measures
| Measure |
GSK2321138A Group
n=94 Participants
Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
|
Fluarix Group
n=95 Participants
Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
|
|---|---|---|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
H1N1, Day 28
|
2.9 fold change
Interval 2.3 to 3.6
|
3.4 fold change
Interval 2.7 to 4.2
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
H3N2, Day 28
|
3.7 fold change
Interval 3.1 to 4.5
|
3.8 fold change
Interval 3.1 to 4.7
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
VICT, Day 28
|
4.4 fold change
Interval 3.3 to 5.8
|
4.5 fold change
Interval 3.4 to 6.0
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
YAMA, Day 28
|
8.3 fold change
Interval 6.8 to 10.1
|
3.4 fold change
Interval 2.8 to 4.0
|
SECONDARY outcome
Timeframe: At Days 28 and 56Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.
Outcome measures
| Measure |
GSK2321138A Group
n=96 Participants
Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
|
Fluarix Group
n=101 Participants
Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
|
|---|---|---|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
H1N1, Day 28
|
9.9 fold change
Interval 7.0 to 14.1
|
12.7 fold change
Interval 9.1 to 17.7
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
H1N1, Day 56
|
19.8 fold change
Interval 15.4 to 25.6
|
19.2 fold change
Interval 15.2 to 24.2
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
H3N2, Day 28
|
4.9 fold change
Interval 3.7 to 6.3
|
5.1 fold change
Interval 3.9 to 6.7
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
H3N2, Day 56
|
11.1 fold change
Interval 9.0 to 13.7
|
10.3 fold change
Interval 8.3 to 12.9
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
VICT, Day 28
|
3.6 fold change
Interval 2.7 to 5.0
|
3.8 fold change
Interval 2.9 to 5.0
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
VICT, Day 56
|
11.3 fold change
Interval 9.4 to 13.6
|
12.1 fold change
Interval 9.8 to 14.8
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
YAMA, Day 28
|
9.9 fold change
Interval 6.9 to 14.0
|
3.4 fold change
Interval 2.5 to 4.5
|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
YAMA, Day 56
|
35.1 fold change
Interval 27.6 to 44.6
|
3.7 fold change
Interval 2.9 to 4.8
|
SECONDARY outcome
Timeframe: At Days 0 and 28Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the primed groups.
Outcome measures
| Measure |
GSK2321138A Group
n=94 Participants
Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
|
Fluarix Group
n=95 Participants
Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
|
|---|---|---|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
H1N1, Day 0
|
48 Participants
|
45 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
H1N1, Day 28
|
73 Participants
|
78 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
H3N2, Day 0
|
39 Participants
|
36 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
H3N2, Day 28
|
75 Participants
|
80 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
VICT, Day 0
|
16 Participants
|
20 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
VICT, Day 28
|
50 Participants
|
52 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
YAMA, Day 0
|
56 Participants
|
62 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
YAMA, Day 28
|
91 Participants
|
90 Participants
|
SECONDARY outcome
Timeframe: At Days 0, 28 and 56Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning Immunogenicity outcomes variables were available and for whom assay results were available for antibodies against at least one study vaccine component after vaccination.
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA). This outcome only covers the results for the unprimed groups.
Outcome measures
| Measure |
GSK2321138A Group
n=192 Participants
Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
|
Fluarix Group
n=198 Participants
Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
|
|---|---|---|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
YAMA, Day 28
|
67 Participants
|
53 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
YAMA, Day 56
|
98 Participants
|
59 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
H1N1, Day 0
|
58 Participants
|
54 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
H1N1, Day 28
|
76 Participants
|
78 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
H1N1, Day 56
|
95 Participants
|
94 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
H3N2, Day 0
|
74 Participants
|
70 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
H3N2, Day 28
|
64 Participants
|
61 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
H3N2, Day 56
|
96 Participants
|
94 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
VICT, Day 0
|
25 Participants
|
35 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
VICT, Day 28
|
36 Participants
|
41 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
VICT, Day 56
|
84 Participants
|
88 Participants
|
|
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
YAMA, Day 0
|
37 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: During the 7-day follow-up period (Days 0 to 6) after any vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet completed.
Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Outcome measures
| Measure |
GSK2321138A Group
n=293 Participants
Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
|
Fluarix Group
n=298 Participants
Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
|
|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Pain
|
125 Participants
|
116 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Grade 3 Pain
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Redness
|
31 Participants
|
34 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Redness >50 mm
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Any Swelling
|
27 Participants
|
24 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Swelling >50 mm
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 7-day follow-up period (Days 0 to 6) after any vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet completed.
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms assessed by the investigator as related to vaccination. Grade 3 drowsiness = prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 irritability= crying that could not be comforted/prevented normal activity. Grade 3 temperature: ≥ 39.0°C.
Outcome measures
| Measure |
GSK2321138A Group
n=293 Participants
Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
|
Fluarix Group
n=298 Participants
Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Drowsiness
|
70 Participants
|
62 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Drowsiness
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Drowsiness
|
64 Participants
|
57 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Irritability
|
90 Participants
|
87 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Irritability
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Irritability
|
83 Participants
|
78 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Loss of appetite
|
89 Participants
|
86 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Loss of appetite
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Loss of appetite
|
79 Participants
|
68 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Temperature ≥ 37.5°C
|
74 Participants
|
79 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Temperature > 39.0°C
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Temperature
|
63 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: During the 28-day follow-up period (Days 0 to 27) after vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
An unsolicited AE covers any untoward medical occurrence in a subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Any = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to vaccination.
Outcome measures
| Measure |
GSK2321138A Group
n=298 Participants
Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
|
Fluarix Group
n=301 Participants
Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Subjects with any AE(s)
|
116 Participants
|
118 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Subjects with Grade 3 AE(s)
|
10 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Subjects with related AE(s)
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Day 180 (study conclusion)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
GSK2321138A Group
n=298 Participants
Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
|
Fluarix Group
n=301 Participants
Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
|
|---|---|---|
|
Number of Subjects With Any and Related Serious Adverse Events (SAEs).
Subjects with any SAE(s)
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any and Related Serious Adverse Events (SAEs).
Subjects with related SAE(s)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 0 to Day 180 (study conclusion)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
Outcome measures
| Measure |
GSK2321138A Group
n=298 Participants
Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
|
Fluarix Group
n=301 Participants
Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
|
|---|---|---|
|
Number of Subjects With Any Adverse Events of Specific Interest (AESIs).
|
0 Participants
|
0 Participants
|
Adverse Events
GSK2321138A Group
Serious events: 0 serious events
Other events: 230 other events
Deaths: 0 deaths
Fluarix Group
Serious events: 2 serious events
Other events: 221 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK2321138A Group
n=298 participants at risk
Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
|
Fluarix Group
n=301 participants at risk
Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
|
|---|---|---|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/298 • SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
|
0.33%
1/301 • SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/298 • SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
|
0.33%
1/301 • SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
|
Other adverse events
| Measure |
GSK2321138A Group
n=298 participants at risk
Subjects aged between 18 and 47 months received the GSK2321138A. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
|
Fluarix Group
n=301 participants at risk
Subjects aged between 18 and 47 months received the Fluarix™ vaccine. "Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
24.2%
72/298 • SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
|
22.9%
69/301 • SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
|
|
Infections and infestations
Pharyngitis
|
6.7%
20/298 • SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
|
7.0%
21/301 • SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
|
|
General disorders
Drowsiness
|
23.9%
70/293 • SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
|
20.8%
62/298 • SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
|
|
General disorders
Irritability
|
30.7%
90/293 • SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
|
29.2%
87/298 • SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
|
|
General disorders
Loss of appetite
|
30.4%
89/293 • SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
|
28.9%
86/298 • SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
|
|
General disorders
Temperature
|
25.3%
74/293 • SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
|
26.5%
79/298 • SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
|
|
General disorders
Pain
|
42.7%
125/293 • SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
|
38.9%
116/298 • SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
|
|
General disorders
Redness
|
10.6%
31/293 • SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
|
11.4%
34/298 • SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
|
|
General disorders
Swelling
|
9.2%
27/293 • SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
|
8.1%
24/298 • SAE(s): during the entire study period (Day 0 - Day 180); Unsolicited AE(s): during the 28-day follow-up period (Days 0 to 27) after any vaccination; Solicited local and general symptoms: during the 7-day (Days 0-6) follow-up period after any vaccination.
For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed. No related SAEs were reported.
|
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