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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

323 participants

Primary outcome timeframe

At Day 21

Results posted on

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

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

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

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 21

Population: 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

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 21

Population: 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

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 21

Population: 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

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 42

Population: 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

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 42

Population: 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

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 0

Population: 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

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 21

Population: 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

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 0

Population: 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

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 21

Population: 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

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 0

Population: 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

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 21

Population: 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

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 0

Population: 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

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 42

Population: 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

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 0

Population: 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

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 42

Population: 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

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 21

Population: 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

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 21

Population: 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

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 21

Population: 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

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 42

Population: 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

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 42

Population: 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

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 21

Population: 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

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 21

Population: 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

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 21

Population: 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

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 42

Population: 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

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 42

Population: 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

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 182

Population: 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

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 21

Population: 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

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 21

Population: 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

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 21

Population: 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

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 42

Population: 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

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 42

Population: 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

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 182

Population: 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

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 182

Population: 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

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 182

Population: 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

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 182

Population: 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

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 21

Population: 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

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 21

Population: 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

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 42

Population: 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

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 42

Population: 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

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 21

Population: 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

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 42

Population: 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

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 period

Population: 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

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 doses

Population: 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

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 doses

Population: 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

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 period

Population: 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

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 period

Population: 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

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 doses

Population: 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

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 doses

Population: 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

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 doses

Population: 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

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 doses

Population: 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

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 21

Population: 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

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 21

Population: 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

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 42

Population: 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

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 42

Population: 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

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 21

Population: 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

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 42

Population: 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

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 182

Population: 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

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 182

Population: 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

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 vaccination

Population: 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

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 vaccination

Population: 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

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 vaccination

Population: 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

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 vaccination

Population: 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

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 vaccination

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

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 vaccination

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

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 vaccination

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

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 vaccination

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

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

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 vaccination

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

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 vaccination

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

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 vaccination

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

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 vaccination

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

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

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 vaccination

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

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 vaccination

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

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 vaccination

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

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 vaccination

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

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

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

Serious events: 2 serious events
Other events: 61 other events
Deaths: 0 deaths

Arepanrix/F2 Group

Serious events: 2 serious events
Other events: 125 other events
Deaths: 0 deaths

GSK2340273A/F1 Group

Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths

GSK2340273A/F2 Group

Serious events: 0 serious events
Other events: 55 other events
Deaths: 0 deaths

Serious adverse events

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

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

Phone: 866-435-7343

Results disclosure agreements

  • Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
  • Publication restrictions are in place

Restriction type: OTHER