Trial Outcomes & Findings for Safety and Immune Response of Candidate H1N1 Influenza Vaccines GSK2340274A and GSK234072A in Children 3 to Less Than 10 Years Old (NCT NCT01161160)

Results Overview

Seroconversion rate (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer below (\<) 10 and a post-vaccination reciprocal titre greater than or equal to (≥) 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09), following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance. The CBER criterion was fulfilled if the lower 95% confidence interval (CI) for SCR was (\>) 40%. The CHMP criterion was fulfilled if the point estimate for SCR was \> 40%.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

209 participants

Primary outcome timeframe

At Day 21

Results posted on

2018-09-06

Participant Flow

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Participant milestones

Participant milestones
Measure	Arepanrix 1/2 Group Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Overall Study STARTED	76	75	58
Overall Study COMPLETED	76	75	58
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Immune Response of Candidate H1N1 Influenza Vaccines GSK2340274A and GSK234072A in Children 3 to Less Than 10 Years Old

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arepanrix 1/2 Group n=76 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=75 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=58 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Total n=209 Participants Total of all reporting groups
Age, Continuous	6 Years STANDARD_DEVIATION 2.03 • n=5 Participants	6 Years STANDARD_DEVIATION 2.02 • n=7 Participants	6 Years STANDARD_DEVIATION 2 • n=5 Participants	6 Years STANDARD_DEVIATION 2.01 • n=4 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	38 Participants n=7 Participants	27 Participants n=5 Participants	95 Participants n=4 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	37 Participants n=7 Participants	31 Participants n=5 Participants	114 Participants n=4 Participants
Race/Ethnicity, Customized Asian-Central/South Asian heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Asian-East Asian heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Asian-South East Asian heritage	76 Participants n=5 Participants	74 Participants n=7 Participants	57 Participants n=5 Participants	207 Participants n=4 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 for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.

Seroconversion rate (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer below (\<) 10 and a post-vaccination reciprocal titre greater than or equal to (≥) 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09), following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance. The CBER criterion was fulfilled if the lower 95% confidence interval (CI) for SCR was (\>) 40%. The CHMP criterion was fulfilled if the point estimate for SCR was \> 40%.

Outcome measures

Outcome measures
Measure	Arepanrix 1/2 Group n=76 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=75 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=58 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Strain	75 Participants	74 Participants	57 Participants

PRIMARY outcome

Timeframe: At Day 0

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was \> 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%.

Outcome measures

Outcome measures
Measure	Arepanrix 1/2 Group n=76 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=75 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=58 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain	28 Participants	24 Participants	18 Participants

PRIMARY outcome

Timeframe: At Day 21

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjeects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was \> 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%.

Outcome measures

Outcome measures
Measure	Arepanrix 1/2 Group n=76 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=75 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=58 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain	75 Participants	74 Participants	57 Participants

PRIMARY outcome

Timeframe: At Day 21

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.

GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CHMP criterion was fulfilled if the point estimate for GMFR was \> 2.5.

Outcome measures

Outcome measures
Measure	Arepanrix 1/2 Group n=76 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=75 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=58 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain	25.7 Fold increase Interval 20.7 to 32.0	27.1 Fold increase Interval 22.4 to 32.8	32.2 Fold increase Interval 24.7 to 42.0

SECONDARY outcome

Timeframe: At Day 182

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.

Seroconversion rate (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titer \< 10 and a post-vaccination reciprocal titer ≥ 40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for SCR was \> 40%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SCR was \> 40%.

Outcome measures

Outcome measures
Measure	Arepanrix 1/2 Group n=73 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=74 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=58 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Number of Seroconverted Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain	46 Participants	53 Participants	40 Participants

SECONDARY outcome

Timeframe: At Day 0 and Day 182

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was \> 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%.

Outcome measures

Outcome measures
Measure	Arepanrix 1/2 Group n=73 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=74 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=58 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain Flu A/CAL/7/09, Day 0	27 Participants	24 Participants	18 Participants
Number of Seroprotected Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain Flu A/CAL/7/09, Day 182	55 Participants	63 Participants	46 Participants

SECONDARY outcome

Timeframe: At Day 182

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.

GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CHMP criterion was fulfilled if the post-vaccination point estimate for SCF was \> 2.5.

Outcome measures

Outcome measures
Measure	Arepanrix 1/2 Group n=73 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=74 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=58 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain	6.6 Fold increase Interval 5.4 to 8.2	8 Fold increase Interval 6.4 to 10.1	8.9 Fold increase Interval 6.8 to 11.7

SECONDARY outcome

Timeframe: At Day 21

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.

The cut-off value for the humoral immune response in terms of vaccine H1N1 HI antibodies were egual to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.

Outcome measures

Outcome measures
Measure	Arepanrix 1/2 Group n=76 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=75 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=58 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects With HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Above the Cut-off Value	76 Participants	75 Participants	58 Participants

SECONDARY outcome

Timeframe: At Day 21

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 21 days after vaccination were available.

Titers are presented as geometric mean titers (GMTs), for the seropositivity cut-off value of ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.

Outcome measures

Outcome measures
Measure	Arepanrix 1/2 Group n=76 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=75 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=58 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Strain	448.6 Titers Interval 323.9 to 621.3	434.1 Titers Interval 321.0 to 587.0	418.8 Titers Interval 297.6 to 589.1

SECONDARY outcome

Timeframe: At Day 182

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.

The cut-off value for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.

Outcome measures

Outcome measures
Measure	Arepanrix 1/2 Group n=73 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=74 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=58 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects With HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Above the Cut-off Value	72 Participants	72 Participants	58 Participants

SECONDARY outcome

Timeframe: At Day 182

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects for whom assay results for antibodies against A/California-like HA antigen for the blood sample taken 182 days after vaccination were available.

Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.

Outcome measures

Outcome measures
Measure	Arepanrix 1/2 Group n=73 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=74 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=58 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
HI Antibody Titers Against Flu A/CAL/7/09 H1N1 Strain	117.4 Titers Interval 84.5 to 163.1	128.3 Titers Interval 95.8 to 171.9	115.7 Titers Interval 80.7 to 166.0

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 the study vaccine.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain for children less than 6 years= cried when limb was moved/spontaneously painful. Grade 3 pain for children aged 6 to \< 10 years= 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 1/2 Group n=76 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=75 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=58 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling	1 Participants	5 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	41 Participants	41 Participants	23 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	3 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	0 Participants	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness	0 Participants	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling	0 Participants	0 Participants	0 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 aged 3 to 5 years who received the study vaccine.

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)\]. Any = occurrence of any general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness= drowsiness that prevented normal activity. Grade 3 irritability= crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever \> 39.0 °C or \> 40.0 °C. Related= general symptom assessed by the investigator as causally related to the vaccination. This outcome measure refers to subjects aged 3 to 5 years.

Outcome measures

Outcome measures
Measure	Arepanrix 1/2 Group n=33 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=31 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=24 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite	1 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite	1 Participants	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever	2 Participants	5 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever	1 Participants	2 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever	1 Participants	5 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness	5 Participants	3 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness	1 Participants	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability	2 Participants	7 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability	0 Participants	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite	6 Participants	4 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 aged 6 to 10 years who received the study vaccine.

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever \[defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)\]. Any = occurrence of any general symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom= symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C, but ≤ 40.0 °C. Related= general symptom assessed by the investigator as causally related to the vaccination. This outcome measure refers to subjects aged 6 to 10 years.

Outcome measures

Outcome measures
Measure	Arepanrix 1/2 Group n=41 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=44 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=33 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue	4 Participants	3 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Gastrointestinal	2 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Gastrointestinal	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Gastrointestinal	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache	7 Participants	9 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache	0 Participants	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Joint pain at other location	5 Participants	1 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Joint pain at other location	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Joint pain at other location	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Muscle aches	6 Participants	7 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Muscle aches	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Muscle aches	1 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering	4 Participants	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating	2 Participants	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating	0 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever	4 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever	1 Participants	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to day 21

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.

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. Analysis of intensity and relationship to vaccination of MAEs was not performed.

Outcome measures

Outcome measures
Measure	Arepanrix 1/2 Group n=76 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=75 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=58 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects With Medically-attended Adverse Events (MAEs)	14 Participants	9 Participants	1 Participants

SECONDARY outcome

Timeframe: During the entire study period (Day 0 to Day 182)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.

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. Analysis of intensity and relationship to vaccination of MAEs was not performed.

Outcome measures

Outcome measures
Measure	Arepanrix 1/2 Group n=76 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=75 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=58 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects With MAEs	29 Participants	29 Participants	18 Participants

SECONDARY outcome

Timeframe: Up to Day 21

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.

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 1/2 Group n=76 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=75 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=58 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects With Potential Immune-mediated Diseases (pIMDs)	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the entire study period (Day 0 to Day 182)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.

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 1/2 Group n=76 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=75 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=58 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects With pIMDs	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within the 21-day (Days 0-20) post-vaccination period

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.

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 1/2 Group n=76 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=75 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=58 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects With Unsolicited Adverse Events (AEs)	22 Participants	21 Participants	5 Participants

SECONDARY outcome

Timeframe: Within the 42-day (Days 0-41) post-vaccination period

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.

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 1/2 Group n=76 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=75 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=58 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects With Unsolicited Adverse Events (AEs)	28 Participants	28 Participants	23 Participants

SECONDARY outcome

Timeframe: Up to 21 days after vaccination

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.

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 1/2 Group n=76 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=75 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=58 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects With Serious Adverse Events (SAEs)	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the entire study period (Day 0 to Day 182)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received the study vaccine.

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 1/2 Group n=76 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=75 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=58 Participants Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects With Serious Adverse Events (SAEs)	1 Participants	0 Participants	1 Participants

Adverse Events

Arepanrix 1/2 Group

Serious events: 1 serious events

Other events: 52 other events

Deaths: 0 deaths

Pandemrix 1/2 Group

Serious events: 0 serious events

Other events: 52 other events

Deaths: 0 deaths

Arepanrix Group

Serious events: 1 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arepanrix 1/2 Group n=76 participants at risk Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Pandemrix 1/2 Group n=75 participants at risk Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.	Arepanrix Group n=58 participants at risk Healthy male or female children aged 3 to less than (\<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix™ vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
Infections and infestations Dengue fever	1.3% 1/76 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicted AEs: during the 42-day (Days 0-41) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 182). The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/75 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicted AEs: during the 42-day (Days 0-41) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 182). The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/58 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicted AEs: during the 42-day (Days 0-41) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 182). The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.
Infections and infestations Influenza	0.00% 0/76 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicted AEs: during the 42-day (Days 0-41) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 182). The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	0.00% 0/75 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicted AEs: during the 42-day (Days 0-41) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 182). The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.	1.7% 1/58 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicted AEs: during the 42-day (Days 0-41) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 182). The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets.

Other adverse events

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