Trial Outcomes & Findings for Safety and Immune Response of Candidate H1N1 Influenza Vaccine GSK2340274A Following Seasonal Influenza Vaccination in Adults (NCT NCT01059617)
NCT ID: NCT01059617
Last Updated: 2018-08-20
Results Overview
Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
133 participants
Primary outcome timeframe
21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).
Results posted on
2018-08-20
Participant Flow
Participant milestones
| Measure |
Flulaval/Arepanrix Group
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
34
|
33
|
33
|
|
Overall Study
COMPLETED
|
26
|
33
|
25
|
27
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
8
|
6
|
Reasons for withdrawal
| Measure |
Flulaval/Arepanrix Group
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Overall Study
Other
|
7
|
1
|
8
|
6
|
Baseline Characteristics
Safety and Immune Response of Candidate H1N1 Influenza Vaccine GSK2340274A Following Seasonal Influenza Vaccination in Adults
Baseline characteristics by cohort
| Measure |
Flulaval/Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=34 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=33 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Total
n=133 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
29.6 Years
STANDARD_DEVIATION 6.44 • n=5 Participants
|
29.0 Years
STANDARD_DEVIATION 7.05 • n=7 Participants
|
28.6 Years
STANDARD_DEVIATION 6.17 • n=5 Participants
|
29.8 Years
STANDARD_DEVIATION 7.24 • n=4 Participants
|
29.3 Years
STANDARD_DEVIATION 6.73 • n=21 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
72 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).Population: The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).
Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=21 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=25 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
|
21 Subjects
|
28 Subjects
|
25 Subjects
|
26 Subjects
|
PRIMARY outcome
Timeframe: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).Population: The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).
Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 40 against the tested vaccine virus.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=21 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=25 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Seroprotected Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
|
21 Subjects
|
33 Subjects
|
25 Subjects
|
27 Subjects
|
PRIMARY outcome
Timeframe: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 122 to Day 164).Population: The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).
Geometric mean fold-rise (GMFR), or seronversion 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 |
Flulaval/Arepanrix Group
n=21 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=25 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
|
40.3 Fold
Interval 22.9 to 71.2
|
20.8 Fold
Interval 12.5 to 34.6
|
57.4 Fold
Interval 31.6 to 104.2
|
25.8 Fold
Interval 15.9 to 41.8
|
PRIMARY outcome
Timeframe: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).Population: The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=21 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=25 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
|
21 Subjects
|
33 Subjects
|
25 Subjects
|
27 Subjects
|
PRIMARY outcome
Timeframe: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).Population: The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).
Titers were expressed as geometric mean antibody titers (GMTs).
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=21 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=25 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
|
650.7 Titers
Interval 485.5 to 872.1
|
259.4 Titers
Interval 186.4 to 361.0
|
799.0 Titers
Interval 630.5 to 1012.4
|
332.7 Titers
Interval 222.0 to 498.6
|
PRIMARY outcome
Timeframe: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).Population: The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).
VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=21 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=25 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
|
18 Subjects
|
21 Subjects
|
24 Subjects
|
20 Subjects
|
PRIMARY outcome
Timeframe: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).Population: The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).
Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer \< 1:10 and a post-vaccination reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=21 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=25 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
|
16 Subjects
|
18 Subjects
|
6 Subjects
|
2 Subjects
|
PRIMARY outcome
Timeframe: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).Population: The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).
Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 1:40 against the tested vaccine virus.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=21 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=25 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Seroprotected Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
|
20 Subjects
|
30 Subjects
|
18 Subjects
|
14 Subjects
|
PRIMARY outcome
Timeframe: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 122 to Day 164).Population: The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).
Geometric mean fold-rise (GMFR), or seronversion 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 |
Flulaval/Arepanrix Group
n=21 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=25 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
|
7.5 Fold increase
Interval 4.8 to 11.8
|
4.7 Fold increase
Interval 3.2 to 7.0
|
2.6 Fold increase
Interval 2.0 to 3.3
|
1.9 Fold increase
Interval 1.5 to 2.6
|
PRIMARY outcome
Timeframe: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).Population: The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=21 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=25 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
|
21 Subjects
|
33 Subjects
|
24 Subjects
|
27 Subjects
|
PRIMARY outcome
Timeframe: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).Population: The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).
Titers were expressed as geometric mean antibody titers (GMTs).
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=21 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=25 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
|
144.9 Titers
Interval 97.2 to 216.1
|
123.1 Titers
Interval 87.1 to 174.0
|
49.2 Titers
Interval 33.9 to 71.2
|
35.2 Titers
Interval 25.7 to 48.2
|
PRIMARY outcome
Timeframe: 21 days following the second dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccines (At Day 164).Population: The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).
VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=21 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=25 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
|
17 Subjects
|
18 Subjects
|
8 Subjects
|
3 Subjects
|
SECONDARY outcome
Timeframe: At Day 122 and Day 304Population: The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 304.
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=21 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=32 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=21 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
>=1:10 Flu A/CAL/7/09 H1N1 Day 122 (N=21;32;21;27)
|
12 Subjects
|
14 Subjects
|
11 Subjects
|
13 Subjects
|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
>=1:10 Flu A/CAL/7/09 H1N1 Day 304 (N=21;32;21;27)
|
21 Subjects
|
32 Subjects
|
21 Subjects
|
27 Subjects
|
SECONDARY outcome
Timeframe: At Days 122 and 304Population: The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 304.
Titers were expressed as geometric mean antibody titers (GMTs).
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=21 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=32 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=21 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
GMT Flu A/CAL/7/09 H1N1 Day 122
|
16.1 Titers
Interval 8.9 to 29.3
|
12.8 Titers
Interval 7.8 to 21.0
|
15.6 Titers
Interval 8.2 to 29.5
|
12.9 Titers
Interval 8.1 to 20.7
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
GMT Flu A/CAL/7/09 H1N1 Day 304
|
157.4 Titers
Interval 98.2 to 252.2
|
100.3 Titers
Interval 68.0 to 148.2
|
289.9 Titers
Interval 188.2 to 446.6
|
116.0 Titers
Interval 72.7 to 185.2
|
SECONDARY outcome
Timeframe: Entire study period up to Day 507Population: The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at Day 304.
VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=21 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=32 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=21 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
|
13 Subjects
|
14 Subjects
|
17 Subjects
|
17 Subjects
|
SECONDARY outcome
Timeframe: At Days 0 and 304Population: The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 304.
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=21 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=32 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=21 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
>=1:10 Flu A/BRI/59/07 H1N1 Day 0 (N=21;32;21;27)
|
18 Subjects
|
29 Subjects
|
20 Subjects
|
22 Subjects
|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
>=1:10 Flu A/BRI/59/07 H1N1 Day 304 (N=21;32;21;27
|
21 Subjects
|
32 Subjects
|
21 Subjects
|
27 Subjects
|
SECONDARY outcome
Timeframe: At Day 0 and Day 304Population: The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen for blood sample taken at Day 304.
Titers were expressed as geometric mean antibody titers (GMTs).
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=21 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=32 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=21 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
GMT Flu A/BRI/59/07 H1N1 Day 0
|
19.3 Titers
Interval 13.2 to 28.2
|
25.6 Titers
Interval 17.2 to 37.9
|
21.6 Titers
Interval 15.4 to 30.4
|
18.2 Titers
Interval 12.4 to 26.7
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
GMT Flu A/BRI/59/07 H1N1 Day 304
|
129.0 Titers
Interval 89.8 to 185.2
|
114.4 Titers
Interval 80.0 to 163.4
|
48.0 Titers
Interval 35.5 to 64.9
|
37.0 Titers
Interval 25.5 to 53.7
|
SECONDARY outcome
Timeframe: For the entire study period up to Day 507Population: The According-To-Protocol cohort for immunogenicity at Day 304 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at Day 304.
VRR for microneutralization titers was defined as the incidence rate of vaccinees with at least a 4-fold increase in post vaccination reciprocal titer relative to Day 0. The cut-off value for microneutralization titers is 1:28.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=21 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=32 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=21 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Vaccine Response Rate (VRR) for Microneutralization (MN) Antibodies Titers Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
|
14 Subjects
|
16 Subjects
|
3 Subjects
|
7 Subjects
|
SECONDARY outcome
Timeframe: Before administration of Arepanrix vaccine (Day 0 to Day 122)Population: The ATP cohort for immunogenicity at Day 164 included subjects who received protocol specified vaccine(s) during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after second H1N1 vaccine dose (Day 164). Subjects with missing results were not included.
CD4 T cell-mediated immune responses against the antigens A/California/7/2009, A/Brisbane/59/2007 and A/Uruguay/716/2007 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin-2, Tumor Necrosis Factor alpha or Interferon-gamma. The frequency was presented as number of cytokine-producing CD4+ cells per million CD4+ cells. All doubles= T cell expressing at least 2 cytokines. Subjects with missing results were not included.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=44 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=43 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 Double CD40L, Day 0 [N=41,41]
|
1134.0 cells/million T cells
Interval 824.0 to 1749.0
|
1076.0 cells/million T cells
Interval 635.0 to 1444.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 Double CD40L, Day 7 [N=43,41]
|
1521.0 cells/million T cells
Interval 1009.0 to 2191.0
|
1076.0 cells/million T cells
Interval 595.0 to 1571.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 Double CD40L, Day 14 [N=44,42]
|
1585.5 cells/million T cells
Interval 1157.0 to 2553.0
|
809.0 cells/million T cells
Interval 656.0 to 1692.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 Double CD40L, Day 21 [N=41,43]
|
1504.0 cells/million T cells
Interval 1071.0 to 2144.0
|
1060.0 cells/million T cells
Interval 655.0 to 1569.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 Double CD40L, Day 122 [N=40,42]
|
1402.0 cells/million T cells
Interval 844.0 to 1796.0
|
1033.5 cells/million T cells
Interval 540.0 to 1358.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 Double CD40L, Day 0 [N=41,41]
|
1283.0 cells/million T cells
Interval 813.0 to 2123.0
|
1135.0 cells/million T cells
Interval 883.0 to 1915.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 Double CD40L, Day 7 [N=42,40]
|
1598.5 cells/million T cells
Interval 1312.0 to 3071.0
|
1436.5 cells/million T cells
Interval 857.0 to 2035.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 Double CD40L, Day 14 [N=43,43]
|
1952.0 cells/million T cells
Interval 1260.0 to 3155.0
|
1356.0 cells/million T cells
Interval 753.0 to 2138.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 Double CD40L, Day 21 [N=41,43]
|
1955.0 cells/million T cells
Interval 1304.0 to 2614.0
|
1296.0 cells/million T cells
Interval 927.0 to 1925.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 Double CD40L, Day 122 [N=41,40]
|
1494.0 cells/million T cells
Interval 1066.0 to 2092.0
|
1051.0 cells/million T cells
Interval 717.0 to 1766.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double IFNg, Day 0 [N=41,41]
|
1441.0 cells/million T cells
Interval 1040.0 to 1900.0
|
1161.0 cells/million T cells
Interval 745.0 to 1868.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double IFNg, Day 7 [N=43,41]
|
1964.0 cells/million T cells
Interval 1236.0 to 3008.0
|
1231.0 cells/million T cells
Interval 1033.0 to 2016.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double IFNg, Day 14 [N=44,43]
|
2148.0 cells/million T cells
Interval 1591.0 to 2778.0
|
1196.0 cells/million T cells
Interval 776.0 to 1729.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double IFNg, Day 21 [N=41,43]
|
1973.0 cells/million T cells
Interval 1283.0 to 2858.0
|
1121.0 cells/million T cells
Interval 903.0 to 1903.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double IFNg, Day 122 [N=41,42]
|
1535.0 cells/million T cells
Interval 1146.0 to 2205.0
|
1181.0 cells/million T cells
Interval 742.0 to 1883.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 Double IFNg, Day 0 [N=41,41]
|
913.0 cells/million T cells
Interval 646.0 to 1444.0
|
823.0 cells/million T cells
Interval 577.0 to 1222.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 Double IFNg, Day 7 [N=43,41]
|
1307.0 cells/million T cells
Interval 912.0 to 2073.0
|
1000.0 cells/million T cells
Interval 604.0 to 1306.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 Double IFNg, Day 14 [N=44,43]
|
1453.0 cells/million T cells
Interval 1139.5 to 1992.0
|
808.0 cells/million T cells
Interval 368.0 to 1260.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 Double IFNg, Day 21 [N=41,42]
|
1398.0 cells/million T cells
Interval 1035.0 to 1773.0
|
943.5 cells/million T cells
Interval 499.0 to 1402.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 Double IFNg, Day 122 [N=41,42]
|
1019.0 cells/million T cells
Interval 703.0 to 1579.0
|
910.0 cells/million T cells
Interval 422.0 to 1193.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 Double IFNg, Day 0 [N=41,41]
|
1073.0 cells/million T cells
Interval 725.0 to 1538.0
|
962.0 cells/million T cells
Interval 552.0 to 1478.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 Double IFNg, Day 7 [N=43,41]
|
1460.0 cells/million T cells
Interval 1019.0 to 2011.0
|
1027.0 cells/million T cells
Interval 663.0 to 1323.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 Double IFNg, Day 14 [N=44,42]
|
1463.0 cells/million T cells
Interval 1077.0 to 2289.5
|
842.0 cells/million T cells
Interval 538.0 to 1539.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 Double IFNg, Day 21 [N=41,43]
|
1361.0 cells/million T cells
Interval 941.0 to 2070.0
|
1005.0 cells/million T cells
Interval 557.0 to 1528.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 Double IFNg, Day 122 [N=40,42]
|
1230.0 cells/million T cells
Interval 734.0 to 1571.5
|
1009.0 cells/million T cells
Interval 464.0 to 1290.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 Double IFNg, Day 0 [N=41,41]
|
1158.0 cells/million T cells
Interval 886.0 to 2090.0
|
1124.0 cells/million T cells
Interval 740.0 to 1970.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 Double IFNg, Day 7 [N=42,40]
|
1532.5 cells/million T cells
Interval 1288.0 to 2787.0
|
1406.5 cells/million T cells
Interval 832.5 to 2205.5
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 Double IFNg, Day 14 [N=43,43]
|
1790.0 cells/million T cells
Interval 1313.0 to 2911.0
|
1281.0 cells/million T cells
Interval 771.0 to 2192.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 Double IFNg, Day 21 [N=41,43]
|
1752.0 cells/million T cells
Interval 1410.0 to 2635.0
|
1262.0 cells/million T cells
Interval 981.0 to 2227.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 Double IFNg, Day 122 [N=41,40]
|
1222.0 cells/million T cells
Interval 1023.0 to 1812.0
|
1109.5 cells/million T cells
Interval 741.5 to 1876.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double IL-2, Day 0 [N=41,41]
|
1464.0 cells/million T cells
Interval 946.0 to 1835.0
|
1220.0 cells/million T cells
Interval 966.0 to 1926.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double IL-2, Day 7 [N=43,41]
|
2089.0 cells/million T cells
Interval 1260.0 to 2887.0
|
1347.0 cells/million T cells
Interval 1068.0 to 2058.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double IL-2, Day 14 [N=44,43]
|
2255.0 cells/million T cells
Interval 1683.0 to 2705.0
|
1284.0 cells/million T cells
Interval 797.0 to 1643.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double IL-2, Day 21 [N=41,43]
|
1991.0 cells/million T cells
Interval 1420.0 to 2898.0
|
1427.0 cells/million T cells
Interval 884.0 to 2037.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double IL-2, Day 122 [N=41,42]
|
1585.0 cells/million T cells
Interval 1038.0 to 2400.0
|
1323.5 cells/million T cells
Interval 858.0 to 1831.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 Double IL-2, Day 0 [N=41,41]
|
1103.0 cells/million T cells
Interval 740.0 to 1810.0
|
855.0 cells/million T cells
Interval 565.0 to 1456.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 Double IL-2, Day 7 [N=43,41]
|
1370.0 cells/million T cells
Interval 888.0 to 2256.0
|
1001.0 cells/million T cells
Interval 738.0 to 1604.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 Double IL-2, Day 14 [N=44,44]
|
1590.0 cells/million T cells
Interval 1222.5 to 2222.5
|
1010.0 cells/million T cells
Interval 520.0 to 1282.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 Double IL-2, Day 21 [N=41,42]
|
1299.0 cells/million T cells
Interval 1011.0 to 2036.0
|
1061.0 cells/million T cells
Interval 659.0 to 1504.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 Double IL-2, Day 122 [N=41,42]
|
1252.0 cells/million T cells
Interval 764.0 to 1801.0
|
835.0 cells/million T cells
Interval 442.0 to 1292.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 Double IL-2, Day 0 [N=41,41]
|
1092.0 cells/million T cells
Interval 701.0 to 1516.0
|
939.0 cells/million T cells
Interval 645.0 to 1439.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 Double IL-2, Day 7 [N=43,41]
|
1375.0 cells/million T cells
Interval 818.0 to 2300.0
|
1116.0 cells/million T cells
Interval 594.0 to 1475.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 Double IL-2, Day 14 [N=44,42]
|
1598.0 cells/million T cells
Interval 1042.0 to 2365.5
|
975.0 cells/million T cells
Interval 585.0 to 1584.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 Double IL-2, Day 21 [N=41,43]
|
1406.0 cells/million T cells
Interval 942.0 to 2074.0
|
1168.0 cells/million T cells
Interval 612.0 to 1552.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 Double IL-2, Day 122 [N=40,42]
|
1276.5 cells/million T cells
Interval 759.0 to 1920.5
|
1049.0 cells/million T cells
Interval 525.0 to 1280.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 Double IL-2, Day 0 [N=41,41]
|
1191.0 cells/million T cells
Interval 663.0 to 1787.0
|
1110.0 cells/million T cells
Interval 777.0 to 1834.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 Double IL-2, Day 7 [N=42,40]
|
1677.0 cells/million T cells
Interval 1154.0 to 2536.0
|
1442.5 cells/million T cells
Interval 823.5 to 1887.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 Double IL-2, Day 14 [N=43,43]
|
1879.0 cells/million T cells
Interval 1369.0 to 2887.0
|
1242.0 cells/million T cells
Interval 677.0 to 1884.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 Double IL-2, Day 21 [N=41,43]
|
1784.0 cells/million T cells
Interval 1464.0 to 2642.0
|
1336.0 cells/million T cells
Interval 873.0 to 1985.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 Double IL-2, Day 122 [N=41,40]
|
1378.0 cells/million T cells
Interval 896.0 to 1887.0
|
961.5 cells/million T cells
Interval 648.0 to 1626.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double TNF-a, Day 0 [N=41,41]
|
1339.0 cells/million T cells
Interval 899.0 to 1615.0
|
1153.0 cells/million T cells
Interval 749.0 to 1757.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double TNF-a, Day 7 [N=43,41]
|
1751.0 cells/million T cells
Interval 908.0 to 2315.0
|
1201.0 cells/million T cells
Interval 868.0 to 1879.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double TNF-a, Day 14 [N=44,43]
|
1849.0 cells/million T cells
Interval 1164.5 to 2332.5
|
1032.0 cells/million T cells
Interval 554.0 to 1747.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double TNF-a, Day 21 [N=41,43]
|
1474.0 cells/million T cells
Interval 1027.0 to 2499.0
|
1142.0 cells/million T cells
Interval 768.0 to 1798.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double TNF-a, Day 122 [N=41,42]
|
1281.0 cells/million T cells
Interval 862.0 to 1781.0
|
1153.0 cells/million T cells
Interval 564.0 to 1796.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 Double TNF-a, Day 0 [N=41,41]
|
1015.0 cells/million T cells
Interval 751.0 to 1476.0
|
867.0 cells/million T cells
Interval 525.0 to 1249.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 Double TNF-a, Day 7 [N=43,41]
|
1245.0 cells/million T cells
Interval 592.0 to 1820.0
|
976.0 cells/million T cells
Interval 576.0 to 1279.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 Double TNF-a, Day 14 [N=44,43]
|
1338.0 cells/million T cells
Interval 913.5 to 2042.0
|
816.0 cells/million T cells
Interval 481.0 to 1350.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 Double TNF-a, Day 21 [N=41,42]
|
1209.0 cells/million T cells
Interval 816.0 to 1798.0
|
936.0 cells/million T cells
Interval 503.0 to 1318.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 Double TNF-a, Day 122 [N=42,41]
|
1016.0 cells/million T cells
Interval 606.0 to 1617.0
|
651.0 cells/million T cells
Interval 411.0 to 1234.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 Double TNF-a, Day 0 [N=41,41]
|
920.0 cells/million T cells
Interval 631.0 to 1294.0
|
786.0 cells/million T cells
Interval 561.0 to 1317.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 Double TNF-a, Day 7 [N=43,41]
|
1186.0 cells/million T cells
Interval 586.0 to 1770.0
|
986.0 cells/million T cells
Interval 570.0 to 1338.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 Double TNF-a, Day 14 [N=44,43]
|
1104.0 cells/million T cells
Interval 818.0 to 1961.0
|
756.0 cells/million T cells
Interval 374.0 to 1440.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 Double TNF-a, Day 21 [N=41,43]
|
1133.0 cells/million T cells
Interval 694.0 to 1854.0
|
909.0 cells/million T cells
Interval 498.0 to 1378.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 Double TNF-a, Day 122 [N=40,42]
|
1104.5 cells/million T cells
Interval 631.5 to 1518.5
|
849.5 cells/million T cells
Interval 493.0 to 1218.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 Double TNF-a, Day 0 [N=41,41]
|
986.0 cells/million T cells
Interval 606.0 to 1426.0
|
875.0 cells/million T cells
Interval 573.0 to 1751.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 Double TNF-a, Day 7 [N=42,40]
|
1093.5 cells/million T cells
Interval 729.0 to 1731.0
|
1037.5 cells/million T cells
Interval 594.0 to 1559.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 Double TNF-a, Day 14 [N=43,43]
|
1408.0 cells/million T cells
Interval 944.0 to 2062.0
|
970.0 cells/million T cells
Interval 582.0 to 1692.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 Double TNF-a, Day 21 [N=41,43]
|
1275.0 cells/million T cells
Interval 859.0 to 1929.0
|
900.0 cells/million T cells
Interval 555.0 to 1615.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 Double TNF-a, Day 122 [N=41,40]
|
1020.0 cells/million T cells
Interval 640.0 to 1439.0
|
748.0 cells/million T cells
Interval 417.5 to 1299.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 All doubles, Day 0 [N=41,41]
|
1699.0 cells/million T cells
Interval 1366.0 to 2352.0
|
1622.0 cells/million T cells
Interval 1070.0 to 2492.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 All doubles, Day 7 [N=43,41]
|
2559.0 cells/million T cells
Interval 1446.0 to 3449.0
|
1649.0 cells/million T cells
Interval 1260.0 to 2440.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 All doubles, Day 14 [N=44,43]
|
2648.5 cells/million T cells
Interval 1994.0 to 3252.5
|
1553.0 cells/million T cells
Interval 953.0 to 2024.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 All doubles, Day 21 [N=41,43]
|
2496.0 cells/million T cells
Interval 1754.0 to 3662.0
|
1599.0 cells/million T cells
Interval 1144.0 to 2366.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 All doubles, Day 122 [N=41,42]
|
1777.0 cells/million T cells
Interval 1277.0 to 2652.0
|
1600.0 cells/million T cells
Interval 1031.0 to 2253.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 All doubles, Day 0 [N=41,41]
|
1331.0 cells/million T cells
Interval 939.0 to 2082.0
|
1073.0 cells/million T cells
Interval 795.0 to 1631.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 All doubles, Day 7 [N=43,41]
|
1746.0 cells/million T cells
Interval 1041.0 to 2590.0
|
1209.0 cells/million T cells
Interval 792.0 to 1723.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 All doubles, Day 14 [N=44,43]
|
1917.5 cells/million T cells
Interval 1385.5 to 2673.0
|
1133.0 cells/million T cells
Interval 653.0 to 1515.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 All doubles, Day 21 [N=41,42]
|
1693.0 cells/million T cells
Interval 1243.0 to 2325.0
|
1267.0 cells/million T cells
Interval 742.0 to 1785.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 All doubles, Day 122 [N=41,42]
|
1534.0 cells/million T cells
Interval 973.0 to 2217.0
|
970.0 cells/million T cells
Interval 620.0 to 1530.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 All doubles, Day 0 [N=41,41]
|
1318.0 cells/million T cells
Interval 851.0 to 1903.0
|
1131.0 cells/million T cells
Interval 732.0 to 1723.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 All doubles, Day 7 [N=43,41]
|
1751.0 cells/million T cells
Interval 1091.0 to 2659.0
|
1292.0 cells/million T cells
Interval 694.0 to 1692.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 All doubles, Day 14 [N=44,42]
|
1807.0 cells/million T cells
Interval 1320.5 to 2845.0
|
1093.5 cells/million T cells
Interval 673.0 to 1913.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 All doubles, Day 21 [N=41,43]
|
1699.0 cells/million T cells
Interval 1187.0 to 2590.0
|
1245.0 cells/million T cells
Interval 746.0 to 1734.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 All doubles, Day 122 [N=40,42]
|
1583.0 cells/million T cells
Interval 949.5 to 2183.0
|
1196.5 cells/million T cells
Interval 575.0 to 1540.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 All doubles, Day 0 [N=41,41]
|
1339.0 cells/million T cells
Interval 936.0 to 2297.0
|
1317.0 cells/million T cells
Interval 935.0 to 2251.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 All doubles, Day 7 [N=42,40]
|
1884.5 cells/million T cells
Interval 1465.0 to 3254.0
|
1764.5 cells/million T cells
Interval 928.5 to 2370.5
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 All doubles, Day 14 [N=43,43]
|
2264.0 cells/million T cells
Interval 1656.0 to 3562.0
|
1567.0 cells/million T cells
Interval 849.0 to 2394.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 All doubles, Day 21 [N=41,43]
|
2212.0 cells/million T cells
Interval 1633.0 to 3137.0
|
1520.0 cells/million T cells
Interval 1020.0 to 2465.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 All doubles, Day 122 [N=41,40]
|
1688.0 cells/million T cells
Interval 1106.0 to 2205.0
|
1150.0 cells/million T cells
Interval 798.0 to 1998.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double CD40L, Day 0 [N=41,41]
|
1549.0 cells/million T cells
Interval 1258.0 to 2252.0
|
1394.0 cells/million T cells
Interval 1011.0 to 2033.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double CD40L, Day 7 [N=43,41]
|
2443.0 cells/million T cells
Interval 1360.0 to 3244.0
|
1457.0 cells/million T cells
Interval 1126.0 to 2255.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double CD40L, Day 14 [N=44,43]
|
2323.5 cells/million T cells
Interval 1714.0 to 3056.5
|
1369.0 cells/million T cells
Interval 867.0 to 1787.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double CD40L, Day 21 [N=41,43]
|
2187.0 cells/million T cells
Interval 1480.0 to 3291.0
|
1453.0 cells/million T cells
Interval 1023.0 to 2112.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double CD40L, Day 122 [N=41,42]
|
1735.0 cells/million T cells
Interval 1178.0 to 2540.0
|
1404.0 cells/million T cells
Interval 944.0 to 2022.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 Double CD40L, Day 0 [N=41,41]
|
1070.0 cells/million T cells
Interval 824.0 to 1784.0
|
942.0 cells/million T cells
Interval 717.0 to 1209.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 Double CD40L, Day 7 [N=43,41]
|
1337.0 cells/million T cells
Interval 885.0 to 2291.0
|
1077.0 cells/million T cells
Interval 708.0 to 1321.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 Double CD40L, Day 14 [N=44,43]
|
1734.5 cells/million T cells
Interval 1097.5 to 2452.5
|
936.0 cells/million T cells
Interval 520.0 to 1303.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 Double CD40L, Day 21 [N=41,42]
|
1336.0 cells/million T cells
Interval 1073.0 to 2220.0
|
1010.0 cells/million T cells
Interval 542.0 to 1527.0
|
—
|
—
|
|
Cell-mediated Immunogenicity (CMI) in Terms of T-cell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California, CD4 Double CD40L, Day 122 [N=41,42]
|
1355.0 cells/million T cells
Interval 816.0 to 1932.0
|
846.0 cells/million T cells
Interval 426.0 to 1389.0
|
—
|
—
|
SECONDARY outcome
Timeframe: After the administration of Arepanrix vaccine (Day 125 to 304)Population: The According-To-Protocol cohort for immunogenicity at Day 304 included all evaluable subjects who had not received a vaccine not specified or forbidden in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen for the blood sample taken at Day 304.
CD4 T cell-mediated immune responses against the antigens A/California/7/2009, A/Brisbane/59/2007 and A/Uruguay/716/2007 were analyzed for cells expressing at least 2 of the following immune markers: CD40 Ligand, Interleukin2, Tumor Necrosis Factor alpha or Interferongamma. The frequency was presented as number of cytokineproducing CD4+ cells per million CD4+ cells. All doubles= T cell expressing at least 2 cytokines.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=18 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=28 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=23 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 All doubles,Day 125[N=14,22,16,17]
|
1582.5 cells/million T cells
Interval 1008.0 to 2074.0
|
1652.0 cells/million T cells
Interval 1211.0 to 2082.0
|
1332.0 cells/million T cells
Interval 691.5 to 1795.5
|
1252.0 cells/million T cells
Interval 1005.0 to 2103.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 All doubles,Day 129[N=17,25,23,22]
|
1750.0 cells/million T cells
Interval 1453.0 to 2641.0
|
2099.0 cells/million T cells
Interval 1525.0 to 2403.0
|
1950.0 cells/million T cells
Interval 1394.0 to 3218.0
|
1907.0 cells/million T cells
Interval 1248.0 to 2820.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 All doubles,Day 136[N=14,22,16,17]
|
2683.0 cells/million T cells
Interval 1863.0 to 3769.0
|
2288.5 cells/million T cells
Interval 1945.5 to 3136.5
|
2546.5 cells/million T cells
Interval 1938.5 to 4540.0
|
2289.0 cells/million T cells
Interval 1560.0 to 3105.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 All doubles,Day 143[N=17,27,20,18]
|
2330.0 cells/million T cells
Interval 1642.0 to 3117.0
|
2393.0 cells/million T cells
Interval 1771.0 to 3336.0
|
2535.5 cells/million T cells
Interval 1886.5 to 3980.0
|
2310.0 cells/million T cells
Interval 1573.0 to 2668.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 All doubles,Day 150[N=16,22,23,22]
|
2690.5 cells/million T cells
Interval 1891.0 to 3282.0
|
2380.0 cells/million T cells
Interval 1651.0 to 2754.0
|
3272.0 cells/million T cells
Interval 1882.0 to 4328.0
|
2200.5 cells/million T cells
Interval 1466.0 to 2756.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 All doubles,Day 157[N=17,22,20,18]
|
3136.0 cells/million T cells
Interval 2389.0 to 3827.0
|
2178.0 cells/million T cells
Interval 1825.0 to 2949.0
|
2981.0 cells/million T cells
Interval 2435.0 to 4139.0
|
2362.5 cells/million T cells
Interval 1549.0 to 2778.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 All doubles,Day 164[N=16,20,19,21]
|
2906.5 cells/million T cells
Interval 1523.0 to 3923.0
|
2316.5 cells/million T cells
Interval 1642.5 to 3041.0
|
2971.0 cells/million T cells
Interval 2069.0 to 4510.0
|
1838.0 cells/million T cells
Interval 1293.0 to 2769.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 All doubles,Day 304[N=18,28,19,27]
|
2041.0 cells/million T cells
Interval 1658.0 to 2727.0
|
1945.5 cells/million T cells
Interval 1458.0 to 2414.5
|
2115.0 cells/million T cells
Interval 1613.0 to 3136.0
|
1797.0 cells/million T cells
Interval 1195.0 to 2338.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 All doubles,Day 125[N=14,21,15,17
|
1066.0 cells/million T cells
Interval 662.0 to 1730.0
|
1097.0 cells/million T cells
Interval 848.0 to 1531.0
|
1146.0 cells/million T cells
Interval 383.0 to 1574.0
|
1115.0 cells/million T cells
Interval 681.0 to 1444.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 All doubles,Day 129[N=17,26,23,22
|
1458.0 cells/million T cells
Interval 1148.0 to 1859.0
|
1576.0 cells/million T cells
Interval 1065.0 to 1764.0
|
1765.0 cells/million T cells
Interval 1111.0 to 2931.0
|
1457.0 cells/million T cells
Interval 1102.0 to 2034.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 All doubles,Day 136[N=18,24,20,22
|
2340.5 cells/million T cells
Interval 1527.0 to 2820.0
|
1779.0 cells/million T cells
Interval 1473.5 to 2074.0
|
2550.5 cells/million T cells
Interval 2017.0 to 4239.5
|
1831.5 cells/million T cells
Interval 1091.0 to 2597.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 All doubles,Day 143[N=17,27,20,18
|
1893.0 cells/million T cells
Interval 1281.0 to 2411.0
|
1735.0 cells/million T cells
Interval 1241.0 to 2310.0
|
2544.0 cells/million T cells
Interval 1910.0 to 4303.5
|
1828.0 cells/million T cells
Interval 1224.0 to 2088.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 All doubles,Day 150[N=16,22,23,21
|
2549.5 cells/million T cells
Interval 1732.5 to 3570.5
|
1918.5 cells/million T cells
Interval 1625.0 to 2043.0
|
3308.0 cells/million T cells
Interval 2028.0 to 4910.0
|
1653.0 cells/million T cells
Interval 980.0 to 2085.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 All doubles,Day 157[N=17,22,20,18
|
2685.0 cells/million T cells
Interval 2296.0 to 3163.0
|
1760.5 cells/million T cells
Interval 1287.0 to 1987.0
|
2971.0 cells/million T cells
Interval 2395.5 to 4264.0
|
1425.5 cells/million T cells
Interval 1107.0 to 2045.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 All doubles,Day 164[N=16,19,19,21
|
2590.0 cells/million T cells
Interval 1566.0 to 3212.0
|
1692.0 cells/million T cells
Interval 1322.0 to 2404.0
|
3168.0 cells/million T cells
Interval 2204.0 to 5242.0
|
1409.0 cells/million T cells
Interval 1012.0 to 1638.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 All doubles,Day 304[N=18,28,19,27
|
1616.0 cells/million T cells
Interval 1352.0 to 2202.0
|
1392.5 cells/million T cells
Interval 1250.5 to 1982.5
|
2138.0 cells/million T cells
Interval 1363.0 to 2493.0
|
1358.0 cells/million T cells
Interval 940.0 to 1791.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 All doubles, Day 125[N=14,21,16,17]
|
1237.5 cells/million T cells
Interval 658.0 to 1899.0
|
998.0 cells/million T cells
Interval 814.0 to 1314.0
|
1094.5 cells/million T cells
Interval 438.0 to 1655.5
|
990.0 cells/million T cells
Interval 644.0 to 1389.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 All doubles, Day 129[N=17,26,21,22]
|
1381.0 cells/million T cells
Interval 996.0 to 1793.0
|
1215.0 cells/million T cells
Interval 829.0 to 1857.0
|
1239.0 cells/million T cells
Interval 1031.0 to 1942.0
|
1176.5 cells/million T cells
Interval 737.0 to 1528.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 All doubles, Day 136[N=18,24,20,22]
|
1791.5 cells/million T cells
Interval 1119.0 to 2198.0
|
1576.0 cells/million T cells
Interval 1109.5 to 1929.0
|
1738.5 cells/million T cells
Interval 1164.5 to 2584.0
|
1555.0 cells/million T cells
Interval 944.0 to 1995.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 All doubles, Day 143[N=16,27,20,18]
|
1661.0 cells/million T cells
Interval 1067.0 to 2078.5
|
1566.0 cells/million T cells
Interval 989.0 to 1863.0
|
1999.0 cells/million T cells
Interval 1262.5 to 2659.0
|
1425.0 cells/million T cells
Interval 1075.0 to 1825.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 All doubles, Day 150[N=16,21,23,22]
|
1921.5 cells/million T cells
Interval 1089.5 to 2633.5
|
1391.0 cells/million T cells
Interval 1197.0 to 1878.0
|
2156.0 cells/million T cells
Interval 1340.0 to 2611.0
|
1308.5 cells/million T cells
Interval 774.0 to 2052.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 All doubles, Day 157[N=17,21,20,18]
|
1924.0 cells/million T cells
Interval 1331.0 to 2549.0
|
1468.0 cells/million T cells
Interval 1210.0 to 1972.0
|
1836.0 cells/million T cells
Interval 1379.5 to 3092.0
|
1510.0 cells/million T cells
Interval 842.0 to 1920.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 All doubles, Day 164[N=16,19,19,21]
|
1870.0 cells/million T cells
Interval 1288.5 to 2622.0
|
1287.0 cells/million T cells
Interval 850.0 to 2133.0
|
2167.0 cells/million T cells
Interval 1676.0 to 3672.0
|
1251.0 cells/million T cells
Interval 898.0 to 1820.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay, CD4 All doubles, Day 304[N=18,28,19,27]
|
1662.0 cells/million T cells
Interval 1162.0 to 2129.0
|
1524.5 cells/million T cells
Interval 969.5 to 1800.5
|
1340.0 cells/million T cells
Interval 1153.0 to 1901.0
|
1226.0 cells/million T cells
Interval 923.0 to 1901.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 All doubles,Day 125[N=14,22,16,17]
|
1416.5 cells/million T cells
Interval 874.0 to 2264.0
|
1310.0 cells/million T cells
Interval 910.0 to 1525.0
|
1574.5 cells/million T cells
Interval 840.0 to 2334.5
|
993.0 cells/million T cells
Interval 698.0 to 1462.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 All doubles,Day 129[N=17,24,23,22]
|
1706.0 cells/million T cells
Interval 1199.0 to 2371.0
|
1429.5 cells/million T cells
Interval 1104.5 to 2011.0
|
1491.0 cells/million T cells
Interval 667.0 to 2784.0
|
1103.5 cells/million T cells
Interval 715.0 to 1674.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 All doubles,Day 136[N=18,25,19,22]
|
2205.0 cells/million T cells
Interval 1308.0 to 2793.0
|
1484.0 cells/million T cells
Interval 1267.0 to 1759.0
|
1502.0 cells/million T cells
Interval 591.0 to 2609.0
|
1130.0 cells/million T cells
Interval 937.0 to 2025.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 All doubles,Day 143[N=16,27,20,18]
|
1596.5 cells/million T cells
Interval 1269.0 to 2477.5
|
1665.0 cells/million T cells
Interval 990.0 to 2345.0
|
1499.5 cells/million T cells
Interval 1012.0 to 2851.5
|
1351.5 cells/million T cells
Interval 1123.0 to 2112.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 All doubles,Day 150[N=16,20,23,22]
|
1851.5 cells/million T cells
Interval 983.0 to 2221.5
|
1612.0 cells/million T cells
Interval 1365.5 to 2014.5
|
1448.0 cells/million T cells
Interval 845.0 to 2483.0
|
1324.5 cells/million T cells
Interval 727.0 to 1884.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 All doubles,Day 157[N=17,22,20,18]
|
1945.0 cells/million T cells
Interval 1225.0 to 2469.0
|
1646.5 cells/million T cells
Interval 1053.0 to 1946.0
|
1951.5 cells/million T cells
Interval 938.0 to 2794.5
|
1334.5 cells/million T cells
Interval 937.0 to 2001.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 All doubles,Day 164[N=16,19,19,22]
|
1734.5 cells/million T cells
Interval 959.0 to 2300.0
|
1422.0 cells/million T cells
Interval 1024.0 to 2265.0
|
2075.0 cells/million T cells
Interval 1257.0 to 3193.0
|
1272.0 cells/million T cells
Interval 891.0 to 1687.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane, CD4 All doubles,Day 304[N=18,28,19,27]
|
1837.0 cells/million T cells
Interval 1345.0 to 2262.0
|
1751.0 cells/million T cells
Interval 1229.0 to 2468.5
|
1398.0 cells/million T cells
Interval 875.0 to 2572.0
|
1602.0 cells/million T cells
Interval 976.0 to 2618.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double CD40L,Day125[N=14,22,16,17]
|
1489.5 cells/million T cells
Interval 959.0 to 1994.0
|
1627.5 cells/million T cells
Interval 1049.0 to 2009.0
|
1220.5 cells/million T cells
Interval 716.5 to 1525.5
|
1174.0 cells/million T cells
Interval 881.0 to 1904.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double CD40L,Day129[N=17,25,23,22]
|
1525.0 cells/million T cells
Interval 1382.0 to 2289.0
|
2009.0 cells/million T cells
Interval 1262.0 to 2236.0
|
1788.0 cells/million T cells
Interval 1278.0 to 2626.0
|
1772.5 cells/million T cells
Interval 1143.0 to 2472.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double CD40L,Day136[N=18,24,20,22]
|
2263.0 cells/million T cells
Interval 1599.0 to 3411.0
|
2049.5 cells/million T cells
Interval 1752.5 to 2955.5
|
2292.5 cells/million T cells
Interval 1621.5 to 4108.0
|
2071.0 cells/million T cells
Interval 1368.0 to 2922.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double CD40L,Day143[N=17,27,20,18]
|
2178.0 cells/million T cells
Interval 1407.0 to 2937.0
|
2123.0 cells/million T cells
Interval 1663.0 to 3014.0
|
2322.5 cells/million T cells
Interval 1744.0 to 3598.5
|
1906.0 cells/million T cells
Interval 1465.0 to 2396.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double CD40L,Day150[N=16,22,23,22]
|
2217.0 cells/million T cells
Interval 1612.5 to 2837.0
|
2059.0 cells/million T cells
Interval 1557.0 to 2434.0
|
2734.0 cells/million T cells
Interval 1658.0 to 3914.0
|
1954.0 cells/million T cells
Interval 1140.0 to 2439.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double CD40L,Day157[N=17,22,20,18]
|
2913.0 cells/million T cells
Interval 2049.0 to 3616.0
|
1943.5 cells/million T cells
Interval 1539.0 to 2537.0
|
2422.5 cells/million T cells
Interval 1896.5 to 3805.0
|
2129.0 cells/million T cells
Interval 1504.0 to 2552.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double CD40L,Day164[N=16,20,19,21]
|
2518.0 cells/million T cells
Interval 1305.5 to 3585.0
|
2125.5 cells/million T cells
Interval 1591.5 to 2707.0
|
2579.0 cells/million T cells
Interval 1760.0 to 4064.0
|
1795.0 cells/million T cells
Interval 1133.0 to 2244.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane, CD4 Double CD40L,Day304[N=18,28,19,27]
|
1889.5 cells/million T cells
Interval 1559.0 to 2633.0
|
1843.5 cells/million T cells
Interval 1340.5 to 2315.0
|
1989.0 cells/million T cells
Interval 1488.0 to 2554.0
|
1664.0 cells/million T cells
Interval 1094.0 to 2274.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 Double CD40L,Day125[N=14,21,15,17
|
972.0 cells/million T cells
Interval 536.0 to 1315.0
|
900.0 cells/million T cells
Interval 730.0 to 1371.0
|
948.0 cells/million T cells
Interval 391.0 to 1161.0
|
1072.0 cells/million T cells
Interval 577.0 to 1257.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 Double CD40L,Day129[N=17,26,23,22
|
1166.0 cells/million T cells
Interval 888.0 to 1676.0
|
1376.0 cells/million T cells
Interval 823.0 to 1647.0
|
1438.0 cells/million T cells
Interval 844.0 to 2307.0
|
1236.5 cells/million T cells
Interval 853.0 to 1684.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 Double CD40L,Day136[N=18,24,20,22
|
1921.0 cells/million T cells
Interval 1353.0 to 2394.0
|
1486.0 cells/million T cells
Interval 1090.5 to 1831.5
|
2323.5 cells/million T cells
Interval 1712.0 to 3753.0
|
1559.0 cells/million T cells
Interval 835.0 to 2269.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 Double CD40L,Day143[N=17,27,20,18
|
1613.0 cells/million T cells
Interval 1180.0 to 2137.0
|
1626.0 cells/million T cells
Interval 1029.0 to 2089.0
|
2264.0 cells/million T cells
Interval 1579.0 to 3809.0
|
1605.0 cells/million T cells
Interval 990.0 to 1982.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 Double CD40L,Day150[N=16,22,23,21
|
2278.0 cells/million T cells
Interval 1592.5 to 3258.0
|
1547.5 cells/million T cells
Interval 1319.0 to 1824.0
|
2995.0 cells/million T cells
Interval 1856.0 to 4618.0
|
1568.0 cells/million T cells
Interval 702.0 to 1769.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 Double CD40L,Day157[N=17,22,20,18
|
2276.0 cells/million T cells
Interval 1897.0 to 2894.0
|
1544.0 cells/million T cells
Interval 1068.0 to 1819.0
|
2662.0 cells/million T cells
Interval 1969.5 to 3735.0
|
1284.5 cells/million T cells
Interval 912.0 to 1937.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 Double CD40L,Day164[N=16,19,19,21
|
2057.0 cells/million T cells
Interval 1309.0 to 2687.0
|
1553.0 cells/million T cells
Interval 916.0 to 2100.0
|
2443.0 cells/million T cells
Interval 1934.0 to 4928.0
|
1215.0 cells/million T cells
Interval 738.0 to 1337.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 Double CD40L,Day304[N=18,28,19,27
|
1537.0 cells/million T cells
Interval 1266.0 to 2060.0
|
1329.0 cells/million T cells
Interval 1116.5 to 1740.0
|
1770.0 cells/million T cells
Interval 1174.0 to 2306.0
|
1144.0 cells/million T cells
Interval 729.0 to 1626.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double CD40L,Day 125 [N=14,21,16,17]
|
1115.0 cells/million T cells
Interval 617.0 to 1782.0
|
1040.0 cells/million T cells
Interval 753.0 to 1302.0
|
845.0 cells/million T cells
Interval 408.0 to 1486.0
|
963.0 cells/million T cells
Interval 562.0 to 1288.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double CD40L,Day 129 [N=17,26,21,22]
|
1303.0 cells/million T cells
Interval 813.0 to 1629.0
|
1075.0 cells/million T cells
Interval 717.0 to 1742.0
|
1096.0 cells/million T cells
Interval 865.0 to 1693.0
|
1069.5 cells/million T cells
Interval 716.0 to 1343.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double CD40L,Day 136 [N=18,24,20,22]
|
1596.5 cells/million T cells
Interval 1081.0 to 2063.0
|
1426.0 cells/million T cells
Interval 1022.0 to 1720.0
|
1546.0 cells/million T cells
Interval 1061.0 to 2284.5
|
1401.0 cells/million T cells
Interval 823.0 to 1847.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double CD40L,Day 143 [N=16,27,20,18]
|
1465.5 cells/million T cells
Interval 947.5 to 1934.5
|
1454.0 cells/million T cells
Interval 1001.0 to 1703.0
|
1753.0 cells/million T cells
Interval 1243.5 to 2347.5
|
1175.5 cells/million T cells
Interval 849.0 to 1564.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double CD40L,Day 150 [N=16,21,23,22]
|
1752.5 cells/million T cells
Interval 1020.0 to 2302.0
|
1214.0 cells/million T cells
Interval 1092.0 to 1582.0
|
1800.0 cells/million T cells
Interval 1141.0 to 2225.0
|
1250.0 cells/million T cells
Interval 677.0 to 1819.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double CD40L,Day 157 [N=17,21,20,18]
|
1796.0 cells/million T cells
Interval 1252.0 to 2291.0
|
1321.0 cells/million T cells
Interval 1013.0 to 1894.0
|
1662.0 cells/million T cells
Interval 1188.0 to 2805.5
|
1190.0 cells/million T cells
Interval 731.0 to 1844.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double CD40L,Day 164 [N=16,19,19,21]
|
1663.0 cells/million T cells
Interval 1136.5 to 2349.5
|
1250.0 cells/million T cells
Interval 800.0 to 1947.0
|
1780.0 cells/million T cells
Interval 1325.0 to 2532.0
|
1083.0 cells/million T cells
Interval 785.0 to 1526.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double CD40L,Day 304 [N=18,28,19,27]
|
1551.5 cells/million T cells
Interval 1126.0 to 1971.0
|
1440.5 cells/million T cells
Interval 944.0 to 1720.5
|
1267.0 cells/million T cells
Interval 979.0 to 1783.0
|
1131.0 cells/million T cells
Interval 847.0 to 1766.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double CD40L,Day 125[N=14,22,16,17]
|
1302.0 cells/million T cells
Interval 880.0 to 2070.0
|
1221.5 cells/million T cells
Interval 843.0 to 1428.0
|
1299.0 cells/million T cells
Interval 777.0 to 1953.0
|
877.0 cells/million T cells
Interval 670.0 to 1361.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double CD40L,Day 129[N=17,24,23,22]
|
1555.0 cells/million T cells
Interval 1037.0 to 2269.0
|
1336.5 cells/million T cells
Interval 984.0 to 1825.5
|
1106.0 cells/million T cells
Interval 619.0 to 1973.0
|
962.5 cells/million T cells
Interval 700.0 to 1536.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double CD40L,Day 136[N=18,25,19,22]
|
1966.5 cells/million T cells
Interval 1197.0 to 2468.0
|
1372.0 cells/million T cells
Interval 1014.0 to 1636.0
|
1433.0 cells/million T cells
Interval 573.0 to 2262.0
|
1096.5 cells/million T cells
Interval 767.0 to 1832.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double CD40L,Day 143[N=16,27,20,18]
|
1348.0 cells/million T cells
Interval 1114.0 to 2231.0
|
1511.0 cells/million T cells
Interval 951.0 to 2084.0
|
1399.5 cells/million T cells
Interval 919.0 to 2504.5
|
1153.5 cells/million T cells
Interval 1030.0 to 1627.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double CD40L,Day 150[N=16,20,23,22]
|
1697.0 cells/million T cells
Interval 845.5 to 1966.5
|
1342.5 cells/million T cells
Interval 1088.0 to 1703.0
|
1358.0 cells/million T cells
Interval 795.0 to 2205.0
|
1142.0 cells/million T cells
Interval 708.0 to 1619.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double CD40L,Day 157[N=17,22,20,18]
|
1700.0 cells/million T cells
Interval 1073.0 to 2170.0
|
1497.5 cells/million T cells
Interval 888.0 to 1834.0
|
1565.5 cells/million T cells
Interval 873.5 to 2389.5
|
1213.0 cells/million T cells
Interval 817.0 to 1738.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double CD40L,Day 164[N=16,19,19,21]
|
1564.0 cells/million T cells
Interval 826.5 to 2136.0
|
1306.0 cells/million T cells
Interval 1018.0 to 2145.0
|
1751.0 cells/million T cells
Interval 1078.0 to 2735.0
|
1005.0 cells/million T cells
Interval 839.0 to 1451.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double CD40L,Day 304[N=18,28,19,27]
|
1790.0 cells/million T cells
Interval 1293.0 to 2074.0
|
1616.5 cells/million T cells
Interval 1174.0 to 2291.5
|
1305.0 cells/million T cells
Interval 887.0 to 2400.0
|
1599.0 cells/million T cells
Interval 870.0 to 2316.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double IFNg, Day 125[N=14,22,16,17]
|
1293.5 cells/million T cells
Interval 675.0 to 1829.0
|
1273.5 cells/million T cells
Interval 905.0 to 1699.0
|
975.0 cells/million T cells
Interval 470.0 to 1576.0
|
884.0 cells/million T cells
Interval 671.0 to 1589.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double IFNg, Day 129[N=17,25,23,22]
|
1482.0 cells/million T cells
Interval 1181.0 to 2157.0
|
1606.0 cells/million T cells
Interval 1163.0 to 2145.0
|
1497.0 cells/million T cells
Interval 1210.0 to 2862.0
|
1608.5 cells/million T cells
Interval 1091.0 to 2305.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double IFNg, Day 136[N=18,24,20,22]
|
1944.0 cells/million T cells
Interval 1389.0 to 2979.0
|
1791.0 cells/million T cells
Interval 1354.5 to 2312.5
|
2037.5 cells/million T cells
Interval 1450.5 to 3850.0
|
1681.5 cells/million T cells
Interval 1084.0 to 2360.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double IFNg, Day 143[N=17,27,20,18]
|
1630.0 cells/million T cells
Interval 1331.0 to 2537.0
|
1833.0 cells/million T cells
Interval 1452.0 to 2494.0
|
1899.0 cells/million T cells
Interval 1301.5 to 3191.5
|
1639.5 cells/million T cells
Interval 1313.0 to 2232.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double IFNg, Day 150[N=16,22,23,22]
|
2150.0 cells/million T cells
Interval 1623.5 to 2774.5
|
1801.5 cells/million T cells
Interval 1360.0 to 2157.0
|
2335.0 cells/million T cells
Interval 1497.0 to 3505.0
|
1815.0 cells/million T cells
Interval 1173.0 to 2268.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double IFNg, Day 157[N=17,22,20,18]
|
2247.0 cells/million T cells
Interval 2015.0 to 2732.0
|
1809.0 cells/million T cells
Interval 1416.0 to 2269.0
|
2234.5 cells/million T cells
Interval 1603.0 to 3188.5
|
1774.0 cells/million T cells
Interval 1183.0 to 2242.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double IFNg, Day 164[N=16,20,19,21]
|
2208.5 cells/million T cells
Interval 1301.0 to 3058.5
|
1617.5 cells/million T cells
Interval 1318.5 to 2253.0
|
2446.0 cells/million T cells
Interval 1488.0 to 3608.0
|
1292.0 cells/million T cells
Interval 1041.0 to 1972.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double IFNg, Day 304[N=18,28,19,27]
|
1748.0 cells/million T cells
Interval 1147.0 to 2200.0
|
1551.5 cells/million T cells
Interval 1107.0 to 1893.5
|
1531.0 cells/million T cells
Interval 1043.0 to 2590.0
|
1301.0 cells/million T cells
Interval 897.0 to 1821.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4Double IFNg,Day 125[N=14,22,16,17]
|
753.0 cells/million T cells
Interval 365.0 to 1120.0
|
832.0 cells/million T cells
Interval 623.0 to 1029.0
|
735.0 cells/million T cells
Interval 361.0 to 1357.0
|
748.0 cells/million T cells
Interval 603.0 to 1087.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4Double IFNg,Day 129[N=17,26,23,22]
|
1155.0 cells/million T cells
Interval 744.0 to 1413.0
|
1100.5 cells/million T cells
Interval 787.0 to 1504.0
|
1469.0 cells/million T cells
Interval 905.0 to 2318.0
|
1147.5 cells/million T cells
Interval 809.0 to 1715.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4Double IFNg,Day 136[N=18,24,23,22]
|
1548.5 cells/million T cells
Interval 1059.0 to 2077.0
|
1321.0 cells/million T cells
Interval 1118.5 to 1516.5
|
1752.0 cells/million T cells
Interval 1379.5 to 3541.0
|
1266.0 cells/million T cells
Interval 743.0 to 2149.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4Double IFNg,Day 143[N=17,27,20,18]
|
1267.0 cells/million T cells
Interval 921.0 to 1950.0
|
1188.0 cells/million T cells
Interval 870.0 to 1829.0
|
1583.5 cells/million T cells
Interval 969.0 to 3473.5
|
1388.5 cells/million T cells
Interval 1099.0 to 1731.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4Double IFNg,Day 150[N=16,23,22,21]
|
1828.5 cells/million T cells
Interval 1200.5 to 2095.0
|
1417.0 cells/million T cells
Interval 1212.0 to 1599.0
|
2118.0 cells/million T cells
Interval 1271.0 to 3433.0
|
1173.0 cells/million T cells
Interval 835.0 to 1687.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4Double IFNg,Day 157[N=17,22,20,18]
|
1771.0 cells/million T cells
Interval 1618.0 to 2164.0
|
1265.5 cells/million T cells
Interval 972.0 to 1693.0
|
2080.0 cells/million T cells
Interval 1445.0 to 2854.0
|
1101.5 cells/million T cells
Interval 763.0 to 1620.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4Double IFNg,Day 164[N=16,19,19,21]
|
1715.5 cells/million T cells
Interval 1249.5 to 2281.0
|
1320.0 cells/million T cells
Interval 954.0 to 1681.0
|
2444.0 cells/million T cells
Interval 1259.0 to 3564.0
|
1031.0 cells/million T cells
Interval 696.0 to 1312.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4Double IFNg,Day 304[N=18,28,19,27]
|
1105.0 cells/million T cells
Interval 950.0 to 1666.0
|
1129.0 cells/million T cells
Interval 919.0 to 1522.0
|
1351.0 cells/million T cells
Interval 816.0 to 2229.0
|
1107.0 cells/million T cells
Interval 730.0 to 1422.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double IFNg,Day 125 [N=14,21,16,17]
|
798.0 cells/million T cells
Interval 493.0 to 1462.0
|
791.0 cells/million T cells
Interval 676.0 to 1032.0
|
965.5 cells/million T cells
Interval 320.5 to 1392.5
|
882.0 cells/million T cells
Interval 509.0 to 1013.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double IFNg,Day 129 [N=17,26,21,22]
|
1067.0 cells/million T cells
Interval 780.0 to 1561.0
|
1012.0 cells/million T cells
Interval 708.0 to 1417.0
|
1061.0 cells/million T cells
Interval 803.0 to 1614.0
|
958.5 cells/million T cells
Interval 615.0 to 1504.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double IFNg,Day 136 [N=18,24,20,22]
|
1429.0 cells/million T cells
Interval 926.0 to 1908.0
|
1142.5 cells/million T cells
Interval 740.0 to 1531.0
|
1390.0 cells/million T cells
Interval 922.5 to 2068.0
|
1198.5 cells/million T cells
Interval 560.0 to 1665.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double IFNg,Day 143 [N=16,27,20,18]
|
1395.5 cells/million T cells
Interval 834.0 to 1811.0
|
1216.0 cells/million T cells
Interval 872.0 to 1486.0
|
1575.5 cells/million T cells
Interval 864.0 to 2056.0
|
1171.0 cells/million T cells
Interval 858.0 to 1363.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double IFNg,Day 150 [N=16,21,23,22]
|
1473.5 cells/million T cells
Interval 897.0 to 2076.0
|
1234.0 cells/million T cells
Interval 963.0 to 1461.0
|
1561.0 cells/million T cells
Interval 1086.0 to 2500.0
|
1104.0 cells/million T cells
Interval 748.0 to 1502.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double IFNg,Day 157 [N=17,21,20,22]
|
1709.0 cells/million T cells
Interval 1081.0 to 2118.0
|
1220.0 cells/million T cells
Interval 803.0 to 1502.0
|
1435.0 cells/million T cells
Interval 1029.5 to 2182.5
|
1088.0 cells/million T cells
Interval 632.0 to 1483.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double IFNg,Day 164 [N=16,19,19,21]
|
1476.5 cells/million T cells
Interval 1119.0 to 2194.0
|
1105.0 cells/million T cells
Interval 799.0 to 1632.0
|
1688.0 cells/million T cells
Interval 1265.0 to 2239.0
|
1090.0 cells/million T cells
Interval 524.0 to 1473.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double IFNg,Day 304 [N=18,28,19,27]
|
1281.5 cells/million T cells
Interval 862.0 to 1806.0
|
1113.0 cells/million T cells
Interval 836.5 to 1477.5
|
1015.0 cells/million T cells
Interval 848.0 to 1402.0
|
1089.0 cells/million T cells
Interval 683.0 to 1392.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double IFNg,Day 125 [N=14,22,16,17]
|
1050.0 cells/million T cells
Interval 742.0 to 1909.0
|
1022.5 cells/million T cells
Interval 873.0 to 1451.0
|
1377.5 cells/million T cells
Interval 784.5 to 2093.0
|
964.0 cells/million T cells
Interval 832.0 to 1243.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double IFNg,Day 129 [N=17,24,23,22]
|
1391.0 cells/million T cells
Interval 824.0 to 1959.0
|
1178.5 cells/million T cells
Interval 1030.5 to 1547.0
|
1308.0 cells/million T cells
Interval 604.0 to 2350.0
|
1008.0 cells/million T cells
Interval 775.0 to 1404.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double IFNg,Day 136 [N=18,25,19,22]
|
1694.0 cells/million T cells
Interval 1075.0 to 2394.0
|
1253.0 cells/million T cells
Interval 899.0 to 1446.0
|
1248.0 cells/million T cells
Interval 582.0 to 2389.0
|
1008.5 cells/million T cells
Interval 825.0 to 1864.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double IFNg,Day 143 [N=16,27,20,18]
|
1311.0 cells/million T cells
Interval 867.5 to 2027.0
|
1293.0 cells/million T cells
Interval 969.0 to 1716.0
|
1205.0 cells/million T cells
Interval 707.0 to 2490.0
|
1252.0 cells/million T cells
Interval 885.0 to 1818.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double IFNg,Day 150 [N=16,20,22,23]
|
1410.0 cells/million T cells
Interval 848.5 to 1843.5
|
1359.5 cells/million T cells
Interval 1041.0 to 1684.5
|
1362.0 cells/million T cells
Interval 699.0 to 2082.0
|
1174.5 cells/million T cells
Interval 674.0 to 1503.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double IFNg,Day 157 [N=17,22,20,18]
|
1397.0 cells/million T cells
Interval 1057.0 to 1958.0
|
1417.0 cells/million T cells
Interval 930.0 to 1723.0
|
1514.0 cells/million T cells
Interval 689.0 to 2352.5
|
1145.5 cells/million T cells
Interval 742.0 to 1805.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double IFNg,Day 164 [N=16,19,19,21]
|
1477.5 cells/million T cells
Interval 863.5 to 2214.0
|
1166.0 cells/million T cells
Interval 927.0 to 1558.0
|
1540.0 cells/million T cells
Interval 856.0 to 2808.0
|
1088.0 cells/million T cells
Interval 749.0 to 1418.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double IFNg,Day 304 [N=18,28,19,27]
|
1471.0 cells/million T cells
Interval 1000.0 to 2137.0
|
1337.5 cells/million T cells
Interval 964.0 to 2236.0
|
1189.0 cells/million T cells
Interval 656.0 to 1903.0
|
1398.0 cells/million T cells
Interval 714.0 to 2317.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double IL-2,Day 125 [N=14,22,16,17]
|
1229.0 cells/million T cells
Interval 764.0 to 1776.0
|
1343.0 cells/million T cells
Interval 851.0 to 1900.0
|
1099.5 cells/million T cells
Interval 521.5 to 1522.5
|
1038.0 cells/million T cells
Interval 701.0 to 1474.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double IL-2,Day 129 [N=17,25,23,22]
|
1331.0 cells/million T cells
Interval 1223.0 to 2042.0
|
1844.0 cells/million T cells
Interval 1144.0 to 2035.0
|
1697.0 cells/million T cells
Interval 1167.0 to 2782.0
|
1629.5 cells/million T cells
Interval 1019.0 to 2114.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double IL-2,Day 136 [N=18,24,20,22]
|
2051.0 cells/million T cells
Interval 1699.0 to 3124.0
|
1933.0 cells/million T cells
Interval 1539.5 to 2477.0
|
2153.0 cells/million T cells
Interval 1709.0 to 3553.0
|
2009.5 cells/million T cells
Interval 1400.0 to 2698.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double IL-2,Day 143 [N=17,27,20,18]
|
1922.0 cells/million T cells
Interval 1339.0 to 2564.0
|
2045.0 cells/million T cells
Interval 1486.0 to 2862.0
|
2246.0 cells/million T cells
Interval 1605.5 to 3199.0
|
1891.0 cells/million T cells
Interval 1431.0 to 2179.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double IL-2,Day 150 [N=16,22,23,22]
|
2189.5 cells/million T cells
Interval 1457.5 to 2654.5
|
1891.0 cells/million T cells
Interval 1415.0 to 2342.0
|
2771.0 cells/million T cells
Interval 1724.0 to 3806.0
|
1908.5 cells/million T cells
Interval 1337.0 to 2430.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double IL-2,Day 157 [N=17,22,20,18]
|
2407.0 cells/million T cells
Interval 1867.0 to 3146.0
|
1816.5 cells/million T cells
Interval 1284.0 to 2592.0
|
2512.0 cells/million T cells
Interval 2137.0 to 3579.5
|
1968.5 cells/million T cells
Interval 1285.0 to 2275.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double IL-2,Day 164 [N=16,20,19,21]
|
2561.5 cells/million T cells
Interval 1249.0 to 3414.0
|
1956.5 cells/million T cells
Interval 1237.5 to 2546.0
|
2536.0 cells/million T cells
Interval 1827.0 to 3889.0
|
1546.0 cells/million T cells
Interval 1106.0 to 1881.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double IL-2,Day 304 [N=18,28,19,27]
|
1665.0 cells/million T cells
Interval 1304.0 to 2382.0
|
1592.5 cells/million T cells
Interval 1317.0 to 2049.5
|
1884.0 cells/million T cells
Interval 1329.0 to 2490.0
|
1460.0 cells/million T cells
Interval 1103.0 to 2038.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 Double IL-2,Day125[N=14,21,15,17]
|
882.0 cells/million T cells
Interval 578.0 to 1314.0
|
986.0 cells/million T cells
Interval 765.0 to 1061.0
|
925.0 cells/million T cells
Interval 314.0 to 1300.0
|
937.0 cells/million T cells
Interval 491.0 to 1321.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 Double IL-2,Day129[N=17,26,23,22]
|
1209.0 cells/million T cells
Interval 966.0 to 1456.0
|
1206.0 cells/million T cells
Interval 851.0 to 1576.0
|
1506.0 cells/million T cells
Interval 952.0 to 2525.0
|
1144.0 cells/million T cells
Interval 900.0 to 1775.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 Double IL-2,Day136[N=18,24,20,22]
|
2064.0 cells/million T cells
Interval 1403.0 to 2270.0
|
1496.5 cells/million T cells
Interval 1142.5 to 1851.0
|
2284.0 cells/million T cells
Interval 1730.0 to 3903.5
|
1558.0 cells/million T cells
Interval 885.0 to 2116.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 Double IL-2,Day143[N=17,27,20,18]
|
1572.0 cells/million T cells
Interval 1098.0 to 2060.0
|
1538.0 cells/million T cells
Interval 1023.0 to 1959.0
|
2217.0 cells/million T cells
Interval 1649.0 to 3774.0
|
1500.0 cells/million T cells
Interval 1036.0 to 1759.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 Double IL-2,Day150[N=16,22,23,21]
|
2168.0 cells/million T cells
Interval 1392.0 to 3140.5
|
1645.5 cells/million T cells
Interval 1387.0 to 1810.0
|
2915.0 cells/million T cells
Interval 1787.0 to 4394.0
|
1309.0 cells/million T cells
Interval 858.0 to 1770.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 Double IL-2,Day157[N=17,22,20,18]
|
2314.0 cells/million T cells
Interval 1892.0 to 2880.0
|
1559.0 cells/million T cells
Interval 1109.0 to 1669.0
|
2485.0 cells/million T cells
Interval 2039.0 to 3925.5
|
1337.0 cells/million T cells
Interval 968.0 to 1743.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 Double IL-2,Day164[N=16,19,19,21]
|
2162.0 cells/million T cells
Interval 1371.0 to 2926.5
|
1581.0 cells/million T cells
Interval 969.0 to 2120.0
|
2806.0 cells/million T cells
Interval 1997.0 to 4641.0
|
1134.0 cells/million T cells
Interval 911.0 to 1444.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4 Double IL-2,Day304[N=18,28,19,27]
|
1441.5 cells/million T cells
Interval 1136.0 to 2003.0
|
1272.5 cells/million T cells
Interval 1081.5 to 1715.0
|
1778.0 cells/million T cells
Interval 1154.0 to 2198.0
|
1208.0 cells/million T cells
Interval 895.0 to 1588.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double IL-2,Day 125 [N=14,21,16,17]
|
916.0 cells/million T cells
Interval 566.0 to 1489.0
|
840.0 cells/million T cells
Interval 666.0 to 1201.0
|
900.0 cells/million T cells
Interval 415.0 to 1384.0
|
851.0 cells/million T cells
Interval 563.0 to 1170.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double IL-2,Day 129 [N=17,26,21,22]
|
1189.0 cells/million T cells
Interval 730.0 to 1391.0
|
1037.0 cells/million T cells
Interval 732.0 to 1583.0
|
1100.0 cells/million T cells
Interval 885.0 to 1619.0
|
999.5 cells/million T cells
Interval 684.0 to 1214.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double IL-2,Day 136 [N=18,24,20,22]
|
1438.5 cells/million T cells
Interval 898.0 to 1892.0
|
1322.5 cells/million T cells
Interval 929.0 to 1661.0
|
1353.0 cells/million T cells
Interval 1072.5 to 2192.5
|
1290.0 cells/million T cells
Interval 852.0 to 1633.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double IL-2,Day 143 [N=16,27,20,18]
|
1359.5 cells/million T cells
Interval 895.5 to 1821.5
|
1255.0 cells/million T cells
Interval 878.0 to 1674.0
|
1642.0 cells/million T cells
Interval 1058.5 to 2268.0
|
1252.5 cells/million T cells
Interval 775.0 to 1580.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double IL-2,Day 150 [N=16,21,23,22]
|
1575.5 cells/million T cells
Interval 920.5 to 2231.5
|
1158.0 cells/million T cells
Interval 954.0 to 1641.0
|
1739.0 cells/million T cells
Interval 1240.0 to 2035.0
|
1063.5 cells/million T cells
Interval 652.0 to 1659.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double IL-2,Day 157 [N=17,21,20,18]
|
1691.0 cells/million T cells
Interval 1134.0 to 2112.0
|
1249.0 cells/million T cells
Interval 979.0 to 1652.0
|
1502.5 cells/million T cells
Interval 1187.5 to 2649.5
|
1199.0 cells/million T cells
Interval 757.0 to 1721.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double IL-2,Day 164 [N=16,19,19,21]
|
1545.0 cells/million T cells
Interval 1171.5 to 2161.5
|
1029.0 cells/million T cells
Interval 806.0 to 1936.0
|
1896.0 cells/million T cells
Interval 1416.0 to 3324.0
|
1028.0 cells/million T cells
Interval 826.0 to 1405.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4 Double IL-2,Day 304 [N=18,28,19,27]
|
1392.5 cells/million T cells
Interval 977.0 to 1737.0
|
1317.0 cells/million T cells
Interval 873.0 to 1575.0
|
1165.0 cells/million T cells
Interval 991.0 to 1720.0
|
1054.0 cells/million T cells
Interval 741.0 to 1683.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double IL-2,Day 125 [N=14,22,16,17]
|
1201.5 cells/million T cells
Interval 737.0 to 1951.0
|
1089.5 cells/million T cells
Interval 856.0 to 1281.0
|
1325.0 cells/million T cells
Interval 758.5 to 2082.5
|
855.0 cells/million T cells
Interval 599.0 to 1188.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double IL-2,Day 129 [N=17,24,23,22]
|
1379.0 cells/million T cells
Interval 1019.0 to 2132.0
|
1257.0 cells/million T cells
Interval 942.5 to 1722.0
|
1238.0 cells/million T cells
Interval 587.0 to 2297.0
|
1055.5 cells/million T cells
Interval 611.0 to 1530.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double IL-2,Day 136 [N=18,25,19,22]
|
1847.5 cells/million T cells
Interval 1146.0 to 2304.0
|
1290.0 cells/million T cells
Interval 946.0 to 1536.0
|
1312.0 cells/million T cells
Interval 429.0 to 2399.0
|
979.5 cells/million T cells
Interval 804.0 to 1888.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double IL-2,Day 143 [N=16,27,20,18]
|
1280.0 cells/million T cells
Interval 1107.5 to 2110.0
|
1381.0 cells/million T cells
Interval 907.0 to 1931.0
|
1280.0 cells/million T cells
Interval 833.5 to 2419.5
|
1117.0 cells/million T cells
Interval 922.0 to 1935.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double IL-2,Day 150 [N=16,20,23,22]
|
1541.0 cells/million T cells
Interval 882.0 to 1940.0
|
1365.0 cells/million T cells
Interval 953.0 to 1773.0
|
1172.0 cells/million T cells
Interval 786.0 to 1987.0
|
1169.5 cells/million T cells
Interval 661.0 to 1620.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double IL-2,Day 157 [N=17,22,20,18]
|
1611.0 cells/million T cells
Interval 1220.0 to 2031.0
|
1299.5 cells/million T cells
Interval 901.0 to 1621.0
|
1587.0 cells/million T cells
Interval 857.5 to 2291.5
|
1068.5 cells/million T cells
Interval 871.0 to 1596.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double IL-2,Day 164 [N=16,19,19,21]
|
1478.5 cells/million T cells
Interval 840.0 to 2005.5
|
1191.0 cells/million T cells
Interval 814.0 to 1955.0
|
1597.0 cells/million T cells
Interval 1163.0 to 2813.0
|
1089.0 cells/million T cells
Interval 659.0 to 1441.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4 Double IL-2,Day 304 [N=18,28,19,27]
|
1578.0 cells/million T cells
Interval 1144.0 to 1908.0
|
1374.0 cells/million T cells
Interval 1047.5 to 2030.0
|
1134.0 cells/million T cells
Interval 757.0 to 2166.0
|
1512.0 cells/million T cells
Interval 831.0 to 2148.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double TNFa,Day 125 [N=14,22,16,17]
|
993.0 cells/million T cells
Interval 686.0 to 1619.0
|
1089.5 cells/million T cells
Interval 660.0 to 1352.0
|
962.0 cells/million T cells
Interval 437.0 to 1385.5
|
859.0 cells/million T cells
Interval 753.0 to 1539.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double TNFa,Day 129 [N=17,25,23,22]
|
1257.0 cells/million T cells
Interval 859.0 to 1687.0
|
1313.0 cells/million T cells
Interval 1030.0 to 1715.0
|
1235.0 cells/million T cells
Interval 725.0 to 2103.0
|
1060.0 cells/million T cells
Interval 863.0 to 1846.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double TNFa,Day 136 [N=18,24,20,22]
|
1769.0 cells/million T cells
Interval 1275.0 to 2758.0
|
1575.0 cells/million T cells
Interval 1134.5 to 2282.5
|
1869.5 cells/million T cells
Interval 1148.5 to 3179.5
|
1288.5 cells/million T cells
Interval 1061.0 to 2365.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double TNFa,Day 143 [N=17,27,20,18]
|
1520.0 cells/million T cells
Interval 945.0 to 2070.0
|
1659.0 cells/million T cells
Interval 1026.0 to 2276.0
|
1672.5 cells/million T cells
Interval 1031.0 to 2637.5
|
1404.5 cells/million T cells
Interval 971.0 to 2045.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double TNFa,Day 150 [N=16,22,23,22]
|
1761.0 cells/million T cells
Interval 1228.0 to 2176.0
|
1549.0 cells/million T cells
Interval 1014.0 to 1952.0
|
2260.0 cells/million T cells
Interval 1190.0 to 3394.0
|
1325.5 cells/million T cells
Interval 966.0 to 2152.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double TNFa,Day 157 [N=17,22,20,18]
|
2529.0 cells/million T cells
Interval 1589.0 to 2887.0
|
1485.5 cells/million T cells
Interval 1042.0 to 1833.0
|
2082.5 cells/million T cells
Interval 1522.5 to 2970.5
|
1392.5 cells/million T cells
Interval 875.0 to 2079.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double TNFa,Day 164 [N=16,20,19,21]
|
1813.5 cells/million T cells
Interval 1043.5 to 3072.0
|
1476.5 cells/million T cells
Interval 903.5 to 2081.5
|
2372.0 cells/million T cells
Interval 1635.0 to 3544.0
|
1278.0 cells/million T cells
Interval 862.0 to 1527.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Brisbane,CD4 Double TNFa,Day 304 [N=18,28,19,27]
|
1257.0 cells/million T cells
Interval 936.0 to 2073.0
|
1357.5 cells/million T cells
Interval 877.5 to 1711.5
|
1396.0 cells/million T cells
Interval 947.0 to 2155.0
|
1169.0 cells/million T cells
Interval 824.0 to 1669.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4Double TNFa,Day 125[N=14,21,15,17]
|
754.5 cells/million T cells
Interval 366.0 to 1445.0
|
777.0 cells/million T cells
Interval 601.0 to 1167.0
|
847.0 cells/million T cells
Interval 288.0 to 1370.0
|
686.0 cells/million T cells
Interval 547.0 to 1209.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4Double TNFa,Day 129[N=17,26,23,22]
|
1044.0 cells/million T cells
Interval 910.0 to 1252.0
|
1129.0 cells/million T cells
Interval 796.0 to 1399.0
|
1074.0 cells/million T cells
Interval 688.0 to 1881.0
|
871.5 cells/million T cells
Interval 599.0 to 1646.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4Double TNFa,Day 136[N=18,24,20,22]
|
1621.5 cells/million T cells
Interval 913.0 to 2476.0
|
1279.5 cells/million T cells
Interval 875.5 to 1426.0
|
1594.5 cells/million T cells
Interval 1059.5 to 3012.0
|
1260.5 cells/million T cells
Interval 700.0 to 2159.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4Double TNFa,Day 143[N=17,27,20,18]
|
1169.0 cells/million T cells
Interval 823.0 to 1925.0
|
1104.0 cells/million T cells
Interval 869.0 to 1511.0
|
1824.5 cells/million T cells
Interval 1000.5 to 3135.5
|
1241.0 cells/million T cells
Interval 768.0 to 1492.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4Double TNFa,Day 150[N=16,26,23,21]
|
1937.0 cells/million T cells
Interval 1239.0 to 2405.0
|
1293.0 cells/million T cells
Interval 1101.0 to 1435.0
|
1967.0 cells/million T cells
Interval 1338.0 to 3590.0
|
989.0 cells/million T cells
Interval 766.0 to 1721.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4Double TNFa,Day 157[N=17,22,20,18]
|
2109.0 cells/million T cells
Interval 1434.0 to 2425.0
|
1243.0 cells/million T cells
Interval 931.0 to 1388.0
|
2244.0 cells/million T cells
Interval 1486.5 to 3019.5
|
1004.0 cells/million T cells
Interval 855.0 to 1238.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4Double TNFa,Day 164[N=16,19,19,21]
|
1692.5 cells/million T cells
Interval 1177.5 to 2662.5
|
1074.0 cells/million T cells
Interval 704.0 to 1598.0
|
2334.0 cells/million T cells
Interval 1653.0 to 3870.0
|
988.0 cells/million T cells
Interval 826.0 to 1338.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/California,CD4Double TNFa,Day 304[N=18,28,19,27]
|
1250.0 cells/million T cells
Interval 975.0 to 1864.0
|
1063.5 cells/million T cells
Interval 841.5 to 1532.5
|
1581.0 cells/million T cells
Interval 983.0 to 1833.0
|
1027.0 cells/million T cells
Interval 750.0 to 1345.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4Double TNFa,Day 125[N=14,21,16,17]
|
886.0 cells/million T cells
Interval 512.0 to 1197.0
|
724.0 cells/million T cells
Interval 455.0 to 883.0
|
763.0 cells/million T cells
Interval 296.0 to 1214.5
|
620.0 cells/million T cells
Interval 443.0 to 944.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4Double TNFa,Day 129[N=17,26,21,22]
|
814.0 cells/million T cells
Interval 677.0 to 1152.0
|
757.5 cells/million T cells
Interval 433.0 to 1227.0
|
878.0 cells/million T cells
Interval 627.0 to 1157.0
|
755.0 cells/million T cells
Interval 519.0 to 977.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4Double TNFa,Day 136[N=18,24,20,22]
|
1140.5 cells/million T cells
Interval 742.0 to 1840.0
|
995.0 cells/million T cells
Interval 621.5 to 1271.5
|
1215.5 cells/million T cells
Interval 771.5 to 1854.5
|
991.0 cells/million T cells
Interval 614.0 to 1576.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4Double TNFa,Day 143[N=16,27,20,18]
|
887.5 cells/million T cells
Interval 685.0 to 1588.0
|
973.0 cells/million T cells
Interval 592.0 to 1371.0
|
1492.0 cells/million T cells
Interval 791.0 to 2038.0
|
938.0 cells/million T cells
Interval 627.0 to 1242.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4Double TNFa,Day 150[N=16,21,23,22]
|
1294.0 cells/million T cells
Interval 788.5 to 1698.5
|
873.0 cells/million T cells
Interval 706.0 to 1221.0
|
1333.0 cells/million T cells
Interval 884.0 to 2188.0
|
836.5 cells/million T cells
Interval 498.0 to 1390.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4Double TNFa,Day 157[N=17,21,20,18]
|
1492.0 cells/million T cells
Interval 1005.0 to 1808.0
|
947.0 cells/million T cells
Interval 811.0 to 1297.0
|
1398.5 cells/million T cells
Interval 952.0 to 2447.0
|
989.5 cells/million T cells
Interval 618.0 to 1387.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4Double TNFa,Day 164[N=16,19,19,21]
|
1358.0 cells/million T cells
Interval 969.5 to 1949.0
|
900.0 cells/million T cells
Interval 595.0 to 1571.0
|
1568.0 cells/million T cells
Interval 1322.0 to 2983.0
|
888.0 cells/million T cells
Interval 565.0 to 1210.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
A/Uruguay,CD4Double TNFa,Day 304[N=18,28,19,27]
|
1136.5 cells/million T cells
Interval 885.0 to 1526.0
|
1078.5 cells/million T cells
Interval 689.0 to 1353.0
|
944.0 cells/million T cells
Interval 708.0 to 1130.0
|
960.0 cells/million T cells
Interval 580.0 to 1272.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4Double TNFa,Day 125[N=14,22,16,17]
|
922.0 cells/million T cells
Interval 563.0 to 1555.0
|
775.0 cells/million T cells
Interval 516.0 to 882.0
|
953.5 cells/million T cells
Interval 462.0 to 1802.5
|
690.0 cells/million T cells
Interval 507.0 to 904.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4Double TNFa,Day 129[N=17,24,23,22]
|
955.0 cells/million T cells
Interval 776.0 to 1569.0
|
869.0 cells/million T cells
Interval 608.0 to 1184.0
|
1077.0 cells/million T cells
Interval 369.0 to 1617.0
|
708.0 cells/million T cells
Interval 470.0 to 1173.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4Double TNFa,Day 136[N=18,25,19,22]
|
1250.0 cells/million T cells
Interval 821.0 to 1373.0
|
802.0 cells/million T cells
Interval 616.0 to 1120.0
|
1054.0 cells/million T cells
Interval 299.0 to 1797.0
|
774.5 cells/million T cells
Interval 500.0 to 1396.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4Double TNFa,Day 143[N=16,27,20,18]
|
1015.0 cells/million T cells
Interval 659.0 to 1389.5
|
961.0 cells/million T cells
Interval 514.0 to 1289.0
|
1189.5 cells/million T cells
Interval 559.5 to 1991.5
|
906.5 cells/million T cells
Interval 636.0 to 1425.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4Double TNFa,Day 150[N=16,20,23,22]
|
1175.5 cells/million T cells
Interval 580.0 to 1468.5
|
1044.5 cells/million T cells
Interval 715.5 to 1347.0
|
849.0 cells/million T cells
Interval 438.0 to 1801.0
|
731.0 cells/million T cells
Interval 400.0 to 1203.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4Double TNFa,Day 157[N=17,22,20,18]
|
1041.0 cells/million T cells
Interval 713.0 to 1616.0
|
965.0 cells/million T cells
Interval 635.0 to 1312.0
|
1156.0 cells/million T cells
Interval 462.5 to 1655.0
|
830.5 cells/million T cells
Interval 712.0 to 1268.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4Double TNFa,Day 164[N=16,19,19,21]
|
1130.5 cells/million T cells
Interval 590.0 to 1790.5
|
866.0 cells/million T cells
Interval 611.0 to 1407.0
|
1282.0 cells/million T cells
Interval 782.0 to 2388.0
|
849.0 cells/million T cells
Interval 455.0 to 1132.0
|
|
Cell-mediated Immunogenicity (CMI) in Terms of Tcell Markers Related to A/California/7/2009, A/Brisbane/59/2007, B/Brisbane/59/2007 and A/Uruguay/716/2007 Antigens
B/Brisbane,CD4Double TNFa,Day 304[N=18,28,19,27]
|
1258.5 cells/million T cells
Interval 873.0 to 1479.0
|
1036.5 cells/million T cells
Interval 747.5 to 1764.5
|
1042.0 cells/million T cells
Interval 552.0 to 1614.0
|
1133.0 cells/million T cells
Interval 573.0 to 1500.0
|
SECONDARY outcome
Timeframe: During the entire study period (up to Day 507).pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=34 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=33 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any and Related Potential Immune-mediated Disease (pIMDs).
Any pIMDs
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Related Potential Immune-mediated Disease (pIMDs).
Related pIMDs
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (up to Day 507).MAEs refer to events that required medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Related = symptom assed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=34 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=33 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any and Related Medically Attended Adverse Events (MAEs).
Any MAEs
|
9 Subjects
|
11 Subjects
|
5 Subjects
|
4 Subjects
|
|
Number of Subjects Reporting Any and Related Medically Attended Adverse Events (MAEs).
Related MAEs
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Up to 21-day (Days 0-20) after vaccinationPopulation: The Total Vaccinated cohort included all vaccinated subjects for whom data were available.
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. Unsolicited AEs were collected after the administration of the Flulaval vaccine or the placebo dose and the data has been pooled based on the vaccination received at Day 0.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=67 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=66 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Unsolicited AEs.
|
13 Subjects
|
12 Subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 84 days following first dose or 63 days following second dose of vaccine.Population: The Total Vaccinated cohort included all vaccinated subjects for whom data were available.
Unsolicited AEs were collected after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine. An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=28 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=29 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=28 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Unsolicited AEs.
|
9 Subjects
|
8 Subjects
|
7 Subjects
|
5 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (up to Day 507).SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=34 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=33 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
Any SAEs
|
3 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
Related SAEs
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Up to Day 234Population: The Total Vaccinated cohort included all vaccinated subjects for whom data were available.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assed by the investigator as causally related to the study vaccination. Missing values will be added once they become available.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=34 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=33 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
Any SAEs
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
Related SAEs
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Within Days 0-233Population: The Total Vaccinated cohort included all vaccinated subjects for whom data were available.
MAEs refer to events that required medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Related = symptom assed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=34 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=33 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any and Related Medically Attended Adverse Events (MAEs).
Any MAEs
|
9 Subjects
|
9 Subjects
|
5 Subjects
|
4 Subjects
|
|
Number of Subjects Reporting Any and Related Medically Attended Adverse Events (MAEs).
Related MAEs
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: Within Days 0-233Population: The Total Vaccinated cohort included all vaccinated subjects for whom data were available.
pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=34 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=33 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any and Related Potential Immune-mediated Disease (pIMDs).
Any pIMDs
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Any and Related Potential Immune-mediated Disease (pIMDs).
Related pIMDs
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) follow-up period after vaccination.Population: The Total Vaccinated cohort included all vaccinated subjects for whom data were available.
Solicited local symptoms assessed were pain, redness and swelling and data collected was pooled by administration of vaccination received at Day 0 (i.e. Flulaval or Saline placebo). Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=66 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=64 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Local Symptoms From Flulaval Group and Placebo Group.
Any Pain
|
35 Subjects
|
5 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local Symptoms From Flulaval Group and Placebo Group.
Grade 3 Pain
|
1 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local Symptoms From Flulaval Group and Placebo Group.
Any Redness
|
4 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local Symptoms From Flulaval Group and Placebo Group.
Grade 3 Redness
|
0 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local Symptoms From Flulaval Group and Placebo Group.
Any Swelling
|
1 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited Local Symptoms From Flulaval Group and Placebo Group.
Grade 3 Swelling
|
0 Subjects
|
0 Subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) follow-up period after vaccination.Population: The Total Vaccinated cohort included all vaccinated subjects for whom data were available.
Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (= axillary temperature equal to or above 38.0 degrees Celsius (°C)) and data collected was pooled by administration of vaccination received at Day 0 (i.e. Flulaval or Saline placebo). 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 above 39.0°C.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=66 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=64 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.
Any Fatigue
|
18 Subjects
|
7 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.
Grade 3 Fatigue
|
1 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.
Related Fatigue
|
15 Subjects
|
7 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.
Any Headache
|
19 Subjects
|
4 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.
Grade 3 Headache
|
1 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.
Related Headache
|
17 Subjects
|
3 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.
Any Joint pain at other location
|
13 Subjects
|
2 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.
Grade 3 Joint pain at other location
|
1 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.
Related Joint pain at other location
|
11 Subjects
|
2 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.
Any Muscle aches
|
20 Subjects
|
3 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.
Grade 3 Muscle aches
|
1 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.
Related Muscle aches
|
18 Subjects
|
3 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.
Any Shivering
|
8 Subjects
|
1 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.
Grade 3 Shivering
|
0 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.
Related Shivering
|
8 Subjects
|
1 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.
Any Sweating
|
9 Subjects
|
1 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.
Grade 3 Sweating
|
0 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.
Related Sweating
|
8 Subjects
|
1 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.
Any Fever ≥ 38.0°C
|
1 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.
Grade 3 Fever ≥ 39.0°C
|
0 Subjects
|
0 Subjects
|
—
|
—
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval Group and Placebo Group.
Related Fever
|
1 Subjects
|
0 Subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) follow-up period after vaccination.Population: The Total Vaccinated cohort included all vaccinated subjects for whom data were available.
Solicited local symptoms assessed were pain, redness and swelling and were collected after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeter (mm).
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=25 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=32 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=29 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Local Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group,Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group
Any Pain
|
19 Subjects
|
14 Subjects
|
24 Subjects
|
10 Subjects
|
|
Number of Subjects Reporting Solicited Local Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group,Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group
Grade 3 Pain
|
4 Subjects
|
1 Subjects
|
4 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Solicited Local Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group,Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group
Any Redness
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Solicited Local Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group,Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group
Grade 3 Redness
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Solicited Local Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group,Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group
Any Swelling
|
3 Subjects
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Solicited Local Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group,Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group
Grade 3 Swelling
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) follow-up period after vaccination.Population: The Total Vaccinated cohort included all vaccinated subjects for whom data were available.
Solicited general symptoms assessed were fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (= axillary temperature equal to or above 38.0 degrees Celsius (°C)) and were collected after the administration of the Arepanrix or the unadjuvanted formulation of Arepanrix vaccine. 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 above 39.0°C.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=25 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=32 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=29 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.
Any Fatigue
|
9 Subjects
|
13 Subjects
|
12 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.
Grade 3 Fatigue
|
0 Subjects
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.
Related Fatigue
|
9 Subjects
|
12 Subjects
|
12 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.
Any Headache
|
7 Subjects
|
11 Subjects
|
9 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.
Grade 3 Headache
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.
Related Headache
|
7 Subjects
|
10 Subjects
|
9 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.
Any Joint pain at other location
|
4 Subjects
|
2 Subjects
|
9 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.
Grade 3 Joint pain at other location
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.
Related Joint pain at other location
|
4 Subjects
|
2 Subjects
|
9 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.
Any Muscle aches
|
8 Subjects
|
12 Subjects
|
12 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.
Grade 3 Muscle aches
|
2 Subjects
|
0 Subjects
|
3 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.
Related Muscle aches
|
8 Subjects
|
12 Subjects
|
12 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.
Any Shivering
|
3 Subjects
|
2 Subjects
|
5 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.
Grade 3 Shivering
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.
Related Shivering
|
3 Subjects
|
2 Subjects
|
5 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.
Any Sweating
|
5 Subjects
|
4 Subjects
|
4 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.
Grade 3 Sweating
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.
Related Sweating
|
5 Subjects
|
4 Subjects
|
4 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.
Any Fever ≥ 38.0°C
|
2 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.
Grade 3 Fever ≥ 39.0°C
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms From Flulaval/Arepanrix Group,Flulaval/Unadjuvanted Arepanrix Group, Placebo/Arepanrix Group and Placebo/Unadjuvanted Arepanrix Group.
Related Fever
|
2 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: On Days 0, 21, 122 and 164Population: The Total Vaccinated cohort included all vaccinated subjects for whom data were available.
Laboratory parameters assessed were white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), hemoglobin (Hgb), hematocrit (Hct) and platelets (PLA). For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=34 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=33 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Unknown, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Unknown, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Above, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Above, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Above, Day 0 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Above, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Above, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Above, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Above, Day 21 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Above, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Above, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Within, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Within, Day 21 · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Unknown, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Unknown, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Unknown, Day 0 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Unknown, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Unknown, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Unknown, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Unknown, Day 21 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Unknown, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Unknown, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Unknown, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Unknown, Day 122 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Unknown, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Unknown, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Unknown, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Unknown, Day 164 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Unknown, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Below, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Below, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Below, Day 0 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Below, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Below, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Below, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Below, Day 21 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Below, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Below, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Below, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Below, Day 122 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Below, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Below, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Below, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Below, Day 164 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Below, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Within, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Within, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Within, Day 0 · Within
|
33 Participants
|
34 Participants
|
33 Participants
|
33 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Within, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Within, Day 21 · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Within, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Within, Day 21 · Within
|
31 Participants
|
34 Participants
|
31 Participants
|
32 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Within, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Within, Day 122 · Unknown
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Within, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Within, Day 122 · Within
|
28 Participants
|
32 Participants
|
28 Participants
|
27 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Within, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Within, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Within, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Within, Day 164 · Within
|
25 Participants
|
33 Participants
|
26 Participants
|
27 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Within, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Within, Day 21 · Within
|
31 Participants
|
34 Participants
|
31 Participants
|
32 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Within, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Within, Day 122 · Unknown
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Within, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Within, Day 122 · Within
|
27 Participants
|
31 Participants
|
28 Participants
|
23 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Within, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Within, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Within, Day 164 · Below
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Within, Day 164 · Within
|
23 Participants
|
31 Participants
|
25 Participants
|
27 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Within, Day 164 · Above
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Above, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Above, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Above, Day 0 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Above, Day 0 · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Above, Day 21 · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Above, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Above, Day 21 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Above, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Above, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Above, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Above, Day 122 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Above, Day 122 · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Above, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Above, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Above, Day 164 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Above, Day 164 · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Unknown, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Unknown, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Unknown, Day 0 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Unknown, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Unknown, Day 21 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Unknown, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Unknown, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Unknown, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Unknown, Day 122 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Unknown, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Unknown, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Unknown, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Unknown, Day 164 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Unknown, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Below, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Below, Day 0 · Below
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Below, Day 0 · Within
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Below, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Below, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Below, Day 21 · Below
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Unknown, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Below, Day 21 · Within
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Below, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Below, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Below, Day 122 · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Unknown, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Below, Day 122 · Within
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Below, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Below, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Below, Day 164 · Below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Below, Day 164 · Within
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Below, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Within, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Within, Day 0 · Below
|
2 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Within, Day 0 · Within
|
30 Participants
|
32 Participants
|
28 Participants
|
31 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Within, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Within, Day 21 · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Within, Day 21 · Below
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Within, Day 21 · Within
|
28 Participants
|
31 Participants
|
26 Participants
|
31 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Within, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Within, Day 122 · Unknown
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Within, Day 122 · Below
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Within, Day 122 · Within
|
27 Participants
|
30 Participants
|
23 Participants
|
26 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Within, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Within, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Within, Day 164 · Below
|
4 Participants
|
5 Participants
|
8 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Within, Day 164 · Within
|
20 Participants
|
27 Participants
|
16 Participants
|
24 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Within, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Above, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Above, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Above, Day 0 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Above, Day 0 · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Above, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Above, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Above, Day 21 · Within
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Above, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Above, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Above, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Above, Day 122 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Above, Day 122 · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Above, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Above, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Above, Day 164 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Above, Day 164 · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Unknown, Day 0 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Unknown, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Unknown, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Unknown, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Unknown, Day 21 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Unknown, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Unknown, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Unknown, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Unknown, Day 122 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Unknown, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Unknown, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Unknown, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Unknown, Day 164 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Unknown, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Below, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Below, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Below, Day 0 · Within
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Below, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Below, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Below, Day 21 · Below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Below, Day 21 · Within
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Within, Day 21 · Below
|
7 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Below, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Below, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Within, Day 21 · Within
|
24 Participants
|
31 Participants
|
24 Participants
|
29 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Below, Day 122 · Below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Below, Day 122 · Within
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Below, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Below, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Below, Day 164 · Below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Below, Day 164 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Below, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Within, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Within, Day 0 · Below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Within, Day 0 · Within
|
31 Participants
|
33 Participants
|
30 Participants
|
33 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Within, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Within, Day 21 · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Within, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Within, Day 21 · Within
|
28 Participants
|
32 Participants
|
27 Participants
|
29 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Within, Day 21 · Above
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Within, Day 122 · Unknown
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Within, Day 122 · Below
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Within, Day 122 · Within
|
26 Participants
|
28 Participants
|
25 Participants
|
26 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Within, Day 122 · Above
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Within, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Within, Day 164 · Below
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Within, Day 164 · Within
|
24 Participants
|
30 Participants
|
24 Participants
|
25 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Within, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Above, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Above, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Above, Day 0 · Within
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Above, Day 0 · Above
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Above, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Above, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Above, Day 21 · Within
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Above, Day 21 · Above
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Above, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Above, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Above, Day 122 · Within
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Above, Day 122 · Above
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Within, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Above, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Above, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Above, Day 164 · Within
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Above, Day 164 · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Within, Day 122 · Unknown
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Below, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Below, Day 21 · Below
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Within, Day 122 · Below
|
3 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Within, Day 122 · Within
|
25 Participants
|
29 Participants
|
22 Participants
|
25 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Below, Day 21 · Within
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Below, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Within, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Within, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Within, Day 164 · Below
|
6 Participants
|
7 Participants
|
8 Participants
|
4 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Within, Day 164 · Within
|
19 Participants
|
26 Participants
|
18 Participants
|
22 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Within, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Above, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Above, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Above, Day 0 · Within
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Above, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Above, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Above, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Above, Day 21 · Within
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Above, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Above, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Above, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Above, Day 122 · Within
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Above, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Above, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Above, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Above, Day 164 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Above, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Unknown, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Unknown, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Unknown, Day 0 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Unknown, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Unknown, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Unknown, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Unknown, Day 21 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Unknown, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Unknown, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Unknown, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Unknown, Day 122 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Unknown, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Unknown, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Unknown, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Unknown, Day 164 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Unknown, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Below, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Below, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Below, Day 0 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Below, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Below, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Below, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Below, Day 21 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Below, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Below, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Below, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Below, Day 122 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Below, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Below, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Below, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Below, Day 164 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Below, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Within, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Within, Day 0 · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Within, Day 0 · Within
|
32 Participants
|
33 Participants
|
33 Participants
|
33 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Within, Day 0 · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Within, Day 21 · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Within, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Within, Day 21 · Within
|
29 Participants
|
34 Participants
|
31 Participants
|
32 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Within, Day 21 · Above
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Within, Day 122 · Unknown
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Within, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Within, Day 122 · Within
|
28 Participants
|
32 Participants
|
28 Participants
|
27 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Within, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Within, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Within, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Within, Day 164 · Within
|
25 Participants
|
33 Participants
|
26 Participants
|
27 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Within, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Above, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Above, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Above, Day 0 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Above, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Above, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Above, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Above, Day 21 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Above, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Above, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Above, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Above, Day 122 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Above, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Above, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Above, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Above, Day 164 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Above, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Unknown, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Unknown, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Unknown, Day 0 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Unknown, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Unknown, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Unknown, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Unknown, Day 21 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Unknown, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Unknown, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Unknown, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Unknown, Day 122 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Unknown, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Unknown, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Unknown, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Unknown, Day 164 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Unknown, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Below, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Below, Day 0 · Below
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Below, Day 0 · Within
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Below, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Below, Day 122 · Unknown
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Below, Day 122 · Below
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Below, Day 122 · Within
|
1 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Below, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Below, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Below, Day 164 · Below
|
1 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Below, Day 164 · Within
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Below, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Within, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Within, Day 0 · Below
|
2 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Within, Day 0 · Within
|
28 Participants
|
26 Participants
|
23 Participants
|
22 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Within, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Within, Day 21 · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Within, Day 21 · Below
|
7 Participants
|
4 Participants
|
8 Participants
|
11 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Within, Day 21 · Within
|
21 Participants
|
26 Participants
|
19 Participants
|
14 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Within, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Within, Day 122 · Unknown
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Within, Day 122 · Below
|
1 Participants
|
3 Participants
|
4 Participants
|
8 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Within, Day 122 · Within
|
24 Participants
|
26 Participants
|
20 Participants
|
12 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Within, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Within, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Within, Day 164 · Below
|
3 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Within, Day 164 · Within
|
19 Participants
|
24 Participants
|
17 Participants
|
18 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Within, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Above, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Above, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Above, Day 0 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Above, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Above, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Above, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Above, Day 21 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Above, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Above, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Above, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Above, Day 122 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Above, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Above, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Above, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Above, Day 164 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Above, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Unknown, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Unknown, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Unknown, Day 0 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Unknown, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Unknown, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Unknown, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Unknown, Day 21 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Unknown, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Below, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Unknown, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Unknown, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Within, Day 21 · Within
|
29 Participants
|
31 Participants
|
25 Participants
|
29 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Unknown, Day 122 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Unknown, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Unknown, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Unknown, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Unknown, Day 164 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Unknown, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Below, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Below, Day 0 · Below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Below, Day 0 · Within
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Below, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Below, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Below, Day 21 · Within
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Below, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Below, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Below, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Below, Day 122 · Within
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Below, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Below, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Below, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Below, Day 164 · Within
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Below, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Within, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Within, Day 0 · Below
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Within, Day 0 · Within
|
32 Participants
|
31 Participants
|
28 Participants
|
31 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Within, Day 0 · Above
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Within, Day 21 · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Within, Day 21 · Below
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Within, Day 21 · Above
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Within, Day 122 · Unknown
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Within, Day 122 · Below
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Within, Day 122 · Within
|
25 Participants
|
29 Participants
|
26 Participants
|
26 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Within, Day 122 · Above
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Within, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Within, Day 164 · Below
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Within, Day 164 · Within
|
25 Participants
|
30 Participants
|
23 Participants
|
25 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Within, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Above, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Above, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Above, Day 0 · Within
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Above, Day 0 · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Above, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Above, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Above, Day 21 · Within
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Above, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Above, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Above, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Above, Day 122 · Within
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Above, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Above, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Above, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Above, Day 164 · Within
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Above, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Unknown, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Unknown, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Unknown, Day 0 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Unknown, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Unknown, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Unknown, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Unknown, Day 21 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Unknown, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Unknown, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Unknown, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Unknown, Day 122 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Unknown, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Unknown, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Unknown, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Unknown, Day 164 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Unknown, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Below, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Below, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Below, Day 0 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Below, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Below, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Below, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Below, Day 21 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Below, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Below, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Below, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Below, Day 122 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Below, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Below, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Below, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Below, Day 164 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Below, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Within, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Within, Day 0 · Below
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Within, Day 0 · Within
|
31 Participants
|
33 Participants
|
33 Participants
|
33 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Within, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Within, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Within, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Above, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Above, Day 122 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Above, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Above, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Above, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Above, Day 164 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Above, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Unknown, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Unknown, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Unknown, Day 0 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Unknown, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Unknown, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Unknown, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Unknown, Day 21 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Unknown, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Unknown, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Unknown, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Unknown, Day 122 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Unknown, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Unknown, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Unknown, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Unknown, Day 164 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Unknown, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Below, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Below, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Below, Day 0 · Within
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Below, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Below, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Below, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Below, Day 21 · Within
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Below, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Below, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Below, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Below, Day 122 · Within
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Below, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Below, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Below, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Below, Day 164 · Within
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Below, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Within, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Within, Day 0 · Below
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Within, Day 0 · Within
|
30 Participants
|
31 Participants
|
29 Participants
|
30 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Within, Day 0 · Above
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Within, Day 21 · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Within, Day 21 · Below
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Within, Day 21 · Within
|
27 Participants
|
29 Participants
|
28 Participants
|
28 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Within, Day 21 · Above
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Within, Day 122 · Unknown
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Within, Day 122 · Below
|
2 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Within, Day 122 · Within
|
25 Participants
|
24 Participants
|
23 Participants
|
25 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Within, Day 122 · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Within, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Within, Day 164 · Below
|
3 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Within, Day 164 · Within
|
21 Participants
|
26 Participants
|
22 Participants
|
22 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Within, Day 164 · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Above, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Above, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Above, Day 0 · Within
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Above, Day 0 · Above
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Above, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Above, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Above, Day 21 · Within
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Above, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Above, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Above, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Above, Day 122 · Within
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Above, Day 122 · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Above, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Above, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Above, Day 164 · Within
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Above, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Unknown, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Unknown, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Unknown, Day 0 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Unknown, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Unknown, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Unknown, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Unknown, Day 21 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Unknown, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Unknown, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Unknown, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Unknown, Day 122 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Unknown, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Unknown, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Unknown, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Unknown, Day 164 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Unknown, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Below, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Below, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Below, Day 0 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Below, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Below, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Below, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Below, Day 21 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Below, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Below, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Below, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Below, Day 122 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Below, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Below, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Below, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Below, Day 164 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Below, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Within, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Within, Day 0 · Below
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Within, Day 0 · Within
|
30 Participants
|
31 Participants
|
28 Participants
|
29 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Within, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Within, Day 21 · Unknown
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Within, Day 21 · Below
|
8 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Within, Day 21 · Within
|
23 Participants
|
30 Participants
|
24 Participants
|
28 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Within, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Within, Day 122 · Unknown
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Within, Day 122 · Below
|
1 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Within, Day 122 · Within
|
27 Participants
|
29 Participants
|
22 Participants
|
25 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Within, Day 122 · Above
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Within, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Within, Day 164 · Below
|
2 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Within, Day 164 · Within
|
23 Participants
|
27 Participants
|
20 Participants
|
24 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Within, Day 164 · Above
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Above, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Above, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Above, Day 0 · Within
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Above, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Above, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Above, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Above, Day 21 · Within
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Above, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Above, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Above, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Above, Day 122 · Within
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Above, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Above, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Above, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Above, Day 164 · Within
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Above, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Unknown, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Unknown, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Unknown, Day 0 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Unknown, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Unknown, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Unknown, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Unknown, Day 21 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Unknown, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Unknown, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Unknown, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Unknown, Day 122 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Unknown, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Unknown, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Unknown, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Unknown, Day 164 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Unknown, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Below, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Below, Day 0 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Below, Day 0 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Below, Day 0 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Below, Day 21 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Below, Day 21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Below, Day 21 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Below, Day 21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Below, Day 122 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Below, Day 122 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Below, Day 122 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Below, Day 122 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Below, Day 164 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Below, Day 164 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Below, Day 164 · Within
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Below, Day 164 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Within, Day 0 · Unknown
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Within, Day 0 · Below
|
2 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Within, Day 0 · Within
|
31 Participants
|
33 Participants
|
29 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: On Days 0, 21, 122 and 164Population: The Total Vaccinated cohort included all vaccinated subjects for whom data were available.
Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatise (AP), creatinine (CREA), blood urea nitrogen (BUN) and bilirubin (BIL) (total (T) and direct (D)). For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=34 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=33 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BUN Baseline Within-Day 21 Below (N=32;34;30;31)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BUN Baseline Within-Day 0 Within (N=33;34;31;32)
|
32 Subjects
|
33 Subjects
|
31 Subjects
|
32 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BUN Baseline Below-Day 21 Below (N=0;0;1;1)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BUN Baseline Below-Day 21 Within (N=0;0;1;1)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BUN Baseline Within-Day 21 Unknown (N=32;34;30;31)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BUN Baseline Within-Day 21 Within (N=32;34;30;31)
|
31 Subjects
|
34 Subjects
|
30 Subjects
|
30 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BUN Baseline Below-Day 122 Below (N=0;0;1;1)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BUN Baseline Below-Day 122 Within (N=0;0;1;1)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BUN Baseline Within-Day 122 Within (N=29;33;29;27)
|
29 Subjects
|
33 Subjects
|
29 Subjects
|
26 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BUN Baseline Within-Day 122 Above (N=29;33;29;27)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BUN Baseline Below-Day 164 Within (N=0;0;1;1)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BUN Baseline Within-Day 164 Below (N=25;33;25;26)
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BUN Baseline Within-Day 164 Within (N=25;33;25;26)
|
25 Subjects
|
32 Subjects
|
24 Subjects
|
25 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BUN Baseline Within-Day 164 Above (N=25;33;25;26)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
CREA Baseline Below-Day 21 Within (N=2;1;4;5)
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
CREA Baseline Within-Day 21 Unknown (N=30;33;27;27
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
CREA Baseline Within-Day 21 Below (N=30;33;27;27)
|
4 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ALAT Baseline Within-Day 0 Within (N=31,34,33,33)
|
31 Subjects
|
33 Subjects
|
31 Subjects
|
33 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ALAT Baseline Within-Day 0 Above (N=31,34,33,33)
|
0 Subjects
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ALAT Baseline Above-Day 0 Above (N=2,0,0,0)
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ALAT Baseline Within-Day 21 Unknown (N=30,34,31,32
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ALAT Baseline Within-Day 21 Within (N=30,34,31,32)
|
30 Subjects
|
34 Subjects
|
31 Subjects
|
31 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ALAT Baseline Above-Day 21 Above (N=2,0,0,0)
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ALAT Baseline Within-Day 122 Within (N=27,33,30,28
|
27 Subjects
|
33 Subjects
|
30 Subjects
|
27 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ALAT Baseline Within-Day 122 Above (N=27,33,30,28)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ALAT Baseline Above-Day 122 Above (N=2,0,0,0)
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ALAT Baseline Within-Day 164 Within (N=24,33,26,27
|
24 Subjects
|
31 Subjects
|
25 Subjects
|
26 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ALAT Baseline Within-Day 164 Above (N=24,33,26,27)
|
0 Subjects
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ALAT Baseline Above-Day 164 Above (N=1,0,0,0)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
AP Baseline Within-Day 0 Within (N=32,33,33,33)
|
32 Subjects
|
33 Subjects
|
33 Subjects
|
33 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
AP Baseline Above-Day 0 Within (N=1,1,0,0)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
AP Baseline Above-Day 0 Above (N=1,1,0,0)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
AP Baseline Within-Day 21 Unknown (N=31,33,31,32)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
AP Baseline Within-Day 21 Within (N=31,33,31,32)
|
31 Subjects
|
33 Subjects
|
31 Subjects
|
31 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
AP Baseline Above-Day 21 Above (N=1,1,0,0)
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
AP Baseline Within-Day 122 Within (N=28,32,30,28)
|
28 Subjects
|
32 Subjects
|
30 Subjects
|
28 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
AP Baseline Above-Day 122 Above (N=1,1,0,0)
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
AP Baseline Within-Day 164 Within (N=24,32,26,27)
|
24 Subjects
|
32 Subjects
|
26 Subjects
|
27 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
AP Baseline Above-Day 164 Above (N=1,1,0,0)
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ASAT Baseline Unknown-Day 0 Within (N=0,1,0,0)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ASAT Baseline Within-Day 0 Within (N=33,33,33,33)
|
32 Subjects
|
32 Subjects
|
32 Subjects
|
33 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ASAT Baseline Within-Day 0 Above (N=33,33,33,33)
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ASAT Baseline Unknown-Day 21 Within (N=0,1,0,0)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ASAT Baseline Within-Day 21 Unknown (N=32,33,31,32
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ASAT Baseline Within-Day 21 Within (N=32,33,31,32)
|
28 Subjects
|
33 Subjects
|
31 Subjects
|
31 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ASAT Baseline Within-Day 21 Above (N=32,33,31,32)
|
3 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ASAT Baseline Unknown-Day 122 Within (N=0,1,0,0)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ASAT Baseline Within-Day 122 Within (N=29,32,30,28
|
28 Subjects
|
32 Subjects
|
30 Subjects
|
28 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ASAT Baseline Within-Day 122 Above (N=29,32,30,28)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ASAT Baseline Unknown-Day 164 Within (N=0,1,0,0)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ASAT Baseline Within-Day 164 Within (N=25,32,26,27
|
24 Subjects
|
31 Subjects
|
25 Subjects
|
26 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ASAT Baseline Within-Day 164 Above (N=25,32,26,27)
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BILT Baseline Within-Day 0 Within (N=32,34,33,33)
|
32 Subjects
|
33 Subjects
|
33 Subjects
|
33 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BILT Baseline Within-Day 0 Above (N=32,34,33,33)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BILT Baseline Above-Day 0 Within (N=1,0,0,0)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BILT Baseline Within-Day 21 Unknown (N=31,34,31,32
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BILT Baseline Within-Day 21 Within (N=31,34,31,32)
|
30 Subjects
|
33 Subjects
|
31 Subjects
|
31 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BILT Baseline Within-Day 21 Above (N=31,34,31,32)
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BILT Baseline Above-Day 21 Within (N=1,0,0,0)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BILT Baseline Within-Day 122 Within (N=28,33,30,28
|
28 Subjects
|
32 Subjects
|
29 Subjects
|
28 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BILT Baseline Within-Day 122 Above (N=28,33,30,28)
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BILT Baseline Above-Day 122 Within (N=1,0,0,0)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BILT Baseline Within-Day 164 Within (N=25,33,26,27
|
25 Subjects
|
32 Subjects
|
25 Subjects
|
27 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BILT Baseline Within-Day 164 Above (N=25,33,26,27)
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BILD Baseline Within-Day 0 Within (N=33,34,33,33)
|
33 Subjects
|
34 Subjects
|
33 Subjects
|
33 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BILD Baseline Within-Day 21 Unknown (N=32,34,31,32
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BILD Baseline Within-Day 21 Within (N=32,34,31,32)
|
32 Subjects
|
34 Subjects
|
31 Subjects
|
31 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BILD Baseline Within-Day 122 Within (N=29,33,30,28
|
29 Subjects
|
33 Subjects
|
30 Subjects
|
28 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BILD Baseline Within-Day 164 Within (N=25,33,26,27
|
25 Subjects
|
33 Subjects
|
26 Subjects
|
27 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
CREA Baseline Below-Day 0 Below (N=2;1;4;5)
|
2 Subjects
|
1 Subjects
|
3 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
CREA Baseline Below-Day 0 Within (N=2;1;4;5)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
CREA Baseline Within-Day 0 Below (N=31;33;29;28)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
CREA Baseline Within-Day 0 Within (N=31;33;29;28)
|
31 Subjects
|
33 Subjects
|
29 Subjects
|
26 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
CREA Baseline Below-Day 21 Below (N=2;1;4;5)
|
1 Subjects
|
1 Subjects
|
2 Subjects
|
4 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
CREA Baseline Within-Day 21 Within (N=30;33;27;27)
|
25 Subjects
|
32 Subjects
|
26 Subjects
|
24 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
CREA Baseline Within-Day 21 Above (N=30;33;27;27)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
CREA Baseline Below-Day 122 Below (N=2;0;4;5)
|
2 Subjects
|
0 Subjects
|
3 Subjects
|
5 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
CREA Baseline Below-Day 122 Within (N=2;0;4;5)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
CREA Baseline Within-Day 122 Below (N=27;33;26;23)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
CREA Baseline Within-Day 122 Within (N=27;33;26;23
|
27 Subjects
|
33 Subjects
|
25 Subjects
|
23 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
CREA Baseline Below-Day 164 Below (N=2;0;4;5)
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
CREA Baseline Below-Day 164 Within (N=2;0;4;5)
|
2 Subjects
|
0 Subjects
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BUN Baseline Below-Day 0 Below (N=0;0;2;1)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
CREA Baseline Within-Day 164 Below (N=23;33;22;22)
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
CREA Baseline Within-Day 164 Within (N=23;33;22;22
|
22 Subjects
|
32 Subjects
|
21 Subjects
|
22 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BUN Baseline Below-Day 0 Within (N=0;0;2;1)
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BUN Baseline Within-Day 0 Below (N=33;34;31;32)
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: At Day 304Population: The Total Vaccinated cohort included all vaccinated subjects for whom data were available. N (Number of participants analyzed)= number of subjects with laboratory results for the specified visit and laboratory parameter in a given baseline category Thus, there are subjects with missing results which have not been mentioned here.
Laboratory parameters assessed were white blood cells (WBC), neutrophils (NEU), lymphocytes (LYM), monocytes (MON), eosinophils (EOS), basophils (BAS), red blood cells (RBC), hemoglobin (Hgb), hematocrit (Hct) and platelets (PLA). For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=25 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=32 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=23 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Within-D304 Unknown (N=24;31;21;26)
|
2 Subjects
|
3 Subjects
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Within-D304 Within (N=24;31;21;26)
|
22 Subjects
|
28 Subjects
|
19 Subjects
|
24 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Unknown-D304 Unknown (N=1;1;2;1)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Unknown-D304 Below (N=1;1;2;1)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Unknown-D304 Within (N=1;1;2;1)
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Below-D304 Below (N=2;4;4;1)
|
0 Subjects
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Below-D304 Within (N=2;4;4;1)
|
2 Subjects
|
3 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Within-D304 Unknown (N=21;26;17;25)
|
2 Subjects
|
3 Subjects
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Within-D304 Below (N=21;26;17;25)
|
3 Subjects
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Within-D304 Within (N=21;26;17;25)
|
16 Subjects
|
21 Subjects
|
14 Subjects
|
22 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Above-D304 Within (N=1;1;0;0)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
EOS Baseline Above-D304 Above (N=1;1;0;0)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Unknown-D304 Unknown (N=1;1;2;1)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Unknown-D304 Unknown (N=1;1;2;1)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Unknown-D304 Below (N=1;1;2;1)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
BAS Baseline Unknown-D304 Within (N=1;1;2;1)
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Unknown-D304 Within (N=1;1;2;1)
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Below-D304 Within (N=3;3;2;1)
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Within-D304 Unknown (N=21;28;19;25)
|
2 Subjects
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Below-D304 Below (N=1;2;1;1)
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Below-D304 Within (N=1;2;1;1)
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Within-D304 Unknown (N=23;29;19;24)
|
2 Subjects
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Within-D304 Below (N=23;29;19;24)
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Within-D304 Below (N=21;28;19;25)
|
3 Subjects
|
3 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Within-D304 Within (N=21;28;19;25)
|
16 Subjects
|
24 Subjects
|
17 Subjects
|
23 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Within-D304 Within (N=23;29;19;24)
|
20 Subjects
|
27 Subjects
|
15 Subjects
|
23 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Within-D304 Above (N=23;29;19;24)
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Above-D304 Within (N=0;0;1;1)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hct Baseline Above-D304 Above (N=0;0;1;1)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Unknown-D304 Unknown (N=1;1;2;1)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Unknown-D304 Below (N=1;1;2;1)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Unknown-D304 Within (N=1;1;2;1)
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
Hgb Baseline Below-D304 Below (N=3;3;2;1)
|
2 Subjects
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Within-D304 Within (N=24;31;21;26)
|
21 Subjects
|
28 Subjects
|
19 Subjects
|
24 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Unknown-D304 Unknown (N=1;1;2;1)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Unknown-D304 Within (N=1;1;2;1)
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Within-D304 Unknown (N=24;31;21;26)
|
2 Subjects
|
3 Subjects
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
LYM Baseline Within-D304 Above (N=24;31;21;26)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Unknown-D304 Unknown (N=1;1;2;1)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Unknown-D304 Within (N=1;1;2;1)
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Below-D304 Unknown (N=3;5;5;10)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Below-D304 Below (N=3;5;5;10)
|
2 Subjects
|
2 Subjects
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Below-D304 Within (N=3;5;5;10)
|
1 Subjects
|
3 Subjects
|
3 Subjects
|
7 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Below-D304 Below (N=2;1;0;1)
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Below-D304 Within (N=2;1;0;1)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Within-D304 Unknown (N=22;29;21;25)
|
2 Subjects
|
3 Subjects
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Within-D304 Unknown (N=21;26;16;16)
|
2 Subjects
|
3 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Within-D304 Below (N=21;26;16;16)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
MON Baseline Within-D304 Within (N=21;26;16;16)
|
19 Subjects
|
22 Subjects
|
14 Subjects
|
13 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Unknown-D304 Unknown (N=1;1;2;1)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Unknown-D304 Within (N=1;1;2;1)
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Within-D304 Below (N=22;29;21;25)
|
1 Subjects
|
2 Subjects
|
4 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Within-D304 Within (N=22;29;21;25)
|
18 Subjects
|
24 Subjects
|
15 Subjects
|
21 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Within-D304 Above (N=22;29;21;25)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
NEU Baseline Above-D304 Within (N=0;1;0;0)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Unknown-D304 Within (N=1;2;1;4)
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
4 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Below-D304 Unknown (N=0;0;0;1)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Within-D304 Unknown (N=23;30;21;22)
|
2 Subjects
|
2 Subjects
|
2 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Within-D304 Below (N=23;30;21;22)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Within-D304 Within (N=23;30;21;22)
|
21 Subjects
|
26 Subjects
|
19 Subjects
|
22 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Within-D304 Above (N=23;30;21;22)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
PLA Baseline Above-D304 Above (N=1;0;0;0)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Unknown-D304 Unknown (N=1;1;2;1)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Unknown-D304 Below (N=1;1;2;1)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Unknown-D304 Within (N=1;1;2;1)
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Below-D304 Unknown (N=0;2;2;0)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Below-D304 Below (N=0;2;2;0)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Below-D304 Within (N=0;2;2;0)
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Within-D304 Unknown (N=23;29;19;26)
|
2 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Within-D304 Below (N=23;29;19;26)
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Within-D304 Within (N=23;29;19;26)
|
20 Subjects
|
26 Subjects
|
16 Subjects
|
25 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Within-D304 Above (N=23;29;19;26)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
RBC Baseline Above-D304 Above (N=1;0;0;0)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Unknown-D304 Unknown (N=1;1;2;1)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Unknown-D304 Within (N=1;1;2;1)
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Below-D304 Below (N=0;1;2;0)
|
0 Subjects
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Below-D304 Within (N=0;1;2;0)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Within-D304 Unknown (N=23;28;19;25)
|
2 Subjects
|
3 Subjects
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Within-D304 Below (N=23;28;19;25)
|
1 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Within-D304 Within (N=23;28;19;25)
|
20 Subjects
|
24 Subjects
|
17 Subjects
|
21 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Within-D304 Above (N=23;28;19;25)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Above-D304 Within (N=1;2;0;1)
|
0 Subjects
|
2 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Haematological Parameters Assessed With Respect to Normal Laboratory Ranges.
WBC Baseline Above-D304 Above (N=1;2;0;1)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
SECONDARY outcome
Timeframe: At Day 304Population: The Total Vaccinated cohort included all vaccinated subjects for whom data were available N (Number of participants analyzed)= number of subjects with laboratory results for the specified visit and laboratory parameter in a given baseline category Thus, there are subjects with missing results which have not been mentioned here.
Laboratory parameters assessed were alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), alkaline phosphatase (AP), creatinine (CREA), blood urea nitrogen (BUN), and bilirubin (BIL) (total (T) and direct (D)). For each parameter and for each status at baseline it was assessed whether the post-vaccination values of the parameter were above, below or within the range (unkown values are also indicated).
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=25 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=32 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=23 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ALAT Baseline Within-D304 Within (N=24;32;23;26)
|
24 Subjects
|
29 Subjects
|
23 Subjects
|
26 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ALAT Baseline Within-D304 Above (N=24;32;23;26)
|
0 Subjects
|
3 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ALAT Baseline Above-D304 Within (N=1;0;0;1)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
AP Baseline Within-D304 Within (N=24;30;22;27)
|
24 Subjects
|
30 Subjects
|
21 Subjects
|
27 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
AP Baseline Within-D304 Above (N=24;30;22;27)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
AP Baseline Above-D304 Within (N=1;1;0;0)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
AP Baseline Above-D304 Above (N=1;1;0;0)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ASAT Baseline Within-D304 Within (N=24;32;23;27)
|
24 Subjects
|
31 Subjects
|
23 Subjects
|
27 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ASAT Baseline Within-D304 Above (N=24;32;23;27)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
ASAT Baseline Above-D304 Within (N=1;0;0;0)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BILT Baseline Within-D304 Within (N=25;31;22;27)
|
24 Subjects
|
29 Subjects
|
22 Subjects
|
27 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BILT Baseline Within-D304 Above (N=25;31;22;27)
|
1 Subjects
|
2 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BILT Baseline Above-D304 Within (N=0;1;1;0)
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BILT Baseline Above-D304 Above (N=0;1;1;0)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BILD Baseline Within-D304 Within (N=25;32;23;27)
|
25 Subjects
|
31 Subjects
|
23 Subjects
|
27 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BILD Baseline Within-D304 Above (N=25;32;23;27)
|
0 Subjects
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
CREA Baseline Below-D304 Below (N=2;0;2;5)
|
1 Subjects
|
0 Subjects
|
2 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
CREA Baseline Below-D304 Within (N=2;0;2;5)
|
1 Subjects
|
0 Subjects
|
0 Subjects
|
3 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
CREA Baseline Within-D304 Below (N=23;31;20;22)
|
0 Subjects
|
1 Subjects
|
2 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
CREA Baseline Within-D304 Within (N=23;31;20;22)
|
23 Subjects
|
30 Subjects
|
18 Subjects
|
21 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BUN Baseline Below-D304 Below (N=0;0;0;1)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BUN Baseline Within-D304 Within (N=25;31;22;25)
|
25 Subjects
|
31 Subjects
|
22 Subjects
|
25 Subjects
|
|
Number of Subjects Reporting Clinical Laboratory Abnormalities in Biochemistry Parameters Assessed With Respect to Normal Laboratory Ranges.
BUN Baseline Above-D304 Within (N=0;0;0;1)
|
0 Subjects
|
0 Subjects
|
0 Subjects
|
1 Subjects
|
SECONDARY outcome
Timeframe: Before vaccination and at Days 7, 14, 21 and 122Population: The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10. Seropositivity rates of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14 and 21 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=54 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=52 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
>= 1:10 Flu A/CAL/7/09 H1N1 pre-vaccination
|
22 Subjects
|
26 Subjects
|
—
|
—
|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
>= 1:10 Flu A/CAL/7/09 H1N1 Day 7
|
30 Subjects
|
25 Subjects
|
—
|
—
|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
>= 1:10 Flu A/CAL/7/09 H1N1 Day 14
|
39 Subjects
|
26 Subjects
|
—
|
—
|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
>= 1:10 Flu A/CAL/7/09 H1N1 Day 21
|
36 Subjects
|
26 Subjects
|
—
|
—
|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
>= 1:10 Flu A/CAL/7/09 H1N1 Day 122
|
26 Subjects
|
26 Subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Before vaccination and at Days 7, 14, 21 and 122Population: The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).
Titers were expressed as geometric mean antibody titers (GMTs). GMTs of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14, 21 and 122 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=54 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=52 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
GMT Flu A/CAL/7/09 H1N1 pre-vaccination
|
12.5 Titers
Interval 8.6 to 18.2
|
13.9 Titers
Interval 9.6 to 20.1
|
—
|
—
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
GMT Flu A/CAL/7/09 H1N1 Day 7
|
14.8 Titers
Interval 10.2 to 21.5
|
13.8 Titers
Interval 9.6 to 20.0
|
—
|
—
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
GMT Flu A/CAL/7/09 H1N1 Day 14
|
19.9 Titers
Interval 13.7 to 28.7
|
13.8 Titers
Interval 9.6 to 19.9
|
—
|
—
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
GMT Flu A/CAL/7/09 H1N1 Day 21
|
17.8 Titers
Interval 12.4 to 25.6
|
13.3 Titers
Interval 9.3 to 19.0
|
—
|
—
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
GMT Flu A/CAL/7/09 H1N1 Day 122
|
13.8 Titers
Interval 9.6 to 19.8
|
13.4 Titers
Interval 9.5 to 18.9
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 122, 129, 136, 143, 150, 157 and 164.Population: The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=21 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=25 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
>= 1:10 A/CAL/7/09 H1N1 Day 122 (N=21;33;25;27)
|
12 Subjects
|
14 Subjects
|
13 Subjects
|
13 Subjects
|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
>= 1:10 A/CAL/7/09 H1N1 Day 129 (N=21;31;25;27)
|
20 Subjects
|
26 Subjects
|
23 Subjects
|
23 Subjects
|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
>= 1:10 A/CAL/7/09 H1N1 Day 136 (N=21;33;23;26)
|
21 Subjects
|
33 Subjects
|
23 Subjects
|
26 Subjects
|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
>= 1:10 A/CAL/7/09 H1N1 Day 143 (N=21;33;25;26)
|
21 Subjects
|
33 Subjects
|
25 Subjects
|
26 Subjects
|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
>= 1:10 A/CAL/7/09 H1N1 Day 150 (N=19;31;25;26)
|
19 Subjects
|
31 Subjects
|
25 Subjects
|
26 Subjects
|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
>= 1:10 A/CAL/7/09 H1N1 Day 157 (N=20;32;24;25)
|
20 Subjects
|
32 Subjects
|
24 Subjects
|
25 Subjects
|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
>= 1:10 A/CAL/7/09 H1N1 Day 164 (N=21;33;25;27)
|
21 Subjects
|
33 Subjects
|
25 Subjects
|
27 Subjects
|
SECONDARY outcome
Timeframe: At Days 122, 129, 136, 143, 150, 157 and 164.Population: The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).
Titers were expressed as geometric mean antibody titers (GMTs).
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=21 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=25 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
GMT Flu A/CAL/7/09 H1N1 Day 157 (N=20;32;24;25)
|
651.3 Titers
Interval 487.1 to 870.8
|
303.2 Titers
Interval 215.1 to 427.4
|
818.1 Titers
Interval 634.9 to 1054.0
|
338.2 Titers
Interval 230.7 to 495.7
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
GMT Flu A/CAL/7/09 H1N1 Day 122 (N=21;33;25;27)
|
16.1 Titers
Interval 8.9 to 29.3
|
12.5 Titers
Interval 7.7 to 20.1
|
13.9 Titers
Interval 8.1 to 24.0
|
12.9 Titers
Interval 8.1 to 20.7
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
GMT Flu A/CAL/7/09 H1N1 Day 129 (N=21;31;25;27)
|
66.7 Titers
Interval 35.7 to 124.6
|
54.6 Titers
Interval 28.7 to 103.9
|
83.3 Titers
Interval 44.2 to 157.3
|
70.3 Titers
Interval 38.8 to 127.6
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
GMT Flu A/CAL/7/09 H1N1 Day 136 (N=21;33;23;26)
|
491.6 Titers
Interval 319.3 to 756.9
|
303.7 Titers
Interval 191.7 to 481.0
|
602.5 Titers
Interval 434.1 to 836.4
|
385.6 Titers
Interval 242.9 to 612.1
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
GMT Flu A/CAL/7/09 H1N1 Day 143 (N=21;33;25;26)
|
390.1 Titers
Interval 266.3 to 571.5
|
256.6 Titers
Interval 164.9 to 399.3
|
557.3 Titers
Interval 426.5 to 728.3
|
365.6 Titers
Interval 241.3 to 553.9
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
GMT Flu A/CAL/7/09 H1N1 Day 150 (N=19;31;25;26)
|
452.8 Titers
Interval 305.6 to 670.9
|
292.7 Titers
Interval 198.0 to 432.7
|
565.0 Titers
Interval 423.3 to 754.1
|
333.3 Titers
Interval 220.8 to 503.0
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/California/7/2009 (H1N1)V-like Virus-homologous Vaccine Strain.
GMT Flu A/CAL/7/09 H1N1 Day 164 (N=21;33;25;27)
|
650.7 Titers
Interval 485.5 to 872.1
|
259.4 Titers
Interval 186.4 to 361.0
|
799.0 Titers
Interval 630.5 to 1012.4
|
332.7 Titers
Interval 222.0 to 498.6
|
SECONDARY outcome
Timeframe: Before vaccination and at Days 7, 14, 21 and 122Population: The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10. Seropositivity rates of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14, 21 and 122 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=54 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=52 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
>= 1:10 Flu A/BRI/59/07 H1N1 Pre-vaccination
|
48 Subjects
|
44 Subjects
|
—
|
—
|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
>= 1:10 Flu A/BRI/59/07 H1N1 Day 7
|
54 Subjects
|
45 Subjects
|
—
|
—
|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
>= 1:10 Flu A/BRI/59/07 H1N1 Day 14
|
54 Subjects
|
44 Subjects
|
—
|
—
|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
>= 1:10 Flu A/BRI/59/07 H1N1 Day 21
|
54 Subjects
|
44 Subjects
|
—
|
—
|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
>= 1:10 Flu A/BRI/59/07 H1N1 Day 122
|
54 Subjects
|
46 Subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Before vaccination and at Days 7, 14, 21 and 122Population: The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).
Titers were expressed as geometric mean antibody titers (GMTs). GMTs of H1N1 HI antibody titers in terms of humoral immune response was pooled by the vaccination received at Day 0 (i.e. Flulaval or Saline placebo) at Days 7, 14, 21 and 122 upto the administration of the first dose of Arepanrix or the unadjuvanted formulation of Arepanrix vaccine.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=54 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=52 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
GMT Flu A/BRI/59/07 H1N1 pre-vaccination
|
23.3 Titers
Interval 17.7 to 30.5
|
18.7 Titers
Interval 14.6 to 23.9
|
—
|
—
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
GMT Flu A/BRI/59/07 H1N1 Day 7
|
65.5 Titers
Interval 47.4 to 90.6
|
18.3 Titers
Interval 14.4 to 23.3
|
—
|
—
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
GMT Flu A/BRI/59/07 H1N1 Day 14
|
213.6 Titers
Interval 153.0 to 298.2
|
18.4 Titers
Interval 14.2 to 23.8
|
—
|
—
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
GMT Flu A/BRI/59/07 H1N1 Day 21
|
200.3 Titers
Interval 146.0 to 274.8
|
18.8 Titers
Interval 14.6 to 24.1
|
—
|
—
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
GMT Flu A/BRI/59/07 H1N1 Day 122
|
129.4 Titers
Interval 97.6 to 171.6
|
18.1 Titers
Interval 14.3 to 23.1
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 122, 129, 136, 143, 150, 157 and 164.Population: The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10.
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=21 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=25 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
>= 1:10 A/BRI/59/07 H1N1 Day 122 (N=21;33;25;27)
|
21 Subjects
|
33 Subjects
|
22 Subjects
|
24 Subjects
|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
>= 1:10 A/BRI/59/07 H1N1 Day 129 (N=21;31;25;27)
|
21 Subjects
|
31 Subjects
|
25 Subjects
|
26 Subjects
|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
>= 1:10 A/BRI/59/07 H1N1 Day 136 (N=21;33;23;26)
|
21 Subjects
|
33 Subjects
|
23 Subjects
|
26 Subjects
|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
>= 1:10 A/BRI/59/07 H1N1 Day 143 (N=21;33;25;26)
|
21 Subjects
|
33 Subjects
|
25 Subjects
|
25 Subjects
|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
>= 1:10 A/BRI/59/07 H1N1 Day 150 (N=19;31;25;26)
|
19 Subjects
|
31 Subjects
|
25 Subjects
|
26 Subjects
|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
>= 1:10 A/BRI/59/07 H1N1 Day 157 (N=20;32;24;25)
|
20 Subjects
|
32 Subjects
|
24 Subjects
|
25 Subjects
|
|
Number of Seropositive Subjects for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
>= 1:10 A/BRI/59/07 H1N1 Day 164 (N=21;33;25;27)
|
21 Subjects
|
33 Subjects
|
24 Subjects
|
27 Subjects
|
SECONDARY outcome
Timeframe: At Days 122, 129, 136, 143, 150, 157 and 164.Population: The According-To-Protocol cohort for immunogenicity at Day 164 included subjects who had not received a vaccine not specified in the protocol during the primary vaccination course, for whom 3 doses were administered and assay results were available for antibodies against H1N1 antigen at day 21 after the second H1N1 vaccine dose (Day 164).
Titers were expressed as geometric mean antibody titers (GMTs).
Outcome measures
| Measure |
Flulaval/Arepanrix Group
n=21 Participants
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=33 Participants
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=25 Participants
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=27 Participants
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
|---|---|---|---|---|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
GMT A/BRI/59/07 H1N1 Day 122 (N=21;33;25;27)
|
135.6 Titers
Interval 87.5 to 209.9
|
125.7 Titers
Interval 85.3 to 185.0
|
18.4 Titers
Interval 13.5 to 25.0
|
18.0 Titers
Interval 12.2 to 26.4
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
GMT A/BRI/59/07 H1N1 Day 129 (N=21;31;25;27)
|
140.4 Titers
Interval 86.9 to 226.7
|
126.5 Titers
Interval 85.6 to 186.9
|
27.0 Titers
Interval 20.6 to 35.4
|
24.4 Titers
Interval 17.9 to 33.3
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
GMT A/BRI/59/07 H1N1 Day 136 (N=21;33;23;26)
|
144.9 Titers
Interval 90.0 to 233.4
|
144.1 Titers
Interval 98.0 to 211.9
|
44.4 Titers
Interval 32.2 to 61.2
|
38.9 Titers
Interval 26.5 to 57.2
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
GMT A/BRI/59/07 H1N1 Day 143 (N=21;33;25;26)
|
140.3 Titers
Interval 91.5 to 215.1
|
129.6 Titers
Interval 88.9 to 189.1
|
38.8 Titers
Interval 29.1 to 51.7
|
35.4 Titers
Interval 23.9 to 52.3
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
GMT A/BRI/59/07 H1N1 Day 150 (N=19;31;25;26)
|
146.1 Titers
Interval 91.2 to 234.2
|
138.2 Titers
Interval 93.5 to 204.1
|
44.0 Titers
Interval 33.0 to 58.8
|
34.5 Titers
Interval 24.5 to 48.5
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
GMT A/BRI/59/07 H1N1 Day 157 (N=20;32;24;25)
|
144.2 Titers
Interval 93.4 to 222.7
|
131.5 Titers
Interval 89.1 to 194.1
|
49.6 Titers
Interval 35.9 to 68.6
|
33.8 Titers
Interval 24.1 to 47.5
|
|
Titers for Hemagglutination Inhibition (HI) Antibodies Against A/Brisbane/59/2007 (H1N1) Virus-heterologous Vaccine Strain.
GMT A/BRI/59/07 H1N1 Day 164 (N=21;33;25;27)
|
144.9 Titers
Interval 97.2 to 216.1
|
123.1 Titers
Interval 87.1 to 174.0
|
49.2 Titers
Interval 33.9 to 71.2
|
35.2 Titers
Interval 25.7 to 48.2
|
Adverse Events
Flulaval/Arepanrix Group
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Flulaval/Unadjuvanted Arepanrix Group
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo/Arepanrix Group
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Placebo/Unadjuvanted Arepanrix Group
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Flulaval Group
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Flulaval/Arepanrix Group
n=33 participants at risk
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=34 participants at risk
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=33 participants at risk
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=33 participants at risk
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval Group
n=67 participants at risk
subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
|
Placebo Group
n=66 participants at risk
subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
|
|---|---|---|---|---|---|---|
|
Vascular disorders
Aortic aneurysm
|
3.0%
1/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/34 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
—
0/0 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
—
0/0 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/34 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
3.0%
1/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
—
0/0 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
—
0/0 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/34 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
3.0%
1/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
—
0/0 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
—
0/0 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
|
Infections and infestations
Hepatitis C
|
3.0%
1/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/34 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
—
0/0 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
—
0/0 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
2.9%
1/34 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
—
0/0 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
—
0/0 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
3.0%
1/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/34 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
—
0/0 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
—
0/0 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
Other adverse events
| Measure |
Flulaval/Arepanrix Group
n=33 participants at risk
subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval/Unadjuvanted Arepanrix Group
n=34 participants at risk
subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Arepanrix Group
n=33 participants at risk
subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Placebo/Unadjuvanted Arepanrix Group
n=33 participants at risk
subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
|
Flulaval Group
n=67 participants at risk
subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
|
Placebo Group
n=66 participants at risk
subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
|
|---|---|---|---|---|---|---|
|
General disorders
Pain
|
57.6%
19/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
41.2%
14/34 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
72.7%
24/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
30.3%
10/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/67 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/66 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
|
General disorders
Fatigue
|
27.3%
9/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
38.2%
13/34 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
36.4%
12/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
24.2%
8/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/67 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/66 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
|
General disorders
Headache
|
21.2%
7/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
32.4%
11/34 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
27.3%
9/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
24.2%
8/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/67 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/66 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
|
General disorders
Joint pain at other location
|
12.1%
4/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
5.9%
2/34 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
27.3%
9/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
9.1%
3/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/67 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/66 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
|
General disorders
Muscle aches
|
24.2%
8/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
35.3%
12/34 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
36.4%
12/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
15.2%
5/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/67 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/66 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
|
General disorders
Shivering
|
9.1%
3/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
5.9%
2/34 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
15.2%
5/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/67 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/66 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
|
General disorders
Sweating
|
15.2%
5/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
11.8%
4/34 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
12.1%
4/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/67 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/66 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
|
General disorders
Swelling
|
9.1%
3/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
2.9%
1/34 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
6.1%
2/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
3.0%
1/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/67 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/66 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
|
General disorders
Redness
|
0.00%
0/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/34 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/33 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
6.0%
4/67 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
0.00%
0/66 • SAEs: During the entire study period (up to Day 507). Solicited AEs: During a 7-day follow-up period after administration of vaccine. Unsolicted AEs: Up to 21days (Days 0-20) after vaccination and within 84 days after dose 1 or 63 days after dose 2.
Even though all subjects reporting solicited and unsolicited AEs were analysed, no subjects reported unsolicited AEs which was equal to or above the 5% frequency threshold.
|
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