Trial Outcomes & Findings for Safety and Immunogenicity of H1N1 Vaccines in Children Aged 6 Months to Less Than 9 Years of Age (NCT NCT00976820)
NCT ID: NCT00976820
Last Updated: 2017-12-12
Results Overview
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (\<) 10 and a post-vaccination reciprocal HI titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
COMPLETED
PHASE2
323 participants
At Day 21
2017-12-12
Participant Flow
Out of the 323 subjects originally enrolled in the study, 1 subject was not included in the Total Vaccinated Cohort.
Participant milestones
| Measure |
Arepanrix/F1 Group
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh \[for children under (\<) 12 months of age\]. The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F2 Group
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
67
|
128
|
64
|
63
|
|
Overall Study
COMPLETED
|
59
|
108
|
60
|
56
|
|
Overall Study
NOT COMPLETED
|
8
|
20
|
4
|
7
|
Reasons for withdrawal
| Measure |
Arepanrix/F1 Group
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh \[for children under (\<) 12 months of age\]. The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F2 Group
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
16
|
2
|
3
|
|
Overall Study
Poor Compliance. Numerous Visits Booked
|
1
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
1
|
4
|
Baseline Characteristics
Safety and Immunogenicity of H1N1 Vaccines in Children Aged 6 Months to Less Than 9 Years of Age
Baseline characteristics by cohort
| Measure |
Arepanrix/F1 Group
n=67 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F2 Group
n=128 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Total
n=322 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.6 Months
STANDARD_DEVIATION 31.6 • n=5 Participants
|
47.4 Months
STANDARD_DEVIATION 28.6 • n=7 Participants
|
50.3 Months
STANDARD_DEVIATION 29.0 • n=5 Participants
|
54.4 Months
STANDARD_DEVIATION 30.4 • n=4 Participants
|
50.6 Months
STANDARD_DEVIATION 29.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
148 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
174 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African heritage/African American
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan native
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian heritage
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian heritage
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian heritage
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African heritage
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian/European heritage
|
46 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
214 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not specified
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At Day 21Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (\<) 10 and a post-vaccination reciprocal HI titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=55 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=58 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=60 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
|
53 Participants
|
45 Participants
|
36 Participants
|
60 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 21Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=47 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=55 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=57 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=57 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
|
45 Participants
|
41 Participants
|
34 Participants
|
54 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 21Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=101 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=54 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=57 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=59 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
|
98 Participants
|
41 Participants
|
34 Participants
|
56 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=40 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=46 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=44 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=43 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
|
39 Participants
|
46 Participants
|
38 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=84 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=46 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=44 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=44 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
|
83 Participants
|
46 Participants
|
38 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the Total Vaccinated Cohort at Day 21, which included all subjects who received at least 1 study vaccination.
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=59 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=61 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=62 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=66 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
|
3 Participants
|
12 Participants
|
15 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 21Population: The analysis was performed on the Total Vaccinated Cohort at Day 21, which included all subjects who received at least 1 study vaccination.
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=56 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=59 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=60 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
|
55 Participants
|
46 Participants
|
39 Participants
|
62 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=49 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=55 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=58 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=57 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
|
2 Participants
|
12 Participants
|
14 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 21Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=49 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=55 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=57 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=57 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
|
48 Participants
|
42 Participants
|
37 Participants
|
56 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=102 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=54 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=58 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=59 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
|
24 Participants
|
12 Participants
|
14 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 21Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=103 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=54 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=57 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=59 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
|
102 Participants
|
42 Participants
|
37 Participants
|
58 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=40 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=46 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=44 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=43 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain - First Analysis
|
1 Participants
|
9 Participants
|
9 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=42 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=46 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=44 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=43 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - First Analysis
|
42 Participants
|
46 Participants
|
41 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 0Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=84 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=46 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=44 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=44 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Strain - Second Analysis
|
20 Participants
|
9 Participants
|
9 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=87 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=46 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=44 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=44 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
|
87 Participants
|
46 Participants
|
41 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 21Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=55 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=58 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=60 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
|
39.2 Fold change
Interval 29.2 to 52.5
|
14.4 Fold change
Interval 10.2 to 20.4
|
7.8 Fold change
Interval 5.6 to 11.0
|
38.6 Fold change
Interval 28.8 to 51.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 21Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=47 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=55 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=57 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=57 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis
|
40.8 Fold change
Interval 29.7 to 56.2
|
13.2 Fold change
Interval 9.2 to 18.8
|
7.6 Fold change
Interval 5.4 to 10.6
|
35.9 Fold change
Interval 26.4 to 49.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 21Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=101 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=54 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=57 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=59 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
|
33.6 Fold change
Interval 27.3 to 41.3
|
13.8 Fold change
Interval 9.7 to 19.6
|
7.6 Fold change
Interval 5.4 to 10.6
|
36.2 Fold change
Interval 26.8 to 48.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=40 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=46 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=44 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=43 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - First Analysis
|
217.2 Fold change
Interval 163.9 to 287.9
|
44.2 Fold change
Interval 30.6 to 63.9
|
24.1 Fold change
Interval 15.9 to 36.5
|
155.3 Fold change
Interval 105.7 to 228.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 42Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=84 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=46 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=44 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=44 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain - Second Analysis
|
151.6 Fold change
Interval 114.0 to 201.6
|
44.2 Fold change
Interval 30.6 to 63.9
|
24.1 Fold change
Interval 15.9 to 36.5
|
157.1 Fold change
Interval 107.8 to 228.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and at Day 21Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=59 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=61 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=62 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=66 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seropositive Subjects for HI Antibodies - Preliminary Analysis
Flu A/CAL/7/09, PRE
|
4 Participants
|
13 Participants
|
15 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Seropositive Subjects for HI Antibodies - Preliminary Analysis
Flu A/CAL/7/09, D21
|
56 Participants
|
57 Participants
|
56 Participants
|
63 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and at Day 21Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=49 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=55 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=58 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=57 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seropositive Subjects for HI Antibodies - First Analysis
Flu A/CAL/7/09, PRE
|
3 Participants
|
13 Participants
|
14 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Seropositive Subjects for HI Antibodies - First Analysis
Flu A/CAL/7/09, D21
|
49 Participants
|
53 Participants
|
54 Participants
|
57 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and at Day 21Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=103 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=54 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=58 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=59 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seropositive Subjects for HI Antibodies - Second Analysis
Flu A/CAL/7/09, PRE
|
27 Participants
|
13 Participants
|
14 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Seropositive Subjects for HI Antibodies - Second Analysis
Flu A/CAL/7/09, D21
|
103 Participants
|
53 Participants
|
54 Participants
|
59 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and at Day 42Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=42 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=46 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=44 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=43 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seropositive Subjects for HI Antibodies - First Analysis
Flu A/CAL/7/09, PRE
|
2 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Seropositive Subjects for HI Antibodies - First Analysis
Flu A/CAL/7/09, D42
|
42 Participants
|
46 Participants
|
44 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and at Day 42Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=87 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=46 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=44 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=44 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seropositive Subjects for HI Antibodies - Second Analysis
Flu A/CAL/7/09, PRE
|
23 Participants
|
10 Participants
|
9 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Seropositive Subjects for HI Antibodies - Second Analysis
Flu A/CAL/7/09, D42
|
87 Participants
|
46 Participants
|
44 Participants
|
44 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and at Day 182Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:10. The vaccine strain assessed was Flu A/CAL/7/09.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=84 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=47 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=52 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=54 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seropositive Subjects for HI Antibodies
Flu A/CAL/7/09, PRE
|
18 Participants
|
13 Participants
|
12 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Seropositive Subjects for HI Antibodies
Flu A/CAL/7/09, D182
|
84 Participants
|
45 Participants
|
50 Participants
|
54 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and at Day 21Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=59 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=61 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=62 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=66 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
Flu A/CAL/7/09, PRE
|
6.2 Titers
Interval 4.9 to 7.7
|
9.8 Titers
Interval 6.9 to 13.9
|
10.9 Titers
Interval 7.6 to 15.7
|
10.3 Titers
Interval 7.4 to 14.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Preliminary Analysis
Flu A/CAL/7/09, D21
|
253.0 Titers
Interval 185.8 to 344.4
|
141.4 Titers
Interval 90.8 to 220.1
|
82.7 Titers
Interval 52.9 to 129.5
|
387.9 Titers
Interval 286.7 to 524.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and at Day 21Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=49 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=55 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=58 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=57 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis
Flu A/CAL/7/09, PRE
|
6.1 Titers
Interval 4.7 to 7.8
|
10.5 Titers
Interval 7.2 to 15.5
|
10.9 Titers
Interval 7.5 to 15.8
|
10.8 Titers
Interval 7.4 to 15.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis
Flu A/CAL/7/09, D21
|
270.1 Titers
Interval 194.2 to 375.5
|
138.4 Titers
Interval 86.3 to 222.0
|
83.4 Titers
Interval 52.9 to 131.4
|
386.4 Titers
Interval 280.3 to 532.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and at Day 21Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=103 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=54 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=58 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=59 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis
Flu A/CAL/7/09, PRE
|
10.8 Titers
Interval 8.2 to 14.3
|
10.7 Titers
Interval 7.2 to 15.8
|
10.9 Titers
Interval 7.5 to 15.8
|
10.5 Titers
Interval 7.3 to 15.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis
Flu A/CAL/7/09, D21
|
377.3 Titers
Interval 299.6 to 475.3
|
147.2 Titers
Interval 92.4 to 234.3
|
83.4 Titers
Interval 52.9 to 131.4
|
379.4 Titers
Interval 277.9 to 518.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and at Day 42Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=42 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=46 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=44 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=43 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis
Flu A/CAL/7/09, PRE
|
5.7 Titers
Interval 4.6 to 7.1
|
9.3 Titers
Interval 6.4 to 13.6
|
9.5 Titers
Interval 6.4 to 14.0
|
9.3 Titers
Interval 6.4 to 13.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - First Analysis
Flu A/CAL/7/09, D42
|
1238.5 Titers
Interval 1050.2 to 1460.5
|
413.5 Titers
Interval 296.6 to 576.4
|
228.0 Titers
Interval 156.9 to 331.3
|
1444.4 Titers
Interval 1146.0 to 1820.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and at Day 42Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=87 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=46 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=44 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=44 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis
Flu A/CAL/7/09, PRE
|
11.1 Titers
Interval 8.2 to 15.1
|
9.3 Titers
Interval 6.4 to 13.6
|
9.5 Titers
Interval 6.4 to 14.0
|
9.2 Titers
Interval 6.3 to 13.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain - Second Analysis
Flu A/CAL/7/09, D42
|
1671.6 Titers
Interval 1471.8 to 1898.4
|
413.5 Titers
Interval 296.6 to 576.4
|
228.0 Titers
Interval 156.9 to 331.3
|
1440.5 Titers
Interval 1149.0 to 1805.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and at Day 182Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=84 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=47 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=52 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=54 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain
Flu A/CAL/7/09, PRE
|
10.0 Titers
Interval 7.3 to 13.6
|
11.9 Titers
Interval 7.7 to 18.6
|
10.6 Titers
Interval 7.2 to 15.7
|
9.6 Titers
Interval 6.8 to 13.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/CAL/7/09 Influenza Strain
Flu A/CAL/7/09, D182
|
267.9 Titers
Interval 219.5 to 327.0
|
122.7 Titers
Interval 86.4 to 174.3
|
82.8 Titers
Interval 59.5 to 115.2
|
296.2 Titers
Interval 230.5 to 380.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 182Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer lower than (\<) 10 and a post-vaccination reciprocal titer higher than or equal to (≥) 40, or a pre-vaccination reciprocal hemagglutination inhibition (HI) titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=82 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=47 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=52 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=54 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroconverted Subjects Against Flu A/CAL/7/09 Influenza Strain
|
78 Participants
|
35 Participants
|
34 Participants
|
50 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and at Day 182Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
A seroprotected subject was defined as a vaccinated subject with reciprocal HI titers higher than or equal to (≥) 40 against the tested virus.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=84 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=47 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=52 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=54 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain
Flu A/CAL/7/09, PRE
|
16 Participants
|
12 Participants
|
12 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Seroprotected Subjects Against Flu A/CAL/7/09 Influenza Strain
Flu A/CAL/7/09, D182
|
84 Participants
|
43 Participants
|
43 Participants
|
53 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 182Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 182, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
SCF was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=82 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=47 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=52 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=54 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 Influenza Strain
|
26.6 Fold change
Interval 20.6 to 34.3
|
10.3 Fold change
Interval 7.1 to 14.8
|
7.8 Fold change
Interval 5.5 to 10.9
|
31.0 Fold change
Interval 22.7 to 42.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and at Day 21Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:8. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=84 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=44 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=55 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=52 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain
Flu A/Neth/602/09, PRE
|
30 Participants
|
17 Participants
|
20 Participants
|
25 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain
Flu A/Neth/602/09, D21
|
82 Participants
|
39 Participants
|
35 Participants
|
51 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and at Day 21Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=84 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=44 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=55 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=52 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain
Flu A/Neth/602/09, PRE
|
13.8 Titers
Interval 9.0 to 20.9
|
15.0 Titers
Interval 8.2 to 27.2
|
15.3 Titers
Interval 8.8 to 26.6
|
19.3 Titers
Interval 11.1 to 33.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain
Flu A/Neth/602/09, D21
|
296.1 Titers
Interval 181.7 to 482.7
|
231.1 Titers
Interval 111.9 to 477.3
|
138.3 Titers
Interval 63.2 to 302.7
|
427.6 Titers
Interval 244.5 to 748.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and at Day 42Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
A seropositive subject was defined as a subject with antibody titers greater than or equal to (≥) 1:8. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=68 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=36 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=42 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=40 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain
Flu A/Neth/602/09, PRE
|
26 Participants
|
13 Participants
|
13 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Seropositive Subjects for Neutralizing Antibodies Against Flu A/Neth/602/09 Influenza Strain
Flu A/Neth/602/09, D42
|
63 Participants
|
35 Participants
|
33 Participants
|
34 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and at Day 42Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Titers are presented as geometric mean titers (GMTs) and measured in titers.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=68 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=36 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=42 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=40 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain
Flu A/Neth/602/09, PRE
|
15.0 Titers
Interval 9.3 to 24.1
|
12.0 Titers
Interval 6.7 to 21.4
|
13.6 Titers
Interval 7.3 to 25.5
|
16.7 Titers
Interval 9.1 to 30.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Titers for Neutralizing Antibodies Against the Flu A/Neth/602/09 Influenza Strain
Flu A/Neth/602/09, D42
|
1786.9 Titers
Interval 1258.6 to 2537.0
|
428.4 Titers
Interval 208.7 to 879.6
|
146.1 Titers
Interval 74.3 to 287.5
|
1389.3 Titers
Interval 835.5 to 2310.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and at Day 21Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Vaccine responses are defined as the incidence rate of vaccinated subjects with at least a 4-fold increase in post vaccination reciprocal titer relative to that prior to first vaccination. The vaccine strain assessed was Flu A/Neth/602/09 H1N1.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=70 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=37 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=43 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=45 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Vaccine Responses for Neutralizing Antibody Concentrations
|
57 Participants
|
27 Participants
|
24 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and at Day 42Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.
Vaccine response was defined as at least a 4-fold increase in post vaccination reciprocal titer relative to that prior to first vaccination. The vaccine strain assessed was Flu A/Neth/602/09.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=54 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=30 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=34 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=32 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Vaccine Responses for Neutralizing Antibody Concentrations
|
54 Participants
|
26 Participants
|
23 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=18 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=48 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=12 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=47 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
n=45 Participants
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
n=17 Participants
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
n=44 Participants
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
n=18 Participants
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Preliminary Analysis
Grade 3 Pain
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Preliminary Analysis
Grade 3 Swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Preliminary Analysis
Any Pain
|
14 Participants
|
26 Participants
|
9 Participants
|
27 Participants
|
18 Participants
|
12 Participants
|
15 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Preliminary Analysis
Any Redness
|
4 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Preliminary Analysis
Grade 3 Redness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Preliminary Analysis
Any Swelling
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=18 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=1 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=49 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=47 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
n=12 Participants
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
n=46 Participants
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
n=17 Participants
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
n=44 Participants
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
n=18 Participants
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Grade 3 Pain, Dose 1
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Grade 3 Swelling, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Any Swelling, Dose 2
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Any Pain, Dose 1
|
14 Participants
|
1 Participants
|
26 Participants
|
27 Participants
|
9 Participants
|
19 Participants
|
12 Participants
|
15 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Any Redness, Dose 1
|
4 Participants
|
0 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Grade 3 Redness, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Any Swelling, Dose 1
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Any Pain, Dose 2
|
13 Participants
|
0 Participants
|
25 Participants
|
22 Participants
|
7 Participants
|
11 Participants
|
8 Participants
|
9 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Grade 3 Pain, Dose 2
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Any Redness, Dose 2
|
1 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Grade 3 Redness, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Grade 3 Swelling, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Any Pain, Across doses
|
15 Participants
|
1 Participants
|
33 Participants
|
35 Participants
|
9 Participants
|
22 Participants
|
12 Participants
|
18 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Grade 3 Pain, Across doses
|
1 Participants
|
0 Participants
|
1 Participants
|
7 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Any Redness, Across doses
|
4 Participants
|
0 Participants
|
6 Participants
|
7 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Grade 3 Redness, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Any Swelling, Across doses
|
2 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - First Analysis
Grade 3 Swelling, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=25 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=18 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=1 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=22 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
n=46 Participants
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
n=53 Participants
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
n=26 Participants
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
n=24 Participants
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
n=22 Participants
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
n=17 Participants
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
n=23 Participants
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
n=21 Participants
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
n=18 Participants
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Second Analysis
Grade 3 Pain, Dose 1
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Second Analysis
Any Redness, Dose 1
|
3 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Second Analysis
Grade 3 Swelling, Dose 2
|
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 Any and Grade 3 Solicited Local Symptoms - Second Analysis
Any Redness, Across Doses
|
4 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Second Analysis
Any Swelling, Across Doses
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Second Analysis
Grade 3 Redness, Across Doses
|
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 Any and Grade 3 Solicited Local Symptoms - Second Analysis
Grade 3 Swelling, Across Doses
|
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 Any and Grade 3 Solicited Local Symptoms - Second Analysis
Any Pain, Dose 1
|
15 Participants
|
14 Participants
|
1 Participants
|
12 Participants
|
20 Participants
|
34 Participants
|
22 Participants
|
10 Participants
|
9 Participants
|
12 Participants
|
8 Participants
|
7 Participants
|
10 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Second Analysis
Grade 3 Redness, Dose 1
|
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 Any and Grade 3 Solicited Local Symptoms - Second Analysis
Any Swelling, Dose 1
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Second Analysis
Grade 3 Swelling, Dose 1
|
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 Any and Grade 3 Solicited Local Symptoms - Second Analysis
Any Pain, Dose 2
|
10 Participants
|
13 Participants
|
0 Participants
|
12 Participants
|
18 Participants
|
35 Participants
|
19 Participants
|
5 Participants
|
6 Participants
|
8 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Second Analysis
Grade 3 Pain, Dose 2
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Second Analysis
Any Redness, Dose 2
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Second Analysis
Grade 3 Redness, Dose 2
|
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 Any and Grade 3 Solicited Local Symptoms - Second Analysis
Any Swelling, Dose 2
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Second Analysis
Any Pain, Across Doses
|
19 Participants
|
15 Participants
|
1 Participants
|
16 Participants
|
25 Participants
|
44 Participants
|
22 Participants
|
11 Participants
|
11 Participants
|
12 Participants
|
9 Participants
|
9 Participants
|
12 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Second Analysis
Grade 3 Pain, Across Doses
|
3 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=48 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=45 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=44 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=47 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Grade 3 Drowsiness
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Any Temperature (Axillary)
|
6 Participants
|
2 Participants
|
1 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Grade 3 Temperature (Axillary)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Any Drowsiness
|
11 Participants
|
8 Participants
|
9 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Related Drowsiness
|
8 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Any Irritability
|
18 Participants
|
14 Participants
|
8 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Grade 3 Irritability
|
3 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Related Irritability
|
15 Participants
|
12 Participants
|
8 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Any Loss of appetite
|
17 Participants
|
6 Participants
|
9 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Grade 3 Loss of appetite
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Related Loss of appetite
|
12 Participants
|
3 Participants
|
8 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Related Temperature (Axillary)
|
3 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating, temperature \[defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=12 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=17 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=18 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=18 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Related Gastro-intestinal symptoms
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Any Joint pain at other location
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Grade 3 Joint pain at other location
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Any Muscle aches
|
2 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Grade 3 Muscle aches
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Grade 3 Shivering
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Any Sweating
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Grade 3 Sweating
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Related Sweating
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Any Temperature (Axillary)
|
2 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Related Temperature (Axillary)
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Any Fatigue
|
4 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Grade 3 Fatigue
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Related Fatigue
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Any Gastro-intestinal symptoms
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Grade 3 Gastro-intestinal symptoms
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Any Headache
|
4 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Grade 3 Headache
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Related Headache
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Related Joint pain at other location
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Related Muscle aches
|
2 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Any Shivering
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Related Shivering
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - Preliminary Analysis
Grade 3 Temperature (Axillary)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=49 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=46 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=44 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=47 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Loss of appetite, Dose 1
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Loss of appetite, Dose 1
|
12 Participants
|
3 Participants
|
8 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Temperature (Axillary), Dose 1
|
6 Participants
|
2 Participants
|
1 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Temperature (Axillary), Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Drowsiness, Dose 1
|
11 Participants
|
8 Participants
|
9 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Drowsiness, Dose 1
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Drowsiness, Dose 1
|
8 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Irritability, Dose 1
|
18 Participants
|
15 Participants
|
8 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Irritability, Dose 1
|
3 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Drowsiness, Dose 2
|
6 Participants
|
7 Participants
|
7 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Drowsiness, Dose 2
|
2 Participants
|
5 Participants
|
7 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Irritability, Dose 2
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Irritability, Dose 2
|
11 Participants
|
12 Participants
|
11 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Loss of appetite, Dose 2
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Loss of appetite, Dose 2
|
8 Participants
|
5 Participants
|
5 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Temperature (Axillary), Dose 2
|
7 Participants
|
3 Participants
|
3 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Temperature (Axillary), Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Temperature (Axillary), Dose 2
|
6 Participants
|
2 Participants
|
0 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Drowsiness, Across doses
|
15 Participants
|
13 Participants
|
14 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Drowsiness, Across doses
|
1 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Drowsiness, Across doses
|
9 Participants
|
9 Participants
|
12 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Irritability, Across doses
|
22 Participants
|
21 Participants
|
17 Participants
|
28 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Irritability, Across doses
|
4 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Irritability, Across doses
|
20 Participants
|
17 Participants
|
17 Participants
|
25 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Loss of appetite, Across doses
|
23 Participants
|
11 Participants
|
11 Participants
|
25 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Loss of appetite, Across doses
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Loss of appetite, Across doses
|
17 Participants
|
7 Participants
|
10 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Temperature (Axillary), Across doses
|
11 Participants
|
4 Participants
|
4 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Temperature (Axillary), Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Temperature (Axillary), Across doses
|
8 Participants
|
2 Participants
|
1 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Irritability, Dose 1
|
15 Participants
|
12 Participants
|
8 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Loss of appetite, Dose 1
|
17 Participants
|
6 Participants
|
9 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Temperature (Axillary), Dose 1
|
3 Participants
|
1 Participants
|
1 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Drowsiness, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Irritability, Dose 2
|
12 Participants
|
13 Participants
|
11 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Loss of appetite, Dose 2
|
10 Participants
|
7 Participants
|
5 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, and shivering, sweating, temperature \[defined as axillary temperature equal to or above (≥) 38 degrees Celsius (° C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=12 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=17 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=18 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=18 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Fatigue, Dose 1
|
4 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Fatigue, Dose 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Fatigue, Dose 1
|
3 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Gastrointestinal symptoms, Dose 1
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Gastrointestinal symptoms, Dose 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Gastrointestinal symptoms, Dose 1
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Headache, Dose 1
|
4 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Headache, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Headache, Dose 1
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Joint pain at other location, Dose 1
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Joint pain at other location, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Joint pain at other location, Dose 1
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Muscle aches, Dose 1
|
2 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Muscle aches, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Muscle aches, Dose 1
|
2 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Shivering, Dose 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Shivering, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Shivering, Dose 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Sweating, Dose 1
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Sweating, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Sweating, Dose 1
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Temperature (Axillary), Dose 1
|
2 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Temperature (Axillary), Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Temperature (Axillary), Dose 1
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Fatigue, Dose 2
|
3 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Fatigue, Dose 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Fatigue, Dose 2
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Gastrointestinal symptoms, Dose 2
|
2 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Gastrointestinal symptoms, Dose 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Gastrointestinal symptoms, Dose 2
|
2 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Headache, Dose 2
|
3 Participants
|
2 Participants
|
4 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Headache, Dose 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Headache, Dose 2
|
3 Participants
|
2 Participants
|
3 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Joint pain at other location, Dose 2
|
4 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Joint pain at other location, Dose 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Joint pain at other location, Dose 2
|
4 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Muscle aches, Dose 2
|
2 Participants
|
1 Participants
|
2 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Muscle aches, Dose 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Shivering, Dose 2
|
2 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Shivering, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Shivering, Dose 2
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Sweating, Dose 2
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Sweating, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Sweating, Dose 2
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Temperature (Axillary), Dose 2
|
2 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Temperature (Axillary), Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Temperature (Axillary), Dose 2
|
2 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Fatigue, Across doses
|
5 Participants
|
4 Participants
|
8 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Fatigue, Across doses
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Fatigue, Across doses
|
4 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Gastrointestinal symptoms, Across doses
|
3 Participants
|
3 Participants
|
7 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Gastrointestinal symptoms, Across doses
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Gastrointestinal symptoms, Across doses
|
3 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Headache, Across doses
|
5 Participants
|
4 Participants
|
5 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Headache, Across doses
|
4 Participants
|
3 Participants
|
4 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Joint pain at other location, Across doses
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Joint pain at other location, Across doses
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Joint pain at other location, Across doses
|
4 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Muscle aches, Across doses
|
3 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Muscle aches, Across doses
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Shivering, Across doses
|
2 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Shivering, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Shivering, Across doses
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Sweating, Across doses
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Sweating, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Sweating, Across doses
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Any Temperature (Axillary), Across doses
|
4 Participants
|
1 Participants
|
2 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Temperature (Axillary), Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Temperature (Axillary), Across doses
|
4 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Muscle aches, Dose 2
|
2 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Grade 3 Headache, Across doses
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 to Less Than 9 Years With Any, Grade 3 and Related Solicited General Symptoms - First Analysis
Related Muscle aches, Across doses
|
3 Participants
|
3 Participants
|
2 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature \[defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=25 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=46 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=53 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=22 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
n=24 Participants
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
n=22 Participants
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
n=23 Participants
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
n=21 Participants
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Any Drowsiness, Dose 1
|
5 Participants
|
20 Participants
|
13 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Grade 3 Drowsiness, Dose 1
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Related Drowsiness, Dose 1
|
2 Participants
|
13 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Any Irritability, Dose 1
|
8 Participants
|
22 Participants
|
14 Participants
|
14 Participants
|
9 Participants
|
6 Participants
|
8 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Grade 3 Irritability, Dose 1
|
2 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Related Irritability, Dose 1
|
6 Participants
|
15 Participants
|
8 Participants
|
13 Participants
|
8 Participants
|
4 Participants
|
8 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Any Loss of appetite, Dose 1
|
7 Participants
|
19 Participants
|
12 Participants
|
9 Participants
|
2 Participants
|
4 Participants
|
8 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Related Loss of appetite, Dose 1
|
3 Participants
|
12 Participants
|
5 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
7 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Any Temperature (Axillary), Dose 1
|
4 Participants
|
6 Participants
|
9 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Grade 3 Temperature (Axillary), Dose 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Related Temperature (Axillary), Dose 1
|
4 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Any Drowsiness, Dose 2
|
5 Participants
|
9 Participants
|
9 Participants
|
8 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Grade 3 Drowsiness, Dose 2
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Related Drowsiness, Dose 2
|
2 Participants
|
5 Participants
|
5 Participants
|
7 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Any Irritability, Dose 2
|
6 Participants
|
23 Participants
|
10 Participants
|
13 Participants
|
10 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Grade 3 Irritability, Dose 2
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Related Irritability, Dose 2
|
5 Participants
|
19 Participants
|
8 Participants
|
13 Participants
|
9 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Any Loss of appetite, Dose 2
|
7 Participants
|
13 Participants
|
10 Participants
|
11 Participants
|
7 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Grade 3 Loss of appetite, Dose 2
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Related Loss of appetite, Dose 2
|
4 Participants
|
10 Participants
|
7 Participants
|
11 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Any Temperature (Axillary), Dose 2
|
3 Participants
|
6 Participants
|
8 Participants
|
10 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Grade 3 Temperature (Axillary), Dose 2
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Related Temperature (Axillary), Dose 2
|
2 Participants
|
5 Participants
|
5 Participants
|
9 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Any Drowsiness, Across doses
|
7 Participants
|
23 Participants
|
19 Participants
|
10 Participants
|
7 Participants
|
6 Participants
|
9 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Grade 3 Drowsiness, Across doses
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Related Drowsiness, Across doses
|
3 Participants
|
16 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
3 Participants
|
8 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Any Irritability, Across doses
|
9 Participants
|
30 Participants
|
20 Participants
|
19 Participants
|
14 Participants
|
7 Participants
|
12 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Grade 3 Irritability, Across doses
|
3 Participants
|
7 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Related Irritability, Across doses
|
7 Participants
|
23 Participants
|
14 Participants
|
18 Participants
|
12 Participants
|
5 Participants
|
12 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Any Loss of appetite, Across doses
|
10 Participants
|
26 Participants
|
19 Participants
|
15 Participants
|
7 Participants
|
4 Participants
|
9 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Grade 3 Loss of appetite, Across doses
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Related Loss of appetite, Across doses
|
5 Participants
|
19 Participants
|
10 Participants
|
12 Participants
|
5 Participants
|
2 Participants
|
8 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Any Temperature (Axillary), Across doses
|
6 Participants
|
10 Participants
|
14 Participants
|
13 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Grade 3 Temperature (Axillary), Across doses
|
2 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Related Temperature (Axillary), Across doses
|
5 Participants
|
6 Participants
|
6 Participants
|
11 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Less Than 6 Years Old With Any, Grade 3 and Related Solicited General Symptoms - Second Analysis
Grade 3 Loss of appetite, Dose 1
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and temperature \[defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=26 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=17 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=18 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=18 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Muscle aches, Dose 1
|
5 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Shivering, Dose 1
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Shivering, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Fatigue, Dose 1
|
8 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Fatigue, Dose 1
|
4 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Gastrointestinal symptoms, Dose 1
|
4 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Gastrointestinal symptoms, Dose 1
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Gastrointestinal symptoms, Dose 1
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Headache, Dose 1
|
9 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Headache, Dose 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Headache, Dose 1
|
3 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Joint pain at other location, Dose 1
|
5 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Joint pain at other location, Dose 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Joint pain at other location, Dose 1
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Muscle aches, Dose 1
|
7 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Muscle aches, Dose 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Shivering, Dose 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Sweating, Dose 1
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Sweating, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Sweating, Dose 1
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Temperature (Axillary), Dose 1
|
6 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Temperature (Axillary), Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Temperature (Axillary), Dose 1
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Fatigue, Dose 2
|
7 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Fatigue, Dose 2
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Fatigue, Dose 2
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Gastrointestinal symptoms, Dose 2
|
6 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Gastrointestinal symptoms, Dose 2
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Muscle aches, Dose 2
|
8 Participants
|
1 Participants
|
2 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Temperature (Axillary), Dose 2
|
6 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Temperature (Axillary), Dose 2
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Temperature (Axillary), Dose 2
|
4 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Fatigue, Across doses
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Gastrointestinal symptoms, Across doses
|
8 Participants
|
3 Participants
|
7 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Gastrointestinal symptoms, Across doses
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Headache, Across doses
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Joint pain at other location, Across doses
|
6 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Muscle aches, Across doses
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Muscle aches, Across doses
|
8 Participants
|
3 Participants
|
2 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Shivering, Across doses
|
5 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Shivering, Across doses
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Temperature (Axillary), Across doses
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Sweating, Across doses
|
4 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Sweating, Across doses
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Shivering, Dose 2
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Sweating, Dose 2
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Sweating, Dose 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Sweating, Dose 2
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Fatigue, Across doses
|
11 Participants
|
4 Participants
|
8 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Fatigue, Across doses
|
6 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Gastrointestinal symptoms, Across doses
|
3 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Headache, Across doses
|
12 Participants
|
4 Participants
|
5 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Headache, Across doses
|
6 Participants
|
3 Participants
|
4 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Joint pain at other location, Across doses
|
10 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Joint pain at other location, Across doses
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Muscle aches, Across doses
|
11 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Shivering, Across doses
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Sweating, Across doses
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Temperature (Axillary), Across doses
|
9 Participants
|
1 Participants
|
2 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Temperature (Axillary), Across doses
|
6 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Fatigue, Dose 1
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Gastrointestinal symptoms, Dose 2
|
2 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Headache, Dose 2
|
7 Participants
|
2 Participants
|
4 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Headache, Dose 2
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Headache, Dose 2
|
4 Participants
|
2 Participants
|
3 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Joint pain at other location, Dose 2
|
6 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Joint pain at other location, Dose 2
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Joint pain at other location, Dose 2
|
5 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Muscle aches, Dose 2
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Related Muscle aches, Dose 2
|
6 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Any Shivering, Dose 2
|
3 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects Aged Between 6 and 9 Years With Any, Grade 3 and Related Solicited General Symptoms- Second Analysis
Grade 3 Shivering, Dose 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), at Day 7 and at Day 21Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Among haematological parameters assessed were basophils \[BAS\], eosinophils \[EOS\], hematocrit \[HCT\], hemoglobin level \[HGB\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelet count \[PLC\], red blood cells \[RBC\] and white blood cells \[WBC\]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=60 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=60 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=61 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=66 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
RBC, PRE · Unknown
|
6 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
EOS, PRE · Above
|
2 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
EOS, D7 · Within
|
42 Participants
|
46 Participants
|
45 Participants
|
50 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
LYM, PRE · Above
|
8 Participants
|
6 Participants
|
6 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
PLC, D21 · Within
|
43 Participants
|
51 Participants
|
57 Participants
|
57 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
MON, D21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
RBC, D21 · Below
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
RBC, D21 · Within
|
51 Participants
|
48 Participants
|
57 Participants
|
62 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
WBC, PRE · Within
|
30 Participants
|
22 Participants
|
26 Participants
|
33 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
WBC, D7 · Below
|
2 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
WBC, D21 · Below
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
NEU, PRE · Above
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
NEU, D7 · Unknown
|
4 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
NEU, D7 · Below
|
3 Participants
|
2 Participants
|
6 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
WBC, D21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
BAS, PRE · Unknown
|
6 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
BAS, PRE · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
BAS, PRE · Within
|
31 Participants
|
24 Participants
|
28 Participants
|
35 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
BAS, PRE · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
BAS, D7 · Unknown
|
4 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
BAS, D7 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
BAS, D7 · Within
|
56 Participants
|
56 Participants
|
58 Participants
|
61 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
BAS, D7 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
BAS, D21 · Unknown
|
3 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
BAS, D21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
BAS, D21 · Within
|
54 Participants
|
52 Participants
|
61 Participants
|
64 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
BAS, D21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
EOS, PRE · Unknown
|
6 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
EOS, PRE · Below
|
1 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
EOS, PRE · Within
|
28 Participants
|
20 Participants
|
20 Participants
|
28 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
EOS, D7 · Unknown
|
4 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
EOS, D7 · Below
|
8 Participants
|
8 Participants
|
6 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
EOS, D7 · Above
|
6 Participants
|
2 Participants
|
7 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
EOS, D21 · Unknown
|
3 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
EOS, D21 · Below
|
6 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
EOS, D21 · Within
|
42 Participants
|
46 Participants
|
51 Participants
|
54 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
EOS, D21 · Above
|
6 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HCT, PRE · Unknown
|
6 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HCT, PRE · Below
|
3 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HCT, PRE · Within
|
24 Participants
|
22 Participants
|
24 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HCT, PRE · Above
|
4 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HCT, D7 · Unknown
|
4 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HCT, D7 · Below
|
7 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HCT, D7 · Within
|
47 Participants
|
48 Participants
|
49 Participants
|
52 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HCT, D7 · Above
|
2 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HCT, D21 · Unknown
|
3 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HCT, D21 · Below
|
10 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HCT, D21 · Within
|
41 Participants
|
42 Participants
|
53 Participants
|
54 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HCT, D21 · Above
|
3 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HGB, PRE · Unknown
|
6 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HGB, PRE · Below
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HGB, PRE · Within
|
25 Participants
|
22 Participants
|
23 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HGB, PRE · Above
|
4 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HGB, D7 · Unknown
|
3 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HGB, D7 · Below
|
5 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HGB, D7 · Within
|
50 Participants
|
51 Participants
|
52 Participants
|
55 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HGB, D7 · Above
|
2 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HGB, D21 · Unknown
|
3 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HGB, D21 · Below
|
3 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HGB, D21 · Within
|
48 Participants
|
46 Participants
|
56 Participants
|
55 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
HGB, D21 · Above
|
3 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
LYM, PRE · Unknown
|
6 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
LYM, PRE · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
LYM, PRE · Within
|
23 Participants
|
17 Participants
|
22 Participants
|
27 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
LYM, D7 · Unknown
|
4 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
LYM, D7 · Below
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
LYM, D7 · Within
|
28 Participants
|
33 Participants
|
44 Participants
|
38 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
LYM, D7 · Above
|
26 Participants
|
23 Participants
|
14 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
LYM, D21 · Unknown
|
3 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
LYM, D21 · Below
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
LYM, D21 · Within
|
27 Participants
|
35 Participants
|
38 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
LYM, D21 · Above
|
26 Participants
|
17 Participants
|
22 Participants
|
21 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
MON, PRE · Unknown
|
6 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
MON, PRE · Below
|
5 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
MON, PRE · Within
|
26 Participants
|
21 Participants
|
22 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
MON, PRE · Above
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
MON, D7 · Unknown
|
4 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
MON, D7 · Below
|
10 Participants
|
11 Participants
|
7 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
MON, D7 · Within
|
46 Participants
|
44 Participants
|
51 Participants
|
48 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
MON, D7 · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
MON, D21 · Unknown
|
3 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
MON, D21 · Below
|
8 Participants
|
10 Participants
|
13 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
MON, D21 · Within
|
46 Participants
|
42 Participants
|
48 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
NEU, PRE · Unknown
|
6 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
NEU, PRE · Below
|
2 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
NEU, PRE · Within
|
27 Participants
|
21 Participants
|
25 Participants
|
31 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
NEU, D7 · Within
|
52 Participants
|
54 Participants
|
50 Participants
|
50 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
NEU, D7 · Above
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
NEU, D21 · Unknown
|
3 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
NEU, D21 · Below
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
NEU, D21 · Within
|
51 Participants
|
49 Participants
|
59 Participants
|
62 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
NEU, D21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
PLC, PRE · Unknown
|
7 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
PLC, PRE · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
PLC, PRE · Within
|
26 Participants
|
20 Participants
|
27 Participants
|
33 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
PLC, PRE · Above
|
4 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
PLC, D7 · Unknown
|
3 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
PLC, D7 · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
PLC, D7 · Within
|
49 Participants
|
50 Participants
|
51 Participants
|
51 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
PLC, D7 · Above
|
8 Participants
|
5 Participants
|
7 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
PLC, D21 · Unknown
|
4 Participants
|
6 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
PLC, D21 · Below
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
PLC, D21 · Above
|
9 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
RBC, PRE · Below
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
RBC, PRE · Within
|
29 Participants
|
23 Participants
|
25 Participants
|
34 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
RBC, PRE · Above
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
RBC, D7 · Unknown
|
4 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
RBC, D7 · Below
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
RBC, D7 · Within
|
52 Participants
|
54 Participants
|
54 Participants
|
56 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
RBC, D7 · Above
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
RBC, D21 · Unknown
|
3 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
RBC, D21 · Above
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
WBC, PRE · Unknown
|
6 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
WBC, PRE · Below
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
WBC, PRE · Above
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
WBC, D7 · Unknown
|
4 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
WBC, D7 · Within
|
53 Participants
|
55 Participants
|
56 Participants
|
54 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
WBC, D7 · Above
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
WBC, D21 · Unknown
|
3 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Preliminary Analysis
WBC, D21 · Within
|
53 Participants
|
52 Participants
|
60 Participants
|
61 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), at Day 7 and at Day 21Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Biochemical parameters assessed for lab abnormalities were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], bilirubin \[BLR\], bilirubin conjugated/direct \[BCD\], creatinine \[CRE\] and blood urea nitrogen \[BUN\]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=60 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=60 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=61 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=66 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BCD, PRE · Unkown
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
ALT, PRE · Within
|
35 Participants
|
27 Participants
|
28 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
AST, PRE · Unkown
|
5 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
AST, D7 · Unkown
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
AST, D7 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BLR, D7 · Within
|
59 Participants
|
60 Participants
|
60 Participants
|
65 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BLR, D7 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BCD, PRE · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BCD, PRE · Within
|
35 Participants
|
27 Participants
|
28 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BCD, D7 · Within
|
59 Participants
|
60 Participants
|
60 Participants
|
65 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BCD, D21 · Unkown
|
0 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
CRE, PRE · Unkown
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
CRE, D7 · Unkown
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
CRE, D7 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
CRE, D21 · Below
|
23 Participants
|
15 Participants
|
17 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BUN, PRE · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BUN, PRE · Within
|
33 Participants
|
23 Participants
|
25 Participants
|
35 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BUN, PRE · Above
|
2 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BUN, D7 · Below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BUN, D7 · Above
|
4 Participants
|
9 Participants
|
8 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BUN, D21 · Within
|
54 Participants
|
48 Participants
|
52 Participants
|
59 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BUN, D21 · Above
|
3 Participants
|
6 Participants
|
9 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BLR, D21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BLR, D21 · Within
|
57 Participants
|
54 Participants
|
61 Participants
|
63 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BLR, D21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
ALT, PRE · Unkown
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
ALT, PRE · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
ALT, PRE · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
ALT, D7 · Unkown
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
ALT, D7 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
ALT, D7 · Within
|
59 Participants
|
59 Participants
|
59 Participants
|
64 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
ALT, D7 · Above
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
ALT, D21 · Unkown
|
0 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
ALT, D21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
ALT, D21 · Within
|
57 Participants
|
54 Participants
|
61 Participants
|
63 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
ALT, D21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
AST, PRE · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
AST, PRE · Within
|
32 Participants
|
26 Participants
|
28 Participants
|
34 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
AST, PRE · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
AST, D7 · Within
|
57 Participants
|
57 Participants
|
58 Participants
|
63 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
AST, D7 · Above
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
AST, D21 · Unkown
|
0 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
AST, D21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
AST, D21 · Within
|
56 Participants
|
52 Participants
|
60 Participants
|
61 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
AST, D21 · Above
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BLR, PRE · Unkown
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BLR, PRE · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BLR, PRE · Within
|
35 Participants
|
27 Participants
|
28 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BLR, PRE · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BLR, D7 · Unkown
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BLR, D7 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BLR, D21 · Unkown
|
0 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BCD, PRE · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BCD, D7 · Unkown
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BCD, D7 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BCD, D7 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BCD, D21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BCD, D21 · Within
|
57 Participants
|
54 Participants
|
61 Participants
|
63 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BCD, D21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
CRE, PRE · Below
|
15 Participants
|
10 Participants
|
7 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
CRE, PRE · Within
|
20 Participants
|
17 Participants
|
21 Participants
|
24 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
CRE, PRE · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
CRE, D7 · Below
|
23 Participants
|
19 Participants
|
17 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
CRE, D7 · Within
|
36 Participants
|
41 Participants
|
43 Participants
|
47 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
CRE, D21 · Unkown
|
0 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
CRE, D21 · Within
|
34 Participants
|
39 Participants
|
44 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
CRE, D21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BUN, PRE · Unkown
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BUN, D7 · Unkown
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BUN, D7 · Within
|
55 Participants
|
51 Participants
|
51 Participants
|
62 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BUN, D21 · Unkown
|
0 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Preliminary Analysis
BUN, D21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), at Day 7, at Day 21 and at Day 42Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Among haematological parameters assessed were basophils \[BAS\], eosinophils \[EOS\], hematocrit \[HCT\], hemoglobin level \[HGB\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelet count \[PLC\], red blood cells \[RBC\] and white blood cells \[WBC\]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=66 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
PLC, PRE · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
PLC, PRE · Within
|
49 Participants
|
48 Participants
|
56 Participants
|
51 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
BAS, PRE · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
BAS, PRE · Unknown
|
3 Participants
|
7 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
EOS, D42 · Within
|
46 Participants
|
50 Participants
|
47 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HCT, D7 · Within
|
47 Participants
|
48 Participants
|
49 Participants
|
52 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HCT, D7 · Above
|
2 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HCT, PRE · Above
|
6 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
BAS, PRE · Within
|
60 Participants
|
56 Participants
|
61 Participants
|
65 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
BAS, PRE · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
BAS, D7 · Unknown
|
4 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
BAS, D7 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
BAS, D7 · Within
|
56 Participants
|
56 Participants
|
58 Participants
|
61 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
BAS, D7 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
BAS, D21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
BAS, D21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
BAS, D42 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
EOS, PRE · Unknown
|
2 Participants
|
6 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
EOS, PRE · Above
|
3 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
EOS, D7 · Within
|
42 Participants
|
46 Participants
|
45 Participants
|
50 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
EOS, D21 · Unknown
|
3 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HCT, D21 · Unknown
|
3 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HGB, PRE · Unknown
|
6 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HGB, D7 · Unknown
|
3 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HGB, D7 · Below
|
5 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HGB, D7 · Within
|
50 Participants
|
51 Participants
|
52 Participants
|
55 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HGB, D21 · Below
|
3 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HGB, D21 · Within
|
48 Participants
|
47 Participants
|
56 Participants
|
55 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HGB, D21 · Above
|
3 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HGB, D42 · Unknown
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HGB, D42 · Above
|
3 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
LYM, PRE · Unknown
|
4 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
LYM, PRE · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
LYM, D7 · Unknown
|
4 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
LYM, D21 · Within
|
27 Participants
|
36 Participants
|
38 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
LYM, D42 · Above
|
22 Participants
|
23 Participants
|
17 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
MON, PRE · Unknown
|
5 Participants
|
6 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
MON, PRE · Below
|
10 Participants
|
4 Participants
|
15 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
MON, PRE · Within
|
48 Participants
|
53 Participants
|
46 Participants
|
52 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
MON, D7 · Unknown
|
4 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
MON, D7 · Below
|
10 Participants
|
11 Participants
|
7 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
MON, D7 · Within
|
46 Participants
|
44 Participants
|
51 Participants
|
48 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
MON, D42 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
RBC, PRE · Above
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
RBC, D21 · Within
|
51 Participants
|
49 Participants
|
57 Participants
|
62 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
RBC, D21 · Above
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
WBC, D7 · Below
|
2 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
WBC, D42 · Unknown
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
MON, D21 · Within
|
46 Participants
|
43 Participants
|
48 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
MON, D21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
MON, D42 · Unknown
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
MON, D42 · Below
|
17 Participants
|
21 Participants
|
16 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
PLC, PRE · Unknown
|
8 Participants
|
8 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
MON, D42 · Within
|
37 Participants
|
38 Participants
|
41 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
NEU, PRE · Unknown
|
4 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
NEU, PRE · Below
|
6 Participants
|
4 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
NEU, PRE · Within
|
52 Participants
|
51 Participants
|
56 Participants
|
54 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
NEU, PRE · Above
|
1 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
NEU, D7 · Unknown
|
4 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
NEU, D7 · Below
|
3 Participants
|
2 Participants
|
6 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
NEU, D7 · Within
|
52 Participants
|
54 Participants
|
50 Participants
|
50 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
NEU, D7 · Above
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
NEU, D21 · Unknown
|
3 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
NEU, D21 · Below
|
3 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
NEU, D21 · Within
|
51 Participants
|
50 Participants
|
59 Participants
|
62 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
NEU, D21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
NEU, D42 · Unknown
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
NEU, D42 · Below
|
5 Participants
|
10 Participants
|
13 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
NEU, D42 · Within
|
48 Participants
|
48 Participants
|
40 Participants
|
50 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
NEU, D42 · Above
|
1 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
PLC, PRE · Above
|
6 Participants
|
6 Participants
|
4 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
PLC, D7 · Unknown
|
3 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
PLC, D7 · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
PLC, D7 · Within
|
49 Participants
|
50 Participants
|
51 Participants
|
51 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
PLC, D7 · Above
|
8 Participants
|
5 Participants
|
7 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
PLC, D21 · Unknown
|
4 Participants
|
6 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
PLC, D21 · Below
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
PLC, D21 · Within
|
43 Participants
|
52 Participants
|
57 Participants
|
57 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
PLC, D21 · Above
|
9 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
PLC, D42 · Unknown
|
3 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
PLC, D42 · Below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
PLC, D42 · Within
|
47 Participants
|
59 Participants
|
53 Participants
|
50 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
PLC, D42 · Above
|
6 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
RBC, PRE · Unknown
|
4 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
RBC, PRE · Below
|
4 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
RBC, PRE · Within
|
54 Participants
|
56 Participants
|
55 Participants
|
59 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
RBC, D7 · Unknown
|
4 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
RBC, D7 · Below
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
RBC, D7 · Within
|
52 Participants
|
54 Participants
|
54 Participants
|
56 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
RBC, D7 · Above
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
RBC, D21 · Unknown
|
3 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
RBC, D21 · Below
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
RBC, D42 · Unknown
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
RBC, D42 · Below
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
RBC, D42 · Within
|
52 Participants
|
55 Participants
|
52 Participants
|
51 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
RBC, D42 · Above
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
WBC, PRE · Unknown
|
5 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
WBC, PRE · Below
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
WBC, PRE · Within
|
57 Participants
|
54 Participants
|
59 Participants
|
55 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
WBC, PRE · Above
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
WBC, D7 · Unknown
|
4 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
WBC, D7 · Within
|
53 Participants
|
55 Participants
|
56 Participants
|
54 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
WBC, D7 · Above
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
WBC, D21 · Unknown
|
3 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
WBC, D21 · Below
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
WBC, D21 · Within
|
53 Participants
|
53 Participants
|
60 Participants
|
61 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
WBC, D21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
WBC, D42 · Below
|
3 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
WBC, D42 · Within
|
51 Participants
|
56 Participants
|
50 Participants
|
52 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
WBC, D42 · Above
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
BAS, D21 · Unknown
|
3 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
BAS, D21 · Within
|
54 Participants
|
53 Participants
|
61 Participants
|
64 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
BAS, D42 · Unknown
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
BAS, D42 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
BAS, D42 · Within
|
54 Participants
|
59 Participants
|
57 Participants
|
55 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
EOS, PRE · Below
|
5 Participants
|
7 Participants
|
6 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
EOS, PRE · Within
|
53 Participants
|
45 Participants
|
51 Participants
|
46 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
EOS, D7 · Unknown
|
4 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
EOS, D7 · Below
|
8 Participants
|
8 Participants
|
6 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
EOS, D7 · Above
|
6 Participants
|
2 Participants
|
7 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
EOS, D21 · Below
|
6 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
EOS, D21 · Within
|
42 Participants
|
47 Participants
|
51 Participants
|
54 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
EOS, D21 · Above
|
6 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
EOS, D42 · Unknown
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
EOS, D42 · Below
|
3 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
EOS, D42 · Above
|
5 Participants
|
4 Participants
|
7 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HCT, PRE · Unknown
|
5 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HCT, PRE · Below
|
8 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
LYM, D7 · Below
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HCT, PRE · Within
|
44 Participants
|
48 Participants
|
52 Participants
|
53 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HCT, D7 · Unknown
|
4 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HCT, D7 · Below
|
7 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HCT, D21 · Below
|
10 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HCT, D21 · Within
|
41 Participants
|
43 Participants
|
53 Participants
|
54 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HCT, D21 · Above
|
3 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HCT, D42 · Unknown
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HCT, D42 · Below
|
12 Participants
|
5 Participants
|
10 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HCT, D42 · Within
|
41 Participants
|
48 Participants
|
46 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HCT, D42 · Above
|
1 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HGB, PRE · Below
|
5 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HGB, PRE · Within
|
45 Participants
|
52 Participants
|
55 Participants
|
58 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HGB, PRE · Above
|
7 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HGB, D7 · Above
|
2 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HGB, D21 · Unknown
|
3 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HGB, D42 · Below
|
8 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
HGB, D42 · Within
|
43 Participants
|
49 Participants
|
50 Participants
|
49 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
LYM, PRE · Within
|
38 Participants
|
35 Participants
|
43 Participants
|
46 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
LYM, PRE · Above
|
21 Participants
|
21 Participants
|
18 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
LYM, D7 · Within
|
28 Participants
|
33 Participants
|
44 Participants
|
38 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
LYM, D7 · Above
|
26 Participants
|
23 Participants
|
14 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
LYM, D21 · Unknown
|
3 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
LYM, D21 · Below
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
LYM, D21 · Above
|
26 Participants
|
17 Participants
|
22 Participants
|
21 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
LYM, D42 · Unknown
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
LYM, D42 · Below
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
LYM, D42 · Within
|
31 Participants
|
36 Participants
|
40 Participants
|
36 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
MON, PRE · Above
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
MON, D7 · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
MON, D21 · Unknown
|
3 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - First Analysis
MON, D21 · Below
|
8 Participants
|
10 Participants
|
13 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), at Day 7, at Day 21 and at Day 42Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Biochemical parameters assessed for lab abnormalities were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], bilirubin \[BLR\], bilirubin conjugated/direct \[BCD\], creatinine \[CRE\] and blood urea nitrogen \[BUN\]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=66 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
ALT, D7 · Unknown
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
AST, PRE · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
AST, PRE · Within
|
57 Participants
|
59 Participants
|
63 Participants
|
61 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
AST, D7 · Unknown
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BLR, D7 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BUN, D42 · Above
|
5 Participants
|
6 Participants
|
7 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BLR, D21 · Within
|
57 Participants
|
55 Participants
|
61 Participants
|
63 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BLR, D21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BLR, D42 · Unknown
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
ALT, PRE · Unknown
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
ALT, PRE · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
ALT, PRE · Within
|
61 Participants
|
59 Participants
|
63 Participants
|
64 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
ALT, PRE · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
ALT, D7 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
ALT, D7 · Within
|
59 Participants
|
59 Participants
|
59 Participants
|
64 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
ALT, D7 · Above
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
ALT, D21 · Unknown
|
0 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
ALT, D21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
ALT, D21 · Within
|
57 Participants
|
55 Participants
|
61 Participants
|
63 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
ALT, D21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
ALT, D42 · Unknown
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
ALT, D42 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
ALT, D42 · Within
|
53 Participants
|
59 Participants
|
56 Participants
|
55 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
ALT, D42 · Above
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
AST, PRE · Unknown
|
6 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
AST, PRE · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
AST, D7 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
AST, D7 · Within
|
57 Participants
|
57 Participants
|
58 Participants
|
63 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
AST, D7 · Above
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
AST, D21 · Unknown
|
0 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
AST, D21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
AST, D21 · Within
|
56 Participants
|
53 Participants
|
60 Participants
|
61 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
AST, D21 · Above
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
AST, D42 · Unknown
|
2 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
AST, D42 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
AST, D42 · Within
|
53 Participants
|
57 Participants
|
57 Participants
|
54 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
AST, D42 · Above
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BLR, PRE · Unknown
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BLR, PRE · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BLR, PRE · Within
|
62 Participants
|
60 Participants
|
63 Participants
|
64 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BLR, PRE · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BLR, D7 · Unknown
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BLR, D7 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BLR, D7 · Within
|
59 Participants
|
60 Participants
|
60 Participants
|
65 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BLR, D21 · Unknown
|
0 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BLR, D21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BLR, D42 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BLR, D42 · Within
|
53 Participants
|
60 Participants
|
57 Participants
|
55 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BLR, D42 · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BCD, PRE · Unknown
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BCD, PRE · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BCD, PRE · Within
|
61 Participants
|
60 Participants
|
63 Participants
|
64 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BCD, PRE · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BCD, D7 · Unknown
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BCD, D7 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BCD, D7 · Within
|
59 Participants
|
60 Participants
|
60 Participants
|
65 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BCD, D7 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BCD, D21 · Unknown
|
0 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BCD, D21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BCD, D21 · Within
|
57 Participants
|
55 Participants
|
61 Participants
|
63 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BCD, D21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BCD, D42 · Unknown
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BCD, D42 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BCD, D42 · Within
|
54 Participants
|
60 Participants
|
57 Participants
|
55 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BCD, D42 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
CRE, PRE · Unknown
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
CRE, PRE · Below
|
22 Participants
|
17 Participants
|
15 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
CRE, PRE · Within
|
39 Participants
|
43 Participants
|
48 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
CRE, PRE · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
CRE, D7 · Unknown
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
CRE, D7 · Below
|
23 Participants
|
19 Participants
|
17 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
CRE, D7 · Within
|
36 Participants
|
41 Participants
|
43 Participants
|
47 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
CRE, D7 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
CRE, D21 · Unknown
|
0 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
CRE, D21 · Below
|
23 Participants
|
15 Participants
|
17 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
CRE, D21 · Within
|
34 Participants
|
40 Participants
|
44 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
CRE, D21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
CRE, D42 · Unknown
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
CRE, D42 · Below
|
20 Participants
|
16 Participants
|
13 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
CRE, D42 · Within
|
34 Participants
|
44 Participants
|
44 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
CRE, D42 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BUN, PRE · Unknown
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BUN, PRE · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BUN, PRE · Within
|
55 Participants
|
55 Participants
|
58 Participants
|
58 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BUN, PRE · Above
|
6 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BUN, D7 · Unknown
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BUN, D7 · Below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BUN, D7 · Within
|
55 Participants
|
51 Participants
|
51 Participants
|
62 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BUN, D7 · Above
|
4 Participants
|
9 Participants
|
8 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BUN, D21 · Unknown
|
0 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BUN, D21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BUN, D21 · Within
|
54 Participants
|
49 Participants
|
52 Participants
|
59 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BUN, D21 · Above
|
3 Participants
|
6 Participants
|
9 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BUN, D42 · Unknown
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BUN, D42 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - First Analysis
BUN, D42 · Within
|
49 Participants
|
54 Participants
|
50 Participants
|
49 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), at Day 7 and at Day 21Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Among haematological parameters assessed were basophils \[BAS\], eosinophils \[EOS\], hematocrit \[HCT\], hemoglobin level \[HGB\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelet count \[PLC\], red blood cells \[RBC\] and white blood cells \[WBC\], Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=126 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=66 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HGB, D7 · Within
|
98 Participants
|
51 Participants
|
52 Participants
|
55 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HGB, D7 · Above
|
9 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HGB, D21 · Unknown
|
4 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HGB, D21 · Below
|
10 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HGB, D21 · Within
|
97 Participants
|
47 Participants
|
56 Participants
|
55 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HGB, D21 · Above
|
5 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HGB, D42 · Unknown
|
5 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HGB, D42 · Below
|
13 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HGB, D42 · Within
|
90 Participants
|
49 Participants
|
50 Participants
|
49 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HGB, D42 · Above
|
6 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
LYM, PRE · Unknown
|
5 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
LYM, PRE · Below
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
BAS, PRE · Within
|
121 Participants
|
60 Participants
|
62 Participants
|
65 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
WBC, D21 · Below
|
4 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HGB, D7 · Below
|
9 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
BAS, PRE · Unknown
|
5 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
BAS, PRE · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
BAS, PRE · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
BAS, D7 · Unknown
|
5 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
BAS, D7 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
BAS, D7 · Within
|
115 Participants
|
56 Participants
|
58 Participants
|
61 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
BAS, D7 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
BAS, D21 · Unknown
|
4 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
BAS, D21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
BAS, D21 · Within
|
112 Participants
|
53 Participants
|
61 Participants
|
64 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
BAS, D21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
BAS, D42 · Unknown
|
5 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
BAS, D42 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
BAS, D42 · Within
|
109 Participants
|
59 Participants
|
57 Participants
|
55 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
BAS, D42 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
EOS, PRE · Unknown
|
5 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
EOS, PRE · Below
|
11 Participants
|
7 Participants
|
6 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
EOS, PRE · Within
|
100 Participants
|
48 Participants
|
51 Participants
|
49 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
EOS, PRE · Above
|
10 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
EOS, D7 · Unknown
|
5 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
EOS, D7 · Below
|
20 Participants
|
8 Participants
|
6 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
EOS, D7 · Within
|
84 Participants
|
46 Participants
|
45 Participants
|
50 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
EOS, D7 · Above
|
11 Participants
|
2 Participants
|
7 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
EOS, D21 · Unknown
|
4 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
EOS, D21 · Below
|
14 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
EOS, D21 · Within
|
90 Participants
|
47 Participants
|
51 Participants
|
54 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
EOS, D21 · Above
|
8 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
EOS, D42 · Unknown
|
5 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
EOS, D42 · Below
|
8 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
EOS, D42 · Within
|
94 Participants
|
50 Participants
|
47 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
EOS, D42 · Above
|
7 Participants
|
4 Participants
|
7 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HCT, PRE · Unknown
|
6 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HCT, PRE · Below
|
22 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HCT, PRE · Within
|
90 Participants
|
50 Participants
|
52 Participants
|
56 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HCT, PRE · Above
|
8 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HCT, D7 · Unknown
|
5 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HCT, D7 · Below
|
26 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HCT, D7 · Within
|
82 Participants
|
48 Participants
|
49 Participants
|
52 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HCT, D7 · Above
|
7 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HCT, D21 · Unknown
|
4 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HCT, D21 · Below
|
32 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HCT, D21 · Within
|
77 Participants
|
43 Participants
|
53 Participants
|
54 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HCT, D21 · Above
|
3 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HCT, D42 · Unknown
|
6 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HCT, D42 · Below
|
24 Participants
|
5 Participants
|
10 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HCT, D42 · Within
|
80 Participants
|
48 Participants
|
46 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HCT, D42 · Above
|
4 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HGB, PRE · Unknown
|
5 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HGB, PRE · Below
|
15 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HGB, PRE · Within
|
96 Participants
|
53 Participants
|
55 Participants
|
59 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HGB, PRE · Above
|
10 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
HGB, D7 · Unknown
|
4 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
LYM, PRE · Within
|
83 Participants
|
37 Participants
|
44 Participants
|
47 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
LYM, PRE · Above
|
37 Participants
|
22 Participants
|
18 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
LYM, D7 · Unknown
|
5 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
LYM, D7 · Below
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
LYM, D7 · Within
|
73 Participants
|
33 Participants
|
44 Participants
|
38 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
LYM, D7 · Above
|
39 Participants
|
23 Participants
|
14 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
LYM, D21 · Unknown
|
4 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
LYM, D21 · Below
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
LYM, D21 · Within
|
72 Participants
|
36 Participants
|
38 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
LYM, D21 · Above
|
38 Participants
|
17 Participants
|
22 Participants
|
21 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
LYM, D42 · Unknown
|
5 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
LYM, D42 · Below
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
LYM, D42 · Within
|
75 Participants
|
36 Participants
|
40 Participants
|
36 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
LYM, D42 · Above
|
31 Participants
|
23 Participants
|
17 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
MON, PRE · Unknown
|
5 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
MON, PRE · Below
|
26 Participants
|
7 Participants
|
15 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
MON, PRE · Within
|
95 Participants
|
53 Participants
|
46 Participants
|
53 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
MON, PRE · Above
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
MON, D7 · Unknown
|
5 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
MON, D7 · Below
|
19 Participants
|
11 Participants
|
7 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
MON, D7 · Within
|
96 Participants
|
44 Participants
|
51 Participants
|
48 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
MON, D7 · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
MON, D21 · Unknown
|
4 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
MON, D21 · Below
|
18 Participants
|
10 Participants
|
13 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
MON, D21 · Within
|
94 Participants
|
43 Participants
|
48 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
MON, D21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
MON, D42 · Unknown
|
5 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
MON, D42 · Below
|
22 Participants
|
21 Participants
|
16 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
MON, D42 · Within
|
87 Participants
|
38 Participants
|
41 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
MON, D42 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
NEU, PRE · Unknown
|
5 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
NEU, PRE · Below
|
9 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
NEU, PRE · Within
|
109 Participants
|
52 Participants
|
56 Participants
|
57 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
NEU, PRE · Above
|
3 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
NEU, D7 · Unknown
|
5 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
NEU, D7 · Below
|
4 Participants
|
2 Participants
|
6 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
NEU, D7 · Within
|
109 Participants
|
54 Participants
|
50 Participants
|
50 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
NEU, D7 · Above
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
NEU, D21 · Unknown
|
4 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
NEU, D21 · Below
|
10 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
NEU, D21 · Within
|
100 Participants
|
50 Participants
|
59 Participants
|
62 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
NEU, D21 · Above
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
NEU, D42 · Unknown
|
5 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
NEU, D42 · Below
|
12 Participants
|
10 Participants
|
13 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
NEU, D42 · Within
|
96 Participants
|
48 Participants
|
40 Participants
|
50 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
NEU, D42 · Above
|
1 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
PLC, PRE · Unknown
|
6 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
PLC, PRE · Below
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
PLC, PRE · Within
|
107 Participants
|
51 Participants
|
57 Participants
|
54 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
PLC, PRE · Above
|
12 Participants
|
6 Participants
|
4 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
PLC, D7 · Unknown
|
5 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
PLC, D7 · Below
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
PLC, D7 · Within
|
95 Participants
|
50 Participants
|
51 Participants
|
51 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
PLC, D7 · Above
|
20 Participants
|
5 Participants
|
7 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
PLC, D21 · Unknown
|
7 Participants
|
6 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
PLC, D21 · Below
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
PLC, D21 · Within
|
89 Participants
|
52 Participants
|
57 Participants
|
57 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
PLC, D21 · Above
|
18 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
PLC, D42 · Unknown
|
6 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
PLC, D42 · Below
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
PLC, D42 · Within
|
93 Participants
|
59 Participants
|
53 Participants
|
50 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
PLC, D42 · Above
|
15 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
RBC, PRE · Unknown
|
6 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
RBC, PRE · Below
|
6 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
RBC, PRE · Within
|
113 Participants
|
58 Participants
|
56 Participants
|
62 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
RBC, PRE · Above
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
RBC, D7 · Unknown
|
5 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
RBC, D7 · Below
|
4 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
RBC, D7 · Within
|
110 Participants
|
54 Participants
|
54 Participants
|
56 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
RBC, D7 · Above
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
RBC, D21 · Unknown
|
4 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
RBC, D21 · Below
|
5 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
RBC, D21 · Within
|
107 Participants
|
49 Participants
|
57 Participants
|
62 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
RBC, D21 · Above
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
RBC, D42 · Unknown
|
6 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
RBC, D42 · Below
|
4 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
RBC, D42 · Within
|
103 Participants
|
55 Participants
|
52 Participants
|
51 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
RBC, D42 · Above
|
1 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
WBC, PRE · Unknown
|
5 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
WBC, PRE · Below
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
WBC, PRE · Within
|
118 Participants
|
57 Participants
|
60 Participants
|
59 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
WBC, PRE · Above
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
WBC, D7 · Unknown
|
5 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
WBC, D7 · Below
|
3 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
WBC, D7 · Within
|
110 Participants
|
55 Participants
|
56 Participants
|
54 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
WBC, D7 · Above
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
WBC, D21 · Unknown
|
4 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
WBC, D21 · Within
|
107 Participants
|
53 Participants
|
60 Participants
|
61 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
WBC, D21 · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
WBC, D42 · Unknown
|
5 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
WBC, D42 · Below
|
7 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
WBC, D42 · Within
|
102 Participants
|
56 Participants
|
50 Participants
|
52 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities - Second Analysis
WBC, D42 · Above
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), at Day 7, at Day 21 and at Day 42Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Biochemical parameters assessed for lab abnormalities were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], bilirubin \[BLR\], bilirubin conjugated/direct \[BCD\], creatinine \[CRE\] and blood urea nitrogen \[BUN\]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=126 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=66 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
AST, D7 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
CRE, PRE · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
AST, PRE · Above
|
5 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
AST, D7 · Unknown
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BLR, D7 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BUN, D7 · Unknown
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
ALT, PRE · Unknown
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
ALT, PRE · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
ALT, PRE · Within
|
124 Participants
|
59 Participants
|
63 Participants
|
64 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
ALT, PRE · Above
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
ALT, D7 · Unknown
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
ALT, D7 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
ALT, D7 · Within
|
118 Participants
|
59 Participants
|
59 Participants
|
64 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
ALT, D7 · Above
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
ALT, D21 · Unknown
|
0 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
ALT, D21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
ALT, D21 · Within
|
115 Participants
|
55 Participants
|
61 Participants
|
63 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
ALT, D21 · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
ALT, D42 · Unknown
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
ALT, D42 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
ALT, D42 · Within
|
110 Participants
|
59 Participants
|
56 Participants
|
55 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
ALT, D42 · Above
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
AST, PRE · Unknown
|
4 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
AST, PRE · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
AST, PRE · Within
|
117 Participants
|
59 Participants
|
63 Participants
|
62 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
AST, D7 · Within
|
113 Participants
|
57 Participants
|
58 Participants
|
63 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
AST, D7 · Above
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
AST, D21 · Unknown
|
1 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
AST, D21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
AST, D21 · Within
|
112 Participants
|
53 Participants
|
60 Participants
|
61 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
AST, D21 · Above
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
AST, D42 · Unknown
|
3 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
AST, D42 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
AST, D42 · Within
|
105 Participants
|
57 Participants
|
57 Participants
|
54 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
AST, D42 · Above
|
6 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BLR, PRE · Unknown
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BLR, PRE · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BLR, PRE · Within
|
124 Participants
|
60 Participants
|
63 Participants
|
64 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BUN, D7 · Below
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BLR, PRE · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BLR, D7 · Unknown
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BLR, D7 · Within
|
118 Participants
|
60 Participants
|
60 Participants
|
65 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BLR, D7 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BLR, D21 · Unknown
|
0 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BLR, D21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BLR, D21 · Within
|
116 Participants
|
55 Participants
|
61 Participants
|
63 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BLR, D21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BLR, D42 · Unknown
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BLR, D42 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BLR, D42 · Within
|
110 Participants
|
60 Participants
|
57 Participants
|
55 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BUN, D7 · Within
|
110 Participants
|
51 Participants
|
51 Participants
|
62 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BLR, D42 · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BCD, PRE · Unknown
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BCD, PRE · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BCD, PRE · Within
|
124 Participants
|
60 Participants
|
63 Participants
|
64 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BCD, PRE · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BCD, D7 · Unknown
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BCD, D7 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BCD, D7 · Within
|
118 Participants
|
60 Participants
|
60 Participants
|
65 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BCD, D7 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BCD, D21 · Unknown
|
0 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BCD, D21 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BCD, D21 · Within
|
116 Participants
|
55 Participants
|
61 Participants
|
63 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BCD, D21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BCD, D42 · Unknown
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BCD, D42 · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BCD, D42 · Within
|
111 Participants
|
60 Participants
|
57 Participants
|
55 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BCD, D42 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
CRE, PRE · Unknown
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
CRE, PRE · Below
|
38 Participants
|
17 Participants
|
15 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
CRE, PRE · Within
|
86 Participants
|
43 Participants
|
48 Participants
|
45 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
CRE, D7 · Unknown
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
CRE, D7 · Below
|
38 Participants
|
19 Participants
|
17 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
CRE, D7 · Within
|
80 Participants
|
41 Participants
|
43 Participants
|
47 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
CRE, D7 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
CRE, D21 · Unknown
|
0 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
CRE, D21 · Below
|
40 Participants
|
15 Participants
|
17 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
CRE, D21 · Within
|
76 Participants
|
40 Participants
|
44 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
CRE, D21 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
CRE, D42 · Unknown
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
CRE, D42 · Below
|
37 Participants
|
16 Participants
|
13 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
CRE, D42 · Within
|
74 Participants
|
44 Participants
|
44 Participants
|
37 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
CRE, D42 · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BUN, PRE · Unknown
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BUN, PRE · Below
|
4 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BUN, PRE · Within
|
110 Participants
|
56 Participants
|
58 Participants
|
58 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BUN, PRE · Above
|
10 Participants
|
4 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BUN, D7 · Above
|
7 Participants
|
9 Participants
|
8 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BUN, D21 · Unknown
|
0 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BUN, D21 · Below
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BUN, D21 · Within
|
107 Participants
|
49 Participants
|
52 Participants
|
59 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BUN, D21 · Above
|
5 Participants
|
6 Participants
|
9 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BUN, D42 · Unknown
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BUN, D42 · Below
|
4 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BUN, D42 · Within
|
96 Participants
|
54 Participants
|
50 Participants
|
49 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities - Second Analysis
BUN, D42 · Above
|
11 Participants
|
6 Participants
|
7 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 182Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Among haematological parameters assessed were basophils \[BAS\], eosinophils \[EOS\], hematocrit \[HCT\], hemoglobin level \[HGB\], lymphocytes \[LYM\], monocytes \[MON\], neutrophils \[NEU\], platelet count \[PLC\], red blood cells \[RBC\] and white blood cells \[WBC\]. Haematological laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=108 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=53 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=56 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=59 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Haematological Laboratory Abnormalities
BAS · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
MON · Within
|
82 Participants
|
39 Participants
|
40 Participants
|
35 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
RBC · Above
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
WBC · Unknown
|
8 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
BAS · Unknown
|
8 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
BAS · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
BAS · Within
|
100 Participants
|
51 Participants
|
53 Participants
|
54 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
EOS · Unknown
|
8 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
EOS · Below
|
10 Participants
|
8 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
EOS · Within
|
83 Participants
|
39 Participants
|
47 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
EOS · Above
|
7 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
HCT · Unknown
|
9 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
HCT · Below
|
17 Participants
|
5 Participants
|
7 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
HCT · Within
|
70 Participants
|
42 Participants
|
43 Participants
|
43 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
HCT · Above
|
12 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
HGB · Unknown
|
8 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
HGB · Below
|
8 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
HGB · Within
|
79 Participants
|
44 Participants
|
45 Participants
|
50 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
HGB · Above
|
13 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
LYM · Unknown
|
8 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
LYM · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
LYM · Within
|
72 Participants
|
37 Participants
|
41 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
LYM · Above
|
28 Participants
|
14 Participants
|
12 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
MON · Unknown
|
8 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
MON · Below
|
18 Participants
|
12 Participants
|
13 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
MON · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
NEU · Unknown
|
8 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
NEU · Below
|
8 Participants
|
5 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
NEU · Within
|
92 Participants
|
43 Participants
|
51 Participants
|
48 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
NEU · Above
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
PLC · Unknown
|
9 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
PLC · Below
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
PLC · Within
|
92 Participants
|
51 Participants
|
52 Participants
|
48 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
PLC · Above
|
6 Participants
|
0 Participants
|
1 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
RBC · Unknown
|
9 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
RBC · Below
|
6 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
RBC · Within
|
91 Participants
|
47 Participants
|
51 Participants
|
51 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
WBC · Below
|
2 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
WBC · Within
|
98 Participants
|
47 Participants
|
51 Participants
|
49 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Haematological Laboratory Abnormalities
WBC · Above
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 182Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Biochemical parameters assessed for lab abnormalities were alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], bilirubin \[BLR\], bilirubin conjugated/direct \[BCD\], creatinine \[CRE\] and blood urea nitrogen \[BUN\]. Biochemical laboratory values were unknown, below, within or above the laboratory reference range defined for the specified time point and laboratory parameter.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=108 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=53 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=56 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=59 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Biochemical Laboratory Abnormalities
AST · Within
|
106 Participants
|
50 Participants
|
53 Participants
|
57 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities
ALT · Unknown
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities
ALT · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities
ALT · Within
|
107 Participants
|
51 Participants
|
54 Participants
|
58 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities
ALT · Above
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities
AST · Unknown
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities
AST · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities
AST · Above
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities
BLR · Unknown
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities
BLR · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities
BLR · Within
|
107 Participants
|
52 Participants
|
55 Participants
|
58 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities
BLR · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities
BCD · Unknown
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities
BCD · Below
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities
BCD · Within
|
106 Participants
|
52 Participants
|
55 Participants
|
58 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities
BCD · Above
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities
CRE · Unknown
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities
CRE · Below
|
35 Participants
|
16 Participants
|
18 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities
CRE · Within
|
72 Participants
|
36 Participants
|
37 Participants
|
40 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities
CRE · Above
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities
BUN · Unknown
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities
BUN · Below
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities
BUN · Within
|
99 Participants
|
48 Participants
|
53 Participants
|
51 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Biochemical Laboratory Abnormalities
BUN · Above
|
6 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 21 days (Days 0-20) post vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
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 |
Arepanrix/F2 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=67 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs) - Preliminary Analysis
|
20 Participants
|
16 Participants
|
14 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 42 days (Days 0-41) post vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
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 |
Arepanrix/F2 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=67 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs) - First Analysis
|
35 Participants
|
25 Participants
|
23 Participants
|
33 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 41 days (Days 0-40) post vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
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 |
Arepanrix/F2 Group
n=128 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=67 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs) - Second Analysis
|
65 Participants
|
24 Participants
|
23 Participants
|
34 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 84 days (Days 0-83) post vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
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 |
Arepanrix/F2 Group
n=128 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=67 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
|
76 Participants
|
30 Participants
|
32 Participants
|
36 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 21 days (Days 0-20) post vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=67 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any Medically-attended Adverse Events (MAEs) - Preliminary Analysis
|
5 Participants
|
3 Participants
|
4 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 41 days (Days 0-40) post vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=67 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any Medically-attended Adverse Events (MAEs) - First Analysis
|
14 Participants
|
8 Participants
|
9 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 42 days (Days 0-41) post vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=128 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=67 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any Medically-attended Adverse Events (MAEs) - Second Analysis
|
31 Participants
|
8 Participants
|
9 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 182 days (Days 0-181) post vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=128 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=67 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any Medically-attended Adverse Events (MAEs)
|
62 Participants
|
24 Participants
|
25 Participants
|
32 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Throughout the entire study period (Day 0 - Day 385)Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=128 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=67 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Any Medically-attended Adverse Events (MAEs)
|
87 Participants
|
39 Participants
|
34 Participants
|
39 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 21 days (Days 0-20) post vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=67 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - Preliminary Analysis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 42 days (Days 0-41) post vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=67 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - First Analysis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 42 days (Days 0-41) post vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=128 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=67 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs) - Second Analysis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 182 days (Days 0-181) post vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=128 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=67 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Throughout the entire study period (Day 0 - Day 385)Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=128 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=67 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 21 days (Days 0-20) post vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=67 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) - Preliminary Analysis
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 42 days (Days 0-41) post vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=67 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) - First Analysis
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 42 days (Day 0-41) post vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=128 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=67 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) - Second Analysis
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Within 182 days (Days 0-181) post vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=128 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=67 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Throughout the entire study period (Day 0 - Day 385)Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least 1 study vaccination.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Arepanrix/F2 Group
n=128 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=64 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F1 Group
n=67 Participants
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-5Y Group
Subjects, aged 6 months (M) - 5 years (Y), male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6M-35M Group
Subjects, aged 6 months (M) - 35 months, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 3Y-6Y Group
Subjects, aged 3 years (Y) - 6 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 6Y-9Y Group
Subjects, aged 6 years (Y) - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Arepanrix/F1 Group
Arepanrix/F2 Group
GSK2340273A/F1 Group
GSK2340273A/F2 Group
Serious adverse events
| Measure |
Arepanrix/F1 Group
n=67 participants at risk
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F2 Group
n=128 participants at risk
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=64 participants at risk
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 participants at risk
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|
|
Infections and infestations
Appendiceal abscess
|
0.00%
0/67 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
0.78%
1/128 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
0.00%
0/64 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
0.00%
0/63 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
|
Infections and infestations
Tonsillitis
|
1.5%
1/67 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
0.00%
0/128 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
0.00%
0/64 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
0.00%
0/63 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
|
Nervous system disorders
Convulsion
|
1.5%
1/67 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
0.78%
1/128 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
0.00%
0/64 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
0.00%
0/63 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
Other adverse events
| Measure |
Arepanrix/F1 Group
n=67 participants at risk
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
Arepanrix/F2 Group
n=128 participants at risk
Subjects, aged 6 months - 9 years, male or female, received 2 doses of Arepanrix™-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F1 Group
n=64 participants at risk
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 1 (F1) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
GSK2340273A/F2 Group
n=63 participants at risk
Subjects, aged 6 months - 9 years, male or female, received 2 doses of GSK2340273A-formulation 2 (F2) vaccine administered at a 21-day interval. The first dose was administered intramuscularly in the deltoid region of the non-dominant arm (or left arm if dominance was not yet identified) or left anterolateral thigh (for children \< 12 months of age). The second vaccine dose was administered in the deltoid region of the dominant arm (or right arm) or right anterolateral thigh (children \< 12 months of age).
|
|---|---|---|---|---|
|
General disorders
Pain
|
76.1%
51/67 • Number of events 77 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
71.1%
91/128 • Number of events 148 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
53.1%
34/64 • Number of events 50 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
47.6%
30/63 • Number of events 41 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
|
General disorders
Pyrexia
|
47.8%
32/67 • Number of events 36 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
32.0%
41/128 • Number of events 50 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
17.2%
11/64 • Number of events 12 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
15.9%
10/63 • Number of events 11 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
|
Nervous system disorders
Somnolence
|
25.4%
17/67 • Number of events 24 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
32.8%
42/128 • Number of events 51 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
20.3%
13/64 • Number of events 15 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
22.2%
14/63 • Number of events 16 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
|
General disorders
Swelling
|
10.4%
7/67 • Number of events 9 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
11.7%
15/128 • Number of events 17 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
1.6%
1/64 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
1.6%
1/63 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
5/67 • Number of events 6 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
9.4%
12/128 • Number of events 12 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
6.2%
4/64 • Number of events 4 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
3.2%
2/63 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
|
Gastrointestinal disorders
Vomiting
|
6.0%
4/67 • Number of events 4 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
4.7%
6/128 • Number of events 6 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
3.1%
2/64 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
9.5%
6/63 • Number of events 7 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.0%
2/67 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
8.6%
11/128 • Number of events 12 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
3.1%
2/64 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
3.2%
2/63 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
|
General disorders
Chills
|
6.0%
4/67 • Number of events 4 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
3.9%
5/128 • Number of events 5 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
3.1%
2/64 • Number of events 3 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
3.2%
2/63 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.5%
3/67 • Number of events 3 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
15.6%
20/128 • Number of events 23 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
9.4%
6/64 • Number of events 7 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
9.5%
6/63 • Number of events 6 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.3%
27/67 • Number of events 36 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
35.2%
45/128 • Number of events 54 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
18.8%
12/64 • Number of events 14 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
17.5%
11/63 • Number of events 14 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
20.9%
14/67 • Number of events 18 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
10.2%
13/128 • Number of events 14 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
1.6%
1/64 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
3.2%
2/63 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
|
General disorders
Fatigue
|
9.0%
6/67 • Number of events 6 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
8.6%
11/128 • Number of events 15 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
6.2%
4/64 • Number of events 7 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
12.7%
8/63 • Number of events 8 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
1.5%
1/67 • Number of events 1 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
6.2%
8/128 • Number of events 10 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
4.7%
3/64 • Number of events 4 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
11.1%
7/63 • Number of events 7 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
|
Nervous system disorders
Headache
|
16.4%
11/67 • Number of events 15 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
11.7%
15/128 • Number of events 19 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
6.2%
4/64 • Number of events 4 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
9.5%
6/63 • Number of events 8 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
|
Psychiatric disorders
Irritability
|
41.8%
28/67 • Number of events 41 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
39.1%
50/128 • Number of events 69 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
32.8%
21/64 • Number of events 28 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
27.0%
17/63 • Number of events 19 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.9%
8/67 • Number of events 11 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
8.6%
11/128 • Number of events 15 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
4.7%
3/64 • Number of events 4 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
4.8%
3/63 • Number of events 3 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
4/67 • Number of events 5 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
7.8%
10/128 • Number of events 11 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
6.2%
4/64 • Number of events 6 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
9.5%
6/63 • Number of events 8 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
|
Infections and infestations
Otitis media
|
3.0%
2/67 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
6.2%
8/128 • Number of events 10 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
3.1%
2/64 • Number of events 2 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
4.8%
3/63 • Number of events 4 • Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6). Unsolicited AEs: during the 84-day post-vaccination (Days 0-83). SAEs: during the entire study period (Day 0 - Day 385).
|
Additional Information
GSK Response Center
GlaxoSmithKline
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