Trial Outcomes & Findings for Safety, Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A) (NCT NCT00971321)

NCT ID: NCT00971321

Last Updated: 2019-02-25

Results Overview

Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 157 participants
• Primary outcome timeframe: At Day 0
• Results posted on: 2019-02-25

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

Measure	GSK2340272A F1 Group Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Up to Day 42 STARTED	104	53
Up to Day 42 COMPLETED	104	53
Up to Day 42 NOT COMPLETED	0	0
Up to Month 7 STARTED	104	53
Up to Month 7 COMPLETED	100	51
Up to Month 7 NOT COMPLETED	4	2
Up to Month 11-12 STARTED	104	53
Up to Month 11-12 COMPLETED	99	50
Up to Month 11-12 NOT COMPLETED	5	3

Reasons for withdrawal

Measure	GSK2340272A F1 Group Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Up to Month 7 Withdrawal by Subject	1	0
Up to Month 7 Migrated/moved from study area	3	2
Up to Month 11-12 Withdrawal by Subject	2	1
Up to Month 11-12 Migrated/moved from study area	2	2
Up to Month 11-12 Lost to Follow-up	1	0

Baseline Characteristics

Safety, Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)

Baseline characteristics by cohort

Measure	GSK2340272A F1 Group n=104 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=53 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	Total n=157 Participants Total of all reporting groups
Age, Continuous	19.3 Months STANDARD_DEVIATION 9.3 • n=93 Participants	19.7 Months STANDARD_DEVIATION 8.8 • n=4 Participants	19.4 Months STANDARD_DEVIATION 9.1 • n=27 Participants
Sex: Female, Male Female	43 Participants n=93 Participants	26 Participants n=4 Participants	69 Participants n=27 Participants
Sex: Female, Male Male	61 Participants n=93 Participants	27 Participants n=4 Participants	88 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · African Heritage / African American	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · American Indian or Alaskan Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Caucasian / European Heritage	96 Participants n=93 Participants	46 Participants n=4 Participants	142 Participants n=27 Participants
Race/Ethnicity, Customized Geographic ancestry · Other	6 Participants n=93 Participants	7 Participants n=4 Participants	13 Participants n=27 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 for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.

Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

Outcome measures

Measure	GSK2340272A F1 Group n=101 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=48 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies	5 Participants	6 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 for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.

Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

Outcome measures

Measure	GSK2340272A F1 Group n=97 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=50 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies	97 Participants	50 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 subjeects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.

Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

Outcome measures

Measure	GSK2340272A F1 Group n=101 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=48 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies	5.75 Titers Interval 5.0 to 6.63	6.82 Titers Interval 5.22 to 8.91

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 for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.

Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

Outcome measures

Measure	GSK2340272A F1 Group n=97 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=50 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies	2007.70 Titers Interval 1805.24 to 2232.87	2259.61 Titers Interval 1947.61 to 2621.59

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 for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.

Seroconversion (SCR) was defined as the percentage of vaccinees that have either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The strain assessed was Flu A/California/7/2009 (H1N1).

Outcome measures

Measure	GSK2340272A F1 Group n=97 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=48 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibodies	97 Participants	48 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 for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.

Seroprotection (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The strain assessed was Flu A/California/7/2009 (H1N1).

Outcome measures

Measure	GSK2340272A F1 Group n=97 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=50 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies	97 Participants	50 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 for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.

Seroconversion factor was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The strain assessed was Flu A/California/7/2009 (H1N1).

Outcome measures

Measure	GSK2340272A F1 Group n=97 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=48 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers	346.86 Fold change Interval 287.54 to 418.42	322.67 Fold change Interval 231.61 to 449.52

SECONDARY outcome

Timeframe: At Days 0, 21, 42, and at Month 11-12

Population: The ATP cohort for antibody persistence at Month 11-12 included all evaluable subjects who had received at least one dose of vaccine according to their treatment assignment and for whom data concerning immunogenicity outcome measures and assay results were available for antibodies against the study vaccine component at Month 11-12.

Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

Outcome measures

Measure	GSK2340272A F1 Group n=83 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=37 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies Flu A/CAL/7/2009, Day 0	4 Participants	4 Participants
Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies Flu A/CAL/7/2009, Day 21	83 Participants	37 Participants
Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies Flu A/CAL/7/2009, Day 42	83 Participants	37 Participants
Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies Flu A/CAL/7/2009, Month 11-12	83 Participants	37 Participants

SECONDARY outcome

Timeframe: At Days 0, 21, 42 and at Month 11-12

Population: The ATP cohort for antibody persistence at Month 11-12 included all evaluable subjects who had received at least one dose of vaccine according to their treatment assignment and for whom data concerning immunogenicity outcome measures and assay results were available for antibodies against the study vaccine component at Month 11-12.

Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

Outcome measures

Measure	GSK2340272A F1 Group n=83 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=37 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies Flu A/CAL/7/2009, Day 42	1758.0 Titers Interval 1553.8 to 1989.1	1879.2 Titers Interval 1504.2 to 2347.7
Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies Flu A/CAL/7/2009, Month 11-12	212.5 Titers Interval 182.8 to 247.0	239.3 Titers Interval 201.6 to 284.0
Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies Flu A/CAL/7/2009, Day 0	5.8 Titers Interval 5.0 to 6.8	6.2 Titers Interval 5.0 to 7.8
Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies Flu A/CAL/7/2009, Day 21	234.0 Titers Interval 202.9 to 269.8	255.5 Titers Interval 205.4 to 317.9

SECONDARY outcome

Timeframe: At Days 21, 42 and at Month 11-12

Population: The ATP cohort for antibody persistence at Month 11-12 included all evaluable subjects who had received at least one dose of vaccine according to their treatment assignment and for whom data concerning immunogenicity outcome measures and assay results were available for antibodies against the study vaccine component at Month 11-12.

Seroconversion (SCR) was defined as the percentage of vaccinees that have either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The strain assessed was Flu A/California/7/2009 (H1N1).

Outcome measures

Measure	GSK2340272A F1 Group n=83 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=37 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibody Titers Flu A/CAL/7/2009, Day 42	83 Participants	37 Participants
Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibody Titers Flu A/CAL/7/2009, Month 11-12	81 Participants	36 Participants
Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibody Titers Flu A/CAL/7/2009, Day 21	82 Participants	37 Participants

SECONDARY outcome

Timeframe: At Days 0, 21, 42 and at Month 11-12

Population: The ATP cohort for antibody persistence at Month 11-12 included all evaluable subjects who had received at least one dose of vaccine according to their treatment assignment and for whom data concerning immunogenicity outcome measures and assay results were available for antibodies against the study vaccine component at Month 11-12.

Seroprotection (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The strain assessed was Flu A/California/7/2009 (H1N1).

Outcome measures

Measure	GSK2340272A F1 Group n=83 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=37 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies Flu A/CAL/7/2009, Day 0	3 Participants	3 Participants
Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies Flu A/CAL/7/2009, Day 21	83 Participants	37 Participants
Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies Flu A/CAL/7/2009, Day 42	83 Participants	37 Participants
Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies Flu A/CAL/7/2009, Month 11-12	83 Participants	37 Participants

SECONDARY outcome

Timeframe: At Days 21, 42 and at Month 11-12

Population: The ATP cohort for antibody persistence at Month 11-12 included all evaluable subjects who had received at least one dose of vaccine according to their treatment assignment and for whom data concerning immunogenicity outcome measures and assay results were available for antibodies against the study vaccine component at Month 11-12.

Seroconversion factor was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The strain assessed was Flu A/California/7/2009 (H1N1).

Outcome measures

Measure	GSK2340272A F1 Group n=83 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=37 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers Flu A/CAL/7/2009, Month 11-12	36.6 Fold change Interval 30.0 to 44.6	38.6 Fold change Interval 29.5 to 50.4
Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers Flu A/CAL/7/2009, Day 21	40.3 Fold change Interval 34.3 to 47.2	41.2 Fold change Interval 32.2 to 52.7
Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers Flu A/CAL/7/2009, Day 42	302.5 Fold change Interval 248.2 to 368.7	302.8 Fold change Interval 211.8 to 432.9

SECONDARY outcome

Timeframe: At Days 0, 21 and 42

Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.

Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:8. The strain assessed was Flu A/Neth/602/09.

Outcome measures

Measure	GSK2340272A F1 Group n=65 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=32 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Titers for Serum Neutralising Antibodies Flu A/Neth/602/2009, Day 0	5.35 Titers Interval 3.94 to 7.26	5.40 Titers Interval 3.76 to 7.77
Titers for Serum Neutralising Antibodies Flu A/Neth/602/2009, Day 21	37.88 Titers Interval 26.46 to 54.22	51.23 Titers Interval 29.85 to 87.9
Titers for Serum Neutralising Antibodies Flu A/Neth/602/2009, Day 42	1488.85 Titers Interval 1144.23 to 1937.25	1907.39 Titers Interval 1250.94 to 2908.34

SECONDARY outcome

Timeframe: At Days 0, 21, 42 and at Month 11-12

Population: The ATP cohort for antibody persistence at Month 11-12 included all evaluable subjects who had received at least one dose of vaccine according to their treatment assignment and for whom data concerning immunogenicity outcome measures and assay results were available for antibodies against the study vaccine component at Month 11-12.

Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:8. The strain assessed was Flu A/Neth/602/09.

Outcome measures

Measure	GSK2340272A F1 Group n=57 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=24 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Titers for Serum Neutralising Antibodies Flu A/Neth/602/09, Day 0	5.6 Titers Interval 3.9 to 7.9	5.7 Titers Interval 3.6 to 8.9
Titers for Serum Neutralising Antibodies Flu A/Neth/602/09, Day 21	36.9 Titers Interval 24.5 to 55.4	50.8 Titers Interval 25.6 to 100.7
Titers for Serum Neutralising Antibodies Flu A/Neth/602/09, Day 42	1416.1 Titers Interval 1048.1 to 1913.3	1960.6 Titers Interval 1097.0 to 3504.0
Titers for Serum Neutralising Antibodies Flu A/Neth/602/09, Month 11-12	312.8 Titers Interval 223.1 to 438.6	444.4 Titers Interval 286.5 to 689.3

SECONDARY outcome

Timeframe: At Days 21 and 42

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 42, which included all evaluable subjects for whom assay results were available for antibodies against H1N1 antigen for the blood sample taken 21 days after the second dose for all subjects.

Vaccine response rate was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination for neutralising antibody response. For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The strain assessed was Flu A/Neth/602/2009.

Outcome measures

Measure	GSK2340272A F1 Group n=61 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=29 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Number of Subjects With Vaccine Response for Serum Neutralising Antibodies Flu A/Neth/602/2009, Day 21	34 Participants	18 Participants
Number of Subjects With Vaccine Response for Serum Neutralising Antibodies Flu A/Neth/602/2009, Day 42	60 Participants	29 Participants

SECONDARY outcome

Timeframe: At Days 21, 42 and at Month 11-12

Population: The ATP cohort for antibody persistence at Month 11-12 included all evaluable subjects who had received at least one dose of vaccine according to their treatment assignment and for whom data concerning immunogenicity outcome measures and assay results were available for antibodies against the study vaccine component at Month 11-12.

Vaccine response rate was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination for neutralising antibody response. For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The strain assessed was Flu A/Neth/602/2009.

Outcome measures

Measure	GSK2340272A F1 Group n=25 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=12 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Number of Subjects With Vaccine Response for Serum Neutralising Antibodies Flu A/Neth/602/2009, Day 21	14 Participants	8 Participants
Number of Subjects With Vaccine Response for Serum Neutralising Antibodies Flu A/Neth/602/2009, Day 42	24 Participants	12 Participants
Number of Subjects With Vaccine Response for Serum Neutralising Antibodies Flu A/Neth/602/2009, Month 11-12	19 Participants	10 Participants

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period after each dose and across doses

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who had their symptom sheets filled in.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.

Outcome measures

Measure	GSK2340272A F1 Group n=104 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=53 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across doses	38 Participants	21 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	37 Participants	31 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	19 Participants	17 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	0 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	12 Participants	11 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	43 Participants	27 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	3 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	34 Participants	23 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	1 Participants	6 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	30 Participants	17 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	1 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across doses	54 Participants	37 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	4 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across doses	41 Participants	27 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across doses	1 Participants	6 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across doses	1 Participants	5 Participants

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period after each dose and across doses

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who has their symptom sheets filled in.

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Measure	GSK2340272A F1 Group n=104 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=53 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability, Across doses	54 Participants	31 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Across doses	54 Participants	35 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Dose 1	24 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness, Dose 1	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness, Dose 1	17 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Dose 1	33 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability, Dose 1	2 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability, Dose 1	28 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Dose 1	25 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite, Dose 1	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite, Dose 1	18 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 1	21 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 1	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 1	16 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Dose 2	36 Participants	25 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness, Dose 2	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness, Dose 2	35 Participants	22 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Dose 2	48 Participants	31 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability, Dose 2	3 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability, Dose 2	45 Participants	27 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite, Dose 2	44 Participants	30 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite, Dose 2	4 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite, Dose 2	41 Participants	26 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 2	70 Participants	37 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 2	4 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 2	64 Participants	34 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness, Across doses	47 Participants	31 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness, Across doses	0 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness, Across doses	43 Participants	26 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability, Across doses	60 Participants	38 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability, Across doses	5 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite, Across doses	5 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite, Across doses	49 Participants	29 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Across doses	79 Participants	41 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Across doses	5 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Across doses	70 Participants	37 Participants

SECONDARY outcome

Timeframe: During the entire study period (Day 0 up to Month 7 and Day 0 up to Month 11-12)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

Outcome measures

Measure	GSK2340272A F1 Group n=104 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=53 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Number of Subjects With Any Medically-attended Events (MAEs) Any MAEs, up to Month 7	92 Participants	40 Participants
Number of Subjects With Any Medically-attended Events (MAEs) Any MAEs, up to Month 11-12	94 Participants	45 Participants

SECONDARY outcome

Timeframe: During the entire study period (Day 0 up to Month 11-12)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

Outcome measures

Measure	GSK2340272A F1 Group n=104 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=53 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Number of Subjects With Any Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Disease (pIMDs)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Days 0, 21 and 42

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Among biochemical parameters assessed were: alanine aminotrasferase [ALAT], aspartate aminotransferase [ASAT], bilirubin total [BIL/T], bilirubin direct [BIL/D], creatinine [CREA] and blood urea nitrogen [BUN]. Levels of biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above.

Outcome measures

Measure	GSK2340272A F1 Group n=104 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=53 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/D, Day 0 · Below	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BUN, Day 42 · Unknown	1 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BUN, Day 42 · Below	1 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ALAT, Day 0 · Unknown	3 Participants	4 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ALAT, Day 0 · Below	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ALAT, Day 0 · Within	101 Participants	49 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ALAT, Day 0 · Above	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ALAT, Day 21 · Unknown	1 Participants	1 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ALAT, Day 21 · Below	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ALAT, Day 21 · Within	100 Participants	50 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ALAT, Day 21 · Above	3 Participants	1 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ALAT, Day 42 · Unknown	1 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ALAT, Day 42 · Below	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ALAT, Day 42 · Within	98 Participants	53 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ALAT, Day 42 · Above	4 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ASAT, Day 0 · Unknown	3 Participants	3 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ASAT, Day 0 · Below	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ASAT, Day 0 · Within	100 Participants	49 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ASAT, Day 0 · Above	1 Participants	1 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ASAT, Day 21 · Unknown	4 Participants	3 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ASAT, Day 21 · Below	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ASAT, Day 21 · Within	94 Participants	48 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ASAT, Day 21 · Above	6 Participants	1 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ASAT, Day 42 · Unknown	1 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ASAT, Day 42 · Below	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ASAT, Day 42 · Within	96 Participants	53 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels ASAT, Day 42 · Above	6 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/T, Day 0 · Unknown	3 Participants	4 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/T, Day 0 · Below	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/T, Day 0 · Within	101 Participants	49 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/T, Day 0 · Above	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/T, Day 21 · Unknown	2 Participants	1 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/T, Day 21 · Below	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/T, Day 21 · Within	102 Participants	51 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/T, Day 21 · Above	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/T, Day 42 · Unknown	1 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/T, Day 42 · Below	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/T, Day 42 · Within	102 Participants	53 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/T, Day 42 · Above	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/D, Day 0 · Unknown	3 Participants	4 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/D, Day 0 · Within	101 Participants	49 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/D, Day 0 · Above	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/D, Day 21 · Unknown	1 Participants	1 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/D, Day 21 · Below	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/D, Day 21 · Within	103 Participants	51 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/D, Day 21 · Above	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/D, Day 42 · Unknown	1 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/D, Day 42 · Below	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/D, Day 42 · Within	102 Participants	53 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BIL/D, Day 42 · Above	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels CREA, Day 0 · Unknown	3 Participants	3 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels CREA, Day 0 · Below	32 Participants	16 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels CREA, Day 0 · Within	67 Participants	34 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels CREA, Day 0 · Above	2 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels CREA, Day 21 · Unknown	1 Participants	2 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels CREA, Day 21 · Below	34 Participants	19 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels CREA, Day 21 · Within	69 Participants	30 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels CREA, Day 21 · Above	0 Participants	1 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels CREA, Day 42 · Unknown	1 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels CREA, Day 42 · Below	37 Participants	16 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels CREA, Day 42 · Within	65 Participants	37 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels CREA, Day 42 · Above	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BUN, Day 0 · Unknown	3 Participants	4 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BUN, Day 0 · Below	1 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BUN, Day 0 · Within	77 Participants	36 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BUN, Day 0 · Above	23 Participants	13 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BUN, Day 21 · Unknown	1 Participants	1 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BUN, Day 21 · Below	0 Participants	0 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BUN, Day 21 · Within	79 Participants	37 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BUN, Day 21 · Above	24 Participants	14 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BUN, Day 42 · Within	76 Participants	41 Participants
Number of Subjects With Normal/Abnormal Biochemical Levels BUN, Day 42 · Above	25 Participants	12 Participants

SECONDARY outcome

Timeframe: During a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Outcome measures

Measure	GSK2340272A F1 Group n=104 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=53 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s)	98 Participants	47 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AE(s)	18 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s)	12 Participants	8 Participants

SECONDARY outcome

Timeframe: During the entire study period (Day 0 up to Month 11-12)

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Measure	GSK2340272A F1 Group n=104 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK2340272A F2 Group n=53 Participants Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Number of Subjects With Serious Adverse Events (SAEs)	2 Participants	6 Participants

Adverse Events

GSK 2340272A F1 Group

Serious events: 2 serious events

Other events: 103 other events

Deaths: 0 deaths

GSK 2340272A F2 Group

Serious events: 6 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Measure	GSK 2340272A F1 Group n=104 participants at risk Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK 2340272A F2 Group n=53 participants at risk Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/104 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	1.9% 1/53 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Infections and infestations Bronchiolitis	0.96% 1/104 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	0.00% 0/53 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Infections and infestations Bronchitis	0.96% 1/104 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	1.9% 1/53 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Infections and infestations Conjunctivitis	0.96% 1/104 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	0.00% 0/53 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Infections and infestations Otitis media	0.96% 1/104 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	0.00% 0/53 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Infections and infestations Pneumonia	0.00% 0/104 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	1.9% 1/53 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Infections and infestations Viral rash	0.00% 0/104 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	1.9% 1/53 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/104 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	1.9% 1/53 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/104 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	1.9% 1/53 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/104 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	1.9% 1/53 • Number of events 1 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).

Other adverse events

Measure	GSK 2340272A F1 Group n=104 participants at risk Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.	GSK 2340272A F2 Group n=53 participants at risk Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (\<) 12 months at study entry.
Respiratory, thoracic and mediastinal disorders Asthma	3.8% 4/104 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	9.4% 5/53 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Infections and infestations Bronchitis	11.5% 12/104 • Number of events 14 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	11.3% 6/53 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Infections and infestations Conjunctivitis	5.8% 6/104 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	3.8% 2/53 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Respiratory, thoracic and mediastinal disorders Cough	12.5% 13/104 • Number of events 13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	13.2% 7/53 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Metabolism and nutrition disorders Decreased appetite	51.9% 54/104 • Number of events 69 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	66.0% 35/53 • Number of events 47 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Gastrointestinal disorders Diarrhoea	14.4% 15/104 • Number of events 16 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	13.2% 7/53 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Skin and subcutaneous tissue disorders Erythema	39.4% 41/104 • Number of events 53 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	50.9% 27/53 • Number of events 40 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Infections and infestations Gastroenteritis	11.5% 12/104 • Number of events 14 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	15.1% 8/53 • Number of events 11 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Psychiatric disorders Irritability	58.7% 61/104 • Number of events 83 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	71.7% 38/53 • Number of events 48 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Infections and infestations Laryngitis	5.8% 6/104 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	5.7% 3/53 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Infections and infestations Otitis media	5.8% 6/104 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	5.7% 3/53 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Infections and infestations Otitis media acute	8.7% 9/104 • Number of events 10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	1.9% 1/53 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
General disorders Pain	51.9% 54/104 • Number of events 80 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	69.8% 37/53 • Number of events 58 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Infections and infestations Pharyngitis	10.6% 11/104 • Number of events 13 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	3.8% 2/53 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
General disorders Pyrexia	77.9% 81/104 • Number of events 100 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	81.1% 43/53 • Number of events 55 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Skin and subcutaneous tissue disorders Rash	7.7% 8/104 • Number of events 8 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	0.00% 0/53 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Infections and infestations Respiratory tract infection	4.8% 5/104 • Number of events 6 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	5.7% 3/53 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Infections and infestations Rhinitis	3.8% 4/104 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	5.7% 3/53 • Number of events 4 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Nervous system disorders Somnolence	45.2% 47/104 • Number of events 60 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	58.5% 31/53 • Number of events 39 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
General disorders Swelling	36.5% 38/104 • Number of events 42 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	39.6% 21/53 • Number of events 28 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Infections and infestations Tonsillitis	1.9% 2/104 • Number of events 2 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	5.7% 3/53 • Number of events 3 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Infections and infestations Upper respiratory tract infection	56.7% 59/104 • Number of events 90 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	45.3% 24/53 • Number of events 34 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).
Gastrointestinal disorders Vomiting	5.8% 6/104 • Number of events 7 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).	17.0% 9/53 • Number of events 10 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).

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