Trial Outcomes & Findings for Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population (NCT NCT00306995)
NCT ID: NCT00306995
Last Updated: 2020-02-10
Results Overview
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
385 participants
Primary outcome timeframe
At Day 10 post Dose 1
Results posted on
2020-02-10
Participant Flow
After Part I, the core study (study period from Visit 1 on Day 0 up to the phone contact on Day 51), the enrolled subjects were stratified into Subset 1 (Part II - Visit 5 on Day 189 to study conclusion, i.e ., Visit 7 on Day 365) or Subset 2 (Part II - Visit 6 on Day 365 to study conclusion, i.e ., phone contact on Day 395).
Participant milestones
| Measure |
SB218352_15 Group:
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_8 Group:
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_4 Group:
Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2 Group:
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_8AL Group:
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_4AL Group:
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2.
|
|---|---|---|---|---|---|---|---|
|
Study Part I
STARTED
|
55
|
55
|
55
|
55
|
55
|
55
|
55
|
|
Study Part I
COMPLETED
|
55
|
55
|
55
|
55
|
55
|
55
|
54
|
|
Study Part I
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Study Part II for Subset 1
STARTED
|
27
|
26
|
27
|
27
|
27
|
26
|
23
|
|
Study Part II for Subset 1
COMPLETED
|
27
|
26
|
27
|
27
|
27
|
26
|
23
|
|
Study Part II for Subset 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Study Part II for Subset 2
STARTED
|
23
|
24
|
23
|
22
|
23
|
26
|
24
|
|
Study Part II for Subset 2
COMPLETED
|
23
|
23
|
23
|
22
|
23
|
26
|
24
|
|
Study Part II for Subset 2
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
SB218352_15 Group:
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_8 Group:
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_4 Group:
Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2 Group:
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_8AL Group:
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_4AL Group:
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2.
|
|---|---|---|---|---|---|---|---|
|
Study Part I
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Study Part II for Subset 2
Serious Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety Study of Pandemic Candidate Influenza Vaccines in the Elderly Population
Baseline characteristics by cohort
| Measure |
SB218352_15 Group:
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_8 Group:
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_4 Group:
n=55 Participants
Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2 Group:
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_8AL Group:
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_4AL Group:
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2.
|
Total
n=385 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
68.4 Years
STANDARD_DEVIATION 5.11 • n=99 Participants
|
69.0 Years
STANDARD_DEVIATION 5.66 • n=107 Participants
|
69.2 Years
STANDARD_DEVIATION 5.77 • n=206 Participants
|
69.1 Years
STANDARD_DEVIATION 5.94 • n=7 Participants
|
68.4 Years
STANDARD_DEVIATION 5.92 • n=31 Participants
|
68.4 Years
STANDARD_DEVIATION 6.31 • n=30 Participants
|
69.8 Years
STANDARD_DEVIATION 5.91 • n=3 Participants
|
68.9 Years
STANDARD_DEVIATION 5.80 • n=6 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
41 Participants
n=30 Participants
|
22 Participants
n=3 Participants
|
212 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
14 Participants
n=30 Participants
|
33 Participants
n=3 Participants
|
173 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Arabic/North African
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White-Caucasian
|
55 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
54 Participants
n=7 Participants
|
55 Participants
n=31 Participants
|
55 Participants
n=30 Participants
|
55 Participants
n=3 Participants
|
384 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: At Day 10 post Dose 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Outcome measures
| Measure |
SB218352_4AL Group:
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=51 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=53 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum Haemagglutination-inhibition (HI) Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
|
18.8 Titer
Interval 12.3 to 28.5
|
16.9 Titer
Interval 12.3 to 23.3
|
24.4 Titer
Interval 17.1 to 35.0
|
9.8 Titer
Interval 7.5 to 12.8
|
23.3 Titer
Interval 16.9 to 32.0
|
15.6 Titer
Interval 11.0 to 22.1
|
14.6 Titer
Interval 10.2 to 20.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 21 post Dose 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Outcome measures
| Measure |
SB218352_4AL Group:
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=51 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=53 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
|
20.0 Titers
Interval 13.3 to 30.0
|
17.8 Titers
Interval 12.9 to 24.6
|
32.5 Titers
Interval 22.1 to 47.8
|
12.0 Titers
Interval 9.1 to 15.9
|
42.1 Titers
Interval 28.7 to 61.7
|
20.1 Titers
Interval 14.0 to 28.9
|
21.9 Titers
Interval 13.8 to 34.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 10 post Dose 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer lower than (\<) 1:10 and a post-vaccination titre higher than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer
Outcome measures
| Measure |
SB218352_4AL Group:
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=51 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=53 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects Against Influenza A Subtype H9N2
|
10 Participants
|
8 Participants
|
12 Participants
|
1 Participants
|
14 Participants
|
11 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 21 post Dose 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer \< 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer
Outcome measures
| Measure |
SB218352_4AL Group:
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=51 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=53 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects Against Influenza A Subtype H9N2
|
10 Participants
|
10 Participants
|
19 Participants
|
3 Participants
|
20 Participants
|
17 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 10 post Dose 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seroconversion factor was defined as the fold increase in serum HI GMTs on day 10 compared to day 0.
Outcome measures
| Measure |
SB218352_4AL Group:
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=51 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=53 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Seroconversion Factor for Influenza A Subtype H9N2
|
2.4 Fold change
Interval 1.6 to 3.7
|
2.4 Fold change
Interval 1.7 to 3.3
|
2.7 Fold change
Interval 1.9 to 4.0
|
1.4 Fold change
Interval 1.2 to 1.7
|
3.1 Fold change
Interval 2.3 to 4.2
|
2.1 Fold change
Interval 1.5 to 3.0
|
2.0 Fold change
Interval 1.4 to 2.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 21 post Dose 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seroconversion factor was defined as the fold increase in serum HI GMTs on day 21 compared to day 0.
Outcome measures
| Measure |
SB218352_4AL Group:
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=51 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=53 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Seroconversion Factor for Influenza A Subtype H9N2
|
2.6 Fold change
Interval 1.7 to 3.9
|
2.5 Fold change
Interval 1.8 to 3.5
|
3.6 Fold change
Interval 2.3 to 5.7
|
1.7 Fold change
Interval 1.4 to 2.2
|
5.5 Fold change
Interval 3.7 to 8.4
|
2.7 Fold change
Interval 1.8 to 4.0
|
3.0 Fold change
Interval 1.8 to 5.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 10 post Dose 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.
Outcome measures
| Measure |
SB218352_4AL Group:
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=51 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=53 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects Against H9N2
|
16 Participants
|
11 Participants
|
19 Participants
|
6 Participants
|
20 Participants
|
13 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 21 post Dose 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.
Outcome measures
| Measure |
SB218352_4AL Group:
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=51 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=53 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects Against H9N2
|
15 Participants
|
13 Participants
|
24 Participants
|
7 Participants
|
27 Participants
|
19 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 10 post Dose 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.
Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer \< 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.
Outcome measures
| Measure |
SB218352_4AL Group:
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
n=21 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
n=20 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
n=18 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
n=20 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
n=21 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Seroprotection Power Against H9N2
|
7 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
6 Participants
|
8 Participants
|
7 Participants
|
4 Participants
|
0 Participants
|
10 Participants
|
7 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: At Day 21 post Dose 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.
Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer \< 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.
Outcome measures
| Measure |
SB218352_4AL Group:
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
n=21 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
n=20 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
n=18 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
n=20 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
n=21 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Seroprotection Power Against H9N2
|
7 Participants
|
1 Participants
|
7 Participants
|
3 Participants
|
8 Participants
|
9 Participants
|
8 Participants
|
9 Participants
|
8 Participants
|
4 Participants
|
0 Participants
|
12 Participants
|
6 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: At Day 21 post Dose 2 (Day 42)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Outcome measures
| Measure |
SB218352_4AL Group:
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=51 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=53 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
|
38.0 Titers
Interval 26.7 to 54.1
|
26.0 Titers
Interval 20.0 to 34.0
|
55.9 Titers
Interval 40.1 to 77.8
|
20.0 Titers
Interval 15.2 to 26.2
|
63.1 Titers
Interval 45.3 to 87.9
|
36.0 Titers
Interval 25.8 to 50.2
|
31.0 Titers
Interval 21.3 to 45.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.
Anti-H9N2 antibody titers were expressed as Geometric Mean Titers (GMTs).
Outcome measures
| Measure |
SB218352_4AL Group:
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
n=20 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Serum HI Antibody Titers Against the Influenza A Virus Strain Subtype H9N2 (Anti-H9N2)
|
44.0 Titers
Interval 30.3 to 64.0
|
28.3 Titers
Interval 18.9 to 42.4
|
49.5 Titers
Interval 31.8 to 77.4
|
32.2 Titers
Interval 21.8 to 47.5
|
71.0 Titers
Interval 50.0 to 100.7
|
51.3 Titers
Interval 30.4 to 86.7
|
51.1 Titers
Interval 32.8 to 79.5
|
103.0 Titers
Interval 63.3 to 167.5
|
41.3 Titers
Interval 27.1 to 62.7
|
41.9 Titers
Interval 23.7 to 74.1
|
21.4 Titers
Interval 14.5 to 31.6
|
108.1 Titers
Interval 69.4 to 168.5
|
62.5 Titers
Interval 40.9 to 95.3
|
54.9 Titers
Interval 37.4 to 80.5
|
PRIMARY outcome
Timeframe: At Day 21 post Dose 2 (Day 42)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer \< 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in postvaccination titer
Outcome measures
| Measure |
SB218352_4AL Group:
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=51 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=53 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects Against Influenza A Subtype H9N2
|
22 Participants
|
16 Participants
|
31 Participants
|
11 Participants
|
28 Participants
|
22 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.
Seroconversion rate was defined as the percentage of vaccinees who had a pre-vaccination HI titer \< 1:10 and a post-vaccination titre ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four-fold increase in post-vaccination titer
Outcome measures
| Measure |
SB218352_4AL Group:
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
n=20 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects Against Influenza A Subtype H9N2
|
15 Participants
|
10 Participants
|
15 Participants
|
13 Participants
|
20 Participants
|
18 Participants
|
19 Participants
|
19 Participants
|
10 Participants
|
12 Participants
|
4 Participants
|
17 Participants
|
15 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: At Day 21 post Dose 2 (Day 42)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seroconversion factor defined as the fold increase in serum HI GMTs on day 21 post Dose 3 (Day 42) compared to day 0.
Outcome measures
| Measure |
SB218352_4AL Group:
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=51 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=53 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Seroconversion Factor for Influenza A Subtype H9N2
|
4.9 Fold change
Interval 3.4 to 7.2
|
3.7 Fold change
Interval 2.8 to 4.9
|
6.3 Fold change
Interval 4.3 to 9.0
|
2.9 Fold change
Interval 2.3 to 3.7
|
8.3 Fold change
Interval 5.8 to 11.9
|
4.9 Fold change
Interval 3.5 to 6.8
|
4.3 Fold change
Interval 2.9 to 6.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.
Seroconversion factor was defined as the fold increase in serum HI GMTs on day 21 post Dose 3 (Day 210 for Subset 1 and Day 386 for Subset 2) compared to day 0.
Outcome measures
| Measure |
SB218352_4AL Group:
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
n=20 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Seroconversion Factor for Influenza A Subtype H9N2
|
6.4 Fold change
Interval 4.3 to 9.6
|
4.3 Fold change
Interval 2.8 to 6.4
|
5.4 Fold change
Interval 3.6 to 8.2
|
4.4 Fold change
Interval 3.1 to 6.4
|
10.5 Fold change
Interval 7.0 to 15.6
|
8.3 Fold change
Interval 5.1 to 13.5
|
7.9 Fold change
Interval 4.6 to 13.6
|
11.9 Fold change
Interval 6.4 to 21.9
|
5.5 Fold change
Interval 3.5 to 8.6
|
5.6 Fold change
Interval 3.2 to 9.6
|
2.8 Fold change
Interval 1.9 to 4.2
|
11.2 Fold change
Interval 5.9 to 21.1
|
2.0 Fold change
Interval 1.3 to 3.2
|
5.4 Fold change
Interval 3.0 to 9.9
|
PRIMARY outcome
Timeframe: At Day 21 post Dose 2 (Day 42)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.
Outcome measures
| Measure |
SB218352_4AL Group:
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=51 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=53 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=54 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects Against H9N2
|
25 Participants
|
19 Participants
|
41 Participants
|
14 Participants
|
35 Participants
|
27 Participants
|
27 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.
Seroprotection rate was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually was accepted as indicating protection.
Outcome measures
| Measure |
SB218352_4AL Group:
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
n=20 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects Against H9N2
|
18 Participants
|
11 Participants
|
18 Participants
|
17 Participants
|
22 Participants
|
18 Participants
|
21 Participants
|
20 Participants
|
13 Participants
|
13 Participants
|
6 Participants
|
20 Participants
|
17 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: At Day 21 post Dose 2 (Day 42)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.
Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer \< 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.
Outcome measures
| Measure |
SB218352_4AL Group:
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
n=21 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
n=20 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
n=18 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
n=20 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
n=20 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Seroprotection Power Against H9N2
|
12 Participants
|
4 Participants
|
13 Participants
|
9 Participants
|
13 Participants
|
12 Participants
|
14 Participants
|
17 Participants
|
12 Participants
|
7 Participants
|
1 Participants
|
14 Participants
|
9 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: At Day 21 post Dose 3 (Day 210 for Subset 1 groups and Day 386 for Subset 2 groups)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.
Seroprotection power was defined as the proportion of subjects who were unprotected prior to the vaccination (HI titer \< 1:40 on day 0) and had a protective post-vaccination titer of ≥ 1:40.
Outcome measures
| Measure |
SB218352_4AL Group:
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=21 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
n=21 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
n=21 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
n=20 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
n=18 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
n=20 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
n=21 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Seroprotection Power Against H9N2
|
18 Participants
|
11 Participants
|
13 Participants
|
15 Participants
|
21 Participants
|
17 Participants
|
20 Participants
|
20 Participants
|
12 Participants
|
11 Participants
|
4 Participants
|
17 Participants
|
16 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: During the 30-days (Day 0-30) post vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort (TVc), which included all vaccinated subjects.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
SB218352_4AL Group:
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Any AEs
|
4 Participants
|
7 Participants
|
8 Participants
|
6 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Grade 3 AEs
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
Related AEs
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 0 to Day 51Population: The analysis was performed on the Total Vaccinated Cohort (TVc), which included all vaccinated subjects.
A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization).
Outcome measures
| Measure |
SB218352_4AL Group:
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 0, 10, 21 and 42 post vaccinationPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Among expressed immune markers were interferon-gamma (IFN-γ) and cluster of differentiation 40 - ligand (CD40-L).
Outcome measures
| Measure |
SB218352_4AL Group:
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells
CD4-ALL DOUBLES, Day 0
|
691.00 T-cells/million cells
Interval 547.0 to 873.0
|
594.50 T-cells/million cells
Interval 453.5 to 1020.5
|
557.00 T-cells/million cells
Interval 509.0 to 827.0
|
472.00 T-cells/million cells
Interval 305.0 to 1025.0
|
738.00 T-cells/million cells
Interval 558.0 to 1284.0
|
785.00 T-cells/million cells
Interval 489.0 to 1072.0
|
782.00 T-cells/million cells
Interval 441.0 to 1052.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells
CD4-ALL DOUBLES, DAY 10
|
1194.00 T-cells/million cells
Interval 760.0 to 1453.0
|
874.00 T-cells/million cells
Interval 626.0 to 1399.0
|
1049.00 T-cells/million cells
Interval 779.0 to 1753.0
|
844.00 T-cells/million cells
Interval 478.0 to 1548.0
|
1275.00 T-cells/million cells
Interval 884.0 to 1691.0
|
1148.00 T-cells/million cells
Interval 702.0 to 1891.0
|
1066.50 T-cells/million cells
Interval 647.0 to 1809.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells
CD4-ALL DOUBLES, DAY 21
|
989.50 T-cells/million cells
Interval 734.0 to 1912.5
|
972.50 T-cells/million cells
Interval 820.0 to 1466.0
|
1118.00 T-cells/million cells
Interval 904.0 to 1424.0
|
791.50 T-cells/million cells
Interval 390.0 to 1229.0
|
1555.00 T-cells/million cells
Interval 1073.0 to 1873.0
|
1396.00 T-cells/million cells
Interval 923.0 to 1962.0
|
1212.00 T-cells/million cells
Interval 784.0 to 1822.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells
CD4-ALL DOUBLES, DAY 42
|
1198.00 T-cells/million cells
Interval 791.5 to 1646.5
|
1059.50 T-cells/million cells
Interval 894.0 to 1636.0
|
1100.00 T-cells/million cells
Interval 733.0 to 1567.0
|
965.00 T-cells/million cells
Interval 651.0 to 1645.0
|
1600.00 T-cells/million cells
Interval 936.0 to 2156.0
|
1349.00 T-cells/million cells
Interval 722.0 to 1812.0
|
967.00 T-cells/million cells
Interval 647.0 to 1693.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells
CD4-CD40L, Day 0
|
714.00 T-cells/million cells
Interval 368.0 to 866.0
|
600.00 T-cells/million cells
Interval 449.0 to 976.0
|
583.00 T-cells/million cells
Interval 471.0 to 810.0
|
438.00 T-cells/million cells
Interval 308.0 to 920.0
|
720.00 T-cells/million cells
Interval 442.0 to 1263.0
|
574.00 T-cells/million cells
Interval 467.0 to 1095.0
|
750.00 T-cells/million cells
Interval 441.0 to 1028.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells
CD4-CD40L, DAY 10
|
1158.00 T-cells/million cells
Interval 760.0 to 1378.0
|
886.00 T-cells/million cells
Interval 613.0 to 1399.0
|
1028.00 T-cells/million cells
Interval 779.0 to 1446.0
|
769.00 T-cells/million cells
Interval 478.0 to 1552.0
|
1161.00 T-cells/million cells
Interval 630.0 to 1639.0
|
1148.00 T-cells/million cells
Interval 668.0 to 1922.0
|
981.00 T-cells/million cells
Interval 626.0 to 1654.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells
CD4-CD40L, DAY 21
|
974.50 T-cells/million cells
Interval 710.0 to 1790.0
|
900.50 T-cells/million cells
Interval 753.0 to 1421.0
|
1069.00 T-cells/million cells
Interval 851.0 to 1320.0
|
788.50 T-cells/million cells
Interval 376.0 to 1229.0
|
1536.00 T-cells/million cells
Interval 884.0 to 1820.0
|
1243.50 T-cells/million cells
Interval 730.0 to 1511.0
|
1074.00 T-cells/million cells
Interval 752.0 to 1483.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells
CD4-CD40L, DAY 42
|
1177.50 T-cells/million cells
Interval 746.5 to 1608.5
|
984.00 T-cells/million cells
Interval 824.0 to 1636.0
|
1037.00 T-cells/million cells
Interval 721.0 to 1545.0
|
999.00 T-cells/million cells
Interval 651.0 to 1645.0
|
1492.50 T-cells/million cells
Interval 836.0 to 2147.5
|
1088.00 T-cells/million cells
Interval 649.0 to 1748.0
|
945.00 T-cells/million cells
Interval 641.0 to 1644.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells
CD4-IFN-γ, Day 0
|
212.50 T-cells/million cells
Interval 177.0 to 464.0
|
217.50 T-cells/million cells
Interval 149.0 to 295.5
|
278.00 T-cells/million cells
Interval 120.0 to 353.0
|
160.00 T-cells/million cells
Interval 80.0 to 280.0
|
299.00 T-cells/million cells
Interval 125.0 to 434.0
|
233.00 T-cells/million cells
Interval 109.0 to 761.0
|
198.00 T-cells/million cells
Interval 172.0 to 395.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells
CD4-IFN-γ, DAY 10
|
400.00 T-cells/million cells
Interval 170.0 to 581.0
|
245.00 T-cells/million cells
Interval 196.0 to 425.0
|
466.00 T-cells/million cells
Interval 273.0 to 612.0
|
365.00 T-cells/million cells
Interval 93.0 to 674.0
|
463.00 T-cells/million cells
Interval 239.0 to 926.0
|
457.00 T-cells/million cells
Interval 196.0 to 539.0
|
582.50 T-cells/million cells
Interval 336.0 to 693.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells
CD4-IFN-γ, DAY 21
|
391.00 T-cells/million cells
Interval 204.0 to 911.5
|
412.00 T-cells/million cells
Interval 298.0 to 654.0
|
411.00 T-cells/million cells
Interval 231.0 to 638.0
|
228.50 T-cells/million cells
Interval 171.0 to 558.0
|
484.00 T-cells/million cells
Interval 305.0 to 784.0
|
482.00 T-cells/million cells
Interval 253.0 to 651.0
|
516.00 T-cells/million cells
Interval 291.0 to 629.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific Cluster of Differentiation 4 (CD4) T-cells
CD4-IFN-γ, DAY 42
|
445.00 T-cells/million cells
Interval 361.5 to 790.0
|
483.00 T-cells/million cells
Interval 232.0 to 733.0
|
342.00 T-cells/million cells
Interval 234.0 to 449.0
|
344.00 T-cells/million cells
Interval 211.0 to 632.0
|
669.50 T-cells/million cells
Interval 312.5 to 915.5
|
332.00 T-cells/million cells
Interval 245.0 to 739.0
|
346.00 T-cells/million cells
Interval 232.0 to 549.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 0, 10, 21 and 42 post-vaccinationPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Among expressed immune markers were interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α).
Outcome measures
| Measure |
SB218352_4AL Group:
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Antigen-specific CD4 T-cells
CD4-IL-2, DAY 0
|
487.50 T-cells/million cells
Interval 269.0 to 579.0
|
437.00 T-cells/million cells
Interval 320.0 to 641.5
|
414.00 T-cells/million cells
Interval 322.0 to 661.0
|
381.00 T-cells/million cells
Interval 208.0 to 559.0
|
509.00 T-cells/million cells
Interval 377.0 to 987.0
|
491.00 T-cells/million cells
Interval 356.0 to 922.0
|
524.00 T-cells/million cells
Interval 351.0 to 801.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific CD4 T-cells
CD4-IL-2, DAY 10
|
821.00 T-cells/million cells
Interval 616.0 to 1155.0
|
622.00 T-cells/million cells
Interval 392.0 to 981.0
|
751.00 T-cells/million cells
Interval 582.0 to 1234.0
|
579.00 T-cells/million cells
Interval 264.0 to 1106.0
|
924.00 T-cells/million cells
Interval 619.0 to 1284.0
|
985.00 T-cells/million cells
Interval 581.0 to 1423.0
|
814.00 T-cells/million cells
Interval 460.0 to 1271.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific CD4 T-cells
CD4-IL-2, DAY 21
|
799.00 T-cells/million cells
Interval 640.0 to 1405.5
|
764.00 T-cells/million cells
Interval 632.0 to 1070.0
|
888.00 T-cells/million cells
Interval 557.0 to 1221.0
|
625.00 T-cells/million cells
Interval 227.0 to 865.0
|
988.00 T-cells/million cells
Interval 763.0 to 1697.0
|
1013.50 T-cells/million cells
Interval 819.0 to 1790.0
|
814.00 T-cells/million cells
Interval 569.0 to 1281.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific CD4 T-cells
CD4-IL-2, DAY 42
|
953.00 T-cells/million cells
Interval 658.5 to 1331.0
|
890.00 T-cells/million cells
Interval 583.0 to 1216.0
|
913.00 T-cells/million cells
Interval 561.0 to 1334.0
|
761.00 T-cells/million cells
Interval 534.0 to 1224.0
|
1233.50 T-cells/million cells
Interval 707.5 to 1743.5
|
876.00 T-cells/million cells
Interval 562.0 to 1529.0
|
714.00 T-cells/million cells
Interval 559.0 to 1322.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific CD4 T-cells
CD4-TNF-α, DAY 0
|
495.50 T-cells/million cells
Interval 348.0 to 669.0
|
395.00 T-cells/million cells
Interval 282.0 to 680.5
|
380.00 T-cells/million cells
Interval 273.0 to 669.0
|
337.00 T-cells/million cells
Interval 240.0 to 705.0
|
538.00 T-cells/million cells
Interval 327.0 to 759.0
|
470.00 T-cells/million cells
Interval 287.0 to 999.0
|
495.00 T-cells/million cells
Interval 321.0 to 676.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific CD4 T-cells
CD4-TNF-α, DAY 10
|
793.00 T-cells/million cells
Interval 637.0 to 875.0
|
641.00 T-cells/million cells
Interval 414.0 to 929.0
|
817.00 T-cells/million cells
Interval 665.0 to 1229.0
|
522.00 T-cells/million cells
Interval 376.0 to 1073.0
|
728.00 T-cells/million cells
Interval 534.0 to 1126.0
|
822.00 T-cells/million cells
Interval 491.0 to 1141.0
|
717.00 T-cells/million cells
Interval 347.0 to 1062.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific CD4 T-cells
CD4-TNF-α, DAY 21
|
650.50 T-cells/million cells
Interval 458.5 to 1307.5
|
672.50 T-cells/million cells
Interval 557.0 to 1150.0
|
923.00 T-cells/million cells
Interval 637.0 to 1207.0
|
491.50 T-cells/million cells
Interval 359.0 to 837.0
|
1244.00 T-cells/million cells
Interval 749.0 to 1455.0
|
842.50 T-cells/million cells
Interval 676.0 to 1303.0
|
870.00 T-cells/million cells
Interval 519.0 to 1252.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific CD4 T-cells
CD4-TNF-α, DAY 42
|
829.00 T-cells/million cells
Interval 592.5 to 1128.5
|
722.00 T-cells/million cells
Interval 520.0 to 988.0
|
868.00 T-cells/million cells
Interval 530.0 to 1163.0
|
717.00 T-cells/million cells
Interval 368.0 to 1261.0
|
1079.50 T-cells/million cells
Interval 696.5 to 1621.0
|
899.00 T-cells/million cells
Interval 505.0 to 1436.0
|
608.00 T-cells/million cells
Interval 464.0 to 994.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 10, 21 and 42 post-vaccinationPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Among expressed immune markers were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L). Descriptive comparison of the CMI response after Dose 1 and Dose 2 of the monovalent candidate pandemic influenza A vaccine. CMI response was determined in terms of the proportion of lymphocytes (CD4+ and CD8+ per million T cells) activated in vitro by the vaccine antigen on Days 10 and 21 after the Dose 1 and on Day 21 after Dose 2 as compared to Day 0 (pre-vaccination). The results were calculated based on the individual difference between each post-vaccination timepoint (Day 10, Day 21, Day 42) and Day 0.
Outcome measures
| Measure |
SB218352_4AL Group:
n=19 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=21 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=21 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=21 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=20 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cytokine-positive CD4 T-cells Frequency
CD4-ALL DOUBLES, DAY 10
|
398.00 CD4+ T-cells/million cells
Interval 11.0 to 773.0
|
139.00 CD4+ T-cells/million cells
Interval -69.5 to 981.0
|
295.00 CD4+ T-cells/million cells
Interval 9.0 to 859.0
|
342.00 CD4+ T-cells/million cells
Interval -58.0 to 657.0
|
434.50 CD4+ T-cells/million cells
Interval 24.0 to 796.5
|
326.00 CD4+ T-cells/million cells
Interval 127.5 to 731.0
|
219.00 CD4+ T-cells/million cells
Interval -64.0 to 767.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD4 T-cells Frequency
CD4-ALL DOUBLES, DAY 21
|
440.50 CD4+ T-cells/million cells
Interval 177.0 to 1195.0
|
283.00 CD4+ T-cells/million cells
Interval 98.0 to 660.0
|
248.00 CD4+ T-cells/million cells
Interval 108.0 to 539.0
|
252.50 CD4+ T-cells/million cells
Interval -62.0 to 669.0
|
645.00 CD4+ T-cells/million cells
Interval 274.0 to 1037.0
|
477.00 CD4+ T-cells/million cells
Interval 280.5 to 766.0
|
359.00 CD4+ T-cells/million cells
Interval -114.0 to 780.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD4 T-cells Frequency
CD4-ALL DOUBLES, DAY 42
|
554.00 CD4+ T-cells/million cells
Interval 353.0 to 751.0
|
445.50 CD4+ T-cells/million cells
Interval 252.5 to 786.5
|
384.00 CD4+ T-cells/million cells
Interval 116.0 to 678.0
|
441.00 CD4+ T-cells/million cells
Interval 298.0 to 708.0
|
689.00 CD4+ T-cells/million cells
Interval 9.0 to 1104.0
|
360.00 CD4+ T-cells/million cells
Interval -120.0 to 766.0
|
482.50 CD4+ T-cells/million cells
Interval -3.0 to 791.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD4 T-cells Frequency
CD4-CD40L, DAY 10
|
335.00 CD4+ T-cells/million cells
Interval -9.0 to 741.0
|
104.50 CD4+ T-cells/million cells
Interval -37.0 to 930.0
|
302.00 CD4+ T-cells/million cells
Interval -18.0 to 859.0
|
303.50 CD4+ T-cells/million cells
Interval -28.0 to 650.0
|
384.50 CD4+ T-cells/million cells
Interval 10.5 to 745.5
|
299.50 CD4+ T-cells/million cells
Interval 20.5 to 680.5
|
149.50 CD4+ T-cells/million cells
Interval -98.5 to 686.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD4 T-cells Frequency
CD4-CD40L, DAY 21
|
433.00 CD4+ T-cells/million cells
Interval 158.0 to 1095.0
|
286.00 CD4+ T-cells/million cells
Interval 70.0 to 547.0
|
195.00 CD4+ T-cells/million cells
Interval 4.0 to 481.0
|
237.00 CD4+ T-cells/million cells
Interval -42.5 to 639.5
|
630.00 CD4+ T-cells/million cells
Interval 48.0 to 996.0
|
429.50 CD4+ T-cells/million cells
Interval 142.0 to 623.0
|
271.00 CD4+ T-cells/million cells
Interval -114.0 to 735.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD4 T-cells Frequency
CD4-CD40L, DAY 42
|
513.00 CD4+ T-cells/million cells
Interval 336.0 to 725.0
|
445.00 CD4+ T-cells/million cells
Interval 232.5 to 765.0
|
228.00 CD4+ T-cells/million cells
Interval 62.0 to 687.0
|
451.00 CD4+ T-cells/million cells
Interval 310.0 to 751.0
|
685.00 CD4+ T-cells/million cells
Interval -3.0 to 1071.0
|
320.00 CD4+ T-cells/million cells
Interval -14.0 to 737.0
|
440.00 CD4+ T-cells/million cells
Interval -88.0 to 691.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD4 T-cells Frequency
CD4-IFN-γ, DAY 10
|
165.00 CD4+ T-cells/million cells
Interval 23.0 to 273.0
|
72.50 CD4+ T-cells/million cells
Interval -54.5 to 375.0
|
105.00 CD4+ T-cells/million cells
Interval -17.0 to 200.0
|
78.50 CD4+ T-cells/million cells
Interval 0.0 to 438.0
|
167.00 CD4+ T-cells/million cells
Interval 92.0 to 427.0
|
134.50 CD4+ T-cells/million cells
Interval -108.0 to 451.5
|
172.50 CD4+ T-cells/million cells
Interval 3.5 to 478.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD4 T-cells Frequency
CD4-IFN-γ, DAY 21
|
229.00 CD4+ T-cells/million cells
Interval -57.0 to 600.0
|
150.00 CD4+ T-cells/million cells
Interval 83.0 to 260.0
|
107.00 CD4+ T-cells/million cells
Interval -58.0 to 256.0
|
77.50 CD4+ T-cells/million cells
Interval -41.0 to 304.0
|
145.50 CD4+ T-cells/million cells
Interval 57.0 to 506.0
|
120.00 CD4+ T-cells/million cells
Interval -34.0 to 442.0
|
205.00 CD4+ T-cells/million cells
Interval -3.0 to 343.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD4 T-cells Frequency
CD4-IFN-γ, DAY 42
|
186.00 CD4+ T-cells/million cells
Interval 103.0 to 375.0
|
233.50 CD4+ T-cells/million cells
Interval 64.5 to 544.0
|
125.00 CD4+ T-cells/million cells
Interval 27.0 to 196.0
|
136.00 CD4+ T-cells/million cells
Interval 60.0 to 248.0
|
320.00 CD4+ T-cells/million cells
Interval -19.0 to 621.0
|
145.00 CD4+ T-cells/million cells
Interval -115.0 to 236.0
|
124.00 CD4+ T-cells/million cells
Interval 8.5 to 350.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD4 T-cells Frequency
CD4-IL-2, DAY 10
|
242.00 CD4+ T-cells/million cells
Interval 120.0 to 668.0
|
158.50 CD4+ T-cells/million cells
Interval -90.0 to 523.0
|
226.00 CD4+ T-cells/million cells
Interval 51.0 to 574.0
|
225.00 CD4+ T-cells/million cells
Interval 0.0 to 442.0
|
369.50 CD4+ T-cells/million cells
Interval -38.0 to 645.0
|
289.50 CD4+ T-cells/million cells
Interval 48.0 to 729.5
|
152.00 CD4+ T-cells/million cells
Interval -45.5 to 648.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD4 T-cells Frequency
CD4-IL2, DAY 21
|
518.00 CD4+ T-cells/million cells
Interval 224.0 to 701.0
|
257.00 CD4+ T-cells/million cells
Interval 150.0 to 499.0
|
227.00 CD4+ T-cells/million cells
Interval 48.0 to 547.0
|
117.00 CD4+ T-cells/million cells
Interval -64.5 to 459.0
|
400.50 CD4+ T-cells/million cells
Interval 132.0 to 789.0
|
401.00 CD4+ T-cells/million cells
Interval 170.5 to 644.0
|
297.00 CD4+ T-cells/million cells
Interval 15.0 to 549.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD4 T-cells Frequency
CD4-IL-2, DAY 42
|
523.00 CD4+ T-cells/million cells
Interval 381.0 to 629.0
|
493.00 CD4+ T-cells/million cells
Interval 198.0 to 766.5
|
363.50 CD4+ T-cells/million cells
Interval 57.0 to 613.0
|
359.00 CD4+ T-cells/million cells
Interval 180.0 to 656.0
|
648.00 CD4+ T-cells/million cells
Interval 40.0 to 970.0
|
285.00 CD4+ T-cells/million cells
Interval 58.0 to 540.0
|
294.50 CD4+ T-cells/million cells
Interval 158.0 to 457.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD4 T-cells Frequency
CD4-TNF-α, DAY 10
|
194.00 CD4+ T-cells/million cells
Interval -33.0 to 469.0
|
140.50 CD4+ T-cells/million cells
Interval -42.0 to 540.5
|
324.00 CD4+ T-cells/million cells
Interval 50.0 to 425.0
|
122.00 CD4+ T-cells/million cells
Interval -68.0 to 501.0
|
210.50 CD4+ T-cells/million cells
Interval -61.0 to 423.0
|
221.50 CD4+ T-cells/million cells
Interval 41.0 to 608.5
|
194.00 CD4+ T-cells/million cells
Interval 70.5 to 550.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD4 T-cells Frequency
CD4-TNF-α, DAY 21
|
156.50 CD4+ T-cells/million cells
Interval 31.0 to 937.0
|
229.00 CD4+ T-cells/million cells
Interval 139.0 to 340.0
|
293.00 CD4+ T-cells/million cells
Interval 150.0 to 412.0
|
142.50 CD4+ T-cells/million cells
Interval -17.0 to 430.0
|
470.50 CD4+ T-cells/million cells
Interval 233.0 to 795.0
|
282.50 CD4+ T-cells/million cells
Interval 164.0 to 610.5
|
259.00 CD4+ T-cells/million cells
Interval 12.0 to 648.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD4 T-cells Frequency
CD4-TNF-α, DAY 42
|
313.00 CD4+ T-cells/million cells
Interval 239.0 to 484.0
|
252.50 CD4+ T-cells/million cells
Interval 106.0 to 606.0
|
291.50 CD4+ T-cells/million cells
Interval 177.0 to 693.0
|
239.00 CD4+ T-cells/million cells
Interval 114.0 to 574.0
|
454.00 CD4+ T-cells/million cells
Interval 234.0 to 805.0
|
157.00 CD4+ T-cells/million cells
Interval -46.0 to 538.0
|
175.00 CD4+ T-cells/million cells
Interval -20.5 to 510.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 0, 10, 21 and 42 post-vaccinationPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Among expressed immune markers were interferon-gamma (IFN-γ) and cluster of differentiation 40 - ligand (CD40-L).
Outcome measures
| Measure |
SB218352_4AL Group:
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=21 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells
CD8-ALL DOUBLES, Day 0
|
83.00 CD8+ T-cells/million cells
Interval 1.0 to 263.0
|
12.00 CD8+ T-cells/million cells
Interval 1.0 to 124.0
|
107.00 CD8+ T-cells/million cells
Interval 1.0 to 168.0
|
83.50 CD8+ T-cells/million cells
Interval 1.0 to 294.0
|
83.00 CD8+ T-cells/million cells
Interval 1.0 to 302.0
|
62.00 CD8+ T-cells/million cells
Interval 1.0 to 186.0
|
104.00 CD8+ T-cells/million cells
Interval 27.0 to 292.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells
CD8-ALL DOUBLES, DAY 10
|
73.00 CD8+ T-cells/million cells
Interval 9.0 to 347.0
|
17.50 CD8+ T-cells/million cells
Interval 1.0 to 175.0
|
104.50 CD8+ T-cells/million cells
Interval 1.0 to 320.0
|
102.00 CD8+ T-cells/million cells
Interval 1.0 to 235.0
|
34.00 CD8+ T-cells/million cells
Interval 1.0 to 313.0
|
47.50 CD8+ T-cells/million cells
Interval 1.0 to 195.0
|
148.00 CD8+ T-cells/million cells
Interval 2.0 to 218.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells
CD8-ALL DOUBLES, DAY 21
|
98.00 CD8+ T-cells/million cells
Interval 1.0 to 304.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 265.0
|
76.00 CD8+ T-cells/million cells
Interval 1.0 to 187.5
|
51.00 CD8+ T-cells/million cells
Interval 1.0 to 378.0
|
172.00 CD8+ T-cells/million cells
Interval 1.0 to 482.0
|
19.00 CD8+ T-cells/million cells
Interval 1.0 to 151.0
|
57.00 CD8+ T-cells/million cells
Interval 1.0 to 361.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells
CD8-ALL DOUBLES, DAY 42
|
173.50 CD8+ T-cells/million cells
Interval 1.0 to 434.0
|
100.00 CD8+ T-cells/million cells
Interval 1.0 to 358.0
|
17.50 CD8+ T-cells/million cells
Interval 1.0 to 438.5
|
147.50 CD8+ T-cells/million cells
Interval 1.0 to 301.0
|
163.00 CD8+ T-cells/million cells
Interval 1.0 to 307.0
|
70.00 CD8+ T-cells/million cells
Interval 1.0 to 258.0
|
167.50 CD8+ T-cells/million cells
Interval 43.0 to 336.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells
CD8-CD40L, Day 0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 102.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 113.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 54.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 52.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 60.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 58.5
|
49.00 CD8+ T-cells/million cells
Interval 1.0 to 101.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells
CD8-CD40L, DAY 10
|
49.50 CD8+ T-cells/million cells
Interval 1.0 to 98.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 9.5
|
1.50 CD8+ T-cells/million cells
Interval 1.0 to 81.5
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 190.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 95.5
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 4.0
|
3.50 CD8+ T-cells/million cells
Interval 1.0 to 60.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells
CD8-CD40L, DAY 21
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 51.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 49.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 1.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 7.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 56.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 52.0
|
51.00 CD8+ T-cells/million cells
Interval 1.0 to 82.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells
CD8-CD40L, DAY 42
|
26.50 CD8+ T-cells/million cells
Interval 1.0 to 135.0
|
3.50 CD8+ T-cells/million cells
Interval 1.0 to 149.5
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 100.0
|
25.50 CD8+ T-cells/million cells
Interval 1.0 to 97.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 78.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 49.0
|
48.00 CD8+ T-cells/million cells
Interval 1.0 to 101.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells
CD8-IFN-γ, Day 0
|
50.50 CD8+ T-cells/million cells
Interval 1.0 to 155.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 113.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 107.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 103.0
|
52.50 CD8+ T-cells/million cells
Interval 1.0 to 150.0
|
21.50 CD8+ T-cells/million cells
Interval 1.0 to 108.0
|
97.00 CD8+ T-cells/million cells
Interval 1.0 to 204.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells
CD8-IFN-γ, DAY 10
|
48.50 CD8+ T-cells/million cells
Interval 1.0 to 141.0
|
49.00 CD8+ T-cells/million cells
Interval 1.0 to 192.5
|
68.00 CD8+ T-cells/million cells
Interval 1.0 to 156.0
|
50.00 CD8+ T-cells/million cells
Interval 1.0 to 155.0
|
49.50 CD8+ T-cells/million cells
Interval 1.0 to 167.5
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 50.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 131.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells
CD8-IFN-γ, DAY 21
|
49.00 CD8+ T-cells/million cells
Interval 1.0 to 128.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 51.0
|
15.50 CD8+ T-cells/million cells
Interval 1.0 to 159.0
|
29.00 CD8+ T-cells/million cells
Interval 1.0 to 107.0
|
50.00 CD8+ T-cells/million cells
Interval 1.0 to 303.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 76.0
|
54.00 CD8+ T-cells/million cells
Interval 1.0 to 155.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific Cluster of Differentiation 8 (CD8) T-cells
CD8-IFN-γ, DAY 42
|
94.50 CD8+ T-cells/million cells
Interval 1.0 to 129.0
|
50.50 CD8+ T-cells/million cells
Interval 1.0 to 198.5
|
25.00 CD8+ T-cells/million cells
Interval 1.0 to 122.5
|
82.00 CD8+ T-cells/million cells
Interval 1.0 to 277.0
|
98.00 CD8+ T-cells/million cells
Interval 1.0 to 313.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 130.0
|
60.00 CD8+ T-cells/million cells
Interval 1.0 to 111.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 0, 10, 21 and 42 post-vaccinationPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Among expressed immune markers were interleukin-2 (IL-2) and tumour necrosis factor-alpha (TNF-α).
Outcome measures
| Measure |
SB218352_4AL Group:
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=21 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Antigen-specific CD8 T-cells
CD8-TNF-α, DAY 21
|
48.00 CD8+ T-cells/million cells
Interval 1.0 to 289.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 97.0
|
75.00 CD8+ T-cells/million cells
Interval 1.0 to 272.5
|
23.00 CD8+ T-cells/million cells
Interval 1.0 to 374.0
|
100.00 CD8+ T-cells/million cells
Interval 1.0 to 388.0
|
51.00 CD8+ T-cells/million cells
Interval 1.0 to 100.0
|
57.00 CD8+ T-cells/million cells
Interval 1.0 to 220.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific CD8 T-cells
CD8-IL-2, Day 0
|
25.00 CD8+ T-cells/million cells
Interval 1.0 to 179.0
|
4.00 CD8+ T-cells/million cells
Interval 1.0 to 62.0
|
52.00 CD8+ T-cells/million cells
Interval 1.0 to 152.0
|
34.50 CD8+ T-cells/million cells
Interval 1.0 to 198.0
|
7.50 CD8+ T-cells/million cells
Interval 1.0 to 90.0
|
20.00 CD8+ T-cells/million cells
Interval 1.0 to 128.0
|
56.00 CD8+ T-cells/million cells
Interval 1.0 to 238.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific CD8 T-cells
CD8-IL-2, DAY 10
|
71.50 CD8+ T-cells/million cells
Interval 1.0 to 231.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 100.0
|
27.50 CD8+ T-cells/million cells
Interval 1.0 to 154.5
|
64.00 CD8+ T-cells/million cells
Interval 1.0 to 235.0
|
1.50 CD8+ T-cells/million cells
Interval 1.0 to 155.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 195.0
|
50.00 CD8+ T-cells/million cells
Interval 1.0 to 166.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific CD8 T-cells
CD8-IL-2, DAY 21
|
38.00 CD8+ T-cells/million cells
Interval 1.0 to 304.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 73.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 46.0
|
23.00 CD8+ T-cells/million cells
Interval 1.0 to 211.0
|
24.00 CD8+ T-cells/million cells
Interval 1.0 to 173.0
|
19.00 CD8+ T-cells/million cells
Interval 1.0 to 97.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 192.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific CD8 T-cells
CD8-IL-2, DAY 42
|
29.50 CD8+ T-cells/million cells
Interval 1.0 to 365.0
|
25.00 CD8+ T-cells/million cells
Interval 1.0 to 262.0
|
49.50 CD8+ T-cells/million cells
Interval 1.0 to 291.5
|
24.50 CD8+ T-cells/million cells
Interval 1.0 to 151.0
|
47.00 CD8+ T-cells/million cells
Interval 1.0 to 153.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 260.0
|
98.50 CD8+ T-cells/million cells
Interval 1.0 to 248.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific CD8 T-cells
CD8-TNF-α, Day 0
|
77.00 CD8+ T-cells/million cells
Interval 1.0 to 155.0
|
10.50 CD8+ T-cells/million cells
Interval 1.0 to 96.0
|
60.00 CD8+ T-cells/million cells
Interval 1.0 to 105.0
|
50.00 CD8+ T-cells/million cells
Interval 1.0 to 155.0
|
85.50 CD8+ T-cells/million cells
Interval 10.0 to 267.0
|
19.50 CD8+ T-cells/million cells
Interval 1.0 to 154.5
|
51.00 CD8+ T-cells/million cells
Interval 1.0 to 241.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific CD8 T-cells
CD8-TNF-α, DAY 10
|
51.50 CD8+ T-cells/million cells
Interval 1.0 to 198.0
|
1.00 CD8+ T-cells/million cells
Interval 1.0 to 124.0
|
107.50 CD8+ T-cells/million cells
Interval 1.0 to 242.0
|
49.00 CD8+ T-cells/million cells
Interval 1.0 to 198.0
|
82.00 CD8+ T-cells/million cells
Interval 1.0 to 210.0
|
25.00 CD8+ T-cells/million cells
Interval 1.0 to 150.0
|
77.00 CD8+ T-cells/million cells
Interval 1.0 to 171.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Antigen-specific CD8 T-cells
CD8-TNF-α, DAY 42
|
110.00 CD8+ T-cells/million cells
Interval 3.0 to 434.0
|
49.00 CD8+ T-cells/million cells
Interval 1.0 to 163.5
|
29.50 CD8+ T-cells/million cells
Interval 1.0 to 386.5
|
76.00 CD8+ T-cells/million cells
Interval 1.0 to 301.0
|
163.00 CD8+ T-cells/million cells
Interval 1.0 to 307.0
|
101.00 CD8+ T-cells/million cells
Interval 1.0 to 258.0
|
157.00 CD8+ T-cells/million cells
Interval 50.0 to 226.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 10, 21 and 42 post-vaccinationPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Among expressed immune markers were interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α) and cluster of differentiation 40 - ligand (CD40-L). Descriptive comparison of the CMI response after Dose 1 and Dose 2 of the monovalent candidate pandemic influenza A vaccine. CMI response was determined in terms of the proportion of lymphocytes (CD4+ and CD8+ per million T cells) activated in vitro by the vaccine antigen on Days 10 and 21 after the Dose 1 and on Day 21 after Dose 2 as compared to Day 0 (pre-vaccination). The results were calculated based on the individual difference between each post-vaccination timepoint (Day 10, Day 21, Day 42) and Day 0.
Outcome measures
| Measure |
SB218352_4AL Group:
n=16 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=17 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=17 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=19 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=17 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=20 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cytokine-positive CD8 T-cells Frequency
CD8-CD40L, DAY 10
|
24.00 CD8+ T-cells/million cells
Interval -5.0 to 94.5
|
0.00 CD8+ T-cells/million cells
Interval 0.0 to 0.0
|
0.00 CD8+ T-cells/million cells
Interval 0.0 to 1.0
|
0.00 CD8+ T-cells/million cells
Interval 0.0 to 103.0
|
0.00 CD8+ T-cells/million cells
Interval 0.0 to 109.0
|
0.00 CD8+ T-cells/million cells
Interval -50.0 to 1.0
|
0.00 CD8+ T-cells/million cells
Interval -50.0 to 48.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD8 T-cells Frequency
CD8-ALL DOUBLES, DAY 10
|
4.00 CD8+ T-cells/million cells
Interval -155.0 to 267.0
|
0.00 CD8+ T-cells/million cells
Interval -21.0 to 49.0
|
2.00 CD8+ T-cells/million cells
Interval -86.0 to 143.0
|
0.00 CD8+ T-cells/million cells
Interval -50.0 to 100.0
|
0.00 CD8+ T-cells/million cells
Interval -234.0 to 155.0
|
0.00 CD8+ T-cells/million cells
Interval -99.0 to 47.0
|
16.00 CD8+ T-cells/million cells
Interval -145.0 to 152.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD8 T-cells Frequency
CD8-ALL DOUBLES, DAY 21
|
0.00 CD8+ T-cells/million cells
Interval -48.0 to 218.0
|
0.00 CD8+ T-cells/million cells
Interval -37.0 to 59.5
|
-46.00 CD8+ T-cells/million cells
Interval -118.0 to 85.0
|
0.00 CD8+ T-cells/million cells
Interval -45.0 to 223.0
|
0.00 CD8+ T-cells/million cells
Interval -98.0 to 1.0
|
0.00 CD8+ T-cells/million cells
Interval -126.0 to 51.0
|
-31.00 CD8+ T-cells/million cells
Interval -266.0 to 105.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD8 T-cells Frequency
CD8-ALL DOUBLES, DAY 42
|
94.00 CD8+ T-cells/million cells
Interval -54.0 to 386.0
|
-1.50 CD8+ T-cells/million cells
Interval -47.0 to 344.0
|
-50.50 CD8+ T-cells/million cells
Interval -128.0 to 0.0
|
2.00 CD8+ T-cells/million cells
Interval 0.0 to 204.0
|
-5.00 CD8+ T-cells/million cells
Interval -188.0 to 126.0
|
44.00 CD8+ T-cells/million cells
Interval -99.0 to 99.0
|
-29.00 CD8+ T-cells/million cells
Interval -50.0 to 335.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD8 T-cells Frequency
CD8-CD40L, DAY 21
|
0.00 CD8+ T-cells/million cells
Interval -86.0 to 62.0
|
0.00 CD8+ T-cells/million cells
Interval -76.0 to 45.0
|
0.00 CD8+ T-cells/million cells
Interval -48.0 to 0.0
|
0.00 CD8+ T-cells/million cells
Interval 0.0 to 0.0
|
0.00 CD8+ T-cells/million cells
Interval -48.0 to 0.0
|
0.00 CD8+ T-cells/million cells
Interval -1.0 to 0.0
|
0.00 CD8+ T-cells/million cells
Interval -18.0 to 60.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD8 T-cells Frequency
CD8-CD40L, DAY 42
|
0.00 CD8+ T-cells/million cells
Interval -81.0 to 135.0
|
0.00 CD8+ T-cells/million cells
Interval -101.0 to 48.0
|
0.00 CD8+ T-cells/million cells
Interval -48.0 to 47.0
|
0.00 CD8+ T-cells/million cells
Interval 0.0 to 81.0
|
0.00 CD8+ T-cells/million cells
Interval 0.0 to 0.0
|
0.00 CD8+ T-cells/million cells
Interval -49.0 to 0.0
|
0.00 CD8+ T-cells/million cells
Interval -7.0 to 46.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD8 T-cells Frequency
CD8-IFN-γ, DAY 10
|
0.00 CD8+ T-cells/million cells
Interval -100.5 to 135.0
|
0.00 CD8+ T-cells/million cells
Interval -42.0 to 49.0
|
0.00 CD8+ T-cells/million cells
Interval -24.0 to 48.0
|
0.00 CD8+ T-cells/million cells
Interval -3.0 to 50.0
|
0.00 CD8+ T-cells/million cells
Interval -50.0 to 73.0
|
-35.00 CD8+ T-cells/million cells
Interval -102.0 to 0.0
|
0.00 CD8+ T-cells/million cells
Interval -87.0 to 105.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD8 T-cells Frequency
CD8-IFN-γ, DAY 21
|
0.00 CD8+ T-cells/million cells
Interval -50.0 to 74.0
|
0.00 CD8+ T-cells/million cells
Interval -24.5 to 25.0
|
0.00 CD8+ T-cells/million cells
Interval -63.0 to 76.0
|
0.00 CD8+ T-cells/million cells
Interval 0.0 to 105.0
|
0.00 CD8+ T-cells/million cells
Interval -96.0 to 73.0
|
-6.00 CD8+ T-cells/million cells
Interval -96.0 to 0.0
|
0.00 CD8+ T-cells/million cells
Interval -159.0 to 54.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD8 T-cells Frequency
CD8-IFN-γ, DAY 42
|
0.00 CD8+ T-cells/million cells
Interval -50.0 to 120.0
|
0.00 CD8+ T-cells/million cells
Interval -124.0 to 124.0
|
-0.50 CD8+ T-cells/million cells
Interval -48.0 to 0.0
|
14.00 CD8+ T-cells/million cells
Interval 0.0 to 140.0
|
-50.00 CD8+ T-cells/million cells
Interval -96.0 to 67.0
|
0.00 CD8+ T-cells/million cells
Interval -96.0 to 0.0
|
49.00 CD8+ T-cells/million cells
Interval -134.0 to 86.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD8 T-cells Frequency
CD8-IL-2, DAY 10
|
0.00 CD8+ T-cells/million cells
Interval -80.0 to 160.5
|
0.00 CD8+ T-cells/million cells
Interval -21.0 to 96.0
|
-1.00 CD8+ T-cells/million cells
Interval -103.0 to 59.0
|
0.00 CD8+ T-cells/million cells
Interval -98.0 to 100.0
|
0.00 CD8+ T-cells/million cells
Interval -50.0 to 118.0
|
0.00 CD8+ T-cells/million cells
Interval -38.0 to 47.0
|
2.50 CD8+ T-cells/million cells
Interval -123.0 to 66.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD8 T-cells Frequency
CD8-IL-2, DAY 21
|
0.00 CD8+ T-cells/million cells
Interval -60.0 to 98.0
|
0.00 CD8+ T-cells/million cells
Interval -16.0 to 78.5
|
-28.00 CD8+ T-cells/million cells
Interval -151.0 to 0.0
|
0.00 CD8+ T-cells/million cells
Interval 0.0 to 129.0
|
0.00 CD8+ T-cells/million cells
Interval -81.0 to 38.0
|
0.00 CD8+ T-cells/million cells
Interval -38.0 to 50.0
|
-1.00 CD8+ T-cells/million cells
Interval -205.0 to 113.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD8 T-cells Frequency
CD8-IL-2, DAY 42
|
46.00 CD8+ T-cells/million cells
Interval -102.0 to 292.0
|
0.00 CD8+ T-cells/million cells
Interval -45.0 to 147.0
|
-69.50 CD8+ T-cells/million cells
Interval -106.0 to 97.0
|
0.00 CD8+ T-cells/million cells
Interval -67.0 to 112.0
|
0.00 CD8+ T-cells/million cells
Interval -13.0 to 98.0
|
0.00 CD8+ T-cells/million cells
Interval -69.0 to 0.0
|
0.00 CD8+ T-cells/million cells
Interval -46.0 to 247.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD8 T-cells Frequency
CD8-TNF-α, DAY 10
|
-24.50 CD8+ T-cells/million cells
Interval -127.5 to 114.5
|
0.00 CD8+ T-cells/million cells
Interval 0.0 to 47.0
|
4.00 CD8+ T-cells/million cells
Interval -99.0 to 99.0
|
0.00 CD8+ T-cells/million cells
Interval -48.0 to 194.0
|
-3.00 CD8+ T-cells/million cells
Interval -140.0 to 46.0
|
0.00 CD8+ T-cells/million cells
Interval -97.0 to 47.0
|
23.00 CD8+ T-cells/million cells
Interval -49.5 to 121.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD8 T-cells Frequency
CD8-TNF-α, DAY 21
|
-24.50 CD8+ T-cells/million cells
Interval -127.5 to 114.5
|
0.00 CD8+ T-cells/million cells
Interval 0.0 to 47.0
|
-10.50 CD8+ T-cells/million cells
Interval -97.0 to 21.0
|
0.00 CD8+ T-cells/million cells
Interval -45.0 to 247.0
|
0.00 CD8+ T-cells/million cells
Interval -49.0 to 47.0
|
0.00 CD8+ T-cells/million cells
Interval -50.0 to 75.0
|
-7.00 CD8+ T-cells/million cells
Interval -127.0 to 114.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cytokine-positive CD8 T-cells Frequency
CD8-TNF-α, DAY 42
|
99.00 CD8+ T-cells/million cells
Interval -34.0 to 243.0
|
24.00 CD8+ T-cells/million cells
Interval -95.0 to 120.0
|
0.00 CD8+ T-cells/million cells
Interval -99.0 to 47.0
|
0.00 CD8+ T-cells/million cells
Interval -52.0 to 255.0
|
0.00 CD8+ T-cells/million cells
Interval -62.0 to 149.0
|
48.00 CD8+ T-cells/million cells
Interval -69.0 to 159.0
|
74.00 CD8+ T-cells/million cells
Interval -7.0 to 289.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 4-days post Dose 1 (Days 0-3), post Dose 2 (Days 21-24) and across these dosesPopulation: The analysis was performed on the Total Vaccinated Cohort (TVc) included all vaccinated subjects (for whom diary card was available).
Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevents normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm).
Outcome measures
| Measure |
SB218352_4AL Group:
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Solicited Local Symptoms
Any Pain, Dose 1
|
8 Participants
|
8 Participants
|
8 Participants
|
2 Participants
|
8 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Any Redness (mm), Dose 1
|
6 Participants
|
5 Participants
|
7 Participants
|
1 Participants
|
10 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Redness (mm), Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Any Swelling (mm), Dose 1
|
4 Participants
|
7 Participants
|
4 Participants
|
1 Participants
|
8 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Swelling (mm), Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Any Pain, Dose 2
|
4 Participants
|
6 Participants
|
7 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Any Redness (mm), Dose 2
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Redness (mm), Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Any Swelling (mm), Dose 2
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Swelling (mm), Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Any Pain, Across doses
|
9 Participants
|
9 Participants
|
12 Participants
|
4 Participants
|
10 Participants
|
7 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Pain, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Any Redness (mm), Across doses
|
8 Participants
|
7 Participants
|
8 Participants
|
2 Participants
|
11 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Redness (mm), Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Any Swelling (mm), Across doses
|
5 Participants
|
7 Participants
|
5 Participants
|
2 Participants
|
10 Participants
|
2 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Swelling (mm), Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups)Population: The analysis was performed on the Total Vaccinated Cohort (TVc) of Subsets, which included all vaccinated subjects (for whom the diary card was available).
Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = pain which prevents normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm).
Outcome measures
| Measure |
SB218352_4AL Group:
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Solicited Local Symptoms
Any Pain
|
8 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
9 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Redness (mm)
|
5 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Redness (mm)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Any Swelling (mm)
|
7 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Solicited Local Symptoms
Grade 3 Swelling (mm)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 4-days (Day 0-3) post Dose 1Population: The analysis was performed on the Total Vaccinated Cohort (TVc) included all vaccinated subjects (for whom diary card was available).
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (\>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.
Outcome measures
| Measure |
SB218352_4AL Group:
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Fatigue
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Fatigue
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Temperature (Axillary) (°C)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Temperature (Axillary) (°C)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Temperature (Axillary) (°C)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Headache
|
4 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
8 Participants
|
5 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Headache
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Headache
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Myalgia
|
1 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Myalgia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Myalgia
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Shivering
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Shivering
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Shivering
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Sweating
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Sweating
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Sweating
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Arthralgia
|
3 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Arthralgia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Arthralgia
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Fatigue
|
4 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 4-days post Dose 2 (Days 21-24)Population: The analysis was performed on the Total Vaccinated Cohort (TVc) included all vaccinated subjects (for whom diary card was available).
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (\>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.
Outcome measures
| Measure |
SB218352_4AL Group:
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Solicited General Symptoms
Any Arthralgia
|
5 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Arthralgia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Arthralgia
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Fatigue
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Fatigue
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Fatigue
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Temperature (Axillary) (°C)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Temperature (Axillary) (°C)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Temperature (Axillary) (°C)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Headache
|
3 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Headache
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Headache
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Myalgia
|
4 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Myalgia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Myalgia
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Shivering
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Shivering
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Shivering
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Sweating
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Sweating
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Sweating
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 4-Days (Day 0-3) across doses 1 and 2Population: The analysis was performed on the Total Vaccinated Cohort (TVc) included all vaccinated subjects (for whom diary card was available).
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature higher than (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = axillary temperature higher than (\>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.
Outcome measures
| Measure |
SB218352_4AL Group:
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=55 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Solicited General Symptoms
Any Arthralgia
|
7 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Arthralgia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Arthralgia
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Fatigue
|
5 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Fatigue
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Fatigue
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Temperature (Axillary) (°C)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Temperature (Axillary) (°C)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Temperature (Axillary) (°C)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Headache
|
6 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
11 Participants
|
6 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Headache
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Headache
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Myalgia
|
4 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Myalgia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Myalgia
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Shivering
|
4 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Shivering
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Shivering
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Any Sweating
|
2 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Sweating
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms
Related Sweating
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 4 Days post Dose 3 (Days 189-192 for Subset 1 groups and Days 365-368 for Subset 2 groups)Population: The analysis was performed on the Total Vaccinated Cohort (TVc) of Subsets, which included all vaccinated subjects (for whom the diary card was available).
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axilar temperature higher than (≥) 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to the study vaccination. Grade 3 symptom = symptoms that prevented normal activity. Grade 3 fever = fever higher than (\>) 39°C. Related symptom = symptom assessed by the investigator as being casually related to the study vaccination.
Outcome measures
| Measure |
SB218352_4AL Group:
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Solicited General Symptoms
Any Arthralgia
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Arthralgia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Arthralgia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Fatigue
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Fatigue
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Fatigue
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Temperature
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Temperature
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Temperature
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Headache
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Headache
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Headache
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Myalgia
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Myalgia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Myalgia
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Shivering
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Shivering
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Shivering
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Any Sweating
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms
Grade 3 Sweating
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms
Related Sweating
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During the 30-days post Dose 3 (Days 189-219 for Subset 1 groups and Days 365-395 for Subset 2 groups)Population: The analysis was performed on the Total Vaccinated Cohort (TVc) of Subsets, which included all vaccinated subjects (for whom the diary card was available).
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
SB218352_4AL Group:
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Unsolicited AEs
Related unsolicited AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Unsolicited AEs
Any unsolicited AEs
|
1 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Unsolicited AEs
Grade 3 unsolicited AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within the 365-day post-vaccination period (Days 0-364 for Subset 1 groups) and within the 395-day post-vaccination period (Days 0-394 for Subset 2 groups)Population: The analysis was performed on the Total Vaccinated Cohort (TVc) of Subsets, which included all vaccinated subjects (for whom the diary card was available).
A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization).
Outcome measures
| Measure |
SB218352_4AL Group:
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With SAEs
Any SAEs
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With SAEs
Grade 3 SAEs
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With SAEs
Related SAEs
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 30-day post Dose 3 (Days 365-394)Population: The analysis was performed on the Total Vaccinated Cohort (TVc) of Subset 2, which included all vaccinated subjects (for whom the diary card was available).
A SAE was any untoward medical occurrence which resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, resulted in permanent of serious physical disability or incapacity, caused a congenital anomaly or birth defect in the offspring of a subject or might have put the subject at risk based on medical or scientific judgment or necessitated intervention to prevent such an event (e.q. invasive or malignant cancers, intensive treatment in an emergency room or at home for bronchospasm, blood dyscrasias, or convulsion that do not resulted in hospitalization). Only Subset 2 groups had available data for the specified time frame.
Outcome measures
| Measure |
SB218352_4AL Group:
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=24 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Days 189 and 365Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.
Antibody persistence was evaluated in terms of seroprotection rate (SPR) against influenza A subtype H9N2 and seroconversion rate (SCR) against influenza A subtype H9N2.
Outcome measures
| Measure |
SB218352_4AL Group:
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
n=20 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Antibody Persistence
SPR, Day 189
|
10 Participants
|
3 Participants
|
13 Participants
|
6 Participants
|
8 Participants
|
9 Participants
|
11 Participants
|
12 Participants
|
7 Participants
|
5 Participants
|
2 Participants
|
14 Participants
|
7 Participants
|
5 Participants
|
|
Number of Subjects With Antibody Persistence
SPR, Day 365
|
6 Participants
|
4 Participants
|
13 Participants
|
7 Participants
|
11 Participants
|
14 Participants
|
10 Participants
|
20 Participants
|
13 Participants
|
13 Participants
|
6 Participants
|
20 Participants
|
17 Participants
|
16 Participants
|
|
Number of Subjects With Antibody Persistence
SCR, Day 189
|
7 Participants
|
3 Participants
|
8 Participants
|
4 Participants
|
6 Participants
|
9 Participants
|
9 Participants
|
10 Participants
|
6 Participants
|
5 Participants
|
0 Participants
|
9 Participants
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Antibody Persistence
SCR, Day 365
|
5 Participants
|
2 Participants
|
8 Participants
|
5 Participants
|
10 Participants
|
13 Participants
|
8 Participants
|
19 Participants
|
10 Participants
|
12 Participants
|
4 Participants
|
17 Participants
|
15 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: At Days 189 and 365Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom data concerning persistence of the immune response induced by the vaccine were available for the specified time points.
SCF was defined as the fold increase in serum HI GMTs at the post-vaccination time points compared to Day 0, for each vaccine strain.
Outcome measures
| Measure |
SB218352_4AL Group:
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group:
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_15 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_2 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8AL Subset 1
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_8 Subset 1
n=26 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_4 Subset 1
n=27 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189.
|
SB218352_15 Subset 2
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8 Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4 Subset 2
n=22 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2 Subset 2
n=20 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_8AL Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_4AL Subset 2
n=25 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
SB218352_2AL Subset 2
n=23 Participants
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 365.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Seroconversion Factor (SCF) for Influenza A Subtype H9N2.
SCF, Day 365
|
2.9 fold increase
Interval 1.9 to 4.2
|
2.1 fold increase
Interval 1.4 to 3.1
|
3.1 fold increase
Interval 2.1 to 4.6
|
2.1 fold increase
Interval 1.4 to 3.0
|
4.3 fold increase
Interval 3.0 to 6.1
|
5.4 fold increase
Interval 3.5 to 8.5
|
4.3 fold increase
Interval 2.5 to 7.4
|
11.9 fold increase
Interval 6.4 to 21.9
|
5.5 fold increase
Interval 3.5 to 8.6
|
5.6 fold increase
Interval 3.2 to 9.6
|
2.8 fold increase
Interval 1.9 to 4.2
|
11.2 fold increase
Interval 5.9 to 21.1
|
7.5 fold increase
Interval 4.9 to 11.5
|
5.4 fold increase
Interval 3.0 to 9.9
|
|
Seroconversion Factor (SCF) for Influenza A Subtype H9N2.
SCF, Day 189
|
3.2 fold increase
Interval 2.1 to 4.9
|
1.8 fold increase
Interval 1.3 to 2.5
|
2.9 fold increase
Interval 1.9 to 4.5
|
2.3 fold increase
Interval 1.7 to 3.1
|
3.2 fold increase
Interval 2.1 to 5.0
|
3.4 fold increase
Interval 2.2 to 5.2
|
3.7 fold increase
Interval 2.1 to 6.5
|
3.3 fold increase
Interval 1.8 to 6.1
|
2.7 fold increase
Interval 1.5 to 4.9
|
2.1 fold increase
Interval 1.1 to 4.1
|
1.5 fold increase
Interval 1.1 to 1.9
|
5.8 fold increase
Interval 3.4 to 10.0
|
2.2 fold increase
Interval 1.3 to 3.8
|
1.7 fold increase
Interval 1.1 to 2.8
|
Adverse Events
SB218352_15 Group
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
SB218352_8 Group
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
SB218352_4 Group
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
SB218352_2 Group
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
SB218352_8AL Group
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
SB218352_4AL Group
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
SB218352_2AL Group
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SB218352_15 Group
n=55 participants at risk
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_8 Group
n=55 participants at risk
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_4 Group
n=55 participants at risk
Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm , at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2 Group
n=55 participants at risk
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_8AL Group
n=55 participants at risk
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_4AL Group
n=55 participants at risk
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group
n=55 participants at risk
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
1.8%
1/55 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
1.8%
1/55 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
1.8%
1/55 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.8%
1/55 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
0.00%
0/55 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
Other adverse events
| Measure |
SB218352_15 Group
n=55 participants at risk
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 1 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_8 Group
n=55 participants at risk
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_4 Group
n=55 participants at risk
Male and fem le subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm , at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2 Group
n=55 participants at risk
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 non-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_8AL Group
n=55 participants at risk
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 2 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-dominant arm, at D y 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_4AL Group
n=55 participants at risk
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 3 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Day 189 for subjects in Subset I and at Day 0, Day 21 and Day 365 for subjects in Subset 2.
|
SB218352_2AL Group
n=55 participants at risk
Male and female subjects over 60 years of age, healthy or with underlying disease, received 3 doses of SB218352 pandemic influenza A formulation 4 aluminium-adjuvanted vaccine, administered in the deltoid region of the non-domina nt arm, at Day 0, Day 21 and Da y 189 for subjects in Subs t I and at Day 0, Day 21 and Da y 365 for subjects in Subset 2.
|
|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.9%
6/55 • Number of events 9 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
5.5%
3/55 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
9.1%
5/55 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
9.1%
5/55 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
7.3%
4/55 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
14.5%
8/55 • Number of events 11 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
10.9%
6/55 • Number of events 9 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
|
General disorders
Chills
|
3.6%
2/55 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
7.3%
4/55 • Number of events 4 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
9.1%
5/55 • Number of events 8 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
1.8%
1/55 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
7.3%
4/55 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
9.1%
5/55 • Number of events 6 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
5.5%
3/55 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.4%
9/55 • Number of events 15 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
12.7%
7/55 • Number of events 10 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
10.9%
6/55 • Number of events 8 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
5.5%
3/55 • Number of events 6 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
23.6%
13/55 • Number of events 18 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
16.4%
9/55 • Number of events 14 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
12.7%
7/55 • Number of events 12 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
|
General disorders
Fatigue
|
9.1%
5/55 • Number of events 7 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
7.3%
4/55 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
9.1%
5/55 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
3.6%
2/55 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
7.3%
4/55 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
10.9%
6/55 • Number of events 7 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
10.9%
6/55 • Number of events 7 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
|
Nervous system disorders
Headache
|
14.5%
8/55 • Number of events 11 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
10.9%
6/55 • Number of events 7 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
23.6%
13/55 • Number of events 16 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
14.5%
8/55 • Number of events 8 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
21.8%
12/55 • Number of events 14 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
12.7%
7/55 • Number of events 10 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
14.5%
8/55 • Number of events 11 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
9.1%
5/55 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
7.3%
4/55 • Number of events 4 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
7.3%
4/55 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
3.6%
2/55 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
9.1%
5/55 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
3.6%
2/55 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
5.5%
3/55 • Number of events 4 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.3%
4/55 • Number of events 7 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
9.1%
5/55 • Number of events 7 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
9.1%
5/55 • Number of events 7 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
5.5%
3/55 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
10.9%
6/55 • Number of events 8 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
10.9%
6/55 • Number of events 8 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
9.1%
5/55 • Number of events 6 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
|
General disorders
Pain
|
29.1%
16/55 • Number of events 21 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
14.5%
8/55 • Number of events 8 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
23.6%
13/55 • Number of events 15 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
10.9%
6/55 • Number of events 7 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
25.5%
14/55 • Number of events 22 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
25.5%
14/55 • Number of events 20 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
21.8%
12/55 • Number of events 20 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
|
General disorders
Swelling
|
12.7%
7/55 • Number of events 10 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
5.5%
3/55 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
10.9%
6/55 • Number of events 9 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
7.3%
4/55 • Number of events 7 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
23.6%
13/55 • Number of events 15 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
18.2%
10/55 • Number of events 15 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
16.4%
9/55 • Number of events 13 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: up to Day 51.
One subject from the SB218352\_15 Group reported both SAE(s) included in the Adverse Events section.
|
Additional Information
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