Trial Outcomes & Findings for Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children Aged 10 to Less Than 18 Years (NCT NCT01035749)
NCT ID: NCT01035749
Last Updated: 2018-08-17
Results Overview
Seroconversion defined as: - For initially seronegative subjects, antibody titre ≥ 1:40 after vaccination - For initially seropositive subjects, antibody titre after vaccination ≥ 4 fold the pre-vaccination antibody titre
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
310 participants
Primary outcome timeframe
At Day 21
Results posted on
2018-08-17
Participant Flow
310 subjects were enrolled in the study, all of which were vaccinated and completed the Day 42 visit.
Participant milestones
| Measure |
Arepanrix-adjuvanted F1 2D Group
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
66
|
66
|
68
|
110
|
|
Overall Study
COMPLETED
|
66
|
66
|
68
|
110
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children Aged 10 to Less Than 18 Years
Baseline characteristics by cohort
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=66 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=66 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=110 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Total
n=310 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
13.6 Years
STANDARD_DEVIATION 2.27 • n=5 Participants
|
14.5 Years
STANDARD_DEVIATION 2.2 • n=7 Participants
|
14.6 Years
STANDARD_DEVIATION 1.84 • n=5 Participants
|
14.1 Years
STANDARD_DEVIATION 2.13 • n=4 Participants
|
14.19 Years
STANDARD_DEVIATION 2.14 • n=21 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
166 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
144 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At Day 21Population: The analysis was performed on the ATP cohort for immunogenicity at Day21,which included all evaluated subjects for whom the injection site was known,who received the vaccine on Day0 as per protocol (PP) \& for whom assay results for antibodies against A/California-like HA antigen for bloodsample taken 21days after the 1st vaccination were available.
Seroconversion defined as: - For initially seronegative subjects, antibody titre ≥ 1:40 after vaccination - For initially seropositive subjects, antibody titre after vaccination ≥ 4 fold the pre-vaccination antibody titre
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=66 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=65 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=109 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
|
63 Subjects
|
58 Subjects
|
61 Subjects
|
96 Subjects
|
PRIMARY outcome
Timeframe: At Day 0 and Day 21Population: The analysis was performed on the ATP cohort for immunogenicity at Day21,which included all evaluated subjects for whom the injection site was known,who received the vaccine on Day0 as per protocol (PP) \& for whom assay results for antibodies against A/California-like HA antigen for bloodsample taken 21days after the 1st vaccination were available.
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=66 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=65 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=109 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Day 0
|
28 Subjects
|
35 Subjects
|
30 Subjects
|
49 Subjects
|
|
Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
Day 21
|
66 Subjects
|
65 Subjects
|
67 Subjects
|
107 Subjects
|
PRIMARY outcome
Timeframe: At Day 21Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP \& for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 \& 42 were available.
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=66 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=65 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=109 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
HI Antibody Seroconversion Factors Against Flu A/CAL/7/09 H1N1 Strain
|
35.6 Fold increase
Interval 26.4 to 47.9
|
18.3 Fold increase
Interval 13.1 to 25.6
|
28.9 Fold increase
Interval 20.4 to 41.0
|
25.3 Fold increase
Interval 19.2 to 33.3
|
SECONDARY outcome
Timeframe: At Day 0 and Day 42Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP \& for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 \& 42 were available.
Antibody titres were expressed as Geometric mean titers (GMTs).
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=65 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=65 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=108 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
Day 0
|
23.4 Titers
Interval 16.7 to 32.9
|
33 Titers
Interval 22.4 to 48.7
|
23.4 Titers
Interval 16.9 to 32.4
|
22.7 Titers
Interval 17.3 to 29.8
|
|
HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
Day 42
|
646.9 Titers
Interval 532.3 to 786.2
|
469.7 Titers
Interval 386.9 to 570.3
|
977 Titers
Interval 833.1 to 1145.8
|
439.6 Titers
Interval 356.0 to 543.0
|
SECONDARY outcome
Timeframe: At Day 0 and Day 182Population: The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 \& 21 as PP \& for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 \& 182 days after the 1st vaccination were available
Antibody titres were expressed as GMTs.
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=64 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=65 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=109 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
Day 0
|
22.9 Titers
Interval 16.3 to 32.0
|
34.8 Titers
Interval 23.5 to 51.5
|
23.4 Titers
Interval 16.9 to 32.4
|
22.8 Titers
Interval 17.4 to 29.9
|
|
HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
Day 182
|
240.2 Titers
Interval 188.1 to 306.6
|
176.1 Titers
Interval 137.1 to 226.0
|
318.4 Titers
Interval 257.8 to 393.1
|
177.2 Titers
Interval 140.1 to 224.0
|
SECONDARY outcome
Timeframe: At Days 0, 182 and 189Population: The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 \& booster on Day182 as PP \& for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182\&189D after the 1st dose were available
Antibody titres were expressed as Geometric mean titers (GMTs).
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=63 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=63 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=108 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
Day 0
|
23.4 Titers
Interval 16.7 to 32.9
|
33.5 Titers
Interval 22.5 to 50.1
|
23.4 Titers
Interval 16.9 to 32.4
|
22.5 Titers
Interval 17.2 to 29.5
|
|
HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
Day 182
|
237.7 Titers
Interval 185.7 to 304.5
|
172.7 Titers
Interval 133.7 to 223.2
|
318.4 Titers
Interval 257.8 to 393.1
|
177.3 Titers
Interval 140.0 to 224.7
|
|
HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
Day 189
|
589.4 Titers
Interval 506.0 to 686.5
|
416.7 Titers
Interval 352.8 to 492.2
|
552.1 Titers
Interval 474.5 to 642.5
|
273.4 Titers
Interval 233.2 to 320.6
|
SECONDARY outcome
Timeframe: At Day 42Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP \& for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 \& 42 were available
A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre.
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=65 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=65 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=108 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
|
62 Subjects
|
52 Subjects
|
65 Subjects
|
93 Subjects
|
SECONDARY outcome
Timeframe: At Day 0 and Day 21Population: The analysis was performed on the ATP cohort for immunogenicity at Day21,which included all evaluated subjects for whom the injection site was known,who received the vaccine on Day0 as per protocol (PP) \& for whom assay results for antibodies against A/California-like HA antigen for bloodsample taken 21days after the 1st vaccination were available.
Antibody titers were expressed as GMTs.
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=66 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=65 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=109 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
Day 0
|
24.1 Titers
Interval 17.2 to 33.8
|
33 Titers
Interval 22.4 to 48.7
|
23.4 Titers
Interval 16.9 to 32.4
|
22.8 Titers
Interval 17.4 to 29.9
|
|
HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain
Day 21
|
858.7 Titers
Interval 714.5 to 1032.0
|
603.6 Titers
Interval 493.3 to 738.5
|
676.9 Titers
Interval 539.1 to 850.0
|
578.1 Titers
Interval 466.7 to 716.1
|
SECONDARY outcome
Timeframe: At Day 182Population: The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 \& 21 as PP \& for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 \& 182 days after the 1st vaccination were available
A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre.
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=64 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=65 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=109 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
|
48 Subjects
|
34 Subjects
|
56 Subjects
|
67 Subjects
|
SECONDARY outcome
Timeframe: At Day 189Population: The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 \& booster on Day182 as PP \& for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182\&189D after the 1st dose were available
A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre. Day 0 was used as reference activity.
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=63 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=63 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=108 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
|
58 Subjects
|
47 Subjects
|
64 Subjects
|
84 Subjects
|
SECONDARY outcome
Timeframe: At Day 189Population: The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 \& booster on Day182 as PP \& for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182\&189D after the 1st dose 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 greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. Day 182 was used as reference activity.
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=63 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=63 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=108 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain
|
17 Subjects
|
18 Subjects
|
9 Subjects
|
11 Subjects
|
SECONDARY outcome
Timeframe: At Day 0 and Day 42Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP \& for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 \& 42 were available
A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection.
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=65 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=65 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=108 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
The Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1
Day 0
|
27 Subjects
|
35 Subjects
|
30 Subjects
|
48 Subjects
|
|
The Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1
Day 42
|
65 Subjects
|
64 Subjects
|
68 Subjects
|
105 Subjects
|
SECONDARY outcome
Timeframe: At Day 0 and Day 182Population: The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 \& 21 as PP \& for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 \& 182 days after the 1st vaccination were available
A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection.
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=64 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=65 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=109 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1
Day 0
|
26 Subjects
|
36 Subjects
|
30 Subjects
|
49 Subjects
|
|
Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1
Day 182
|
62 Subjects
|
61 Subjects
|
67 Subjects
|
98 Subjects
|
SECONDARY outcome
Timeframe: At Day 0, Day 182 and Day 189Population: The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 \& booster on Day182 as PP \& for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182\&189D after the 1st dose were available
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=63 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=63 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=108 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1
Day 0
|
26 Subjects
|
34 Subjects
|
30 Subjects
|
48 Subjects
|
|
Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1
Day 182
|
61 Subjects
|
59 Subjects
|
67 Subjects
|
97 Subjects
|
|
Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1
Day 189
|
63 Subjects
|
63 Subjects
|
68 Subjects
|
105 Subjects
|
SECONDARY outcome
Timeframe: At Day 42Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42,which included all evaluated subjects for whom the injection site was known, who received the vaccine/placebo on both Day 0 and 21 as PP \& for whom assay results for antibodies (Abs) against A/California-like HA antigen for blood sample taken on Day 21 \& 42 were available.
GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=65 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=65 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=108 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1
|
27.6 Fold increase
Interval 20.7 to 36.7
|
14.2 Fold increase
Interval 10.2 to 19.8
|
41.8 Fold increase
Interval 29.4 to 59.3
|
19.3 Fold increase
Interval 14.7 to 25.5
|
SECONDARY outcome
Timeframe: At Day 182Population: The analysis was performed on the ATP cohort for immunogenicity at Day182,which included all evaluated subjects for whom the injection site was known,who received the vaccine/placebo on Day0 \& 21 as PP \& for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42 \& 182 days after the 1st vaccination were available
GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=64 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=65 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=109 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1
|
10.5 Fold increase
Interval 7.9 to 14.0
|
5.1 Fold increase
Interval 3.7 to 6.9
|
13.6 Fold increase
Interval 9.9 to 18.8
|
7.8 Fold increase
Interval 5.8 to 10.3
|
SECONDARY outcome
Timeframe: At Day 189Population: The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 \& booster on Day182 as PP \& for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182\&189D after the 1st dose were available
GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=63 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=63 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=108 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 0 as Reference Activity
|
25.2 Fold increase
Interval 17.9 to 35.3
|
12.4 Fold increase
Interval 8.3 to 18.6
|
23.6 Fold increase
Interval 16.6 to 33.6
|
12.1 Fold increase
Interval 9.3 to 15.9
|
SECONDARY outcome
Timeframe: At Day 189Population: The analysis was performed on the ATP cohort for immunogenicity at Day189,which included all subjects for whom the injection site was known,who received the vaccine/placebo on Day0,21 \& booster on Day182 as PP \& for whom assay results for Abs against A/California-like HA antigen for bloodsample taken21,42,182\&189D after the 1st dose were available
GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=63 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=63 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=108 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 182 as Reference Activity
|
2.5 Fold increase
Interval 2.0 to 3.1
|
2.4 Fold increase
Interval 1.9 to 3.0
|
1.7 Fold increase
Interval 1.5 to 2.0
|
1.5 Fold increase
Interval 1.3 to 1.8
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dosePopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
Any was defined as occurrence of any local symptom regardless of their intensity grade.Grade 3 redness and swelling was \> 100 millimeter (mm) and grade 3 pain was defined as pain that prevented normal activity.
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=66 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=66 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=110 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Any pain
|
52 Subjects
|
48 Subjects
|
61 Subjects
|
51 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 pain
|
2 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Any Redness
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 Redness
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Any Swelling
|
4 Subjects
|
1 Subjects
|
6 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Grade 3 Swelling
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following booster dosePopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
Any was defined as occurrence of any local symptom regardless of their intensity grade.Grade 3 redness and swelling was \> 100 millimeter (mm) and grade 3 pain was defined as pain that prevented normal activity
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=65 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=65 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=110 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local AEs
Any Pain
|
48 Subjects
|
40 Subjects
|
54 Subjects
|
49 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local AEs
Grade 3 Pain
|
3 Subjects
|
3 Subjects
|
4 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local AEs
Any Redness
|
4 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local AEs
Grade 3 Redness
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local AEs
Any Swelling
|
6 Subjects
|
5 Subjects
|
3 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local AEs
Grade 3 Swelling
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dosePopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering, sweating and fever (Fever = axillary temperature equal to or above 38.0 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 fever = axillary temperature equal to or above (≥) 39.0°C.
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=66 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=66 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=110 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any Arthralgia
|
5 Subjects
|
7 Subjects
|
6 Subjects
|
13 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 Arthralgia
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related Arthralgia
|
5 Subjects
|
6 Subjects
|
5 Subjects
|
10 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any Fatigue
|
26 Subjects
|
19 Subjects
|
24 Subjects
|
36 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 Fatigue
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related Fatigue
|
23 Subjects
|
16 Subjects
|
21 Subjects
|
28 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any Gastrointestinal
|
5 Subjects
|
3 Subjects
|
9 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 Gastrointestinal
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related Gastrointestinal
|
3 Subjects
|
2 Subjects
|
6 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any Headache
|
27 Subjects
|
21 Subjects
|
39 Subjects
|
45 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 Headache
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related Headache
|
23 Subjects
|
16 Subjects
|
27 Subjects
|
31 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any Myalgia
|
17 Subjects
|
20 Subjects
|
28 Subjects
|
21 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 Myalgia
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related Myalgia
|
16 Subjects
|
17 Subjects
|
23 Subjects
|
16 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any Shivering
|
6 Subjects
|
5 Subjects
|
8 Subjects
|
16 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 Shivering
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related Shivering
|
6 Subjects
|
4 Subjects
|
7 Subjects
|
11 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any Sweating
|
6 Subjects
|
8 Subjects
|
11 Subjects
|
15 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 Sweating
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related Sweating
|
6 Subjects
|
3 Subjects
|
8 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any Fever
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 Fever
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related Fever
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
2 Subjects
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following booster dosePopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects. Note: 1 subject moved out of the study area thereby withdrawing from the study.
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering, sweating and fever (Fever = axillary temperature equal to or above 38.0 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 fever = axillary temperature equal to or above (≥) 39.0°C.
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=65 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=65 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=110 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any Arthralgia
|
13 Subjects
|
8 Subjects
|
12 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 Arthralgia
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related Arthralgia
|
13 Subjects
|
5 Subjects
|
8 Subjects
|
6 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any Fatigue
|
29 Subjects
|
20 Subjects
|
28 Subjects
|
19 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 Fatigue
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related Fatigue
|
27 Subjects
|
15 Subjects
|
25 Subjects
|
16 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any Gastrointestinal
|
4 Subjects
|
2 Subjects
|
8 Subjects
|
4 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 Gastrointestinal
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related Gastrointestinal
|
4 Subjects
|
2 Subjects
|
7 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any Headache
|
24 Subjects
|
23 Subjects
|
32 Subjects
|
25 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 Headache
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related Headache
|
23 Subjects
|
16 Subjects
|
24 Subjects
|
18 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any Myalgia
|
19 Subjects
|
16 Subjects
|
17 Subjects
|
20 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 Myalgia
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related Myalgia
|
19 Subjects
|
14 Subjects
|
15 Subjects
|
16 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any Shivering
|
9 Subjects
|
13 Subjects
|
15 Subjects
|
9 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 Shivering
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related Shivering
|
9 Subjects
|
8 Subjects
|
12 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any Sweating
|
5 Subjects
|
3 Subjects
|
4 Subjects
|
9 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 Sweating
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related Sweating
|
5 Subjects
|
3 Subjects
|
3 Subjects
|
6 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Any Fever
|
11 Subjects
|
5 Subjects
|
7 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Grade 3 Fever
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Related Fever
|
10 Subjects
|
1 Subjects
|
6 Subjects
|
2 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (Days 0-364) following the first vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=66 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=66 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=110 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any Medically Attended Events (MAEs)
|
20 Subjects
|
21 Subjects
|
22 Subjects
|
34 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (Days 0-364) following first vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects.
pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=66 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=66 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=110 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: At Days 0, 21, 42, 182 and 189Population: The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects. Note: 1 subject moved out of the study area thereby withdrawing from the study at Days 182 and 189.
Subjects were categorized according to their results at pre-vaccination (PRE), Day 21, Day 42, Day 182 and Day 189 which were within normal, above normal, below the normal ranges or unknown. The laboratory parameters assessed were Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), Total Bilirubin, Creatinine, Hematocrit, Hemoglobin, Platelets, Blood urea nitrogen (BUN) and White blood cells (WBCs).
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=66 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=66 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=110 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ALAT, Day 0 Above
|
1 Subjects
|
1 Subjects
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ALAT, Day 21 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ALAT, Day 21 Below
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hematocrit, Day 182 Above
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ALAT, Day 21 Within
|
64 Subjects
|
64 Subjects
|
64 Subjects
|
108 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ALAT, Day 21 Above
|
2 Subjects
|
2 Subjects
|
4 Subjects
|
2 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ALAT, Day 42 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ALAT, Day 42 Below
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ALAT, Day 42 Within
|
64 Subjects
|
66 Subjects
|
66 Subjects
|
104 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ALAT, Day 42 Above
|
2 Subjects
|
0 Subjects
|
2 Subjects
|
6 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hematocrit, Day 189 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hematocrit, Day 189 Below
|
8 Subjects
|
3 Subjects
|
4 Subjects
|
8 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hematocrit, Day 189 Within
|
57 Subjects
|
62 Subjects
|
64 Subjects
|
102 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hematocrit, Day 189 Above
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hemoglobin, Day 0 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hemoglobin, Day 0 Below
|
10 Subjects
|
8 Subjects
|
8 Subjects
|
17 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ALAT, Day 0 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ALAT, Day 0 Below
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ALAT, Day 0 Within
|
65 Subjects
|
65 Subjects
|
66 Subjects
|
108 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ALAT, Day 182 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ALAT, Day 182 Below
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ALAT, Day 182 Within
|
64 Subjects
|
62 Subjects
|
67 Subjects
|
109 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ALAT, Day 182 Above
|
1 Subjects
|
3 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ALAT, Day 189 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ALAT, Day 189 Below
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ALAT, Day 189 Within
|
64 Subjects
|
61 Subjects
|
67 Subjects
|
110 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ALAT, Day 189 Above
|
1 Subjects
|
4 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ASAT, Day 0 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ASAT, Day 0 Below
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ASAT, Day 0 Within
|
63 Subjects
|
62 Subjects
|
64 Subjects
|
108 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ASAT, Day 0 Above
|
3 Subjects
|
4 Subjects
|
4 Subjects
|
2 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ASAT, Day 21 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ASAT, Day 21 Below
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ASAT, Day 21 Within
|
61 Subjects
|
61 Subjects
|
63 Subjects
|
104 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ASAT, Day 21 Above
|
5 Subjects
|
5 Subjects
|
5 Subjects
|
6 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ASAT, Day 42 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ASAT, Day 42 Below
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ASAT, Day 42 Within
|
65 Subjects
|
60 Subjects
|
67 Subjects
|
103 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ASAT, Day 42 Above
|
1 Subjects
|
6 Subjects
|
1 Subjects
|
7 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ASAT, Day 182 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ASAT, Day 182 Below
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ASAT, Day 182 Within
|
63 Subjects
|
61 Subjects
|
67 Subjects
|
110 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ASAT, Day 182 Above
|
2 Subjects
|
4 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ASAT, Day 189 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ASAT, Day 189 Below
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ASAT, Day 189 Within
|
64 Subjects
|
62 Subjects
|
67 Subjects
|
110 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
ASAT, Day 189 Above
|
1 Subjects
|
3 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Total Bilirubin, Day 0 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Total Bilirubin, Day 0 Below
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Total Bilirubin, Day 0 Within
|
21 Subjects
|
22 Subjects
|
19 Subjects
|
36 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Total Bilirubin, Day 0 Above
|
3 Subjects
|
1 Subjects
|
5 Subjects
|
3 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Total Bilirubin, Day 21 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Total Bilirubin, Day 21 Below
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Total Bilirubin, Day 21 Within
|
23 Subjects
|
21 Subjects
|
21 Subjects
|
34 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Total Bilirubin, Day 21 Above
|
1 Subjects
|
2 Subjects
|
3 Subjects
|
5 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Total Bilirubin, Day 42 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Total Bilirubin, Day 42 Below
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Total Bilirubin, Day 42 Within
|
22 Subjects
|
21 Subjects
|
20 Subjects
|
37 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Total Bilirubin, Day 42 Above
|
2 Subjects
|
2 Subjects
|
4 Subjects
|
2 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Total Bilirubin, Day 182 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Total Bilirubin, Day 182 Below
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Total Bilirubin, Day 182 Within
|
22 Subjects
|
21 Subjects
|
21 Subjects
|
36 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Total Bilirubin, Day 182 Above
|
2 Subjects
|
2 Subjects
|
3 Subjects
|
3 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Total Bilirubin, Day 189 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Total Bilirubin, Day 189 Below
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Total Bilirubin, Day 189 Within
|
22 Subjects
|
22 Subjects
|
21 Subjects
|
35 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Total Bilirubin, Day 189 Above
|
2 Subjects
|
1 Subjects
|
2 Subjects
|
4 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Creatinine, Day 0 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Creatinine, Day 0 Below
|
4 Subjects
|
2 Subjects
|
4 Subjects
|
5 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Creatinine, Day 0 Within
|
41 Subjects
|
47 Subjects
|
46 Subjects
|
77 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Creatinine, Day 0 Above
|
21 Subjects
|
17 Subjects
|
18 Subjects
|
28 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Creatinine, Day 21 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Creatinine, Day 21 Below
|
4 Subjects
|
5 Subjects
|
4 Subjects
|
8 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Creatinine, Day 21 Within
|
46 Subjects
|
48 Subjects
|
45 Subjects
|
74 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Creatinine, Day 21 Above
|
16 Subjects
|
13 Subjects
|
19 Subjects
|
28 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Creatinine, Day 42 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Creatinine, Day 42 Below
|
4 Subjects
|
3 Subjects
|
6 Subjects
|
7 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Creatinine, Day 42 Within
|
42 Subjects
|
48 Subjects
|
43 Subjects
|
80 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Creatinine, Day 42 Above
|
20 Subjects
|
15 Subjects
|
19 Subjects
|
23 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Creatinine, Day 182 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Creatinine, Day 182 Below
|
6 Subjects
|
5 Subjects
|
5 Subjects
|
5 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Creatinine, Day 182 Within
|
51 Subjects
|
52 Subjects
|
53 Subjects
|
94 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Creatinine, Day 182 Above
|
8 Subjects
|
8 Subjects
|
10 Subjects
|
11 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Creatinine, Day 189 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Creatinine, Day 189 Below
|
4 Subjects
|
6 Subjects
|
3 Subjects
|
6 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Creatinine, Day 189 Within
|
53 Subjects
|
54 Subjects
|
52 Subjects
|
91 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Creatinine, Day 189 Above
|
8 Subjects
|
5 Subjects
|
13 Subjects
|
13 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hematocrit, Day 0 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hematocrit, Day 0 Below
|
6 Subjects
|
6 Subjects
|
9 Subjects
|
11 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hematocrit, Day 0 Within
|
60 Subjects
|
59 Subjects
|
59 Subjects
|
99 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hematocrit, Day 0 Above
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hematocrit, Day 21 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hematocrit, Day 21 Below
|
6 Subjects
|
6 Subjects
|
6 Subjects
|
13 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hematocrit, Day 21 Within
|
59 Subjects
|
60 Subjects
|
61 Subjects
|
95 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hematocrit, Day 21 Above
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
2 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hematocrit, Day 42 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hematocrit, Day 42 Below
|
9 Subjects
|
6 Subjects
|
7 Subjects
|
13 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hematocrit, Day 42 Within
|
57 Subjects
|
60 Subjects
|
61 Subjects
|
96 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hematocrit, Day 42 Above
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hematocrit, Day 182 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hematocrit, Day 182 Below
|
10 Subjects
|
3 Subjects
|
6 Subjects
|
8 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hematocrit, Day 182 Within
|
55 Subjects
|
61 Subjects
|
62 Subjects
|
102 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hemoglobin, Day 0 Within
|
56 Subjects
|
57 Subjects
|
58 Subjects
|
92 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hemoglobin, Day 0 Above
|
0 Subjects
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hemoglobin, Day 21 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hemoglobin, Day 21 Below
|
11 Subjects
|
9 Subjects
|
7 Subjects
|
15 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hemoglobin, Day 21 Within
|
54 Subjects
|
56 Subjects
|
59 Subjects
|
93 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hemoglobin, Day 21 Above
|
1 Subjects
|
1 Subjects
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hemoglobin, Day 42 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hemoglobin, Day 42 Below
|
14 Subjects
|
8 Subjects
|
9 Subjects
|
13 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hemoglobin, Day 42 Within
|
51 Subjects
|
57 Subjects
|
58 Subjects
|
97 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hemoglobin, Day 42 Above
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hemoglobin, Day 182 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hemoglobin, Day 182 Below
|
10 Subjects
|
4 Subjects
|
6 Subjects
|
12 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hemoglobin, Day 182 Within
|
54 Subjects
|
60 Subjects
|
62 Subjects
|
98 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hemoglobin, Day 182 Above
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hemoglobin, Day 189 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hemoglobin, Day 189 Below
|
9 Subjects
|
3 Subjects
|
4 Subjects
|
14 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hemoglobin, Day 189 Within
|
55 Subjects
|
61 Subjects
|
64 Subjects
|
96 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Hemoglobin, Day 189 Above
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Platelets, Day 0 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Platelets, Day 0 Below
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Platelets, Day 0 Within
|
24 Subjects
|
23 Subjects
|
24 Subjects
|
39 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Platelets, Day 0 Above
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Platelets, Day 21 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Platelets, Day 21 Below
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Platelets, Day 21 Within
|
23 Subjects
|
23 Subjects
|
24 Subjects
|
37 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Platelets, Day 21 Above
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Platelets, Day 42 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Platelets, Day 42 Below
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Platelets, Day 42 Within
|
24 Subjects
|
23 Subjects
|
24 Subjects
|
39 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Platelets, Day 42 Above
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Platelets, Day 182 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Platelets, Day 182 Below
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Platelets, Day 182 Within
|
22 Subjects
|
23 Subjects
|
24 Subjects
|
39 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Platelets, Day 182 Above
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Platelets, Day 189 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Platelets, Day 189 Below
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Platelets, Day 189 Within
|
23 Subjects
|
22 Subjects
|
24 Subjects
|
39 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
Platelets, Day 189 Above
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
BUN, Day 0 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
BUN, Day 0 Below
|
3 Subjects
|
1 Subjects
|
3 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
BUN, Day 0 Within
|
60 Subjects
|
62 Subjects
|
63 Subjects
|
106 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
BUN, Day 0 Above
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
BUN, Day 21 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
BUN, Day 21 Below
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
BUN, Day 21 Within
|
63 Subjects
|
62 Subjects
|
66 Subjects
|
106 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
BUN, Day 21 Above
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
BUN, Day 42 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
BUN, Day 42 Below
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
BUN, Day 42 Within
|
64 Subjects
|
60 Subjects
|
65 Subjects
|
105 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
BUN, Day 42 Above
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
BUN, Day 182 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
BUN, Day 182 Below
|
0 Subjects
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
BUN, Day 182 Within
|
63 Subjects
|
61 Subjects
|
64 Subjects
|
106 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
BUN, Day 182 Above
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
BUN, Day 189 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
BUN, Day 189 Below
|
1 Subjects
|
3 Subjects
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
BUN, Day 189 Within
|
62 Subjects
|
59 Subjects
|
64 Subjects
|
104 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
BUN, Day 189 Above
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
WBCs, Day 0 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
WBCs, Day 0 Below
|
0 Subjects
|
3 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
WBCs, Day 0 Within
|
64 Subjects
|
54 Subjects
|
62 Subjects
|
104 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
WBCs, Day 0 Above
|
2 Subjects
|
9 Subjects
|
6 Subjects
|
5 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
WBCs, Day 21 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
WBCs, Day 21 Below
|
3 Subjects
|
0 Subjects
|
1 Subjects
|
2 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
WBCs, Day 21 Within
|
56 Subjects
|
60 Subjects
|
60 Subjects
|
103 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
WBCs, Day 21 Above
|
7 Subjects
|
6 Subjects
|
7 Subjects
|
5 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
WBCs, Day 42 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
WBCs, Day 42 Below
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
WBCs, Day 42 Within
|
63 Subjects
|
64 Subjects
|
64 Subjects
|
103 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
WBCs, Day 42 Above
|
2 Subjects
|
2 Subjects
|
4 Subjects
|
5 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
WBCs, Day 182 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
WBCs, Day 182 Below
|
1 Subjects
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
WBCs, Day 182 Within
|
62 Subjects
|
60 Subjects
|
64 Subjects
|
106 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
WBCs, Day 182 Above
|
2 Subjects
|
4 Subjects
|
2 Subjects
|
4 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
WBCs, Day 189 Unknown
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
WBCs, Day 189 Below
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
WBCs, Day 189 Within
|
62 Subjects
|
60 Subjects
|
61 Subjects
|
105 Subjects
|
|
Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges
WBCs, Day 189 Above
|
3 Subjects
|
3 Subjects
|
6 Subjects
|
4 Subjects
|
SECONDARY outcome
Timeframe: During the 42-day (Days 0-41) follow up period after first vaccination.Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
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 any symptom regardless of intensity or relationship to vaccination.
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=66 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=66 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=110 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any Unsolicited AEs
|
13 Subjects
|
19 Subjects
|
22 Subjects
|
39 Subjects
|
SECONDARY outcome
Timeframe: During the 21-day (Days 0-20) follow-up period after booster vaccination.Population: The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects. Note: 1 subject moved out of the study area thereby withdrawing from the study.
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 any symptom regardless of intensity or relationship to vaccination.
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=65 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=65 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=110 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any Unsolicited AEs
|
4 Subjects
|
7 Subjects
|
3 Subjects
|
6 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0 to Day 364)Population: The analysis was performed on the Total Vaccinated cohort included all vaccinated subjects.
SAEs: medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=66 Participants
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=66 Participants
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 Participants
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=110 Participants
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
|
2 Subjects
|
2 Subjects
|
1 Subjects
|
5 Subjects
|
Adverse Events
Arepanrix-adjuvanted F1 2D Group
Serious events: 2 serious events
Other events: 60 other events
Deaths: 0 deaths
Arepanrix-adjuvanted F2 2D Group
Serious events: 2 serious events
Other events: 59 other events
Deaths: 0 deaths
Arepanrix-adjuvanted F2 3D Group
Serious events: 1 serious events
Other events: 67 other events
Deaths: 0 deaths
Arepanrix-unadjuvanted F2 2D Group
Serious events: 5 serious events
Other events: 94 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=66 participants at risk
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=66 participants at risk
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 participants at risk
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=110 participants at risk
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/66 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.00%
0/66 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.00%
0/68 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.91%
1/110 • Number of events 1 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/66 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.00%
0/66 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.00%
0/68 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.91%
1/110 • Number of events 1 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/66 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.00%
0/66 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.00%
0/68 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.91%
1/110 • Number of events 1 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/66 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.00%
0/66 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.00%
0/68 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.91%
1/110 • Number of events 1 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
Psychiatric disorders
Suicide attempt
|
1.5%
1/66 • Number of events 1 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.00%
0/66 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.00%
0/68 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.00%
0/110 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/66 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
1.5%
1/66 • Number of events 1 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.00%
0/68 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.00%
0/110 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
Infections and infestations
Cystitis
|
1.5%
1/66 • Number of events 1 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.00%
0/66 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.00%
0/68 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.00%
0/110 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/66 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
1.5%
1/66 • Number of events 1 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.00%
0/68 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.00%
0/110 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/66 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.00%
0/66 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
1.5%
1/68 • Number of events 1 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.91%
1/110 • Number of events 1 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
Other adverse events
| Measure |
Arepanrix-adjuvanted F1 2D Group
n=66 participants at risk
Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 2D Group
n=66 participants at risk
Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
Arepanrix-adjuvanted F2 3D Group
n=68 participants at risk
Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
|
Arepanrix-unadjuvanted F2 2D Group
n=110 participants at risk
Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
|
|---|---|---|---|---|
|
General disorders
Pain (Primary phase)
|
78.8%
52/66 • Number of events 52 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
72.7%
48/66 • Number of events 48 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
89.7%
61/68 • Number of events 61 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
46.4%
51/110 • Number of events 51 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
General disorders
Swelling (Primary phase)
|
9.1%
6/66 • Number of events 6 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
7.6%
5/66 • Number of events 5 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
8.8%
6/68 • Number of events 6 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.91%
1/110 • Number of events 1 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
General disorders
Redness
|
6.2%
4/65 • Number of events 4 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
1.5%
1/65 • Number of events 1 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
1.5%
1/68 • Number of events 1 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.00%
0/110 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
General disorders
Arthralgia (Booster phase)
|
20.0%
13/65 • Number of events 13 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
12.3%
8/65 • Number of events 8 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
17.6%
12/68 • Number of events 12 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
7.3%
8/110 • Number of events 8 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
General disorders
Fatigue (Booster phase)
|
44.6%
29/65 • Number of events 29 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
30.8%
20/65 • Number of events 20 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
41.2%
28/68 • Number of events 28 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
32.7%
36/110 • Number of events 36 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
General disorders
Headache (Primary phase)
|
40.9%
27/66 • Number of events 27 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
31.8%
21/66 • Number of events 21 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
57.4%
39/68 • Number of events 39 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
40.9%
45/110 • Number of events 45 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
General disorders
Myalgia (Booster phase)
|
29.2%
19/65 • Number of events 19 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
24.6%
16/65 • Number of events 16 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
25.0%
17/68 • Number of events 17 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
18.2%
20/110 • Number of events 20 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
General disorders
Shivering (Primary phase)
|
9.1%
6/66 • Number of events 6 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
7.6%
5/66 • Number of events 5 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
11.8%
8/68 • Number of events 8 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
14.5%
16/110 • Number of events 16 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
General disorders
Sweating (Primary phase)
|
9.1%
6/66 • Number of events 6 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
12.1%
8/66 • Number of events 8 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
16.2%
11/68 • Number of events 11 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
13.6%
15/110 • Number of events 15 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
General disorders
Pain (Booster phase)
|
73.8%
48/65 • Number of events 48 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
61.5%
40/65 • Number of events 40 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
79.4%
54/68 • Number of events 54 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
44.5%
49/110 • Number of events 49 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
General disorders
Swelling (Booster phase)
|
9.2%
6/65 • Number of events 6 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
7.7%
5/65 • Number of events 5 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
4.4%
3/68 • Number of events 3 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
0.00%
0/110 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
General disorders
Arthralgia (Primary phase)
|
7.6%
5/66 • Number of events 5 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
10.6%
7/66 • Number of events 7 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
8.8%
6/68 • Number of events 6 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
11.8%
13/110 • Number of events 13 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
General disorders
Fatigue (Primary phase)
|
39.4%
26/66 • Number of events 26 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
28.8%
19/66 • Number of events 19 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
35.3%
24/68 • Number of events 24 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
32.7%
36/110 • Number of events 36 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
General disorders
Headache (Booster phase)
|
36.9%
24/65 • Number of events 24 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
35.4%
23/65 • Number of events 23 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
47.1%
32/68 • Number of events 32 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
22.7%
25/110 • Number of events 25 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
General disorders
Myalgia (Primary phase)
|
25.8%
17/66 • Number of events 17 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
30.3%
20/66 • Number of events 20 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
41.2%
28/68 • Number of events 28 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
19.1%
21/110 • Number of events 21 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
General disorders
Shivering (Booster phase)
|
13.8%
9/65 • Number of events 9 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
20.0%
13/65 • Number of events 13 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
22.1%
15/68 • Number of events 15 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
8.2%
9/110 • Number of events 9 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
General disorders
Sweating (Booster phase)
|
7.7%
5/65 • Number of events 5 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
4.6%
3/65 • Number of events 3 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
5.9%
4/68 • Number of events 4 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
8.2%
9/110 • Number of events 9 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
Gastrointestinal disorders
Gastrointestinal (Primary phase)
|
7.6%
5/66 • Number of events 5 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
4.5%
3/66 • Number of events 3 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
13.2%
9/68 • Number of events 9 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
7.3%
8/110 • Number of events 8 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
Gastrointestinal disorders
Gastrointestinal (Booster phase)
|
6.2%
4/65 • Number of events 4 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
3.1%
2/65 • Number of events 2 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
11.8%
8/68 • Number of events 8 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
4.5%
5/110 • Number of events 5 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
|
Infections and infestations
Fever
|
16.9%
11/65 • Number of events 11 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
7.7%
5/65 • Number of events 5 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
10.3%
7/68 • Number of events 7 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
1.8%
2/110 • Number of events 2 • SAEs were assessed throughout the study period (Days 0-364). Systematically frequent AEs were assessed 7 days after each vaccination and non-systematically frequent AEs were assessed 42 days after first vaccination and 21 days after booster vaccination.
1 subject moved out of the study area thereby withdrawing from the study in Arepanrix-adjuvanted F1 2D Group and Arepanrix-adjuvanted F2 2D Group, respectively.
|
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