Trial Outcomes & Findings for Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine When Administered in Children Who Previously Participated in Study 115345 (NCT NCT01702454)
NCT ID: NCT01702454
Last Updated: 2018-09-07
Results Overview
Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
470 participants
Primary outcome timeframe
At Day 0 and Day 7
Results posted on
2018-09-07
Participant Flow
Participant milestones
| Measure |
Fluarix Quadrivalent Primed Group
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Overall Study
STARTED
|
241
|
229
|
|
Overall Study
COMPLETED
|
238
|
221
|
|
Overall Study
NOT COMPLETED
|
3
|
8
|
Reasons for withdrawal
| Measure |
Fluarix Quadrivalent Primed Group
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Overall Study
Consent withdrawal
|
0
|
1
|
|
Overall Study
Migrated/moved from study area
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
Baseline Characteristics
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine When Administered in Children Who Previously Participated in Study 115345
Baseline characteristics by cohort
| Measure |
Fluarix Quadrivalent Primed Group
n=241 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=229 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Total
n=470 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.2 Years
STANDARD_DEVIATION 7.54 • n=5 Participants
|
32.5 Years
STANDARD_DEVIATION 7.39 • n=7 Participants
|
32.8 Years
STANDARD_DEVIATION 7.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
210 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
127 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
260 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Day 0 and Day 7Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.
Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=224 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=209 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
H1N1, Day 0 [N=221,202]
|
43.1 Titer
Interval 33.8 to 54.9
|
14.5 Titer
Interval 11.5 to 18.2
|
|
Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
H1N1, Day 7 [N=224,209]
|
445.6 Titer
Interval 376.9 to 526.7
|
45.8 Titer
Interval 32.0 to 65.5
|
|
Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
H3N2, Day 0 [N=221,202]
|
12.3 Titer
Interval 10.7 to 14.1
|
16.4 Titer
Interval 13.2 to 20.4
|
|
Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
H3N2, Day 7 [N=224,209]
|
135.3 Titer
Interval 113.6 to 161.2
|
47.5 Titer
Interval 32.6 to 69.3
|
|
Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Victoria, Day 0 [N=221,202]
|
28.5 Titer
Interval 23.8 to 34.1
|
10.0 Titer
Interval 8.4 to 11.9
|
|
Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Victoria, Day 7 [N=224,209]
|
193.9 Titer
Interval 168.7 to 222.8
|
47.1 Titer
Interval 35.2 to 63.0
|
|
Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Yamagata, Day 0 [N=221,202]
|
11.9 Titer
Interval 10.6 to 13.3
|
6.5 Titer
Interval 5.9 to 7.2
|
|
Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Yamagata, Day 7 [N=224,209]
|
182.6 Titer
Interval 159.0 to 209.6
|
26.1 Titer
Interval 20.9 to 32.7
|
PRIMARY outcome
Timeframe: At Day 0 and Day 7Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.
Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=224 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=209 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
H1N1, Day 0 [N=221,202]
|
189 Subjects
|
64 Subjects
|
|
Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
H1N1, Day 7 [N=224,209]
|
220 Subjects
|
137 Subjects
|
|
Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
H3N2, Day 0 [N=221,202]
|
131 Subjects
|
79 Subjects
|
|
Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
H3N2, Day 7 [N=224,209]
|
218 Subjects
|
99 Subjects
|
|
Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Victoria, Day 0 [N=221,202]
|
187 Subjects
|
58 Subjects
|
|
Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Victoria, Day 7 [N=224,209]
|
224 Subjects
|
174 Subjects
|
|
Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Yamagata, Day 0 [N=221,202]
|
134 Subjects
|
36 Subjects
|
|
Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Yamagata, Day 7 [N=224,209]
|
222 Subjects
|
144 Subjects
|
PRIMARY outcome
Timeframe: At Day 7 post dose 1Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=221 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=202 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1
|
170 Subjects
|
65 Subjects
|
|
Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2
|
180 Subjects
|
73 Subjects
|
|
Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria
|
169 Subjects
|
78 Subjects
|
|
Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata
|
208 Subjects
|
77 Subjects
|
PRIMARY outcome
Timeframe: At Day 7 post dose 1Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.
MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=221 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=202 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1
|
10.3 Fold increase
Interval 8.5 to 12.4
|
3.2 Fold increase
Interval 2.6 to 3.9
|
|
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2
|
10.9 Fold increase
Interval 9.4 to 12.6
|
2.9 Fold increase
Interval 2.4 to 3.6
|
|
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria
|
6.7 Fold increase
Interval 5.9 to 7.6
|
4.6 Fold increase
Interval 3.8 to 5.5
|
|
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata
|
15.2 Fold increase
Interval 13.3 to 17.3
|
4.0 Fold increase
Interval 3.3 to 4.9
|
PRIMARY outcome
Timeframe: At Day 0 and Day 7Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.
Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer ≥ 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=224 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=209 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1, Day 0 [N=221,202]
|
89 Subjects
|
61 Subjects
|
|
Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1, Day 7 [N=224,209]
|
217 Subjects
|
72 Subjects
|
|
Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2, Day 0 [N=221,202]
|
37 Subjects
|
74 Subjects
|
|
Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2, Day 7 [N=224,209]
|
193 Subjects
|
81 Subjects
|
|
Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria, Day 0 [N=221,202]
|
72 Subjects
|
39 Subjects
|
|
Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria, Day 7 [N=224,209]
|
217 Subjects
|
84 Subjects
|
|
Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata, Day 0 [N=221,202]
|
27 Subjects
|
12 Subjects
|
|
Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata, Day 7 [N=224,209]
|
216 Subjects
|
83 Subjects
|
PRIMARY outcome
Timeframe: At Day 0 and Day 7Population: Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.
Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=213 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=179 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata, Day 7 [N=213,179]
|
184.1 Titers
Interval 159.8 to 212.1
|
25.2 Titers
Interval 19.8 to 32.0
|
|
Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1, Day 0 [N=210,173]
|
44.0 Titers
Interval 34.2 to 56.7
|
14.3 Titers
Interval 11.2 to 18.3
|
|
Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1, Day 7 [N=213,179]
|
442.3 Titers
Interval 372.0 to 525.9
|
42.7 Titers
Interval 29.0 to 63.0
|
|
Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2, Day 0 [N=210,173]
|
11.0 Titers
Interval 9.8 to 12.5
|
11.9 Titers
Interval 9.6 to 14.7
|
|
Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2, Day 7 [N=213,179]
|
125.9 Titers
Interval 105.4 to 150.4
|
28.7 Titers
Interval 19.7 to 41.9
|
|
Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria, Day 0 [N=210,173]
|
27.8 Titers
Interval 23.2 to 33.2
|
10.3 Titers
Interval 8.5 to 12.5
|
|
Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria, Day 7 [N=213,179]
|
193.3 Titers
Interval 167.6 to 222.8
|
46.1 Titers
Interval 33.5 to 63.4
|
|
Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata, Day 0 [N=210,173]
|
11.9 Titers
Interval 10.6 to 13.4
|
6.5 Titers
Interval 5.8 to 7.2
|
PRIMARY outcome
Timeframe: At Day 0 and Day 7Population: Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.
Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=213 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=179 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine
H1N1, Day 0 [N=210,173]
|
178 Subjects
|
54 Subjects
|
|
Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine
H1N1, Day 7 [N=213,179]
|
209 Subjects
|
113 Subjects
|
|
Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine
H3N2, Day 0 [N=210,173]
|
120 Subjects
|
52 Subjects
|
|
Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine
H3N2, Day 7 [N=213,179]
|
207 Subjects
|
72 Subjects
|
|
Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine
Victoria, Day 0[ N=210,173]
|
177 Subjects
|
50 Subjects
|
|
Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine
Victoria, Day 7[ N=213,179]
|
213 Subjects
|
145 Subjects
|
|
Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine
Yamagata, Day 0[ N=210,173]
|
127 Subjects
|
31 Subjects
|
|
Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine
Yamagata, Day 7 [N=213,179]
|
211 Subjects
|
120 Subjects
|
PRIMARY outcome
Timeframe: At Day 7 post dose 1Population: Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.
A seroconverted subject was defined as a subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata )antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=210 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=173 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1, Day 7 [N=210,173]
|
160 Subjects
|
54 Subjects
|
|
Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2, Day 7 [N=210,173]
|
173 Subjects
|
49 Subjects
|
|
Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria, Day 7 [N=210,173]
|
162 Subjects
|
66 Subjects
|
|
Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata, Day 7 [N=210,173]
|
197 Subjects
|
65 Subjects
|
PRIMARY outcome
Timeframe: At Day 7 post dose 1Population: Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.
Mean geometric increase was defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=210 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=173 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1, Day 7 [N=210,173]
|
10.0 Fold Increase
Interval 8.1 to 12.2
|
3.1 Fold Increase
Interval 2.5 to 3.9
|
|
Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2, Day 7 [N=210,173]
|
11.2 Fold Increase
Interval 9.7 to 13.1
|
2.4 Fold Increase
Interval 2.0 to 3.0
|
|
Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria, Day 7 [N=210,173]
|
6.9 Fold Increase
Interval 6.0 to 7.8
|
4.5 Fold Increase
Interval 3.7 to 5.4
|
|
Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata, Day 7 [N=210,173]
|
15.2 Fold Increase
Interval 13.3 to 17.4
|
4.0 Fold Increase
Interval 3.2 to 4.9
|
PRIMARY outcome
Timeframe: At Day 0 and Day 7Population: Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.
Seroprotection rate was defined as the number of vaccinees with a serum HI titer greater than or equal to(≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=213 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=179 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1,Day 0 [N=210,173]
|
87 Subjects
|
51 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1, Day 7 [N=213,179]
|
206 Subjects
|
59 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2, Day 0 [N=210,173]
|
29 Subjects
|
48 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2, Day 7 [N=213,179]
|
182 Subjects
|
54 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria, Day 0 [N=210,173]
|
68 Subjects
|
35 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria, Day 7 [N=213,179]
|
206 Subjects
|
70 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata, Day 0 [N=210,173]
|
27 Subjects
|
10 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata, Day 7 [N=213,179]
|
205 Subjects
|
70 Subjects
|
SECONDARY outcome
Timeframe: At Day 0 and Day 7Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.
The cut-off values assessed were less than (\<) 1:10, 1:10 to \< 1:40 and ≥ 1:40. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=224 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=209 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1 (<1:10), Day 0 [N=221,202]
|
32 Subjects
|
138 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1 (<1:10), Day 7 [N=224,209]
|
4 Subjects
|
72 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2 (<1:10), Day 0 [N=221,202]
|
90 Subjects
|
123 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2 (<1:10), Day 7 [N=224,209]
|
6 Subjects
|
110 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria (<1:10), Day 0 [N=221,202]
|
34 Subjects
|
144 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria (<1:10), Day 7 [N=224,209]
|
0 Subjects
|
35 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata (<1:10), Day 0 [N=221,202]
|
87 Subjects
|
166 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata (<1:10), Day 7 [N=224,209]
|
2 Subjects
|
65 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1 (1:10 to <1:40), Day 0 [N=221,202]
|
100 Subjects
|
3 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1 (1:10 to <1:40), Day 7 [N=224,209]
|
3 Subjects
|
65 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2 (1:10 to <1:40), Day 0 [N=221,202]
|
94 Subjects
|
5 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2 (1:10 to <1:40), Day 7 [N=224,209]
|
25 Subjects
|
18 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria (1:10 to <1:40), Day 0 [N=221,202]
|
115 Subjects
|
19 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria (1:10 to <1:40), Day 7 [N=224,209]
|
7 Subjects
|
90 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata (1:10 to <1:40), Day 0 [N=221,202]
|
107 Subjects
|
24 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata (1:10 to <1:40), Day 7 [N=224,209]
|
6 Subjects
|
61 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1 (≥1: 40), Day 0 [N=221,202]
|
89 Subjects
|
61 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1 (≥1: 40), Day 7 [N=224,209]
|
217 Subjects
|
72 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2 (≥1: 40), Day 0 [N=221,202]
|
37 Subjects
|
74 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2 (≥1: 40), Day 7 [N=224,209]
|
193 Subjects
|
81 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria (≥1: 40), Day 0 [N=221,202]
|
72 Subjects
|
39 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria (≥1: 40), Day 7 [N=224,209]
|
217 Subjects
|
84 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata (≥1: 40), Day 0 [N=221,202]
|
27 Subjects
|
12 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata (≥1: 40), Day 7 [N=224,209]
|
216 Subjects
|
83 Subjects
|
SECONDARY outcome
Timeframe: At Day 0 and Day 7Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=107 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=109 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
H1N1, Day 0 [N=97,90]
|
138.2 Titer
Interval 97.4 to 196.2
|
48.3 Titer
Interval 33.9 to 68.7
|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
H1N1, Day 7 [N=107, 96]
|
1500.9 Titer
Interval 1172.7 to 1920.9
|
139.4 Titer
Interval 78.8 to 246.8
|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
H3N2, Day 0 [N=99,96]
|
66.5 Titer
Interval 55.9 to 79.2
|
82.8 Titer
Interval 60.6 to 113.1
|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
H3N2, Day 7 [N=104,100]
|
422.9 Titer
Interval 342.3 to 522.4
|
325.1 Titer
Interval 187.1 to 564.7
|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Victoria, Day 0 [N=107,109]
|
38.6 Titer
Interval 29.7 to 50.3
|
22.2 Titer
Interval 18.6 to 26.5
|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Victoria, Day 7 [N=107, 108]
|
193.7 Titer
Interval 154.7 to 242.6
|
47.0 Titer
Interval 30.3 to 72.9
|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Yamagata, Day 0 [N=107,107]
|
36.9 Titer
Interval 34.2 to 39.8
|
30.8 Titer
Interval 29.0 to 32.6
|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Yamagata, Day 7 [N=107,107]
|
182.7 Titer
Interval 157.7 to 211.8
|
51.7 Titer
Interval 42.2 to 63.4
|
SECONDARY outcome
Timeframe: At Day 0 and Day 7Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.
Antibody titers were expressed as GMTs. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=107 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=109 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
H1N1, Day 0 [N=106,106]
|
34.6 Titer
Interval 25.3 to 47.3
|
24.1 Titer
Interval 18.6 to 31.1
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
H1N1, Day 7 [N=106, 109]
|
293.9 Titer
Interval 247.2 to 349.3
|
41.3 Titer
Interval 28.9 to 59.0
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
H3N2, Day 0 [N=107,106]
|
38.4 Titer
Interval 33.7 to 43.7
|
58.8 Titer
Interval 47.2 to 73.4
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
H3N2, Day 7 [N=107, 109]
|
189.4 Titer
Interval 155.9 to 230.2
|
114.2 Titer
Interval 84.1 to 155.2
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Victoria, Day 0 [N=106,106]
|
17.4 Titer
Interval 14.2 to 21.3
|
14.3 Titer
Interval 12.4 to 16.5
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Victoria, Day 7 [N=106,109]
|
90.6 Titer
Interval 74.1 to 110.8
|
27.6 Titer
Interval 19.4 to 39.1
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Yamagata, Day 0 [N=106, 106]
|
25.3 Titer
Interval 21.6 to 29.6
|
15.4 Titer
Interval 13.2 to 18.0
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Yamagata, Day 7 [N=106,109]
|
222.0 Titer
Interval 185.7 to 265.4
|
40.6 Titer
Interval 29.5 to 55.7
|
SECONDARY outcome
Timeframe: At Day 7 post dose 1Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.
VRR was defined as the number of vaccinees who had either a pre-vaccination titer \<cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=107 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=108 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.
H1N1 [N=97,89]
|
74 Subjects
|
36 Subjects
|
|
Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.
H3N2 [N=97,94]
|
72 Subjects
|
48 Subjects
|
|
Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.
Victoria [N=107,108]
|
78 Subjects
|
24 Subjects
|
|
Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.
Yamagata [N=107,105]
|
45 Subjects
|
15 Subjects
|
SECONDARY outcome
Timeframe: At Day 7 post dose 1Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.
MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=107 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=108 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1 [N=97, 89]
|
10.6 Fold increase
Interval 8.2 to 13.7
|
3.1 Fold increase
Interval 2.3 to 4.2
|
|
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2 [N=97, 94]
|
6.4 Fold increase
Interval 5.4 to 7.6
|
4.5 Fold increase
Interval 3.2 to 6.2
|
|
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria [N=107,108]
|
5.0 Fold increase
Interval 4.3 to 5.8
|
2.1 Fold increase
Interval 1.6 to 2.8
|
|
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata [N=107,105]
|
5.0 Fold increase
Interval 4.3 to 5.7
|
1.7 Fold increase
Interval 1.4 to 2.0
|
SECONDARY outcome
Timeframe: At Day 7 post dose 1Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.
VRR was defined as the number of vaccinees who had either a pre-vaccination titer \<cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=107 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=106 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.
H1N1 [N=105,106]
|
75 Subjects
|
31 Subjects
|
|
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.
H3N2 [N=107,106]
|
75 Subjects
|
31 Subjects
|
|
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.
Victoria [N=105,106]
|
79 Subjects
|
24 Subjects
|
|
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.
Yamagata [N=105,106]
|
90 Subjects
|
29 Subjects
|
SECONDARY outcome
Timeframe: At Day 7 post dose 1Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.
MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=107 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=106 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1 [N=105,106]
|
8.3 Fold increase
Interval 6.5 to 10.7
|
1.8 Fold increase
Interval 1.5 to 2.1
|
|
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2 [N=105,106]
|
5.2 Fold increase
Interval 4.4 to 6.0
|
1.9 Fold increase
Interval 1.5 to 2.4
|
|
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria [N=105,106]
|
8.8 Fold increase
Interval 7.5 to 10.2
|
2.7 Fold increase
Interval 2.1 to 3.4
|
|
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata [N=107,106]
|
4.9 Fold increase
Interval 4.2 to 5.8
|
2.0 Fold increase
Interval 1.7 to 2.3
|
SECONDARY outcome
Timeframe: At Day 0 and Day 7Population: Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.
The cut-off values assessed were less than (\<) 1:10, 1:10 to \< 1:40,≥ 1:40, ≥1:60 and ≥1:80 . The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=213 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=179 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1, Day 0, <1:10 [N=210,173]
|
32 Subjects
|
119 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1, Day 7, <1:10 [N=213,179]
|
4 Subjects
|
66 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1, Day 0, 1:10 to <1:40 [N=210,173]
|
178 Subjects
|
54 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1, Day 7, 1:10 to <1:40 [N=213,179]
|
209 Subjects
|
113 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1, Day 0, ≥1:40 [N=210,173]
|
87 Subjects
|
51 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1, Day 7, ≥1:40 [N=213,179]
|
206 Subjects
|
59 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1, Day 0, ≥1:60 [N=210,173]
|
73 Subjects
|
47 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1, Day 7, ≥1:60 [N=213,179]
|
204 Subjects
|
57 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1, Day 0, ≥1:80 [N=210,173]
|
73 Subjects
|
47 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1, Day 7, ≥1:80 [N=213,179]
|
204 Subjects
|
57 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2, Day 0, <1:10 [N=210,173]
|
90 Subjects
|
121 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2, Day 7, <1:10 [N=213,179]
|
6 Subjects
|
107 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2, Day 0,1:10 to 1:40 [N=210,173]
|
120 Subjects
|
52 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2, Day 7,1:10 to 1:40 [N=213,179]
|
207 Subjects
|
72 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2, Day 0, ≥1:40 [N=210,173]
|
29 Subjects
|
48 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2, Day 7, ≥1:40 [N=213,179]
|
182 Subjects
|
54 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2, Day 0, ≥1:60 [N=210,173]
|
12 Subjects
|
36 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2, Day 7, ≥1:60 [N=213,179]
|
147 Subjects
|
52 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2, Day 0, ≥1:80 [N=210,173]
|
12 Subjects
|
36 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2, Day 7, ≥1:80 [N=213,179]
|
147 Subjects
|
52 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria, Day 0, <1:10 [N=210,173]
|
33 Subjects
|
123 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria, Day 7, <1:10 [N=213,179]
|
0 Subjects
|
34 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria, Day 0,1:10 to 1:40 [N=210,173]
|
177 Subjects
|
50 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria, Day 7,1:10 to 1:40 [N=213,179]
|
213 Subjects
|
145 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria, Day 0, ≥1:40 [N=210,173]
|
68 Subjects
|
35 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria, Day 7, ≥1:40 [N=213,179]
|
206 Subjects
|
70 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria, Day 0, ≥1:60 [N=210,173]
|
40 Subjects
|
27 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria, Day 7, ≥1:60 [N=213,179]
|
182 Subjects
|
51 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria, Day 0, ≥1:80 [N=210,173]
|
40 Subjects
|
27 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria, Day 7, ≥1:80 [N=213,179]
|
182 Subjects
|
51 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata, Day 0, <1:10 [N=210,173]
|
83 Subjects
|
142 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata, Day 7, <1:10 [N=213,179]
|
2 Subjects
|
59 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata, Day 0,1:10 to 1:40 [N=210,173]
|
127 Subjects
|
31 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata, Day 7,1:10 to 1:40 [N=213,179]
|
211 Subjects
|
120 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata, Day 0, ≥1:40 [N=210,173]
|
27 Subjects
|
10 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata, Day 7, ≥1:40 [N=213,179]
|
205 Subjects
|
70 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata, Day 0, ≥1:60 [N=210,173]
|
7 Subjects
|
4 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata, Day 7, ≥1:60 [N=213,179]
|
177 Subjects
|
44 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata, Day 0, ≥1:80 [N=210,173]
|
7 Subjects
|
4 Subjects
|
|
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata, Day 7, ≥1:80 [N=213,179]
|
177 Subjects
|
44 Subjects
|
SECONDARY outcome
Timeframe: At Day 0 and Day 7Population: Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.
MN antibody titers were expressed as geometric mean titers(GMTs). The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=100 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=89 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1,Day 0[N=90,72]
|
141.4 Titer
Interval 97.6 to 205.0
|
47.3 Titer
Interval 32.1 to 69.6
|
|
Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1,Day 7[N=100,76]
|
1461.3 Titer
Interval 1132.8 to 1885.1
|
138.4 Titer
Interval 71.9 to 266.4
|
|
Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2,Day 0[N=92,76]
|
60.0 Titer
Interval 51.2 to 70.4
|
59.6 Titer
Interval 42.5 to 83.7
|
|
Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2,Day 7[N=97,80]
|
374.6 Titer
Interval 305.4 to 459.4
|
177.7 Titer
Interval 97.4 to 324.2
|
|
Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria,Day 0[N=100,89]
|
37.1 Titer
Interval 28.6 to 48.2
|
23.5 Titer
Interval 19.1 to 28.9
|
|
Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria,Day 7[N=100,88]
|
189.9 Titer
Interval 151.2 to 238.5
|
52.0 Titer
Interval 31.3 to 86.3
|
|
Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata,day 0[N=100,87]
|
37.1 Titer
Interval 34.2 to 40.2
|
30.9 Titer
Interval 28.9 to 32.9
|
|
Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata, Day 7[N=100,88]
|
177.5 Titer
Interval 154.2 to 204.5
|
49.8 Titer
Interval 40.5 to 61.1
|
SECONDARY outcome
Timeframe: At Day 0 and Day 7Population: Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.
NI (Neuraminidase inhibitor) antibody titers were expressed as geometric mean titers(GMTs).The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=100 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=89 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
H1N1, Day 0[N=99,86]
|
34.8 Titer
Interval 25.1 to 48.1
|
23.5 Titer
Interval 17.8 to 31.1
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
H1N1, Day 7[N=99,89]
|
287.1 Titer
Interval 239.8 to 343.6
|
38.3 Titer
Interval 25.7 to 57.1
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
H3N2, Day 0[N=100,86]
|
35.0 Titer
Interval 31.3 to 39.1
|
45.9 Titer
Interval 36.7 to 57.4
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
H3N2, Day 7[N=100,89]
|
175.8 Titer
Interval 143.9 to 214.7
|
84.5 Titer
Interval 60.7 to 117.6
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Victoria, Day 0[N=99,86]
|
16.8 Titer
Interval 13.7 to 20.7
|
15.0 Titer
Interval 12.7 to 17.6
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Victoria, Day 7[N=99,89]
|
89.2 Titer
Interval 72.5 to 109.7
|
29.1 Titer
Interval 19.6 to 43.2
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Yamagata, Day 0[N=99,86]
|
25.1 Titer
Interval 21.3 to 29.5
|
15.4 Titer
Interval 12.9 to 18.3
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Yamagata, Day 7[N=100,89]
|
216.5 Titer
Interval 180.5 to 259.6
|
39.7 Titer
Interval 27.9 to 56.6
|
SECONDARY outcome
Timeframe: At Day 7 post dose 1Population: Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.
VRR was defined as the number of vaccinees who had either a pre-vaccination titer \<cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=100 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=88 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains
H1N1, Day 7[N=90,71]
|
67 Subjects
|
28 Subjects
|
|
Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains
H3N2, Day 7[N=90,74]
|
66 Subjects
|
31 Subjects
|
|
Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains
Victoria, Day 7[N=100,88]
|
74 Subjects
|
21 Subjects
|
|
Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains
Yamagata, Day 7[N=100,86]
|
42 Subjects
|
11 Subjects
|
SECONDARY outcome
Timeframe: At Day 7 post dose 1Population: Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.
MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=100 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=88 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H1N1, Day 7[N=90,71]
|
10.0 Fold Increase
Interval 7.7 to 13.1
|
3.1 Fold Increase
Interval 2.2 to 4.3
|
|
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
H3N2, Day 7[N=90,74]
|
6.2 Fold Increase
Interval 5.2 to 7.5
|
3.4 Fold Increase
Interval 2.4 to 4.9
|
|
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Victoria, Day 7[N=100,88]
|
5.1 Fold Increase
Interval 4.4 to 5.9
|
2.2 Fold Increase
Interval 1.6 to 3.0
|
|
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Yamagata, Day 7[N=100,86]
|
4.8 Fold Increase
Interval 4.2 to 5.4
|
1.6 Fold Increase
Interval 1.3 to 1.9
|
SECONDARY outcome
Timeframe: At Day 7 post dose 1Population: Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.
VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer \<cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=100 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=86 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.
H1N1, Day 7[N=98,86]
|
70 Subjects
|
23 Subjects
|
|
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.
H3N2, Day 7[N=100,86]
|
70 Subjects
|
22 Subjects
|
|
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.
Victoria, Day 7[N=98,86]
|
74 Subjects
|
20 Subjects
|
|
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.
Yamagata, Day 7[N=99,86]
|
85 Subjects
|
23 Subjects
|
SECONDARY outcome
Timeframe: At Day 7 post dose 1Population: Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.
MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=100 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=86 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
H1N1, Day 7[N=98,86]
|
8.1 Fold increase
Interval 6.2 to 10.5
|
1.7 Fold increase
Interval 1.4 to 2.1
|
|
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
H3N2, Day 7[N=100,86]
|
5.0 Fold increase
Interval 4.2 to 6.0
|
1.8 Fold increase
Interval 1.6 to 2.2
|
|
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Victoria, Day 7[N=98,86]
|
5.2 Fold increase
Interval 4.5 to 6.1
|
1.9 Fold increase
Interval 1.5 to 2.5
|
|
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Yamagata, Day 7[N=99,86]
|
8.7 Fold increase
Interval 7.4 to 10.2
|
2.6 Fold increase
Interval 2.0 to 3.5
|
SECONDARY outcome
Timeframe: At Day 0 and Day 7Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available
Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010 (H1N1),A/Victoria/361/2011 (H3N2), A/Victoria/361/2011 and B/Hubei-Wujiagang/158/2009)(Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=54 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=55 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
H3N2,Day 7,30-48M[N=53,50]
|
480.3 Titers
Interval 356.7 to 646.8
|
485.8 Titers
Interval 226.2 to 1043.7
|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
H1N1, Day 0,17-29M[N=47,44]
|
76.8 Titers
Interval 48.8 to 120.9
|
29.0 Titers
Interval 18.7 to 44.9
|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
H1N1, Day 7,17-29M [N=53,48]
|
1112.0 Titers
Interval 746.0 to 1657.8
|
53.0 Titers
Interval 26.9 to 104.2
|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
H1N1, Day 0,30-48M[N=50,46]
|
240.0 Titers
Interval 146.2 to 394.1
|
78.8 Titers
Interval 46.6 to 133.1
|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
H1N1, Day 7,30-48M[N=54,48]
|
2014.5 Titers
Interval 1517.5 to 2674.4
|
366.9 Titers
Interval 155.6 to 865.4
|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
H3N2,Day 0,17-29M[N=49,47]
|
58.1 Titers
Interval 46.3 to 72.9
|
74.5 Titers
Interval 45.8 to 121.5
|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
H3N2,Day 7,17-29M[N=51,50]
|
370.5 Titers
Interval 272.7 to 503.2
|
217.5 Titers
Interval 97.0 to 488.0
|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
H3N2,Day 0,30-48M[N=50,49]
|
76.0 Titers
Interval 58.2 to 99.1
|
91.5 Titers
Interval 60.8 to 137.7
|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
Victoria,Day 0,17-29M[N=53,54]
|
29.2 Titers
Interval 21.7 to 39.2
|
19.8 Titers
Interval 15.9 to 24.8
|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
Victoria,Day 7,17-29M[N=53,53]
|
156.3 Titers
Interval 119.7 to 204.2
|
35.5 Titers
Interval 20.0 to 62.9
|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
Victoria,Day 0,30-48M[N=54,55]
|
50.9 Titers
Interval 33.1 to 78.2
|
24.7 Titers
Interval 18.8 to 32.6
|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
Victoria,Day 7,30-48M[N=54,55]
|
239.1 Titers
Interval 166.7 to 343.0
|
61.8 Titers
Interval 31.6 to 120.8
|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
Yamagata, Day 0,17-29M[N=53,53]
|
35.6 Titers
Interval 32.3 to 39.2
|
29.6 Titers
Interval 28.0 to 31.4
|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
Yamagata, Day 7,17-29M[N=53,52]
|
156.9 Titers
Interval 129.4 to 190.3
|
45.6 Titers
Interval 33.7 to 61.7
|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
Yamagata, Day 0,30-48M[N=54,54]
|
38.3 Titers
Interval 34.0 to 43.1
|
32.0 Titers
Interval 28.9 to 35.4
|
|
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
Yamagata, Day 7,30-48M[N=54,55]
|
212.2 Titers
Interval 170.1 to 264.7
|
58.3 Titers
Interval 44.1 to 77.0
|
SECONDARY outcome
Timeframe: At Day 0 and Day 7Population: Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available.
Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010(H1N1), A/Victoria/361/2011(H3N2),B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009(Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=54 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=55 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
H1N1, Day 0,17-29M[N=53,52]
|
21.6 Titers
Interval 15.0 to 31.3
|
15.8 Titers
Interval 11.9 to 21.1
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
H1N1, Day 7,17-29M[N=53,54]
|
246.3 Titers
Interval 189.1 to 320.8
|
22.9 Titers
Interval 14.9 to 35.1
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
H1N1, Day 0,30-48M[N=53,54]
|
55.5 Titers
Interval 34.2 to 89.9
|
36.1 Titers
Interval 24.2 to 53.9
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
H1N1, Day 7,30-48M[N=53,55]
|
350.7 Titers
Interval 281.1 to 437.4
|
73.7 Titers
Interval 42.9 to 126.7
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
H3N2, Day 0,17-29M[N=53,52]
|
34.7 Titers
Interval 29.2 to 41.2
|
49.8 Titers
Interval 35.9 to 69.3
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
H3N2, Day 7,17-29M[N=53,54]
|
158.0 Titers
Interval 117.8 to 211.8
|
85.3 Titers
Interval 55.4 to 131.4
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
H3N2, Day 0,30-48M[N=54,54]
|
42.4 Titers
Interval 34.9 to 51.6
|
69.0 Titers
Interval 51.1 to 93.2
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
H3N2, Day 7,30-48M[N=54,55]
|
226.4 Titers
Interval 174.9 to 292.9
|
152.2 Titers
Interval 98.5 to 235.1
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
Victoria, Day 0,17-29M[N=53,52]
|
13.2 Titers
Interval 11.0 to 16.0
|
13.1 Titers
Interval 10.9 to 15.7
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
Victoria, Day 7,17-29M[N=53,54]
|
68.8 Titers
Interval 53.3 to 88.9
|
21.1 Titers
Interval 13.4 to 33.2
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
Victoria, Day 0,30-48M[N=53,54]
|
22.8 Titers
Interval 16.0 to 32.4
|
15.7 Titers
Interval 12.6 to 19.4
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
Victoria, Day 7,30-48M[N=53,55]
|
119.2 Titers
Interval 88.2 to 161.1
|
35.9 Titers
Interval 21.0 to 61.4
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
Yamagata, Day 0,17-29M[N=53,52]
|
20.5 Titers
Interval 16.9 to 24.9
|
13.2 Titers
Interval 11.1 to 15.8
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
Yamagata, Day 7,17-29M[N=53,54]
|
181.4 Titers
Interval 143.3 to 229.5
|
29.3 Titers
Interval 19.5 to 44.0
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
Yamagata, Day 0,30-48M[N=53,54]
|
31.1 Titers
Interval 24.4 to 39.7
|
17.9 Titers
Interval 13.8 to 23.1
|
|
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
Yamagata, Day 7,30-48M[N=53,55]
|
271.8 Titers
Interval 208.6 to 354.3
|
55.8 Titers
Interval 34.4 to 90.5
|
SECONDARY outcome
Timeframe: At Day 7 post dose 1Population: Analyses were perfomed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available
VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer \<cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008(Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=54 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=55 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata
H1N1, Day 7, 17-29M[47,44]
|
39 Subjects
|
12 Subjects
|
|
Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata
H1N1, Day 7, 30-48M[50,45]
|
35 Subjects
|
24 Subjects
|
|
Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata
H3N2, Day 7,17-29M[N=48,46]
|
36 Subjects
|
19 Subjects
|
|
Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata
H3N2, Day 7,30-48M[N=49,48]
|
36 Subjects
|
29 Subjects
|
|
Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata
Victoria, Day 7,17-29M[N=53,53]
|
41 Subjects
|
9 Subjects
|
|
Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata
Victoria, Day 7,30-48M[N=54,55]
|
37 Subjects
|
15 Subjects
|
|
Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata
Yamagata, Day 7,17-29M[N=53,51]
|
17 Subjects
|
6 Subjects
|
|
Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata
Yamagata, Day 7,30-48M[N=54,54]
|
28 Subjects
|
9 Subjects
|
SECONDARY outcome
Timeframe: At Day 7 post dose 1Population: Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available.
MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0.The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=54 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=55 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
H1N1, Day 7, 17-29M[N=47,44]
|
13.1 Fold Increase
Interval 9.2 to 18.8
|
2.0 Fold Increase
Interval 1.4 to 3.0
|
|
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
H1N1, Day 7, 30-48M[N=50,45]
|
8.7 Fold Increase
Interval 6.0 to 12.5
|
4.7 Fold Increase
Interval 3.0 to 7.3
|
|
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
H3N2, Day 7,17-29M[N=48,46]
|
6.1 Fold Increase
Interval 4.8 to 7.7
|
3.4 Fold Increase
Interval 2.1 to 5.4
|
|
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
H3N2, Day 7,30-48M[N=49,48]
|
6.7 Fold Increase
Interval 5.1 to 8.8
|
5.9 Fold Increase
Interval 3.8 to 9.2
|
|
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
Victoria, Day 7,17-29M[N=53,53]
|
5.4 Fold Increase
Interval 4.4 to 6.5
|
1.8 Fold Increase
Interval 1.2 to 2.6
|
|
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
Victoria, Day 7,30-48M[N=54,55]
|
4.7 Fold Increase
Interval 3.8 to 5.8
|
2.5 Fold Increase
Interval 1.6 to 3.8
|
|
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
Yamagata, Day 7,17-29M[N=53,51]
|
4.4 Fold Increase
Interval 3.8 to 5.2
|
1.5 Fold Increase
Interval 1.2 to 2.0
|
|
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
Yamagata, Day 7,30-48M[N=54,54]
|
5.5 Fold Increase
Interval 4.5 to 6.9
|
1.8 Fold Increase
Interval 1.4 to 2.4
|
SECONDARY outcome
Timeframe: At Day 7 post dose 1Population: Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available.
VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer \<cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria /361/2011(H3N2), B/Brisbane /60/2008(Victoria ) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=54 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=54 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.
H1N1, Day 7,17-29M[N=53,52]
|
43 Subjects
|
11 Subjects
|
|
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.
H1N1, Day 7,30-48M[N=52,54]
|
32 Subjects
|
20 Subjects
|
|
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.
H3N2, Day 7,17-29M[N=53,52]
|
36 Subjects
|
8 Subjects
|
|
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.
H3N2, Day 7,30-48M[N=54,54]
|
39 Subjects
|
23 Subjects
|
|
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.
Victoria, Day 7,17-29M[N=53,52]
|
40 Subjects
|
8 Subjects
|
|
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.
Victoria, Day 7,30-48M[N=52,54]
|
39 Subjects
|
16 Subjects
|
|
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.
Yamagata, Day 7, 17-29M[N=53,52]
|
46 Subjects
|
10 Subjects
|
|
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.
Yamagata, Day 7, 30-48M[N=52,54]
|
44 Subjects
|
19 Subjects
|
SECONDARY outcome
Timeframe: At Day 7 post dose 1Population: Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available
MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=54 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=54 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
H1N1, Day 7,17-29M[53,52]
|
11.4 Fold Increase
Interval 8.2 to 15.8
|
1.5 Fold Increase
Interval 1.2 to 1.9
|
|
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
H1N1, Day 7,30-48M[N=52,54]
|
6.0 Fold Increase
Interval 4.1 to 8.8
|
2.1 Fold Increase
Interval 1.7 to 2.7
|
|
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
H3N2, Day 7,17-29M[N=53,52]
|
4.6 Fold Increase
Interval 3.6 to 5.8
|
1.7 Fold Increase
Interval 1.4 to 2.0
|
|
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
H3N2, Day 7,30-48M[N=54,54]
|
5.3 Fold Increase
Interval 4.2 to 6.8
|
2.3 Fold Increase
Interval 1.9 to 2.8
|
|
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
Victoria, Day 7,17-29M[N=53,52]
|
5.2 Fold Increase
Interval 4.3 to 6.3
|
1.5 Fold Increase
Interval 1.1 to 2.1
|
|
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
Victoria, Day 7,30-48M[N=52,54]
|
5.1 Fold Increase
Interval 4.1 to 6.5
|
2.3 Fold Increase
Interval 1.6 to 3.4
|
|
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
Yamagata, Day 7, 17-29M[N=53,52]
|
8.8 Fold Increase
Interval 7.2 to 10.8
|
2.2 Fold Increase
Interval 1.5 to 3.2
|
|
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
Yamagata, Day 7, 30-48M[N=52,54]
|
8.7 Fold Increase
Interval 6.9 to 11.0
|
3.2 Fold Increase
Interval 2.3 to 4.5
|
SECONDARY outcome
Timeframe: During a 7-day (Day 0 to 6) follow-up period after first vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed.
Solicited local AEs assessed were pain, redness and swelling. Any = any solicited local AE reported irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=239 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=228 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Any Pain
|
96 Subjects
|
61 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 Pain
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Any Redness
|
82 Subjects
|
48 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 Redness
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Any Swelling
|
49 Subjects
|
25 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 Swelling
|
2 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination Dose 1 periodPopulation: Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.
Duration was defined as number of days with any grade of solicted local and/or general symptoms
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=96 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=61 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Duration of Solicted Symptoms
Drowsiness
|
1.0 Days
Interval 1.0 to 7.0
|
1.0 Days
Interval 1.0 to 4.0
|
|
Duration of Solicted Symptoms
Irritability/fussiness
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 7.0
|
|
Duration of Solicted Symptoms
Loss of appetite
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 5.0
|
|
Duration of Solicted Symptoms
Pain
|
1.0 Days
Interval 1.0 to 5.0
|
1.0 Days
Interval 1.0 to 5.0
|
|
Duration of Solicted Symptoms
Redness
|
2.0 Days
Interval 1.0 to 7.0
|
2.0 Days
Interval 1.0 to 6.0
|
|
Duration of Solicted Symptoms
Swelling
|
2.0 Days
Interval 1.0 to 5.0
|
1.0 Days
Interval 1.0 to 5.0
|
|
Duration of Solicted Symptoms
Temperature
|
1.0 Days
Interval 1.0 to 5.0
|
2.0 Days
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: During the 7 days (Days 0 - 6) post dose 1 vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed.
Solicited general symptoms assessed were drowsiness, Irritability/Fussiness, loss of appetite and Temperature. Any Temperature = axillary temperature ≥37.5 degrees Celsius (°C). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = did not eat at all. Grade 3 temperature = axillary temperature \> 39.0°C.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=238 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=224 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Drowsiness
|
54 Subjects
|
44 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Drowsiness
|
5 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Drowsiness
|
36 Subjects
|
28 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Irritability/Fussiness
|
77 Subjects
|
59 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Irritability/Fussiness
|
5 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Irritability/Fussiness
|
51 Subjects
|
43 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Loss of appetite
|
51 Subjects
|
46 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Loss of appetite
|
8 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Loss of appetite
|
31 Subjects
|
31 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Any Temperature
|
13 Subjects
|
26 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Temperature
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Related Temperature
|
6 Subjects
|
15 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0 - Day 179)Population: Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
MAVs were defined as an AEs with a medically-attended visits i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was a MAV that prevented normal activities and related was defined as a MAV assessed by the investigator to be causally related to the study vaccination.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=241 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=229 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Number of Subjects Reporting AEs With Medically Attended Visits (MAV)
Any MAV
|
149 Subjects
|
130 Subjects
|
|
Number of Subjects Reporting AEs With Medically Attended Visits (MAV)
Grade 3 MAV
|
5 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting AEs With Medically Attended Visits (MAV)
Related MAV
|
0 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (Days 0 - 179)Population: Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
pIMDs were defined as a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune aetiology. Any pIMDs= Any AEs that occured regardless of the relation with vaccination. Related pIMDs= Any pIMD assessed by the investigator as casually related to the study vaccination.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=241 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=229 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)
Any pIMD
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)
Related pIMD
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Within 28 days (Days 0-27) after first vaccinationPopulation: Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
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. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=241 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=229 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs.
Any Unsolicted AEs
|
66 Subjects
|
66 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs.
Grade 3 Unsolicted AEs
|
6 Subjects
|
7 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs.
Related Unsolicted AEs
|
5 Subjects
|
3 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0 - Day 179)Population: Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Fluarix Quadrivalent Primed Group
n=241 Participants
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=229 Participants
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Any SAE(s)
|
7 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Related SAE(s)
|
0 Subjects
|
0 Subjects
|
Adverse Events
Fluarix Quadrivalent Primed Group
Serious events: 7 serious events
Other events: 145 other events
Deaths: 0 deaths
Fluarix Quadrivalent Unprimed Group
Serious events: 8 serious events
Other events: 138 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluarix Quadrivalent Primed Group
n=241 participants at risk
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=229 participants at risk
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/241 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.87%
2/229 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.41%
1/241 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/229 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/241 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.44%
1/229 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/241 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.44%
1/229 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Infections and infestations
Bronchitis
|
0.41%
1/241 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/229 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Infections and infestations
Bronchopneumonia
|
0.41%
1/241 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/229 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Infections and infestations
Laryngitis
|
0.41%
1/241 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/229 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Infections and infestations
Lymphadenitis bacterial
|
0.00%
0/241 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.44%
1/229 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Infections and infestations
Otitis media
|
0.41%
1/241 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/229 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Infections and infestations
Otitis media acute
|
0.41%
1/241 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/229 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/241 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.44%
1/229 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/241 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.44%
1/229 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Infections and infestations
Rhinitis
|
0.41%
1/241 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/229 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Infections and infestations
Sinusitis
|
0.41%
1/241 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/229 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.41%
1/241 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/229 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/241 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.44%
1/229 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.41%
1/241 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/229 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.41%
1/241 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
0.00%
0/229 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
Other adverse events
| Measure |
Fluarix Quadrivalent Primed Group
n=241 participants at risk
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
Fluarix Quadrivalent Unprimed Group
n=229 participants at risk
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
|
|---|---|---|
|
General disorders
Pain
|
40.2%
96/239 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
26.8%
61/228 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Redness
|
34.3%
82/239 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
21.1%
48/228 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Swelling
|
20.5%
49/239 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
11.0%
25/228 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Drowsiness
|
22.7%
54/238 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
19.6%
44/224 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Irritability/Fussiness
|
32.4%
77/238 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
26.3%
59/224 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Loss of Appetite
|
21.4%
51/238 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
20.5%
46/224 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
General disorders
Temperature
|
5.5%
13/238 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
11.6%
26/224 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.7%
9/241 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
5.7%
13/229 • Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.
For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
|
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