Trial Outcomes & Findings for A Dose Ranging Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' GSK1557484A Vaccine in Children 6 to Less Than 36 Months of Age (NCT NCT02719743)

NCT ID: NCT02719743

Last Updated: 2019-06-27

Results Overview

The HI antibody titres were expressed in terms of immunogenicity indices for each group. Immunogenicity index (DGMT) = If the LL of the 95% CI for GMT group ratio is less than 0.25 then DGMT =0. If the LL of the 95% CI for GMT group ratio is greater than 1 then DGMT =1.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

185 participants

Primary outcome timeframe

At Day 42

Results posted on

2019-06-27

Participant Flow

Participant milestones

Participant milestones
Measure	H5N1 Formulation 1 Group Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.	H5N1 Formulation 2 Group Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Study STARTED	38	37	38	37	35
Overall Study COMPLETED	37	34	38	36	33
Overall Study NOT COMPLETED	1	3	0	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	H5N1 Formulation 1 Group Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.	H5N1 Formulation 2 Group Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Overall Study Consent withdrawal	0	2	1	0
Overall Study Migrated/moved from study area	0	0	0	2
Overall Study Lost to Follow-up	1	1	0	0

Baseline Characteristics

A Dose Ranging Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' GSK1557484A Vaccine in Children 6 to Less Than 36 Months of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	H5N1 Formulation 1 Group n=38 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.	H5N1 Formulation 2 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=38 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=35 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	Total n=185 Participants Total of all reporting groups
Age, Continuous	21.9 Months STANDARD_DEVIATION 8.0 • n=5 Participants	22.6 Months STANDARD_DEVIATION 8.1 • n=7 Participants	21.6 Months STANDARD_DEVIATION 9.2 • n=5 Participants	20.8 Months STANDARD_DEVIATION 8.3 • n=4 Participants	20.3 Months STANDARD_DEVIATION 7.8 • n=21 Participants	21.4 Months STANDARD_DEVIATION 8.2 • n=8 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	14 Participants n=7 Participants	16 Participants n=5 Participants	23 Participants n=4 Participants	18 Participants n=21 Participants	88 Participants n=8 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	23 Participants n=7 Participants	22 Participants n=5 Participants	14 Participants n=4 Participants	17 Participants n=21 Participants	97 Participants n=8 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	21 Participants n=5 Participants	21 Participants n=7 Participants	22 Participants n=5 Participants	21 Participants n=4 Participants	19 Participants n=21 Participants	104 Participants n=8 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	16 Participants n=5 Participants	16 Participants n=7 Participants	16 Participants n=5 Participants	16 Participants n=4 Participants	16 Participants n=21 Participants	80 Participants n=8 Participants
Race/Ethnicity, Customized Unspecified	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants

PRIMARY outcome

Timeframe: At Day 42

Population: Analysis was performed on cohort for analysis of the immunogenicity-fever score which included all subjects who have received all study vaccine dose(s) at Day 42 for whom temperature measurements are available during the first 3 days after both vaccine doses 1 and 2.

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=33 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=31 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=35 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=36 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination	0.54 Immunogenicity Index Interval 0.0 to 1.0	0.57 Immunogenicity Index Interval 0.0 to 1.0	0.40 Immunogenicity Index Interval 0.0 to 1.0	0.34 Immunogenicity Index Interval 0.0 to 1.0	1 Immunogenicity Index Interval 0.0 to 1.0

PRIMARY outcome

Timeframe: At Day 42

The MN antibody titres were expressed in terms of immunogenicity indices for each group. Immunogenicity index (DGMT) = If the LL of the 95% CI for GMT group ratio is less than 0.25 then DGMT =0. If the LL of the 95% CI for GMT group ratio is greater than 1 then DGMT =1.

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=31 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=29 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=35 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=36 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination	0.56 Immunogenicity Index Interval 0.0 to 1.0	0.57 Immunogenicity Index Interval 0.0 to 1.0	0.32 Immunogenicity Index Interval 0.0 to 1.0	0.33 Immunogenicity Index Interval 0.0 to 1.0	1 Immunogenicity Index Interval 0.0 to 1.0

PRIMARY outcome

Timeframe: During the 3-day follow-up period (i.e. on the day of vaccination and 2 subsequent days) after Dose 1 and Dose 2.

Fever index was defined as the average temperature for each vaccine group. Fever index (DR) = The average temperature measurement for each vaccine group. Fever index from Days 0-2 after each dose Any temperature \< 38°C (100.4 F) was assigned a value of 0. Any temperature \> 40.5°C was assigned a value of 40.5. DR correspond to 243 minus the sum of recorded temperature values for 3 days after (dose 1 and dose 2)/243.

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=33 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=31 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=35 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=36 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers Following Primary Vaccination.	0.91 Degrees Celsius Interval 0.0 to 1.0	0.95 Degrees Celsius Interval 0.0 to 1.0	0.93 Degrees Celsius Interval 0.0 to 1.0	0.94 Degrees Celsius Interval 0.0 to 1.0	0.84 Degrees Celsius Interval 0.0 to 1.0

PRIMARY outcome

Timeframe: During the 3-day follow-up period (i.e. on the day of vaccination and 2 subsequent days) after Dose 1 and Dose 2.

Fever index was defined as the average temperature for each vaccine group. Fever index (DR)= The average temperature measurement for each vaccine group. Fever index from Days 0-2 after each dose Any temperature \< 38°C (100.4 F) was assigned a value of 0. Any temperature \> 40.5°C was assigned a value of 40.5. DR correspond to 243 minus the sum of recorded temperature values for 3 days after (dose 1 and dose 2)/243.

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=31 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=29 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=35 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=36 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers Following Primary Vaccination.	0.91 Degrees Celsius Interval 0.0 to 1.0	0.95 Degrees Celsius Interval 0.0 to 1.0	0.93 Degrees Celsius Interval 0.0 to 1.0	0.94 Degrees Celsius Interval 0.0 to 1.0	0.84 Degrees Celsius Interval 0.0 to 1.0

PRIMARY outcome

Timeframe: At Day 392 (relative to Day 385) post booster vaccination

Population: Analysis was performed on the Adapted According to Protocol (ATP) cohort for immunogenicity which included all vaccinated subjects who had results available for the relevant assay (HI and MN) for all blood samples collected during relevant analysis intervals for ATP-Day 42; ATP-Day 385 (persistence); ATP-Day 392 post booster dose (ATP-booster)

MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer (Day 392) to the pre-vaccination (Day 385) reciprocal HI titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=33 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=31 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=32 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=34 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. Flu A/Indonesia/5/2005 H5N1 HI	6.6 Fold change Interval 4.9 to 9.0	4.2 Fold change Interval 3.4 to 5.3	3.6 Fold change Interval 2.9 to 4.5	3.4 Fold change Interval 2.8 to 4.1	4.9 Fold change Interval 3.8 to 6.3
Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. Flu A/duck/Bangladesh/19097/2013 H5N1 HI	6.0 Fold change Interval 4.2 to 8.5	4.0 Fold change Interval 3.0 to 5.2	3.4 Fold change Interval 2.7 to 4.2	2.7 Fold change Interval 2.3 to 3.3	5.2 Fold change Interval 3.9 to 7.0
Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. Flu A/Vietnam/1194/2004 H5N1 HI	6.3 Fold change Interval 4.5 to 8.7	3.8 Fold change Interval 3.0 to 4.8	3.6 Fold change Interval 2.9 to 4.5	2.8 Fold change Interval 2.2 to 3.4	5.0 Fold change Interval 3.7 to 6.8
Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers Against Each of the Four Vaccine Influenza Strains. Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 HI	4.9 Fold change Interval 3.5 to 6.9	3.1 Fold change Interval 2.3 to 4.2	2.9 Fold change Interval 2.2 to 3.8	2.4 Fold change Interval 2.0 to 3.0	4.5 Fold change Interval 3.2 to 6.5

PRIMARY outcome

Timeframe: At Day 392 (relative to Day 385) post booster vaccination

MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 392) reciprocal MN titer to the pre-vaccination (Day 385) reciprocal MN titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=33 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=31 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=32 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=34 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains. Flu A/Indonesia/5/2005 H5N1 MN	4.8 Fold change Interval 3.4 to 6.6	3.2 Fold change Interval 2.3 to 4.3	2.8 Fold change Interval 2.0 to 3.8	2.5 Fold change Interval 2.0 to 3.0	4.3 Fold change Interval 3.3 to 5.7
Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains. Flu A/Vietnam/1194/2004 H5N1 MN	2.9 Fold change Interval 2.1 to 4.1	2.9 Fold change Interval 2.2 to 3.8	2.6 Fold change Interval 2.1 to 3.3	2.4 Fold change Interval 1.9 to 3.1	2.9 Fold change Interval 2.2 to 3.8
Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous MN Antibody Titers Against Each of the 3 Vaccine Influenza Strains. Flu A/duck/Bangladesh/19097/2013 H5N1 MN	3.0 Fold change Interval 2.3 to 4.1	2.6 Fold change Interval 2.0 to 3.2	2.1 Fold change Interval 1.6 to 2.8	2.8 Fold change Interval 2.2 to 3.5	2.6 Fold change Interval 1.9 to 3.5

SECONDARY outcome

Timeframe: At Days 42, 385 and 392

Seroconversion rate (SCR) was defined as the proportion of subjects who have either a pre-vaccination reciprocal HI titer less than (\<) 10 and a post-vaccination reciprocal titer 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 vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=33 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=31 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=35 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=36 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/Indonesia/5/2005 H5N1 HI, Day 42	33 Participants	37 Participants	31 Participants	35 Participants	36 Participants
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/Indonesia/5/2005 H5N1 HI, Day 385	26 Participants	28 Participants	28 Participants	21 Participants	33 Participants
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/Indonesia/5/2005 H5N1 HI, Day 392	33 Participants	37 Participants	31 Participants	32 Participants	34 Participants
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42	22 Participants	33 Participants	23 Participants	25 Participants	30 Participants
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385	6 Participants	7 Participants	5 Participants	6 Participants	7 Participants
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392	29 Participants	26 Participants	21 Participants	18 Participants	27 Participants
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/Vietnam/1194/2004 H5N1 HI, Day 42	22 Participants	29 Participants	21 Participants	24 Participants	30 Participants
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/Vietnam/1194/2004 H5N1 HI, Day 385	8 Participants	9 Participants	5 Participants	6 Participants	12 Participants
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/Vietnam/1194/2004 H5N1 HI, Day 392	29 Participants	28 Participants	22 Participants	20 Participants	29 Participants
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42	9 Participants	10 Participants	5 Participants	8 Participants	17 Participants
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392	15 Participants	16 Participants	9 Participants	6 Participants	18 Participants

SECONDARY outcome

Timeframe: At Days 0, 42, 385, 392

Seroprotection rate (SPR) was defined as the proportion of subjects with H5N1 reciprocal HI titers ≥ 40 against the tested vaccine virus The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=33 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=31 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=35 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=36 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/Indonesia/5/2005 H5N1 HI, Day 0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/Indonesia/5/2005 H5N1 HI, Day 42	33 Participants	37 Participants	31 Participants	35 Participants	36 Participants
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/Indonesia/5/2005 H5N1 HI, Day 385	26 Participants	28 Participants	28 Participants	23 Participants	33 Participants
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/Indonesia/5/2005 H5N1 HI, Day 392	33 Participants	37 Participants	31 Participants	32 Participants	34 Participants
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 0	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42	25 Participants	35 Participants	28 Participants	31 Participants	32 Participants
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385	8 Participants	8 Participants	7 Participants	6 Participants	9 Participants
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392	32 Participants	27 Participants	27 Participants	22 Participants	30 Participants
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/Vietnam/1194/2004 H5N1 HI, Day 0	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/Vietnam/1194/2004 H5N1 HI, Day 42	25 Participants	31 Participants	26 Participants	29 Participants	32 Participants
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/Vietnam/1194/2004 H5N1 HI, Day 385	10 Participants	10 Participants	7 Participants	8 Participants	15 Participants
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/Vietnam/1194/2004 H5N1 HI, Day 392	32 Participants	29 Participants	28 Participants	24 Participants	32 Participants
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42	10 Participants	11 Participants	7 Participants	9 Participants	19 Participants
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392	18 Participants	16 Participants	10 Participants	8 Participants	20 Participants

SECONDARY outcome

Timeframe: At Days 0, 42 and 385 (post the primary immunization), at Day 392 (7 days post booster dose)

GMTs were defined as the geometric mean antibody titres calculated on all subjects post the primary immunization (at Day 0, 42, 385) and 7 days post booster dose (at Day 392). The aggregate variables were calculated for each group. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=33 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=31 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=35 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=36 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/Indonesia/5/2005 H5N1 HI, Day 0	5.1 Titers Interval 4.9 to 5.3	5.1 Titers Interval 4.9 to 5.4	5.0 Titers Interval 5.0 to 5.0	5.6 Titers Interval 4.9 to 6.5	5.1 Titers Interval 4.9 to 5.3
Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/Indonesia/5/2005 H5N1 HI, Day 42	858.8 Titers Interval 659.2 to 1118.8	913.6 Titers Interval 672.6 to 1241.1	640.0 Titers Interval 488.3 to 839.0	568.4 Titers Interval 442.7 to 729.8	1118.6 Titers Interval 884.4 to 1414.9
Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/Indonesia/5/2005 H5N1 HI, Day 385	61.5 Titers Interval 47.1 to 80.3	72.1 Titers Interval 51.6 to 100.7	79.1 Titers Interval 59.2 to 105.6	59.6 Titers Interval 45.0 to 79.0	98.1 Titers Interval 76.7 to 125.4
Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/Indonesia/5/2005 H5N1 HI, Day 392	407.6 Titers Interval 315.0 to 527.4	305.4 Titers Interval 227.1 to 410.6	286.2 Titers Interval 216.0 to 379.1	201.0 Titers Interval 156.1 to 258.7	476.2 Titers Interval 348.4 to 650.9
Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 0	5.4 Titers Interval 4.8 to 5.9	5.3 Titers Interval 5.0 to 5.7	5.0 Titers Interval 5.0 to 5.0	6.1 Titers Interval 4.9 to 7.6	5.3 Titers Interval 5.0 to 5.7
Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42	135.3 Titers Interval 97.6 to 187.5	109.9 Titers Interval 81.2 to 148.7	91.5 Titers Interval 70.2 to 119.1	78.5 Titers Interval 58.5 to 105.3	167.1 Titers Interval 128.4 to 217.3
Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385	20.8 Titers Interval 16.3 to 26.6	17.8 Titers Interval 13.2 to 24.1	20.9 Titers Interval 16.1 to 26.9	19.5 Titers Interval 14.2 to 26.8	23.4 Titers Interval 18.8 to 29.2
Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392	126.1 Titers Interval 95.2 to 167.0	77.6 Titers Interval 54.5 to 110.4	70.7 Titers Interval 52.7 to 95.0	53.5 Titers Interval 38.6 to 74.2	125.6 Titers Interval 89.4 to 176.5
Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/Vietnam/1194/2004 H5N1 HI, Day 0	5.0 Titers Interval 5.0 to 5.0	5.1 Titers Interval 4.9 to 5.5	5.1 Titers Interval 4.9 to 5.4	5.8 Titers Interval 4.7 to 7.2	5.3 Titers Interval 5.0 to 5.7
Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/Vietnam/1194/2004 H5N1 HI, Day 42	104.7 Titers Interval 79.0 to 138.6	88.9 Titers Interval 63.2 to 125.0	77.2 Titers Interval 59.7 to 99.9	69.0 Titers Interval 51.7 to 92.0	128.9 Titers Interval 103.1 to 161.2
Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/Vietnam/1194/2004 H5N1 HI, Day 385	21.5 Titers Interval 16.8 to 27.5	18.4 Titers Interval 13.2 to 25.7	21.3 Titers Interval 16.3 to 27.9	20.6 Titers Interval 14.8 to 28.7	26.0 Titers Interval 20.0 to 33.8
Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/Vietnam/1194/2004 H5N1 HI, Day 392	137.5 Titers Interval 107.3 to 176.1	76.2 Titers Interval 53.9 to 107.7	76.5 Titers Interval 56.8 to 103.1	57.8 Titers Interval 41.5 to 80.4	133.9 Titers Interval 95.5 to 187.7
Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 0	5.0 Titers Interval 5.0 to 5.0	5.1 Titers Interval 4.9 to 5.3	5.2 Titers Interval 4.8 to 5.7	5.3 Titers Interval 4.9 to 5.8	5.3 Titers Interval 4.9 to 5.7
Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42	27.8 Titers Interval 21.1 to 36.7	22.8 Titers Interval 17.2 to 30.3	21.6 Titers Interval 16.7 to 27.8	19.9 Titers Interval 15.4 to 25.8	35.8 Titers Interval 27.9 to 46.0
Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385	8.0 Titers Interval 6.4 to 9.9	7.4 Titers Interval 6.0 to 9.0	7.7 Titers Interval 6.6 to 9.1	7.2 Titers Interval 5.8 to 8.8	9.2 Titers Interval 7.6 to 11.2
Geometric Mean Titers (GMTs) for Humoral Immune Response in Terms of HI Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392	37.0 Titers Interval 27.1 to 50.6	24.0 Titers Interval 17.1 to 33.6	22.6 Titers Interval 16.7 to 30.5	17.9 Titers Interval 13.4 to 23.9	42.6 Titers Interval 29.8 to 60.8

SECONDARY outcome

Timeframe: At Day 42 (relative to Day 0), at Day 385 (relative to Day 0) and at Day 392 (relative to Day 0)

MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 42) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam/1194/2004 H5N1 (heterologous), Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous) and Flu A/gyrfalcon/Washington/41088-6/2014 H5N8 (heterologous).

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=33 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=31 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=35 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=36 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains Flu A/Indonesia/5/2005 H5N1 HI, Day 42	168.2 Fold change Interval 127.4 to 222.0	177.7 Fold change Interval 131.5 to 240.1	128.0 Fold change Interval 97.7 to 167.8	101.0 Fold change Interval 74.8 to 136.4	219.5 Fold change Interval 172.6 to 279.0
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains Flu A/Indonesia/5/2005 H5N1 HI, Day 385	12.0 Fold change Interval 9.2 to 15.8	14.0 Fold change Interval 10.0 to 19.7	15.8 Fold change Interval 11.8 to 21.1	10.5 Fold change Interval 7.6 to 14.5	19.2 Fold change Interval 14.8 to 24.9
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains Flu A/Indonesia/5/2005 H5N1 HI, Day 392	79.8 Fold change Interval 61.5 to 103.5	59.4 Fold change Interval 44.5 to 79.4	57.2 Fold change Interval 43.2 to 75.8	35.3 Fold change Interval 25.9 to 48.1	93.3 Fold change Interval 67.9 to 128.3
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 42	22.9 Fold change Interval 17.2 to 30.6	20.4 Fold change Interval 14.9 to 28.1	18.9 Fold change Interval 14.0 to 25.5	12.6 Fold change Interval 9.0 to 17.6	31.3 Fold change Interval 23.5 to 41.6
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 385	3.6 Fold change Interval 2.9 to 4.6	3.3 Fold change Interval 2.4 to 4.5	3.9 Fold change Interval 2.9 to 5.3	3.3 Fold change Interval 2.3 to 4.7	4.2 Fold change Interval 3.3 to 5.3
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains Flu A/duck/Bangladesh/19097/2013 H5N1 HI, Day 392	22.9 Fold change Interval 17.1 to 30.7	14.5 Fold change Interval 10.1 to 20.7	13.9 Fold change Interval 9.8 to 19.8	9.1 Fold change Interval 6.0 to 13.7	23.4 Fold change Interval 16.2 to 33.9
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains Flu A/Vietnam/1194/2004 H5N1 HI, Day 42	20.1 Fold change Interval 15.2 to 26.7	16.7 Fold change Interval 11.7 to 23.8	15.1 Fold change Interval 11.1 to 20.6	11.4 Fold change Interval 8.4 to 15.6	24.3 Fold change Interval 19.0 to 31.0
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains Flu A/Vietnam/1194/2004 H5N1 HI, Day 385	4.1 Fold change Interval 3.1 to 5.3	3.5 Fold change Interval 2.5 to 5.0	3.9 Fold change Interval 2.8 to 5.4	3.6 Fold change Interval 2.6 to 5.2	4.7 Fold change Interval 3.5 to 6.2
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains Flu A/Vietnam/1194/2004 H5N1 HI, Day 392	27.1 Fold change Interval 20.9 to 35.0	14.5 Fold change Interval 10.2 to 20.5	14.5 Fold change Interval 10.0 to 21.1	10.1 Fold change Interval 6.7 to 15.2	25.1 Fold change Interval 17.3 to 36.4
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 42	5.5 Fold change Interval 4.0 to 7.4	4.3 Fold change Interval 3.2 to 5.8	4.1 Fold change Interval 3.0 to 5.6	3.5 Fold change Interval 2.7 to 4.6	6.7 Fold change Interval 5.0 to 9.0
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 385	1.5 Fold change Interval 1.2 to 1.8	1.4 Fold change Interval 1.2 to 1.8	1.5 Fold change Interval 1.2 to 1.8	1.3 Fold change Interval 1.1 to 1.6	1.7 Fold change Interval 1.4 to 2.1
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains Flu A/gyrfalcon/WA/41088-6/2014 H5N8 HI, Day 392	7.1 Fold change Interval 5.1 to 9.9	4.7 Fold change Interval 3.3 to 6.7	4.2 Fold change Interval 3.0 to 6.0	3.2 Fold change Interval 2.3 to 4.3	8.1 Fold change Interval 5.5 to 12.0

SECONDARY outcome

Timeframe: At Day 385 (relative to Day 0)

MGI was defined as the geometric mean of the within-subject ratios of the post-vaccination (Day 385) reciprocal MN titer to the pre-vaccination (Day 0) reciprocal MN titer for the vaccine virus. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=32 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=30 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=32 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=34 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains. Flu A/Indonesia/5/2005 H5N1 MN	14.8 Fold change Interval 12.6 to 17.5	15.3 Fold change Interval 12.5 to 18.6	17.8 Fold change Interval 14.3 to 22.1	14.2 Fold change Interval 11.8 to 17.1	17.5 Fold change Interval 13.7 to 22.4
Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains. Flu A/Vietnam/1194/2004 H5N1 MN	5.8 Fold change Interval 4.2 to 8.1	5.4 Fold change Interval 4.0 to 7.4	7.5 Fold change Interval 5.8 to 9.8	6.1 Fold change Interval 4.5 to 8.3	7.6 Fold change Interval 5.5 to 10.3
Mean Geometric Increase (MGI) for MN Antibodies Against the 3 Vaccine Influenza Strains. Flu A/duck/Bangladesh/19097/2013 H5N1 MN	5.5 Fold change Interval 4.1 to 7.3	5.3 Fold change Interval 3.8 to 7.3	6.9 Fold change Interval 5.0 to 9.4	4.2 Fold change Interval 3.1 to 5.8	7.0 Fold change Interval 5.2 to 9.4

SECONDARY outcome

Timeframe: At Days 0, 42, 385 and Day 392

MN antibody titers were expressed as Geometric Mean Titers (GMTs). The cut-off of the assay was the seropositivity cut-off of ≥ 1:28. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=33 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=31 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=35 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=36 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/Indonesia/5/2005 H5N1 MN, Day 0	14.0 Titers Interval 14.0 to 14.0	14.0 Titers Interval 14.0 to 14.0	14.0 Titers Interval 14.0 to 14.0	14.0 Titers Interval 14.0 to 14.0	14.3 Titers Interval 13.7 to 14.8
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/Indonesia/5/2005 H5N1 MN, Day 42	1214.3 Titers Interval 921.3 to 1600.6	1211.6 Titers Interval 881.3 to 1665.9	707.1 Titers Interval 533.1 to 937.9	727.4 Titers Interval 545.9 to 969.2	1498.5 Titers Interval 1181.7 to 1900.1
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/Indonesia/5/2005 H5N1 MN, Day 385	203.6 Titers Interval 172.8 to 239.8	213.8 Titers Interval 175.2 to 260.9	247.2 Titers Interval 201.4 to 303.5	198.5 Titers Interval 165.1 to 238.7	250.3 Titers Interval 197.1 to 318.0
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/Indonesia/5/2005 H5N1 MN, Day 392	969.1 Titers Interval 710.1 to 1322.6	674.2 Titers Interval 492.3 to 923.3	681.0 Titers Interval 496.3 to 934.4	489.6 Titers Interval 381.7 to 628.0	1085.0 Titers Interval 767.5 to 1533.9
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/Vietnam/1194/2004 H5N1 MN, Day 0	14.6 Titers Interval 13.7 to 15.5	14.8 Titers Interval 13.6 to 16.1	14.0 Titers Interval 14.0 to 14.0	15.2 Titers Interval 13.5 to 17.0	14.6 Titers Interval 13.8 to 15.4
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/Vietnam/1194/2004 H5N1 MN, Day 42	195.2 Titers Interval 156.7 to 243.1	177.3 Titers Interval 147.8 to 212.7	176.9 Titers Interval 139.0 to 225.2	149.3 Titers Interval 117.6 to 189.6	217.6 Titers Interval 187.7 to 252.2
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/Vietnam/1194/2004 H5N1 MN, Day 385	88.0 Titers Interval 64.0 to 121.0	80.7 Titers Interval 58.7 to 111.1	103.6 Titers Interval 80.5 to 133.2	89.0 Titers Interval 67.2 to 118.0	113.0 Titers Interval 85.3 to 149.9
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/Vietnam/1194/2004 H5N1 MN, Day 392	256.6 Titers Interval 212.5 to 309.9	239.2 Titers Interval 202.5 to 282.7	270.4 Titers Interval 237.2 to 308.3	216.5 Titers Interval 179.0 to 261.8	320.0 Titers Interval 259.8 to 394.1
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 0	14.3 Titers Interval 13.7 to 15.0	14.5 Titers Interval 13.5 to 15.7	14.6 Titers Interval 13.7 to 15.6	15.2 Titers Interval 13.8 to 16.7	14.6 Titers Interval 13.8 to 15.4
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 42	161.6 Titers Interval 129.4 to 201.9	147.1 Titers Interval 116.6 to 185.7	161.8 Titers Interval 129.1 to 202.8	140.6 Titers Interval 111.8 to 176.8	179.4 Titers Interval 146.5 to 219.7
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 385	79.2 Titers Interval 59.3 to 105.8	76.3 Titers Interval 55.7 to 104.7	100.7 Titers Interval 74.2 to 136.6	63.0 Titers Interval 47.0 to 84.4	102.0 Titers Interval 76.6 to 135.9
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of MN Antibodies Against Vaccine-homologous/Heterologous Antigens Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 392	240.9 Titers Interval 197.7 to 293.6	194.8 Titers Interval 157.7 to 240.7	202.2 Titers Interval 167.8 to 243.7	174.5 Titers Interval 140.5 to 216.8	262.5 Titers Interval 212.2 to 324.7

SECONDARY outcome

Timeframe: At Day 42, Day 385 (relative to Day 0), Day 392 (relative to Day 0) and D 392 (relative to Day 385)

VRR for MN was defined as the incidence rate of subjects with at least a 4-fold increase in post vaccination reciprocal titer relative to pre vaccination titers. The vaccine strains assessed were Flu A/Indonesia/5/2005 H5N1 (homologous), Flu A/Vietnam /1194/2004 H5N (heterologous) and Flu A/duck/Bangladesh/19097/2013 H5N1 (heterologous).

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=33 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=31 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=35 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=36 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. Flu A/Indonesia/5/2005 H5N1 MN, Day 42	31 Participants	37 Participants	29 Participants	35 Participants	36 Participants
Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. Flu A/Indonesia/5/2005 H5N1 MN, Day 385	32 Participants	37 Participants	29 Participants	32 Participants	34 Participants
Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. Flu A/Indonesia/5/2005 H5N1 MN, Day 392	32 Participants	37 Participants	29 Participants	32 Participants	34 Participants
Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. Flu A/Indonesia/5/2005 H5N1 MN, D 392	24 Participants	14 Participants	15 Participants	13 Participants	21 Participants
Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. Flu A/Vietnam/1194/2004 H5N1 MN, Day 42	31 Participants	36 Participants	29 Participants	32 Participants	34 Participants
Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. Flu A/Vietnam/1194/2004 H5N1 MN, Day 385	27 Participants	27 Participants	28 Participants	25 Participants	27 Participants
Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. Flu A/Vietnam/1194/2004 H5N1 MN, Day 392	31 Participants	37 Participants	30 Participants	30 Participants	31 Participants
Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. Flu A/Vietnam/1194/2004 H5N1 MN, D 392	10 Participants	10 Participants	7 Participants	6 Participants	10 Participants
Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 42	31 Participants	35 Participants	31 Participants	32 Participants	34 Participants
Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 385	27 Participants	29 Participants	25 Participants	23 Participants	28 Participants
Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. Flu A/duck/Bangladesh/19097/2013 H5N1 MN, Day 392	32 Participants	36 Participants	31 Participants	30 Participants	33 Participants
Vaccine Response Rate (VRR) for Homologous and Heterologous MN Antibodies Against Each of the 3 Vaccine Influenza Strains. Flu A/duck/Bangladesh/19097/2013 H5N1 MN, D 392	10 Participants	8 Participants	6 Participants	9 Participants	9 Participants

SECONDARY outcome

Timeframe: At Days 0, 42, 385 and 392

Population: Analysis was performed on the Total Vaccinated cohort (CMI sub-cohort) which included all vaccinated subjects for whom data were available. The CMI sub-cohort included approximately 20 vaccinated subjects per group.

Antigen-specific CD4+/CD8+ T Cells identified as CD4/CD8+ were analysed for T cells expressing two or more of the following immune markers: CD40 Ligand, Interleukin (IL)-2, Tumor Necrosis Factor alpha (TNF-a), Interferon-gamma (IFN-g). The frequency was presented as number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells repsectively. All doubles = T cell expressing at least 2 cytokines.

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=19 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=19 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=18 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=19 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=20 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD4 dble_All (Polypositives), Day 0	42.0 cells/million T cells Interval 3.0 to 185.0	43.0 cells/million T cells Interval 1.0 to 90.0	89.5 cells/million T cells Interval 26.0 to 217.0	74.0 cells/million T cells Interval 1.0 to 277.0	55.5 cells/million T cells Interval 1.0 to 227.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD4 dble_All (Polypositives), Day 42	1629.0 cells/million T cells Interval 707.0 to 4301.0	960.0 cells/million T cells Interval 432.0 to 1379.0	1337.5 cells/million T cells Interval 748.0 to 2793.0	1372.5 cells/million T cells Interval 426.5 to 2911.5	2711.0 cells/million T cells Interval 1669.0 to 5165.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD4 dble_All (Polypositives), Day 385	1255.0 cells/million T cells Interval 560.0 to 2096.0	1413.0 cells/million T cells Interval 469.0 to 1834.0	954.0 cells/million T cells Interval 495.0 to 1199.0	596.0 cells/million T cells Interval 373.0 to 1167.0	1530.0 cells/million T cells Interval 632.5 to 2293.5
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD4 dble_All (Polypositives), Day 392	1129.0 cells/million T cells Interval 582.0 to 3221.0	731.0 cells/million T cells Interval 448.0 to 1461.0	722.5 cells/million T cells Interval 260.0 to 907.0	832.0 cells/million T cells Interval 345.0 to 1497.0	1417.0 cells/million T cells Interval 759.5 to 3955.5
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD4 dble_CD40L, Day 0	19.0 cells/million T cells Interval 1.0 to 52.0	5.0 cells/million T cells Interval 1.0 to 60.0	36.0 cells/million T cells Interval 1.0 to 85.0	26.0 cells/million T cells Interval 1.0 to 133.0	23.0 cells/million T cells Interval 1.0 to 56.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD4 dble_CD40L, Day 42	1341.0 cells/million T cells Interval 378.0 to 2696.0	514.0 cells/million T cells Interval 229.0 to 1200.0	516.0 cells/million T cells Interval 307.5 to 2031.0	717.0 cells/million T cells Interval 295.5 to 1604.5	1671.0 cells/million T cells Interval 635.0 to 3256.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD4 dble_CD40L, Day 385	844.0 cells/million T cells Interval 425.0 to 1660.0	722.0 cells/million T cells Interval 323.0 to 1524.0	315.0 cells/million T cells Interval 148.0 to 511.0	588.0 cells/million T cells Interval 154.0 to 902.0	1074.0 cells/million T cells Interval 562.5 to 2637.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD4 dble_CD40L, Day 392	986.0 cells/million T cells Interval 340.0 to 1802.0	660.0 cells/million T cells Interval 213.0 to 1706.0	424.0 cells/million T cells Interval 239.0 to 645.0	325.0 cells/million T cells Interval 110.0 to 939.0	1130.5 cells/million T cells Interval 801.0 to 3108.5
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD4 dble_IFNγ, Day 0	49.0 cells/million T cells Interval 1.0 to 352.0	24.0 cells/million T cells Interval 1.0 to 118.0	40.5 cells/million T cells Interval 1.0 to 681.0	12.0 cells/million T cells Interval 1.0 to 259.0	47.0 cells/million T cells Interval 4.0 to 391.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD4 dble_IFNγ, Day 42	406.0 cells/million T cells Interval 304.0 to 1481.0	266.0 cells/million T cells Interval 206.0 to 394.0	863.5 cells/million T cells Interval 352.5 to 1229.5	437.5 cells/million T cells Interval 158.5 to 1027.0	803.0 cells/million T cells Interval 260.0 to 1627.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD4 dble_IFNγ, Day 385	316.5 cells/million T cells Interval 70.0 to 569.0	248.5 cells/million T cells Interval 56.0 to 557.0	589.5 cells/million T cells Interval 216.0 to 830.0	163.0 cells/million T cells Interval 62.0 to 355.0	200.0 cells/million T cells Interval 80.0 to 510.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD4 dble_IFNγ, Day 392	329.0 cells/million T cells Interval 109.0 to 784.0	123.0 cells/million T cells Interval 74.0 to 465.0	423.5 cells/million T cells Interval 147.0 to 919.0	253.0 cells/million T cells Interval 112.0 to 608.0	459.5 cells/million T cells Interval 127.0 to 941.5
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD4 dble_IL2, Day 0	72.0 cells/million T cells Interval 27.0 to 183.0	50.0 cells/million T cells Interval 1.0 to 76.0	47.0 cells/million T cells Interval 3.0 to 133.0	75.0 cells/million T cells Interval 1.0 to 223.0	89.5 cells/million T cells Interval 1.0 to 136.5
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD4 dble_IL2, Day 42	2438.0 cells/million T cells Interval 759.0 to 6212.0	1344.0 cells/million T cells Interval 508.0 to 1859.0	1448.0 cells/million T cells Interval 1012.5 to 2993.5	1761.5 cells/million T cells Interval 577.5 to 3085.5	3399.5 cells/million T cells Interval 1593.0 to 5907.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD4 dble_IL2, Day 385	1394.0 cells/million T cells Interval 531.0 to 2151.0	1366.5 cells/million T cells Interval 460.0 to 1938.0	870.5 cells/million T cells Interval 458.0 to 1223.0	621.0 cells/million T cells Interval 410.0 to 1556.0	1676.5 cells/million T cells Interval 779.5 to 2551.5
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD4 dble_IL2, Day 392	1455.0 cells/million T cells Interval 672.0 to 3065.0	893.0 cells/million T cells Interval 627.0 to 1494.0	840.0 cells/million T cells Interval 192.0 to 1067.0	882.0 cells/million T cells Interval 338.0 to 1181.0	1502.5 cells/million T cells Interval 864.5 to 3500.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD4 dble_TNFα, Day 0	98.0 cells/million T cells Interval 1.0 to 249.0	62.0 cells/million T cells Interval 1.0 to 192.0	52.0 cells/million T cells Interval 23.0 to 249.0	71.0 cells/million T cells Interval 29.0 to 296.0	49.5 cells/million T cells Interval 1.0 to 322.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD4 dble_TNFα, Day 42	1970.0 cells/million T cells Interval 569.0 to 4382.0	840.0 cells/million T cells Interval 705.0 to 1446.0	1353.0 cells/million T cells Interval 723.0 to 2501.0	1204.5 cells/million T cells Interval 582.5 to 2853.0	3023.0 cells/million T cells Interval 917.0 to 4946.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD4 dble_TNFα, Day 385	1233.0 cells/million T cells Interval 696.0 to 2030.0	1277.5 cells/million T cells Interval 419.0 to 1921.0	1097.5 cells/million T cells Interval 547.0 to 1517.0	678.0 cells/million T cells Interval 463.0 to 1251.0	1339.0 cells/million T cells Interval 765.0 to 2419.5
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD4 dble_TNFα, Day 392	1257.0 cells/million T cells Interval 504.0 to 2468.0	740.0 cells/million T cells Interval 394.0 to 1266.0	726.5 cells/million T cells Interval 433.0 to 1315.0	908.0 cells/million T cells Interval 620.0 to 1579.0	1743.5 cells/million T cells Interval 741.5 to 3863.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD8 dble_All (Polypositives), Day 0	5.0 cells/million T cells Interval 1.0 to 45.0	30.0 cells/million T cells Interval 1.0 to 40.0	47.0 cells/million T cells Interval 1.0 to 121.0	1.0 cells/million T cells Interval 1.0 to 58.0	3.5 cells/million T cells Interval 1.0 to 68.5
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD8 dble_All (Polypositives), Day 42	63.0 cells/million T cells Interval 42.0 to 238.0	45.0 cells/million T cells Interval 1.0 to 83.0	125.0 cells/million T cells Interval 54.5 to 220.5	128.0 cells/million T cells Interval 10.0 to 323.0	48.0 cells/million T cells Interval 2.0 to 186.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD8 dble_All (Polypositives), Day 385	62.5 cells/million T cells Interval 1.0 to 147.0	1.0 cells/million T cells Interval 1.0 to 107.0	56.0 cells/million T cells Interval 1.0 to 194.0	1.0 cells/million T cells Interval 1.0 to 79.0	33.5 cells/million T cells Interval 1.0 to 108.5
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD8 dble_All (Polypositives), Day 392	33.0 cells/million T cells Interval 1.0 to 88.0	25.0 cells/million T cells Interval 1.0 to 70.0	60.5 cells/million T cells Interval 1.0 to 126.0	26.0 cells/million T cells Interval 1.0 to 99.0	63.0 cells/million T cells Interval 1.0 to 200.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD8 dble_CD40L, Day 385	70.5 cells/million T cells Interval 11.0 to 132.0	53.0 cells/million T cells Interval 1.0 to 93.0	4.0 cells/million T cells Interval 1.0 to 116.0	1.0 cells/million T cells Interval 1.0 to 31.0	88.0 cells/million T cells Interval 1.0 to 197.5
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD8 dble_CD40L, Day 0	1.0 cells/million T cells Interval 1.0 to 21.0	1.0 cells/million T cells Interval 1.0 to 37.0	46.0 cells/million T cells Interval 1.0 to 75.0	1.0 cells/million T cells Interval 1.0 to 57.0	1.0 cells/million T cells Interval 1.0 to 72.5
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD8 dble_CD40L, Day 42	25.0 cells/million T cells Interval 1.0 to 100.0	1.0 cells/million T cells Interval 1.0 to 68.0	7.5 cells/million T cells Interval 1.0 to 60.0	83.0 cells/million T cells Interval 1.0 to 186.0	108.0 cells/million T cells Interval 7.0 to 147.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD8 dble_CD40L, Day 392	18.0 cells/million T cells Interval 1.0 to 95.0	14.0 cells/million T cells Interval 1.0 to 140.0	80.0 cells/million T cells Interval 1.0 to 135.0	10.0 cells/million T cells Interval 1.0 to 55.0	40.0 cells/million T cells Interval 1.0 to 244.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD8 dble_IFNγ, Day 0	33.0 cells/million T cells Interval 1.0 to 64.0	22.0 cells/million T cells Interval 1.0 to 53.0	78.0 cells/million T cells Interval 28.0 to 166.0	1.0 cells/million T cells Interval 1.0 to 138.0	41.5 cells/million T cells Interval 1.0 to 148.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD8 dble_IFNγ, Day 42	77.0 cells/million T cells Interval 1.0 to 321.0	67.0 cells/million T cells Interval 1.0 to 116.0	191.5 cells/million T cells Interval 60.5 to 329.0	131.0 cells/million T cells Interval 1.0 to 243.0	32.0 cells/million T cells Interval 1.0 to 129.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD8 dble_IFNγ, Day 385	103.0 cells/million T cells Interval 1.0 to 322.0	31.0 cells/million T cells Interval 1.0 to 170.0	165.5 cells/million T cells Interval 64.0 to 445.0	1.0 cells/million T cells Interval 1.0 to 251.0	99.5 cells/million T cells Interval 2.5 to 348.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD8 dble_IFNγ, Day 392	174.0 cells/million T cells Interval 56.0 to 484.0	31.0 cells/million T cells Interval 1.0 to 206.0	119.0 cells/million T cells Interval 16.0 to 431.0	28.0 cells/million T cells Interval 1.0 to 366.0	52.0 cells/million T cells Interval 2.0 to 364.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD8 dble_IL2, Day 0	22.0 cells/million T cells Interval 1.0 to 104.0	1.0 cells/million T cells Interval 1.0 to 49.0	1.0 cells/million T cells Interval 1.0 to 90.0	1.0 cells/million T cells Interval 1.0 to 94.0	1.0 cells/million T cells Interval 1.0 to 66.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD8 dble_IL2, Day 42	48.0 cells/million T cells Interval 1.0 to 197.0	53.0 cells/million T cells Interval 1.0 to 166.0	65.5 cells/million T cells Interval 1.0 to 263.0	1.0 cells/million T cells Interval 1.0 to 186.0	1.0 cells/million T cells Interval 1.0 to 168.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD8 dble_IL2, Day 385	32.5 cells/million T cells Interval 1.0 to 218.0	16.0 cells/million T cells Interval 1.0 to 111.0	14.0 cells/million T cells Interval 1.0 to 117.0	1.0 cells/million T cells Interval 1.0 to 94.0	1.0 cells/million T cells Interval 1.0 to 125.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD8 dble_IL2, Day 392	99.0 cells/million T cells Interval 22.0 to 292.0	1.0 cells/million T cells Interval 1.0 to 70.0	64.0 cells/million T cells Interval 1.0 to 156.0	45.0 cells/million T cells Interval 1.0 to 77.0	63.0 cells/million T cells Interval 1.0 to 451.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD8 dble_TNFα, Day 0	103.0 cells/million T cells Interval 1.0 to 516.0	34.0 cells/million T cells Interval 1.0 to 324.0	163.5 cells/million T cells Interval 48.0 to 614.0	116.0 cells/million T cells Interval 1.0 to 521.0	120.5 cells/million T cells Interval 1.0 to 553.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD8 dble_TNFα, Day 42	396.0 cells/million T cells Interval 77.0 to 709.0	125.0 cells/million T cells Interval 24.0 to 294.0	351.5 cells/million T cells Interval 153.5 to 970.5	756.0 cells/million T cells Interval 65.0 to 1557.0	192.0 cells/million T cells Interval 52.0 to 485.0
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD8 dble_TNFα, Day 385	366.5 cells/million T cells Interval 1.0 to 559.0	81.0 cells/million T cells Interval 1.0 to 204.0	301.5 cells/million T cells Interval 29.0 to 641.0	212.0 cells/million T cells Interval 85.0 to 411.0	77.5 cells/million T cells Interval 15.0 to 477.5
Cell Mediated Immunity (CMI) in Terms of T-cell Markers Related to Flu A/Indonesia/05/2005 Antigen. CD8 dble_TNFα, Day 392	130.0 cells/million T cells Interval 1.0 to 708.0	121.0 cells/million T cells Interval 26.0 to 238.0	310.0 cells/million T cells Interval 68.0 to 953.0	207.0 cells/million T cells Interval 47.0 to 369.0	217.0 cells/million T cells Interval 36.0 to 699.0

SECONDARY outcome

Timeframe: During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose

Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.

Solicited local AEs assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb is moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=38 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=35 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=38 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Number of Subjects Reporting Solicited Local Symptoms Pain, Any	15 Participants	16 Participants	20 Participants	17 Participants	20 Participants
Number of Subjects Reporting Solicited Local Symptoms Pain, Grade 3	1 Participants	1 Participants	1 Participants	2 Participants	2 Participants
Number of Subjects Reporting Solicited Local Symptoms Redness (mm), Any	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Solicited Local Symptoms Redness (mm), Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Solicited Local Symptoms Swelling (mm), Any	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects Reporting Solicited Local Symptoms Swelling (mm), Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose

Population: Analysis was performed on the Total Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.cohort which included all vaccinated subjects for whom data were available.

Duration was defined as number of days with any grade of local symptoms.

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=38 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=35 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=38 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Duration of Solicited Local Symptoms Pain, Dose 2	2.0 Days Interval 1.0 to 2.0	1.5 Days Interval 1.0 to 2.0	1.5 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.5	2.0 Days Interval 1.0 to 3.0
Duration of Solicited Local Symptoms Pain, Dose 1	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	3.0 Days Interval 1.0 to 4.0
Duration of Solicited Local Symptoms Pain, Dose 3	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.0	1.5 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0
Duration of Solicited Local Symptoms Swelling, Dose 1	—	—	3.0 Days Interval 3.0 to 3.0	—	—

SECONDARY outcome

Timeframe: During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose

Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.

Assessed solicited general symptoms were fever (defined as temperature ≥ 38.0 degrees Celsius (°C) assessed by any route (oral, axillary, rectal)\], irritability/fussiness, drowsiness and. loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 irritability/Fussiness and Drowsiness = Prevented normal activity, Grade3 Loss of appetite = Did not eat at all. Grade 3 fever = fever \> 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=38 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=35 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=38 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Number of Subjects Reporting Solicited General Symptoms. Drowsiness, Any	18 Participants	13 Participants	17 Participants	16 Participants	25 Participants
Number of Subjects Reporting Solicited General Symptoms. Drowsiness, Grade 3	3 Participants	1 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects Reporting Solicited General Symptoms. Drowsiness, Related	14 Participants	12 Participants	13 Participants	14 Participants	22 Participants
Number of Subjects Reporting Solicited General Symptoms. Irritability / Fussiness, Any	17 Participants	19 Participants	22 Participants	21 Participants	24 Participants
Number of Subjects Reporting Solicited General Symptoms. Irritability / Fussiness, Grade 3	2 Participants	3 Participants	2 Participants	0 Participants	3 Participants
Number of Subjects Reporting Solicited General Symptoms. Irritability / Fussiness, Related	14 Participants	17 Participants	16 Participants	19 Participants	22 Participants
Number of Subjects Reporting Solicited General Symptoms. Loss Of Appetite, Any	13 Participants	14 Participants	20 Participants	13 Participants	24 Participants
Number of Subjects Reporting Solicited General Symptoms. Loss Of Appetite, Grade 3	1 Participants	2 Participants	2 Participants	0 Participants	0 Participants
Number of Subjects Reporting Solicited General Symptoms. Loss Of Appetite, Related	7 Participants	11 Participants	15 Participants	10 Participants	21 Participants
Number of Subjects Reporting Solicited General Symptoms. Temperature/(Axillary) (°C), Any	17 Participants	14 Participants	14 Participants	10 Participants	24 Participants
Number of Subjects Reporting Solicited General Symptoms. Temperature/(Axillary) (°C), Grade 3	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Solicited General Symptoms. Temperature/(Axillary) (°C), Related	12 Participants	12 Participants	14 Participants	10 Participants	22 Participants

SECONDARY outcome

Timeframe: During the 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after any vaccine dose

Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.

Duration was defined as number of days with any grade of general symptoms.

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=38 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=35 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=38 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Duration of Solicited General Symptoms. Drowsiness, Dose 1	1.5 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.0
Duration of Solicited General Symptoms. Drowsiness, Dose 2	2.0 Days Interval 1.0 to 2.5	2.0 Days Interval 2.0 to 3.5	2.0 Days Interval 1.0 to 2.0	1.5 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0
Duration of Solicited General Symptoms. Drowsiness, Dose 3	2.0 Days Interval 2.0 to 2.0	2.0 Days Interval 2.0 to 2.0	2.5 Days Interval 1.0 to 4.0	1.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 2.0
Duration of Solicited General Symptoms. Irritability / fussiness, Dose 1	2.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 4.0	2.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 3.0
Duration of Solicited General Symptoms. Irritability / fussiness, Dose 2	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 4.0	2.0 Days Interval 1.0 to 4.0	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0
Duration of Solicited General Symptoms. Irritability / fussiness, Dose 3	3.0 Days Interval 2.0 to 3.0	1.0 Days Interval 1.0 to 2.0	4.0 Days Interval 3.0 to 5.0	1.5 Days Interval 1.0 to 3.0	2.0 Days Interval 2.0 to 3.0
Duration of Solicited General Symptoms. Loss of appetite, Dose 1	3.0 Days Interval 3.0 to 3.0	2.0 Days Interval 1.0 to 3.0	2.5 Days Interval 2.0 to 5.0	1.5 Days Interval 1.0 to 2.5	2.0 Days Interval 1.0 to 2.5
Duration of Solicited General Symptoms. Loss of appetite, Dose 2	2.0 Days Interval 1.0 to 2.0	3.0 Days Interval 2.0 to 4.0	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 6.0
Duration of Solicited General Symptoms. Loss of appetite, Dose 3	2.5 Days Interval 1.5 to 4.5	2.0 Days Interval 1.5 to 3.0	3.0 Days Interval 2.0 to 4.0	2.0 Days Interval 1.0 to 3.0	2.0 Days Interval 1.0 to 3.5
Duration of Solicited General Symptoms. Temperature, Dose 1	2.0 Days Interval 1.0 to 2.0	1.0 Days Interval 1.0 to 2.0	2.0 Days Interval 1.0 to 4.0	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.0
Duration of Solicited General Symptoms. Temperature, Dose 2	1.0 Days Interval 1.0 to 1.5	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 1.5	1.0 Days Interval 1.0 to 1.0	1.0 Days Interval 1.0 to 3.0
Duration of Solicited General Symptoms. Temperature, Dose 3	2.0 Days Interval 1.0 to 3.0	1.0 Days Interval 1.0 to 1.0	3.0 Days Interval 2.0 to 4.0	—	1.0 Days Interval 1.0 to 1.5

SECONDARY outcome

Timeframe: During the 21-day follow-up period (Day 0-Day 20) after each vaccine dose

Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.

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

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=38 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=35 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=38 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination. Any	20 Participants	23 Participants	20 Participants	21 Participants	21 Participants
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination. Grade 3	1 Participants	1 Participants	3 Participants	5 Participants	3 Participants
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Primary Vaccination. Related	0 Participants	1 Participants	1 Participants	3 Participants	2 Participants

SECONDARY outcome

Timeframe: During the 30-day (Day 385-Day 415) follow-up period after vaccination

Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=34 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=38 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=35 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=33 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=36 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination Any	8 Participants	16 Participants	19 Participants	14 Participants	16 Participants
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination Grade 3	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) Post Booster Vaccination Related	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: During the entire study period (Day 0 to Day 415 approximately)

Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.

MAEs are adverse events with medically-attended visits that were not routine visits for physical examination or vaccination. Any MAE was defined as at least 1 MAE experienced.

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=38 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=35 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=38 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Number of Subjects Reporting Medically Attended Events (MAEs) Any	28 Participants	33 Participants	27 Participants	26 Participants	29 Participants
Number of Subjects Reporting Medically Attended Events (MAEs) Related	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: During the entire study period (Day 0 to Day 415 approximately)

Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.

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. "Any pIMD" = at least one pIMD experienced by the study subject. Related = pIMD assessed by the investigator to be causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=38 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=35 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=38 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Number of Subjects Reporting Potential Immune Mediated Diseases (pIMDs) Any	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Potential Immune Mediated Diseases (pIMDs) Related	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the entire study period (Day 0 to Day 415 approximately)

Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.

A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=38 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=35 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=38 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Number of Subjects Reporting Serious Adverse Events (SAEs) Any	6 Participants	10 Participants	4 Participants	4 Participants	5 Participants
Number of Subjects Reporting Serious Adverse Events (SAEs) Related	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the entire study period (Day 0 to Day 415 approximately)

Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects for whom data were available.

AESI are a subset of adverse events defined in the Committee for Medicinal Products for Human Use (CHMP) Risk Management Plan for Pandemic Vaccines for safety monitoring.

Outcome measures

Outcome measures
Measure	H5N1 Formulation 2 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=38 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=37 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=35 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 1 Group n=38 Participants Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.
Number of Subjects Reporting Adverse Events of Special Interest (AESI) Any	3 Participants	3 Participants	2 Participants	2 Participants	4 Participants
Number of Subjects Reporting Adverse Events of Special Interest (AESI) Related	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants

Adverse Events

H5N1 Formulation 1 Group

Serious events: 5 serious events

Other events: 36 other events

Deaths: 0 deaths

H5N1 Formulation 2 Group

Serious events: 6 serious events

Other events: 31 other events

Deaths: 0 deaths

H5N1 Formulation 3 Group

Serious events: 10 serious events

Other events: 35 other events

Deaths: 0 deaths

H5N1 Formulation 4 Group

Serious events: 4 serious events

Other events: 35 other events

Deaths: 0 deaths

H5N1 Formulation 5 Group

Serious events: 4 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	H5N1 Formulation 1 Group n=38 participants at risk Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.	H5N1 Formulation 2 Group n=37 participants at risk Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=38 participants at risk Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=37 participants at risk Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=35 participants at risk Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Gastrointestinal disorders Abdominal hernia	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Gastrointestinal disorders Vomiting	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Bacteraemia	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Bacterial infection	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Bronchiolitis	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Bronchitis	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Conjunctivitis	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Croup infectious	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Diarrhoea infectious	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Gastroenteritis	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	7.9% 3/38 • Number of events 3 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Herpangina	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Influenza	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Nasopharyngitis	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Oral herpes	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Pneumonia	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	5.4% 2/37 • Number of events 2 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	7.9% 3/38 • Number of events 3 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Pneumonia viral	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Respiratory syncytial virus bronchiolitis	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Respiratory syncytial virus bronchitis	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Respiratory syncytial virus infection	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	5.3% 2/38 • Number of events 2 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Scarlet fever	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	5.3% 2/38 • Number of events 2 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Sinusitis	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Tonsillitis	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Upper respiratory tract infection	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Varicella	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Viral infection	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Viral rash	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Nervous system disorders Febrile convulsion	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 3 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Reproductive system and breast disorders Balanoposthitis	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Vascular disorders Kawasaki's disease	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.

Other adverse events

Other adverse events
Measure	H5N1 Formulation 1 Group n=38 participants at risk Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 1 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered intramuscularly (IM) in anterolateral thigh.	H5N1 Formulation 2 Group n=37 participants at risk Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 2 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 3 Group n=38 participants at risk Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 3 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 4 Group n=37 participants at risk Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 4 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.	H5N1 Formulation 5 Group n=35 participants at risk Subjects received 2 primary doses (adjuvanted) at Days 0 and 21 of H5N1 vaccine Formulation 5 and a booster dose (unadjuvanted) at Day 385 of H5N1 vaccine (GSK1557484A). All doses were administered IM in anterolateral thigh.
Skin and subcutaneous tissue disorders Eczema	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Gastrointestinal disorders Abdominal pain	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Acute sinusitis	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	5.3% 2/38 • Number of events 2 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Blood and lymphatic system disorders Anaemia	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Injury, poisoning and procedural complications Arthropod bite	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Skin and subcutaneous tissue disorders Blister	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Investigations Body height below normal	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Investigations Body temperature increased	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	5.3% 2/38 • Number of events 2 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Respiratory, thoracic and mediastinal disorders Bronchial hyperreactivity	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Bronchiolitis	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	5.4% 2/37 • Number of events 2 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Bronchitis	5.3% 2/38 • Number of events 2 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	5.4% 2/37 • Number of events 2 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Bronchitis viral	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Candida infection	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Investigations Cardiac murmur	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Cellulitis	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Conjunctivitis	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	5.4% 2/37 • Number of events 3 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	5.3% 2/38 • Number of events 2 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Gastrointestinal disorders Constipation	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	5.7% 2/35 • Number of events 2 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Injury, poisoning and procedural complications Contusion	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	5.4% 2/37 • Number of events 2 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	5.3% 2/38 • Number of events 2 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	8.1% 3/37 • Number of events 3 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 2 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Metabolism and nutrition disorders Decreased appetite	65.8% 25/38 • Number of events 39 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	35.1% 13/37 • Number of events 16 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	36.8% 14/38 • Number of events 20 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	54.1% 20/37 • Number of events 30 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	37.1% 13/35 • Number of events 19 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Skin and subcutaneous tissue disorders Dermatitis diaper	5.3% 2/38 • Number of events 2 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Product Issues Device breakage	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Gastrointestinal disorders Diarrhoea	5.3% 2/38 • Number of events 2 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	5.4% 2/37 • Number of events 2 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	5.4% 2/37 • Number of events 2 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	8.6% 3/35 • Number of events 3 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Enterovirus infection	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Eye disorders Erythema of eyelid	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Eye disorders Eyelid oedema	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Nervous system disorders Febrile convulsion	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
General disorders Feeling hot	5.3% 2/38 • Number of events 4 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	7.9% 3/38 • Number of events 3 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Gastrointestinal disorders Flatulence	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Gastrointestinal disorders Food poisoning	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Injury, poisoning and procedural complications Foreign body in eye	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Gastrointestinal disorders Gastritis	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Gastroenteritis	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	5.4% 2/37 • Number of events 3 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Gastroenteritis viral	5.3% 2/38 • Number of events 2 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Injury, poisoning and procedural complications Head injury	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Nervous system disorders Headache	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Hordeolum	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Impetigo	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Influenza	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
General disorders Influenza like illness	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
General disorders Injection site erythema	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
General disorders Injection site urticaria	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Psychiatric disorders Irritability	63.2% 24/38 • Number of events 39 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	45.9% 17/37 • Number of events 26 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	50.0% 19/38 • Number of events 31 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	59.5% 22/37 • Number of events 35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	60.0% 21/35 • Number of events 38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Injury, poisoning and procedural complications Limb injury	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Gastrointestinal disorders Mouth ulceration	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Nasopharyngitis	26.3% 10/38 • Number of events 13 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	21.6% 8/37 • Number of events 10 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	26.3% 10/38 • Number of events 15 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	13.5% 5/37 • Number of events 6 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	25.7% 9/35 • Number of events 10 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Oral herpes	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Otitis media	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Otitis media acute	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
General disorders Pain	52.6% 20/38 • Number of events 39 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	40.5% 15/37 • Number of events 32 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	42.1% 16/38 • Number of events 31 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	54.1% 20/37 • Number of events 31 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	48.6% 17/35 • Number of events 36 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Paronychia	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Eye disorders Periorbital oedema	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Pharyngitis	7.9% 3/38 • Number of events 6 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	13.2% 5/38 • Number of events 5 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	8.6% 3/35 • Number of events 3 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Pharyngotonsillitis	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Pneumonia	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
General disorders Pyrexia	63.2% 24/38 • Number of events 36 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	45.9% 17/37 • Number of events 21 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	39.5% 15/38 • Number of events 16 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	43.2% 16/37 • Number of events 20 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	34.3% 12/35 • Number of events 15 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Skin and subcutaneous tissue disorders Rash	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Skin and subcutaneous tissue disorders Rash papular	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Respiratory, thoracic and mediastinal disorders Respiration abnormal	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Respiratory syncytial virus bronchitis	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	5.4% 2/37 • Number of events 3 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	13.2% 5/38 • Number of events 7 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 3 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	5.7% 2/35 • Number of events 2 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Roseola	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Sinusitis	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 2 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Nervous system disorders Somnolence	65.8% 25/38 • Number of events 42 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	48.6% 18/37 • Number of events 29 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	34.2% 13/38 • Number of events 20 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	45.9% 17/37 • Number of events 29 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	45.7% 16/35 • Number of events 24 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Nervous system disorders Speech disorder developmental	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
General disorders Swelling	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Tonsillitis	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Upper respiratory tract infection	18.4% 7/38 • Number of events 7 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	21.6% 8/37 • Number of events 10 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	15.8% 6/38 • Number of events 6 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	35.1% 13/37 • Number of events 16 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	22.9% 8/35 • Number of events 9 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Skin and subcutaneous tissue disorders Urticaria	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Viral diarrhoea	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Viral infection	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.9% 1/35 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Viral rash	7.9% 3/38 • Number of events 3 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/38 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.7% 1/37 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/35 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.
Gastrointestinal disorders Vomiting	7.9% 3/38 • Number of events 3 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	0.00% 0/37 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	2.6% 1/38 • Number of events 1 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	5.4% 2/37 • Number of events 2 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.	8.6% 3/35 • Number of events 3 • Solicited local and general AEs: during 7-day follow-up period after any vaccine dose. Unsolicited AEs: Days 0-20 after each primary dose and Days 385-415 post booster dose . MAEs, pIMDs, SAEs, AESI: during the entire study period (Days 0-415 approximately). The analysis was performed solely on vaccinated subjects with symptom sheet completed for the reported specific symptom.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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