Trial Outcomes & Findings for Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers. (NCT NCT02534935)

Last Updated: 2021-09-27

Results Overview

Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 percent (%) confidence interval (CIs). LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

396 participants

Primary outcome timeframe

1 month after Vaccination 3

Results posted on

2021-09-27

Participant Flow

In Stage 1, participants received 60 or 120 microgram (mcg) of bivalent rLP2086 vaccine or HAV/saline at Month 1, 2 and 6, and then followed up for 24 months. In Stage 2, participants who received bivalent rLP2086 during Stage 1 had a follow up visit at Month 24. Further participants who received 120 mcg bivalent rLP2086 during Stage 1 were eligible for receiving booster vaccination 6 months after Month 24 visit.

Participant milestones

Participant milestones
Measure	Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) Participants from greater than or equal to (\>=) 12 months to less than (\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.	Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) Participants from \>=12 months to \<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Stage 1: 24 Months STARTED	44	220	132
Stage 1: 24 Months COMPLETED	44	210	127
Stage 1: 24 Months NOT COMPLETED	0	10	5
Stage 2: 8 Months STARTED	40	174	0
Stage 2: 8 Months COMPLETED	40	170	0
Stage 2: 8 Months NOT COMPLETED	0	4	0
Stage 2: Booster Phase (6 Months) STARTED	0	148	0
Stage 2: Booster Phase (6 Months) COMPLETED	0	147	0
Stage 2: Booster Phase (6 Months) NOT COMPLETED	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) Participants from \>=12 months to \<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Stage 1: 24 Months Withdrawal by Subject	3	3
Stage 1: 24 Months No longer willing to participate in study	1	1
Stage 1: 24 Months No longer meets eligibility criteria	3	0
Stage 1: 24 Months Lost to Follow-up	1	1
Stage 1: 24 Months Adverse Event	2	0
Stage 2: 8 Months Moved away/parents resigned from study	4	0
Stage 2: Booster Phase (6 Months) Not received booster vaccination	1	0

Baseline Characteristics

Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months) n=44 Participants Participants from greater than or equal to (\>=) 12 months to less than (\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.	Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months) n=220 Participants Participants from \>=12 months to \<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 n=132 Participants Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.	Total n=396 Participants Total of all reporting groups
Age, Continuous	16.9 months STANDARD_DEVIATION 4.08 • n=5 Participants	17.4 months STANDARD_DEVIATION 3.54 • n=7 Participants	17.3 months STANDARD_DEVIATION 3.58 • n=5 Participants	17.3 months STANDARD_DEVIATION 3.61 • n=4 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	114 Participants n=7 Participants	74 Participants n=5 Participants	209 Participants n=4 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	106 Participants n=7 Participants	58 Participants n=5 Participants	187 Participants n=4 Participants
Race/Ethnicity, Customized Race: White	37 Participants n=5 Participants	210 Participants n=7 Participants	127 Participants n=5 Participants	374 Participants n=4 Participants
Race/Ethnicity, Customized Race: Asian	5 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Race/Ethnicity, Customized Race: Other	2 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	14 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity: Hispanic	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity: Non-Hispanic	44 Participants n=5 Participants	218 Participants n=7 Participants	132 Participants n=5 Participants	394 Participants n=4 Participants

PRIMARY outcome

Timeframe: 1 month after Vaccination 3

Population: All eligible participants randomized to study received,scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. Here,overall number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=9 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=11 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=47 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=51 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=31 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=30 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3 PMB80 [A22]	88.9 percentage of participants Interval 51.8 to 99.7	90.9 percentage of participants Interval 58.7 to 99.8	91.1 percentage of participants Interval 78.8 to 97.5	88.2 percentage of participants Interval 76.1 to 95.6	3.2 percentage of participants Interval 0.1 to 16.7	6.9 percentage of participants Interval 0.8 to 22.8	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3 PMB2001 [A56]	100.0 percentage of participants Interval 66.4 to 100.0	100.0 percentage of participants Interval 69.2 to 100.0	100.0 percentage of participants Interval 92.5 to 100.0	100.0 percentage of participants Interval 92.6 to 100.0	0.0 percentage of participants Interval 0.0 to 14.2	3.3 percentage of participants Interval 0.1 to 17.2	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3 PMB2948 [B24]	88.9 percentage of participants Interval 51.8 to 99.7	81.8 percentage of participants Interval 48.2 to 97.7	71.1 percentage of participants Interval 55.7 to 83.6	72.0 percentage of participants Interval 57.5 to 83.8	3.2 percentage of participants Interval 0.1 to 16.7	6.9 percentage of participants Interval 0.8 to 22.8	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3 PMB2707 [B44]	88.9 percentage of participants Interval 51.8 to 99.7	90.0 percentage of participants Interval 55.5 to 99.7	87.2 percentage of participants Interval 74.3 to 95.2	85.1 percentage of participants Interval 71.7 to 93.8	0.0 percentage of participants Interval 0.0 to 14.2	0.0 percentage of participants Interval 0.0 to 11.6	—	—	—

PRIMARY outcome

Timeframe: within 7 Days after Vaccination 1

Population: Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available.

Local reactions included tenderness at injection site, swelling and redness collected by using an electronic diary (e-diary). Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 centimeter \[cm\]), moderate (2.5 to 7.0 cm) and severe (\>7.0 cm).

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=22 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=22 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=44 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=110 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=110 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=220 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=66 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=66 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 n=132 Participants Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 Tenderness at injection site: Any	68.2 percentage of participants Interval 45.1 to 86.1	50.0 percentage of participants Interval 28.2 to 71.8	59.1 percentage of participants Interval 43.2 to 73.7	50.9 percentage of participants Interval 41.2 to 60.6	64.5 percentage of participants Interval 54.9 to 73.4	57.7 percentage of participants Interval 50.9 to 64.3	15.2 percentage of participants Interval 7.5 to 26.1	19.7 percentage of participants Interval 10.9 to 31.3	17.4 percentage of participants Interval 11.4 to 25.0
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 Tenderness at injection site: Mild	45.5 percentage of participants Interval 24.4 to 67.8	27.3 percentage of participants Interval 10.7 to 50.2	36.4 percentage of participants Interval 22.4 to 52.2	27.3 percentage of participants Interval 19.2 to 36.6	34.5 percentage of participants Interval 25.7 to 44.2	30.9 percentage of participants Interval 24.9 to 37.5	12.1 percentage of participants Interval 5.4 to 22.5	19.7 percentage of participants Interval 10.9 to 31.3	15.9 percentage of participants Interval 10.1 to 23.3
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 Tenderness at injection site: Moderate	22.7 percentage of participants Interval 7.8 to 45.4	18.2 percentage of participants Interval 5.2 to 40.3	20.5 percentage of participants Interval 9.8 to 35.3	20.9 percentage of participants Interval 13.7 to 29.7	24.5 percentage of participants Interval 16.8 to 33.7	22.7 percentage of participants Interval 17.4 to 28.8	3.0 percentage of participants Interval 0.4 to 10.5	0.0 percentage of participants Interval 0.0 to 5.4	1.5 percentage of participants Interval 0.2 to 5.4
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 Tenderness at injection site: Severe	0.0 percentage of participants Interval 0.0 to 15.4	4.5 percentage of participants Interval 0.1 to 22.8	2.3 percentage of participants Interval 0.1 to 12.0	2.7 percentage of participants Interval 0.6 to 7.8	5.5 percentage of participants Interval 2.0 to 11.5	4.1 percentage of participants Interval 1.9 to 7.6	0.0 percentage of participants Interval 0.0 to 5.4	0.0 percentage of participants Interval 0.0 to 5.4	0.0 percentage of participants Interval 0.0 to 2.8
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 Redness: Any	68.2 percentage of participants Interval 45.1 to 86.1	40.9 percentage of participants Interval 20.7 to 63.6	54.5 percentage of participants Interval 38.8 to 69.6	50.9 percentage of participants Interval 41.2 to 60.6	42.7 percentage of participants Interval 33.3 to 52.5	46.8 percentage of participants Interval 40.1 to 53.6	13.6 percentage of participants Interval 6.4 to 24.3	16.7 percentage of participants Interval 8.6 to 27.9	15.2 percentage of participants Interval 9.5 to 22.4
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 Redness: Mild	40.9 percentage of participants Interval 20.7 to 63.6	27.3 percentage of participants Interval 10.7 to 50.2	34.1 percentage of participants Interval 20.5 to 49.9	35.5 percentage of participants Interval 26.6 to 45.1	21.8 percentage of participants Interval 14.5 to 30.7	28.6 percentage of participants Interval 22.8 to 35.1	13.6 percentage of participants Interval 6.4 to 24.3	16.7 percentage of participants Interval 8.6 to 27.9	15.2 percentage of participants Interval 9.5 to 22.4
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 Redness: Moderate	27.3 percentage of participants Interval 10.7 to 50.2	13.6 percentage of participants Interval 2.9 to 34.9	20.5 percentage of participants Interval 9.8 to 35.3	14.5 percentage of participants Interval 8.5 to 22.5	19.1 percentage of participants Interval 12.2 to 27.7	16.8 percentage of participants Interval 12.1 to 22.4	0.0 percentage of participants Interval 0.0 to 5.4	0.0 percentage of participants Interval 0.0 to 5.4	0.0 percentage of participants Interval 0.0 to 2.8
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 Redness: Severe	0.0 percentage of participants Interval 0.0 to 15.4	0.0 percentage of participants Interval 0.0 to 15.4	0.0 percentage of participants Interval 0.0 to 8.0	0.9 percentage of participants Interval 0.0 to 5.0	1.8 percentage of participants Interval 0.2 to 6.4	1.4 percentage of participants Interval 0.3 to 3.9	0.0 percentage of participants Interval 0.0 to 5.4	0.0 percentage of participants Interval 0.0 to 5.4	0.0 percentage of participants Interval 0.0 to 2.8
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 Swelling: Any	36.4 percentage of participants Interval 17.2 to 59.3	22.7 percentage of participants Interval 7.8 to 45.4	29.5 percentage of participants Interval 16.8 to 45.2	30.0 percentage of participants Interval 21.6 to 39.5	27.3 percentage of participants Interval 19.2 to 36.6	28.6 percentage of participants Interval 22.8 to 35.1	7.6 percentage of participants Interval 2.5 to 16.8	12.1 percentage of participants Interval 5.4 to 22.5	9.8 percentage of participants Interval 5.3 to 16.3
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 Swelling: Mild	22.7 percentage of participants Interval 7.8 to 45.4	13.6 percentage of participants Interval 2.9 to 34.9	18.2 percentage of participants Interval 8.2 to 32.7	15.5 percentage of participants Interval 9.3 to 23.6	19.1 percentage of participants Interval 12.2 to 27.7	17.3 percentage of participants Interval 12.5 to 22.9	7.6 percentage of participants Interval 2.5 to 16.8	12.1 percentage of participants Interval 5.4 to 22.5	9.8 percentage of participants Interval 5.3 to 16.3
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 Swelling: Moderate	13.6 percentage of participants Interval 2.9 to 34.9	9.1 percentage of participants Interval 1.1 to 29.2	11.4 percentage of participants Interval 3.8 to 24.6	13.6 percentage of participants Interval 7.8 to 21.5	8.2 percentage of participants Interval 3.8 to 15.0	10.9 percentage of participants Interval 7.1 to 15.8	0.0 percentage of participants Interval 0.0 to 5.4	0.0 percentage of participants Interval 0.0 to 5.4	0.0 percentage of participants Interval 0.0 to 2.8
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 Swelling: Severe	0.0 percentage of participants Interval 0.0 to 15.4	0.0 percentage of participants Interval 0.0 to 15.4	0.0 percentage of participants Interval 0.0 to 8.0	0.9 percentage of participants Interval 0.0 to 5.0	0.0 percentage of participants Interval 0.0 to 3.3	0.5 percentage of participants Interval 0.0 to 2.5	0.0 percentage of participants Interval 0.0 to 5.4	0.0 percentage of participants Interval 0.0 to 5.4	0.0 percentage of participants Interval 0.0 to 2.8

PRIMARY outcome

Timeframe: within 7 Days after Vaccination 2

Population: Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure.

Local reactions included tenderness at injection site, swelling and redness collected by using an e-diary. Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (\>7.0 cm).

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=22 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=22 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=44 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=105 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=107 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=212 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=63 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=65 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 n=128 Participants Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 Tenderness at injection site: Any	45.5 percentage of Participants Interval 24.4 to 67.8	50.0 percentage of Participants Interval 28.2 to 71.8	47.7 percentage of Participants Interval 32.5 to 63.3	45.7 percentage of Participants Interval 36.0 to 55.7	60.7 percentage of Participants Interval 50.8 to 70.0	53.3 percentage of Participants Interval 46.3 to 60.2	14.3 percentage of Participants Interval 6.7 to 25.4	15.4 percentage of Participants Interval 7.6 to 26.5	14.8 percentage of Participants Interval 9.2 to 22.2
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 Tenderness at injection site: Mild	31.8 percentage of Participants Interval 13.9 to 54.9	40.9 percentage of Participants Interval 20.7 to 63.6	36.4 percentage of Participants Interval 22.4 to 52.2	31.4 percentage of Participants Interval 22.7 to 41.2	32.7 percentage of Participants Interval 24.0 to 42.5	32.1 percentage of Participants Interval 25.8 to 38.8	12.7 percentage of Participants Interval 5.6 to 23.5	15.4 percentage of Participants Interval 7.6 to 26.5	14.1 percentage of Participants Interval 8.6 to 21.3
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 Tenderness at injection site: Moderate	13.6 percentage of Participants Interval 2.9 to 34.9	9.1 percentage of Participants Interval 1.1 to 29.2	11.4 percentage of Participants Interval 3.8 to 24.6	12.4 percentage of Participants Interval 6.8 to 20.2	24.3 percentage of Participants Interval 16.5 to 33.5	18.4 percentage of Participants Interval 13.4 to 24.3	1.6 percentage of Participants Interval 0.0 to 8.5	0.0 percentage of Participants Interval 0.0 to 5.5	0.8 percentage of Participants Interval 0.0 to 4.3
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 Tenderness at injection site: Severe	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	1.9 percentage of Participants Interval 0.2 to 6.7	3.7 percentage of Participants Interval 1.0 to 9.3	2.8 percentage of Participants Interval 1.0 to 6.1	0.0 percentage of Participants Interval 0.0 to 5.7	0.0 percentage of Participants Interval 0.0 to 5.5	0.0 percentage of Participants Interval 0.0 to 2.8
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 Redness: Any	50.0 percentage of Participants Interval 28.2 to 71.8	31.8 percentage of Participants Interval 13.9 to 54.9	40.9 percentage of Participants Interval 26.3 to 56.8	33.3 percentage of Participants Interval 24.4 to 43.2	38.3 percentage of Participants Interval 29.1 to 48.2	35.8 percentage of Participants Interval 29.4 to 42.7	6.3 percentage of Participants Interval 1.8 to 15.5	9.2 percentage of Participants Interval 3.5 to 19.0	7.8 percentage of Participants Interval 3.8 to 13.9
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 Redness: Mild	40.9 percentage of Participants Interval 20.7 to 63.6	27.3 percentage of Participants Interval 10.7 to 50.2	34.1 percentage of Participants Interval 20.5 to 49.9	21.9 percentage of Participants Interval 14.4 to 31.0	23.4 percentage of Participants Interval 15.7 to 32.5	22.6 percentage of Participants Interval 17.2 to 28.9	6.3 percentage of Participants Interval 1.8 to 15.5	9.2 percentage of Participants Interval 3.5 to 19.0	7.8 percentage of Participants Interval 3.8 to 13.9
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 Redness: Moderate	9.1 percentage of Participants Interval 1.1 to 29.2	4.5 percentage of Participants Interval 0.1 to 22.8	6.8 percentage of Participants Interval 1.4 to 18.7	11.4 percentage of Participants Interval 6.0 to 19.1	15.0 percentage of Participants Interval 8.8 to 23.1	13.2 percentage of Participants Interval 9.0 to 18.5	0.0 percentage of Participants Interval 0.0 to 5.7	0.0 percentage of Participants Interval 0.0 to 5.5	0.0 percentage of Participants Interval 0.0 to 2.8
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 Redness: Severe	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	0.0 percentage of Participants Interval 0.0 to 3.5	0.0 percentage of Participants Interval 0.0 to 3.4	0.0 percentage of Participants Interval 0.0 to 1.7	0.0 percentage of Participants Interval 0.0 to 5.7	0.0 percentage of Participants Interval 0.0 to 5.5	0.0 percentage of Participants Interval 0.0 to 2.8
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 Swelling: Any	18.2 percentage of Participants Interval 5.2 to 40.3	27.3 percentage of Participants Interval 10.7 to 50.2	22.7 percentage of Participants Interval 11.5 to 37.8	21.0 percentage of Participants Interval 13.6 to 30.0	19.6 percentage of Participants Interval 12.6 to 28.4	20.3 percentage of Participants Interval 15.1 to 26.3	1.6 percentage of Participants Interval 0.0 to 8.5	7.7 percentage of Participants Interval 2.5 to 17.0	4.7 percentage of Participants Interval 1.7 to 9.9
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 Swelling: Mild	18.2 percentage of Participants Interval 5.2 to 40.3	13.6 percentage of Participants Interval 2.9 to 34.9	15.9 percentage of Participants Interval 6.6 to 30.1	14.3 percentage of Participants Interval 8.2 to 22.5	13.1 percentage of Participants Interval 7.3 to 21.0	13.7 percentage of Participants Interval 9.4 to 19.1	1.6 percentage of Participants Interval 0.0 to 8.5	7.7 percentage of Participants Interval 2.5 to 17.0	4.7 percentage of Participants Interval 1.7 to 9.9
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 Swelling: Moderate	0.0 percentage of Participants Interval 0.0 to 15.4	13.6 percentage of Participants Interval 2.9 to 34.9	6.8 percentage of Participants Interval 1.4 to 18.7	6.7 percentage of Participants Interval 2.7 to 13.3	5.6 percentage of Participants Interval 2.1 to 11.8	6.1 percentage of Participants Interval 3.3 to 10.3	0.0 percentage of Participants Interval 0.0 to 5.7	0.0 percentage of Participants Interval 0.0 to 5.5	0.0 percentage of Participants Interval 0.0 to 2.8
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 Swelling: Severe	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	0.0 percentage of Participants Interval 0.0 to 3.5	0.9 percentage of Participants Interval 0.0 to 5.1	0.5 percentage of Participants Interval 0.0 to 2.6	0.0 percentage of Participants Interval 0.0 to 5.7	0.0 percentage of Participants Interval 0.0 to 5.5	0.0 percentage of Participants Interval 0.0 to 2.8

PRIMARY outcome

Timeframe: within 7 Days after Vaccination 3

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=22 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=22 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=44 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=104 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=108 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=212 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=65 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=63 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 n=128 Participants Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 Redness: Severe	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	1.0 percentage of Participants Interval 0.0 to 5.2	0.0 percentage of Participants Interval 0.0 to 3.4	0.5 percentage of Participants Interval 0.0 to 2.6	0.0 percentage of Participants Interval 0.0 to 5.5	0.0 percentage of Participants Interval 0.0 to 5.7	0.0 percentage of Participants Interval 0.0 to 2.8
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 Swelling: Severe	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	1.0 percentage of Participants Interval 0.0 to 5.2	0.0 percentage of Participants Interval 0.0 to 3.4	0.5 percentage of Participants Interval 0.0 to 2.6	0.0 percentage of Participants Interval 0.0 to 5.5	0.0 percentage of Participants Interval 0.0 to 5.7	0.0 percentage of Participants Interval 0.0 to 2.8
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 Tenderness at injection site: Any	54.5 percentage of Participants Interval 32.2 to 75.6	59.1 percentage of Participants Interval 36.4 to 79.3	56.8 percentage of Participants Interval 41.0 to 71.7	51.9 percentage of Participants Interval 41.9 to 61.8	62.0 percentage of Participants Interval 52.2 to 71.2	57.1 percentage of Participants Interval 50.1 to 63.8	16.9 percentage of Participants Interval 8.8 to 28.3	14.3 percentage of Participants Interval 6.7 to 25.4	15.6 percentage of Participants Interval 9.8 to 23.1
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 Tenderness at injection site: Mild	22.7 percentage of Participants Interval 7.8 to 45.4	40.9 percentage of Participants Interval 20.7 to 63.6	31.8 percentage of Participants Interval 18.6 to 47.6	29.8 percentage of Participants Interval 21.2 to 39.6	34.3 percentage of Participants Interval 25.4 to 44.0	32.1 percentage of Participants Interval 25.8 to 38.8	12.3 percentage of Participants Interval 5.5 to 22.8	12.7 percentage of Participants Interval 5.6 to 23.5	12.5 percentage of Participants Interval 7.3 to 19.5
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 Tenderness at injection site: Moderate	31.8 percentage of Participants Interval 13.9 to 54.9	18.2 percentage of Participants Interval 5.2 to 40.3	25.0 percentage of Participants Interval 13.2 to 40.3	17.3 percentage of Participants Interval 10.6 to 26.0	22.2 percentage of Participants Interval 14.8 to 31.2	19.8 percentage of Participants Interval 14.7 to 25.8	4.6 percentage of Participants Interval 1.0 to 12.9	1.6 percentage of Participants Interval 0.0 to 8.5	3.1 percentage of Participants Interval 0.9 to 7.8
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 Tenderness at injection site: Severe	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	4.8 percentage of Participants Interval 1.6 to 10.9	5.6 percentage of Participants Interval 2.1 to 11.7	5.2 percentage of Participants Interval 2.6 to 9.1	0.0 percentage of Participants Interval 0.0 to 5.5	0.0 percentage of Participants Interval 0.0 to 5.7	0.0 percentage of Participants Interval 0.0 to 2.8
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 Redness: Any	40.9 percentage of Participants Interval 20.7 to 63.6	36.4 percentage of Participants Interval 17.2 to 59.3	38.6 percentage of Participants Interval 24.4 to 54.5	32.7 percentage of Participants Interval 23.8 to 42.6	33.3 percentage of Participants Interval 24.6 to 43.1	33.0 percentage of Participants Interval 26.7 to 39.8	7.7 percentage of Participants Interval 2.5 to 17.0	7.9 percentage of Participants Interval 2.6 to 17.6	7.8 percentage of Participants Interval 3.8 to 13.9
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 Redness: Mild	31.8 percentage of Participants Interval 13.9 to 54.9	27.3 percentage of Participants Interval 10.7 to 50.2	29.5 percentage of Participants Interval 16.8 to 45.2	23.1 percentage of Participants Interval 15.4 to 32.4	18.5 percentage of Participants Interval 11.7 to 27.1	20.8 percentage of Participants Interval 15.5 to 26.8	6.2 percentage of Participants Interval 1.7 to 15.0	7.9 percentage of Participants Interval 2.6 to 17.6	7.0 percentage of Participants Interval 3.3 to 12.9
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 Redness: Moderate	9.1 percentage of Participants Interval 1.1 to 29.2	9.1 percentage of Participants Interval 1.1 to 29.2	9.1 percentage of Participants Interval 2.5 to 21.7	8.7 percentage of Participants Interval 4.0 to 15.8	14.8 percentage of Participants Interval 8.7 to 22.9	11.8 percentage of Participants Interval 7.8 to 16.9	1.5 percentage of Participants Interval 0.0 to 8.3	0.0 percentage of Participants Interval 0.0 to 5.7	0.8 percentage of Participants Interval 0.0 to 4.3
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 Swelling: Any	18.2 percentage of Participants Interval 5.2 to 40.3	27.3 percentage of Participants Interval 10.7 to 50.2	22.7 percentage of Participants Interval 11.5 to 37.8	23.1 percentage of Participants Interval 15.4 to 32.4	22.2 percentage of Participants Interval 14.8 to 31.2	22.6 percentage of Participants Interval 17.2 to 28.9	4.6 percentage of Participants Interval 1.0 to 12.9	6.3 percentage of Participants Interval 1.8 to 15.5	5.5 percentage of Participants Interval 2.2 to 10.9
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 Swelling: Mild	9.1 percentage of Participants Interval 1.1 to 29.2	13.6 percentage of Participants Interval 2.9 to 34.9	11.4 percentage of Participants Interval 3.8 to 24.6	16.3 percentage of Participants Interval 9.8 to 24.9	11.1 percentage of Participants Interval 5.9 to 18.6	13.7 percentage of Participants Interval 9.4 to 19.1	4.6 percentage of Participants Interval 1.0 to 12.9	4.8 percentage of Participants Interval 1.0 to 13.3	4.7 percentage of Participants Interval 1.7 to 9.9
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 Swelling: Moderate	9.1 percentage of Participants Interval 1.1 to 29.2	13.6 percentage of Participants Interval 2.9 to 34.9	11.4 percentage of Participants Interval 3.8 to 24.6	5.8 percentage of Participants Interval 2.1 to 12.1	11.1 percentage of Participants Interval 5.9 to 18.6	8.5 percentage of Participants Interval 5.1 to 13.1	0.0 percentage of Participants Interval 0.0 to 5.5	1.6 percentage of Participants Interval 0.0 to 8.5	0.8 percentage of Participants Interval 0.0 to 4.3

PRIMARY outcome

Timeframe: within 7 Days after Vaccination 1

Population: Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available.

Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, \>39.5 to 40.0 degree C and \>40.0 degree C. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed).

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=22 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=22 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=44 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=110 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=110 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=220 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=66 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=66 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 n=132 Participants Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Fever 38 to <38.5 degrees C	22.7 percentage of Participants Interval 7.8 to 45.4	18.2 percentage of Participants Interval 5.2 to 40.3	20.5 percentage of Participants Interval 9.8 to 35.3	7.3 percentage of Participants Interval 3.2 to 13.8	7.3 percentage of Participants Interval 3.2 to 13.8	7.3 percentage of Participants Interval 4.2 to 11.5	6.1 percentage of Participants Interval 1.7 to 14.8	1.5 percentage of Participants Interval 0.0 to 8.2	3.8 percentage of Participants Interval 1.2 to 8.6
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Irritability: Severe	4.5 percentage of Participants Interval 0.1 to 22.8	0.0 percentage of Participants Interval 0.0 to 15.4	2.3 percentage of Participants Interval 0.1 to 12.0	6.4 percentage of Participants Interval 2.6 to 12.7	5.5 percentage of Participants Interval 2.0 to 11.5	5.9 percentage of Participants Interval 3.2 to 9.9	0.0 percentage of Participants Interval 0.0 to 5.4	3.0 percentage of Participants Interval 0.4 to 10.5	1.5 percentage of Participants Interval 0.2 to 5.4
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Fever >=38 degrees C	40.9 percentage of Participants Interval 20.7 to 63.6	31.8 percentage of Participants Interval 13.9 to 54.9	36.4 percentage of Participants Interval 22.4 to 52.2	28.2 percentage of Participants Interval 20.0 to 37.6	27.3 percentage of Participants Interval 19.2 to 36.6	27.7 percentage of Participants Interval 21.9 to 34.1	10.6 percentage of Participants Interval 4.4 to 20.6	1.5 percentage of Participants Interval 0.0 to 8.2	6.1 percentage of Participants Interval 2.7 to 11.6
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Fever 38.5 to <39 degrees C	13.6 percentage of Participants Interval 2.9 to 34.9	9.1 percentage of Participants Interval 1.1 to 29.2	11.4 percentage of Participants Interval 3.8 to 24.6	14.5 percentage of Participants Interval 8.5 to 22.5	13.6 percentage of Participants Interval 7.8 to 21.5	14.1 percentage of Participants Interval 9.8 to 19.4	1.5 percentage of Participants Interval 0.0 to 8.2	0.0 percentage of Participants Interval 0.0 to 5.4	0.8 percentage of Participants Interval 0.0 to 4.1
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Fever 39 to <39.5 degrees C	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	4.5 percentage of Participants Interval 1.5 to 10.3	3.6 percentage of Participants Interval 1.0 to 9.0	4.1 percentage of Participants Interval 1.9 to 7.6	3.0 percentage of Participants Interval 0.4 to 10.5	0.0 percentage of Participants Interval 0.0 to 5.4	1.5 percentage of Participants Interval 0.2 to 5.4
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Fever 39.5 to <=40 degrees C	4.5 percentage of Participants Interval 0.1 to 22.8	4.5 percentage of Participants Interval 0.1 to 22.8	4.5 percentage of Participants Interval 0.6 to 15.5	1.8 percentage of Participants Interval 0.2 to 6.4	1.8 percentage of Participants Interval 0.2 to 6.4	1.8 percentage of Participants Interval 0.5 to 4.6	0.0 percentage of Participants Interval 0.0 to 5.4	0.0 percentage of Participants Interval 0.0 to 5.4	0.0 percentage of Participants Interval 0.0 to 2.8
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Fever >40 degrees C	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	0.0 percentage of Participants Interval 0.0 to 3.3	0.9 percentage of Participants Interval 0.0 to 5.0	0.5 percentage of Participants Interval 0.0 to 2.5	0.0 percentage of Participants Interval 0.0 to 5.4	0.0 percentage of Participants Interval 0.0 to 5.4	0.0 percentage of Participants Interval 0.0 to 2.8
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Irritability: Any	63.6 percentage of Participants Interval 40.7 to 82.8	50.0 percentage of Participants Interval 28.2 to 71.8	56.8 percentage of Participants Interval 41.0 to 71.7	71.8 percentage of Participants Interval 62.4 to 80.0	60.9 percentage of Participants Interval 51.1 to 70.1	66.4 percentage of Participants Interval 59.7 to 72.6	40.9 percentage of Participants Interval 29.0 to 53.7	33.3 percentage of Participants Interval 22.2 to 46.0	37.1 percentage of Participants Interval 28.9 to 46.0
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Irritability: Mild	27.3 percentage of Participants Interval 10.7 to 50.2	9.1 percentage of Participants Interval 1.1 to 29.2	18.2 percentage of Participants Interval 8.2 to 32.7	19.1 percentage of Participants Interval 12.2 to 27.7	16.4 percentage of Participants Interval 10.0 to 24.6	17.7 percentage of Participants Interval 12.9 to 23.4	10.6 percentage of Participants Interval 4.4 to 20.6	13.6 percentage of Participants Interval 6.4 to 24.3	12.1 percentage of Participants Interval 7.1 to 18.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Irritability: Moderate	31.8 percentage of Participants Interval 13.9 to 54.9	40.9 percentage of Participants Interval 20.7 to 63.6	36.4 percentage of Participants Interval 22.4 to 52.2	46.4 percentage of Participants Interval 36.8 to 56.1	39.1 percentage of Participants Interval 29.9 to 48.9	42.7 percentage of Participants Interval 36.1 to 49.6	30.3 percentage of Participants Interval 19.6 to 42.9	16.7 percentage of Participants Interval 8.6 to 27.9	23.5 percentage of Participants Interval 16.5 to 31.6
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Drowsiness: Any	45.5 percentage of Participants Interval 24.4 to 67.8	40.9 percentage of Participants Interval 20.7 to 63.6	43.2 percentage of Participants Interval 28.3 to 59.0	45.5 percentage of Participants Interval 35.9 to 55.2	42.7 percentage of Participants Interval 33.3 to 52.5	44.1 percentage of Participants Interval 37.4 to 50.9	25.8 percentage of Participants Interval 15.8 to 38.0	10.6 percentage of Participants Interval 4.4 to 20.6	18.2 percentage of Participants Interval 12.0 to 25.8
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Drowsiness: Mild	36.4 percentage of Participants Interval 17.2 to 59.3	31.8 percentage of Participants Interval 13.9 to 54.9	34.1 percentage of Participants Interval 20.5 to 49.9	28.2 percentage of Participants Interval 20.0 to 37.6	24.5 percentage of Participants Interval 16.8 to 33.7	26.4 percentage of Participants Interval 20.7 to 32.7	16.7 percentage of Participants Interval 8.6 to 27.9	6.1 percentage of Participants Interval 1.7 to 14.8	11.4 percentage of Participants Interval 6.5 to 18.0
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Drowsiness: Moderate	9.1 percentage of Participants Interval 1.1 to 29.2	9.1 percentage of Participants Interval 1.1 to 29.2	9.1 percentage of Participants Interval 2.5 to 21.7	11.8 percentage of Participants Interval 6.4 to 19.4	15.5 percentage of Participants Interval 9.3 to 23.6	13.6 percentage of Participants Interval 9.4 to 18.9	7.6 percentage of Participants Interval 2.5 to 16.8	4.5 percentage of Participants Interval 0.9 to 12.7	6.1 percentage of Participants Interval 2.7 to 11.6
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Drowsiness: Severe	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	5.5 percentage of Participants Interval 2.0 to 11.5	2.7 percentage of Participants Interval 0.6 to 7.8	4.1 percentage of Participants Interval 1.9 to 7.6	1.5 percentage of Participants Interval 0.0 to 8.2	0.0 percentage of Participants Interval 0.0 to 15.4	0.8 percentage of Participants Interval 0.0 to 4.1
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Loss of or decrease appetite: Any	36.4 percentage of Participants Interval 17.2 to 59.3	36.4 percentage of Participants Interval 17.2 to 59.3	36.4 percentage of Participants Interval 22.4 to 52.2	44.5 percentage of Participants Interval 35.1 to 54.3	46.4 percentage of Participants Interval 36.8 to 56.1	45.5 percentage of Participants Interval 38.7 to 52.3	34.8 percentage of Participants Interval 23.5 to 47.6	10.6 percentage of Participants Interval 4.4 to 20.6	22.7 percentage of Participants Interval 15.9 to 30.8
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Loss of or decrease appetite: Mild	22.7 percentage of Participants Interval 7.8 to 45.4	18.2 percentage of Participants Interval 5.2 to 40.3	20.5 percentage of Participants Interval 9.8 to 35.3	16.4 percentage of Participants Interval 10.0 to 24.6	24.5 percentage of Participants Interval 16.8 to 33.7	20.5 percentage of Participants Interval 15.3 to 26.4	13.6 percentage of Participants Interval 6.4 to 24.3	7.6 percentage of Participants Interval 2.5 to 16.8	10.6 percentage of Participants Interval 5.9 to 17.2
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Loss of or decrease appetite: Moderate	13.6 percentage of Participants Interval 2.9 to 34.9	9.1 percentage of Participants Interval 1.1 to 29.2	11.4 percentage of Participants Interval 3.8 to 24.6	25.5 percentage of Participants Interval 17.6 to 34.6	14.5 percentage of Participants Interval 8.5 to 22.5	20.0 percentage of Participants Interval 14.9 to 25.9	18.2 percentage of Participants Interval 9.8 to 29.6	1.5 percentage of Participants Interval 0.0 to 8.2	9.8 percentage of Participants Interval 5.3 to 16.3
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Loss of or decrease appetite: Severe	0.0 percentage of Participants Interval 0.0 to 15.4	9.1 percentage of Participants Interval 1.1 to 29.2	4.5 percentage of Participants Interval 0.6 to 15.5	2.7 percentage of Participants Interval 0.6 to 7.8	7.3 percentage of Participants Interval 3.2 to 13.8	5.0 percentage of Participants Interval 2.5 to 8.8	3.0 percentage of Participants Interval 0.4 to 10.5	1.5 percentage of Participants Interval 0.0 to 8.2	2.3 percentage of Participants Interval 0.5 to 6.5
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Antipyretic medication use	45.5 percentage of Participants Interval 24.4 to 67.8	59.1 percentage of Participants Interval 36.4 to 79.3	52.3 percentage of Participants Interval 36.7 to 67.5	52.7 percentage of Participants Interval 43.0 to 62.3	40.9 percentage of Participants Interval 31.6 to 50.7	46.8 percentage of Participants Interval 40.1 to 53.6	24.2 percentage of Participants Interval 14.5 to 36.4	15.2 percentage of Participants Interval 7.5 to 26.1	19.7 percentage of Participants Interval 13.3 to 27.5

PRIMARY outcome

Timeframe: within 7 Days after Vaccination 2

Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, \>39.5 to 40.0 degree C and \>40.0 degree C. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed).

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=22 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=22 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=44 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=105 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=107 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=212 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=63 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=65 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 n=128 Participants Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Fever >=38 degrees C	13.6 percentage of Participants Interval 2.9 to 34.9	9.1 percentage of Participants Interval 1.1 to 29.2	11.4 percentage of Participants Interval 3.8 to 24.6	14.3 percentage of Participants Interval 8.2 to 22.5	14.0 percentage of Participants Interval 8.1 to 22.1	14.2 percentage of Participants Interval 9.8 to 19.6	6.3 percentage of Participants Interval 1.8 to 15.5	3.1 percentage of Participants Interval 0.4 to 10.7	4.7 percentage of Participants Interval 1.7 to 9.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Fever 38 to <38.5 degrees C	13.6 percentage of Participants Interval 2.9 to 34.9	0.0 percentage of Participants Interval 0.0 to 15.4	6.8 percentage of Participants Interval 1.4 to 18.7	4.8 percentage of Participants Interval 1.6 to 10.8	8.4 percentage of Participants Interval 3.9 to 15.4	6.6 percentage of Participants Interval 3.7 to 10.8	4.8 percentage of Participants Interval 1.0 to 13.3	3.1 percentage of Participants Interval 0.4 to 10.7	3.9 percentage of Participants Interval 1.3 to 8.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Fever 38.5 to <39 degrees C	0.0 percentage of Participants Interval 0.0 to 15.4	4.5 percentage of Participants Interval 0.1 to 22.8	2.3 percentage of Participants Interval 0.1 to 12.0	6.7 percentage of Participants Interval 2.7 to 13.3	2.8 percentage of Participants Interval 0.6 to 8.0	4.7 percentage of Participants Interval 2.3 to 8.5	1.6 percentage of Participants Interval 0.0 to 8.5	0.0 percentage of Participants Interval 0.0 to 5.5	0.8 percentage of Participants Interval 0.0 to 4.3
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Fever 39 to <39.5 degrees C	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	1.9 percentage of Participants Interval 0.2 to 6.7	1.9 percentage of Participants Interval 0.2 to 6.6	1.9 percentage of Participants Interval 0.5 to 4.8	0.0 percentage of Participants Interval 0.0 to 5.7	0.0 percentage of Participants Interval 0.0 to 5.5	0.0 percentage of Participants Interval 0.0 to 2.8
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Fever 39.5 to <=40 degrees C	0.0 percentage of Participants Interval 0.0 to 15.4	4.5 percentage of Participants Interval 0.1 to 22.8	2.3 percentage of Participants Interval 0.1 to 12.0	1.0 percentage of Participants Interval 0.0 to 5.2	0.9 percentage of Participants Interval 0.0 to 5.1	0.9 percentage of Participants Interval 0.1 to 3.4	0.0 percentage of Participants Interval 0.0 to 5.7	0.0 percentage of Participants Interval 0.0 to 5.5	0.0 percentage of Participants Interval 0.0 to 2.8
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Fever >40 degrees C	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	0.0 percentage of Participants Interval 0.0 to 3.5	0.0 percentage of Participants Interval 0.0 to 3.4	0.0 percentage of Participants Interval 0.0 to 1.7	0.0 percentage of Participants Interval 0.0 to 5.7	0.0 percentage of Participants Interval 0.0 to 5.5	0.0 percentage of Participants Interval 0.0 to 2.8
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Irritability: Any	50.0 percentage of Participants Interval 28.2 to 71.8	40.9 percentage of Participants Interval 20.7 to 63.6	45.5 percentage of Participants Interval 30.4 to 61.2	54.3 percentage of Participants Interval 44.3 to 64.0	55.1 percentage of Participants Interval 45.2 to 64.8	54.7 percentage of Participants Interval 47.8 to 61.5	31.7 percentage of Participants Interval 20.6 to 44.7	18.5 percentage of Participants Interval 9.9 to 30.0	25.0 percentage of Participants Interval 17.8 to 33.4
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Irritability: Mild	40.9 percentage of Participants Interval 20.7 to 63.6	18.2 percentage of Participants Interval 5.2 to 40.3	29.5 percentage of Participants Interval 16.8 to 45.2	19.0 percentage of Participants Interval 12.0 to 27.9	18.7 percentage of Participants Interval 11.8 to 27.4	18.9 percentage of Participants Interval 13.8 to 24.8	7.9 percentage of Participants Interval 2.6 to 17.6	6.2 percentage of Participants Interval 1.7 to 15.0	7.0 percentage of Participants Interval 3.3 to 12.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Irritability: Moderate	4.5 percentage of Participants Interval 0.1 to 22.8	22.7 percentage of Participants Interval 7.8 to 45.4	13.6 percentage of Participants Interval 5.2 to 27.4	31.4 percentage of Participants Interval 22.7 to 41.2	34.6 percentage of Participants Interval 25.6 to 44.4	33.0 percentage of Participants Interval 26.7 to 39.8	22.2 percentage of Participants Interval 12.7 to 34.5	9.2 percentage of Participants Interval 3.5 to 19.0	15.6 percentage of Participants Interval 9.8 to 23.1
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Irritability: Severe	4.5 percentage of Participants Interval 0.1 to 22.8	0.0 percentage of Participants Interval 0.0 to 15.4	2.3 percentage of Participants Interval 0.1 to 12.0	3.8 percentage of Participants Interval 1.0 to 9.5	1.9 percentage of Participants Interval 0.2 to 6.6	2.8 percentage of Participants Interval 1.0 to 6.1	1.6 percentage of Participants Interval 0.0 to 8.5	3.1 percentage of Participants Interval 0.4 to 10.7	2.3 percentage of Participants Interval 0.5 to 6.7
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Loss of or decreased appetite: Severe	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	4.8 percentage of Participants Interval 1.6 to 10.8	4.7 percentage of Participants Interval 1.5 to 10.6	4.7 percentage of Participants Interval 2.3 to 8.5	1.6 percentage of Participants Interval 0.0 to 8.5	0.0 percentage of Participants Interval 0.0 to 5.5	0.8 percentage of Participants Interval 0.0 to 4.3
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Drowsiness: Any	13.6 percentage of Participants Interval 2.9 to 34.9	18.2 percentage of Participants Interval 5.2 to 40.3	15.9 percentage of Participants Interval 6.6 to 30.1	37.1 percentage of Participants Interval 27.9 to 47.1	24.3 percentage of Participants Interval 16.5 to 33.5	30.7 percentage of Participants Interval 24.5 to 37.3	19.0 percentage of Participants Interval 10.2 to 30.9	4.6 percentage of Participants Interval 1.0 to 12.9	11.7 percentage of Participants Interval 6.7 to 18.6
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Drowsiness: Mild	9.1 percentage of Participants Interval 1.1 to 29.2	18.2 percentage of Participants Interval 5.2 to 40.3	13.6 percentage of Participants Interval 5.2 to 27.4	22.9 percentage of Participants Interval 15.2 to 32.1	14.0 percentage of Participants Interval 8.1 to 22.1	18.4 percentage of Participants Interval 13.4 to 24.3	9.5 percentage of Participants Interval 3.6 to 19.6	4.6 percentage of Participants Interval 1.0 to 12.9	7.0 percentage of Participants Interval 3.3 to 12.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Drowsiness: Moderate	4.5 percentage of Participants Interval 0.1 to 22.8	0.0 percentage of Participants Interval 0.0 to 15.4	2.3 percentage of Participants Interval 0.1 to 12.0	13.3 percentage of Participants Interval 7.5 to 21.4	8.4 percentage of Participants Interval 3.9 to 15.4	10.8 percentage of Participants Interval 7.0 to 15.8	7.9 percentage of Participants Interval 2.6 to 17.6	0.0 percentage of Participants Interval 0.0 to 5.5	3.9 percentage of Participants Interval 1.3 to 8.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Drowsiness: Severe	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	1.0 percentage of Participants Interval 0.0 to 5.2	1.9 percentage of Participants Interval 0.2 to 6.6	1.4 percentage of Participants Interval 0.3 to 4.1	1.6 percentage of Participants Interval 0.0 to 8.5	0.0 percentage of Participants Interval 0.0 to 5.5	0.8 percentage of Participants Interval 0.0 to 4.3
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Loss of or decreased appetite: Any	31.8 percentage of Participants Interval 13.9 to 54.9	18.2 percentage of Participants Interval 5.2 to 40.3	25.0 percentage of Participants Interval 13.2 to 40.3	41.0 percentage of Participants Interval 31.5 to 51.0	31.8 percentage of Participants Interval 23.1 to 41.5	36.3 percentage of Participants Interval 29.8 to 43.2	22.2 percentage of Participants Interval 12.7 to 34.5	13.8 percentage of Participants Interval 6.5 to 24.7	18.0 percentage of Participants Interval 11.7 to 25.7
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Loss of or decreased appetite: Mild	27.3 percentage of Participants Interval 10.7 to 50.2	18.2 percentage of Participants Interval 5.2 to 40.3	22.7 percentage of Participants Interval 11.5 to 37.8	19.0 percentage of Participants Interval 12.0 to 27.9	19.6 percentage of Participants Interval 12.6 to 28.4	19.3 percentage of Participants Interval 14.3 to 25.3	11.1 percentage of Participants Interval 4.6 to 21.6	7.7 percentage of Participants Interval 2.5 to 17.0	9.4 percentage of Participants Interval 4.9 to 15.8
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Loss of or decreased appetite: Moderate	4.5 percentage of Participants Interval 0.1 to 22.8	0.0 percentage of Participants Interval 0.0 to 15.4	2.3 percentage of Participants Interval 0.1 to 12.0	17.1 percentage of Participants Interval 10.5 to 25.7	7.5 percentage of Participants Interval 3.3 to 14.2	12.3 percentage of Participants Interval 8.2 to 17.5	9.5 percentage of Participants Interval 3.6 to 19.6	6.2 percentage of Participants Interval 1.7 to 15.0	7.8 percentage of Participants Interval 3.8 to 13.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Antipyretic medication use	45.5 percentage of Participants Interval 24.4 to 67.8	27.3 percentage of Participants Interval 10.7 to 50.2	36.4 percentage of Participants Interval 22.4 to 52.2	35.2 percentage of Participants Interval 26.2 to 45.2	31.8 percentage of Participants Interval 23.1 to 41.5	33.5 percentage of Participants Interval 27.2 to 40.3	19.0 percentage of Participants Interval 10.2 to 30.9	10.8 percentage of Participants Interval 4.4 to 20.9	14.8 percentage of Participants Interval 9.2 to 22.2

PRIMARY outcome

Timeframe: within 7 Days after Vaccination 3

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=22 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=22 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=44 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=104 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=108 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=212 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=65 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=63 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 n=128 Participants Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Loss of or decreased appetite: Any	13.6 percentage of Participants Interval 2.9 to 34.9	22.7 percentage of Participants Interval 7.8 to 45.4	18.2 percentage of Participants Interval 8.2 to 32.7	33.7 percentage of Participants Interval 24.7 to 43.6	35.2 percentage of Participants Interval 26.2 to 45.0	34.4 percentage of Participants Interval 28.1 to 41.2	16.9 percentage of Participants Interval 8.8 to 28.3	19.0 percentage of Participants Interval 10.2 to 30.9	18.0 percentage of Participants Interval 11.7 to 25.7
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Fever >=38 degrees C	4.5 percentage of Participants Interval 0.1 to 22.8	4.5 percentage of Participants Interval 0.1 to 22.8	4.5 percentage of Participants Interval 0.6 to 15.5	10.6 percentage of Participants Interval 5.4 to 18.1	14.8 percentage of Participants Interval 8.7 to 22.9	12.7 percentage of Participants Interval 8.6 to 18.0	4.6 percentage of Participants Interval 1.0 to 12.9	7.9 percentage of Participants Interval 2.6 to 17.6	6.3 percentage of Participants Interval 2.7 to 11.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Fever 38 to <38.5 degrees C	4.5 percentage of Participants Interval 0.1 to 22.8	4.5 percentage of Participants Interval 0.1 to 22.8	4.5 percentage of Participants Interval 0.6 to 15.5	6.7 percentage of Participants Interval 2.7 to 13.4	6.5 percentage of Participants Interval 2.6 to 12.9	6.6 percentage of Participants Interval 3.7 to 10.8	3.1 percentage of Participants Interval 0.4 to 10.7	4.8 percentage of Participants Interval 1.0 to 13.3	3.9 percentage of Participants Interval 1.3 to 8.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Fever 38.5 to <39 degrees C	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	2.9 percentage of Participants Interval 0.6 to 8.2	1.9 percentage of Participants Interval 0.2 to 6.5	2.4 percentage of Participants Interval 0.8 to 5.4	1.5 percentage of Participants Interval 0.0 to 8.3	1.6 percentage of Participants Interval 0.0 to 8.5	1.6 percentage of Participants Interval 0.2 to 5.5
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Fever 39 to <39.5 degrees C	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	1.0 percentage of Participants Interval 0.0 to 5.2	3.7 percentage of Participants Interval 1.0 to 9.2	2.4 percentage of Participants Interval 0.8 to 5.4	0.0 percentage of Participants Interval 0.0 to 5.5	1.6 percentage of Participants Interval 0.0 to 8.5	0.8 percentage of Participants Interval 0.0 to 4.3
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Fever 39.5 to <=40 degrees C	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	0.0 percentage of Participants Interval 0.0 to 3.5	2.8 percentage of Participants Interval 0.6 to 7.9	1.4 percentage of Participants Interval 0.3 to 4.1	0.0 percentage of Participants Interval 0.0 to 5.5	0.0 percentage of Participants Interval 0.0 to 5.7	0.0 percentage of Participants Interval 0.0 to 2.8
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Fever >40 degrees C	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	0.0 percentage of Participants Interval 0.0 to 3.5	0.0 percentage of Participants Interval 0.0 to 3.4	0.0 percentage of Participants Interval 0.0 to 1.7	0.0 percentage of Participants Interval 0.0 to 5.5	0.0 percentage of Participants Interval 0.0 to 5.7	0.0 percentage of Participants Interval 0.0 to 2.8
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Irritability: Any	36.4 percentage of Participants Interval 17.2 to 59.3	36.4 percentage of Participants Interval 17.2 to 59.3	36.4 percentage of Participants Interval 22.4 to 52.2	56.7 percentage of Participants Interval 46.7 to 66.4	44.4 percentage of Participants Interval 34.9 to 54.3	50.5 percentage of Participants Interval 43.5 to 57.4	24.6 percentage of Participants Interval 14.8 to 36.9	30.2 percentage of Participants Interval 19.2 to 43.0	27.3 percentage of Participants Interval 19.8 to 35.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Irritability: Mild	22.7 percentage of Participants Interval 7.8 to 45.4	18.2 percentage of Participants Interval 5.2 to 40.3	20.5 percentage of Participants Interval 9.8 to 35.3	27.9 percentage of Participants Interval 19.5 to 37.5	19.4 percentage of Participants Interval 12.5 to 28.2	23.6 percentage of Participants Interval 18.0 to 29.9	9.2 percentage of Participants Interval 3.5 to 19.0	15.9 percentage of Participants Interval 7.9 to 27.3	12.5 percentage of Participants Interval 7.3 to 19.5
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Irritability: Moderate	13.6 percentage of Participants Interval 2.9 to 34.9	18.2 percentage of Participants Interval 5.2 to 40.3	15.9 percentage of Participants Interval 6.6 to 30.1	26.0 percentage of Participants Interval 17.9 to 35.5	24.1 percentage of Participants Interval 16.4 to 33.3	25.0 percentage of Participants Interval 19.3 to 31.4	13.8 percentage of Participants Interval 6.5 to 24.7	12.7 percentage of Participants Interval 5.6 to 23.5	13.3 percentage of Participants Interval 7.9 to 20.4
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Irritability: Severe	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	2.9 percentage of Participants Interval 0.6 to 8.2	0.9 percentage of Participants Interval 0.0 to 5.1	1.9 percentage of Participants Interval 0.5 to 4.8	1.5 percentage of Participants Interval 0.0 to 8.3	1.6 percentage of Participants Interval 0.0 to 8.5	1.6 percentage of Participants Interval 0.2 to 5.5
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Drowsiness: Any	4.5 percentage of Participants Interval 0.1 to 22.8	22.7 percentage of Participants Interval 7.8 to 45.4	13.6 percentage of Participants Interval 5.2 to 27.4	37.5 percentage of Participants Interval 28.2 to 47.5	30.6 percentage of Participants Interval 22.1 to 40.2	34.0 percentage of Participants Interval 27.6 to 40.8	13.8 percentage of Participants Interval 6.5 to 24.7	12.7 percentage of Participants Interval 5.6 to 23.5	13.3 percentage of Participants Interval 7.9 to 20.4
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Drowsiness: Mild	4.5 percentage of Participants Interval 0.1 to 22.8	22.7 percentage of Participants Interval 7.8 to 45.4	13.6 percentage of Participants Interval 5.2 to 27.4	24.0 percentage of Participants Interval 16.2 to 33.4	23.1 percentage of Participants Interval 15.6 to 32.2	23.6 percentage of Participants Interval 18.0 to 29.9	10.8 percentage of Participants Interval 4.4 to 20.9	9.5 percentage of Participants Interval 3.6 to 19.6	10.2 percentage of Participants Interval 5.5 to 16.7
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Drowsiness: Moderate	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	10.6 percentage of Participants Interval 5.4 to 18.1	6.5 percentage of Participants Interval 2.6 to 12.9	8.5 percentage of Participants Interval 5.1 to 13.1	3.1 percentage of Participants Interval 0.4 to 10.7	1.6 percentage of Participants Interval 0.0 to 8.5	2.3 percentage of Participants Interval 0.5 to 6.7
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Drowsiness: Severe	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	2.9 percentage of Participants Interval 0.6 to 8.2	0.9 percentage of Participants Interval 0.0 to 5.1	1.9 percentage of Participants Interval 0.5 to 4.8	0.0 percentage of Participants Interval 0.0 to 5.5	1.6 percentage of Participants Interval 0.0 to 8.5	0.8 percentage of Participants Interval 0.0 to 4.3
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Loss of or decreased appetite: Mild	13.6 percentage of Participants Interval 2.9 to 34.9	22.7 percentage of Participants Interval 7.8 to 45.4	15.9 percentage of Participants Interval 6.6 to 30.1	15.4 percentage of Participants Interval 9.1 to 23.8	18.5 percentage of Participants Interval 11.7 to 27.1	17.0 percentage of Participants Interval 12.2 to 22.7	9.2 percentage of Participants Interval 3.5 to 19.0	15.9 percentage of Participants Interval 7.9 to 27.3	12.5 percentage of Participants Interval 7.3 to 19.5
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Loss of or decreased appetite: Moderate	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	14.4 percentage of Participants Interval 8.3 to 22.7	14.8 percentage of Participants Interval 8.7 to 22.9	14.6 percentage of Participants Interval 10.2 to 20.1	7.7 percentage of Participants Interval 2.5 to 17.0	1.6 percentage of Participants Interval 0.0 to 8.5	4.7 percentage of Participants Interval 1.7 to 9.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Loss of or decreased appetite: Severe	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	2.3 percentage of Participants Interval 0.1 to 12.0	3.8 percentage of Participants Interval 1.1 to 9.6	1.9 percentage of Participants Interval 0.2 to 6.5	2.8 percentage of Participants Interval 1.0 to 6.1	0.0 percentage of Participants Interval 0.0 to 5.5	1.6 percentage of Participants Interval 0.0 to 8.5	0.8 percentage of Participants Interval 0.0 to 4.3
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Antipyretic medication use	18.2 percentage of Participants Interval 5.2 to 40.3	18.2 percentage of Participants Interval 5.2 to 40.3	18.2 percentage of Participants Interval 8.2 to 32.7	34.6 percentage of Participants Interval 25.6 to 44.6	33.3 percentage of Participants Interval 24.6 to 43.1	34.0 percentage of Participants Interval 27.6 to 40.8	13.8 percentage of Participants Interval 6.5 to 24.7	15.9 percentage of Participants Interval 7.9 to 27.3	14.8 percentage of Participants Interval 9.2 to 22.2

PRIMARY outcome

Timeframe: within 30 Days after Vaccination 1

Population: Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available.

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=22 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=22 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=44 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=110 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=110 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=220 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=66 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=66 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 n=132 Participants Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 1 MAE	9.1 percentage of Participants Interval 1.1 to 29.2	13.6 percentage of Participants Interval 2.9 to 34.9	11.4 percentage of Participants Interval 3.8 to 24.6	18.2 percentage of Participants Interval 11.5 to 26.7	19.1 percentage of Participants Interval 12.2 to 27.7	18.6 percentage of Participants Interval 13.7 to 24.4	18.2 percentage of Participants Interval 9.8 to 29.6	16.7 percentage of Participants Interval 8.6 to 27.9	17.4 percentage of Participants Interval 11.4 to 25.0
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 1 SAE	0.0 percentage of Participants Interval 0.0 to 15.4	4.5 percentage of Participants Interval 0.1 to 22.8	2.3 percentage of Participants Interval 0.1 to 12.0	0.9 percentage of Participants Interval 0.0 to 5.0	1.8 percentage of Participants Interval 0.2 to 6.4	1.4 percentage of Participants Interval 0.3 to 3.9	1.5 percentage of Participants Interval 0.0 to 8.2	1.5 percentage of Participants Interval 0.0 to 8.2	1.5 percentage of Participants Interval 0.2 to 5.4
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 1 NDCMC	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	0.0 percentage of Participants Interval 0.0 to 3.3	0.0 percentage of Participants Interval 0.0 to 3.3	0.0 percentage of Participants Interval 0.0 to 1.7	0.0 percentage of Participants Interval 0.0 to 5.4	0.0 percentage of Participants Interval 0.0 to 5.4	0.0 percentage of Participants Interval 0.0 to 2.8
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 1 AE	18.2 percentage of Participants Interval 5.2 to 40.3	45.5 percentage of Participants Interval 24.4 to 67.8	31.8 percentage of Participants Interval 18.6 to 47.6	38.2 percentage of Participants Interval 29.1 to 47.9	41.8 percentage of Participants Interval 32.5 to 51.6	40.0 percentage of Participants Interval 33.5 to 46.8	33.3 percentage of Participants Interval 22.2 to 46.0	27.3 percentage of Participants Interval 17.0 to 39.6	30.3 percentage of Participants Interval 22.6 to 38.9
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 1 IAE	0.0 percentage of Participants Interval 0.0 to 15.4	4.5 percentage of Participants Interval 0.1 to 22.8	2.3 percentage of Participants Interval 0.1 to 12.0	0.0 percentage of Participants Interval 0.0 to 3.3	0.0 percentage of Participants Interval 0.0 to 3.3	0.0 percentage of Participants Interval 0.0 to 1.7	0.0 percentage of Participants Interval 0.0 to 5.4	0.0 percentage of Participants Interval 0.0 to 5.4	0.0 percentage of Participants Interval 0.0 to 2.8

PRIMARY outcome

Timeframe: within 30 Days after Vaccination 2

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=22 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=22 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=44 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=105 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=108 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=213 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=66 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=65 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 n=131 Participants Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 2 AE	18.2 percentage of Participants Interval 5.2 to 40.3	27.3 percentage of Participants Interval 10.7 to 50.2	22.7 percentage of Participants Interval 11.5 to 37.8	34.3 percentage of Participants Interval 25.3 to 44.2	34.3 percentage of Participants Interval 25.4 to 44.0	34.3 percentage of Participants Interval 27.9 to 41.1	24.2 percentage of Participants Interval 14.5 to 36.4	32.3 percentage of Participants Interval 21.2 to 45.1	28.2 percentage of Participants Interval 20.7 to 36.8
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 2 SAE	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	3.8 percentage of Participants Interval 1.0 to 9.5	0.0 percentage of Participants Interval 0.0 to 3.4	1.9 percentage of Participants Interval 0.5 to 4.7	1.5 percentage of Participants Interval 0.0 to 8.2	0.0 percentage of Participants Interval 0.0 to 5.5	0.8 percentage of Participants Interval 0.0 to 4.2
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 2 MAE	13.6 percentage of Participants Interval 2.9 to 34.9	9.1 percentage of Participants Interval 1.1 to 29.2	11.4 percentage of Participants Interval 3.8 to 24.6	16.2 percentage of Participants Interval 9.7 to 24.7	18.5 percentage of Participants Interval 11.7 to 27.1	17.4 percentage of Participants Interval 12.5 to 23.1	13.6 percentage of Participants Interval 6.4 to 24.3	23.1 percentage of Participants Interval 13.5 to 35.2	18.3 percentage of Participants Interval 12.1 to 26.0
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 2 NDCMC	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	0.0 percentage of Participants Interval 0.0 to 3.5	0.0 percentage of Participants Interval 0.0 to 3.4	0.0 percentage of Participants Interval 0.0 to 1.7	0.0 percentage of Participants Interval 0.0 to 5.4	0.0 percentage of Participants Interval 0.0 to 5.5	0.0 percentage of Participants Interval 0.0 to 2.8
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 2 IAE	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	0.0 percentage of Participants Interval 0.0 to 5.2	0.0 percentage of Participants Interval 0.0 to 3.4	0.5 percentage of Participants Interval 0.0 to 2.6	0.0 percentage of Participants Interval 0.0 to 5.4	0.0 percentage of Participants Interval 0.0 to 5.5	0.0 percentage of Participants Interval 0.0 to 2.8

PRIMARY outcome

Timeframe: within 30 Days after Vaccination 3

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=22 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=22 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=44 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=104 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=108 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=212 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=65 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=64 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 n=129 Participants Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 3 AE	18.2 percentage of Participants Interval 5.2 to 40.3	40.9 percentage of Participants Interval 20.7 to 63.6	29.5 percentage of Participants Interval 16.8 to 45.2	25.0 percentage of Participants Interval 17.0 to 34.4	30.6 percentage of Participants Interval 22.1 to 40.2	27.8 percentage of Participants Interval 21.9 to 34.4	24.6 percentage of Participants Interval 14.8 to 36.9	28.1 percentage of Participants Interval 17.6 to 40.8	26.4 percentage of Participants Interval 19.0 to 34.8
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 3 SAE	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	1.0 percentage of Participants Interval 0.0 to 5.2	0.0 percentage of Participants Interval 0.0 to 3.4	0.5 percentage of Participants Interval 0.0 to 2.6	1.5 percentage of Participants Interval 0.0 to 8.3	0.0 percentage of Participants Interval 0.0 to 5.6	0.8 percentage of Participants Interval 0.0 to 4.2
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 3 MAE	9.1 percentage of Participants Interval 1.1 to 29.2	27.3 percentage of Participants Interval 10.7 to 50.2	18.2 percentage of Participants Interval 8.2 to 32.7	13.5 percentage of Participants Interval 7.6 to 21.6	16.7 percentage of Participants Interval 10.2 to 25.1	15.1 percentage of Participants Interval 10.6 to 20.6	12.3 percentage of Participants Interval 5.5 to 22.8	20.3 percentage of Participants Interval 11.3 to 32.2	16.3 percentage of Participants Interval 10.4 to 23.8
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 3 NDCMC	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	0.0 percentage of Participants Interval 0.0 to 3.5	0.0 percentage of Participants Interval 0.0 to 3.4	0.0 percentage of Participants Interval 0.0 to 1.7	0.0 percentage of Participants Interval 0.0 to 5.5	0.0 percentage of Participants Interval 0.0 to 5.6	0.0 percentage of Participants Interval 0.0 to 2.8
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 3 IAE	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	0.0 percentage of Participants Interval 0.0 to 3.5	0.0 percentage of Participants Interval 0.0 to 5.1	0.5 percentage of Participants Interval 0.0 to 2.6	0.0 percentage of Participants Interval 0.0 to 5.5	0.0 percentage of Participants Interval 0.0 to 5.6	0.0 percentage of Participants Interval 0.0 to 2.8

PRIMARY outcome

Timeframe: within 30 Days after any Vaccination

Population: Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=22 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=22 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=44 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=110 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=110 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=220 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=66 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=66 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 n=132 Participants Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Any Vaccination AE	36.4 percentage of Participants Interval 17.2 to 59.3	63.6 percentage of Participants Interval 40.7 to 82.8	50.0 percentage of Participants Interval 34.6 to 65.4	54.5 percentage of Participants Interval 44.8 to 64.1	61.8 percentage of Participants Interval 52.1 to 70.9	58.2 percentage of Participants Interval 51.4 to 64.8	53.0 percentage of Participants Interval 40.3 to 65.4	54.5 percentage of Participants Interval 41.8 to 66.9	53.8 percentage of Participants Interval 44.9 to 62.5
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Any Vaccination SAE	0.0 percentage of Participants Interval 0.0 to 15.4	4.5 percentage of Participants Interval 0.1 to 22.8	2.3 percentage of Participants Interval 0.1 to 12.0	5.5 percentage of Participants Interval 2.0 to 11.5	1.8 percentage of Participants Interval 0.2 to 6.4	3.6 percentage of Participants Interval 1.6 to 7.0	4.5 percentage of Participants Interval 0.9 to 12.7	1.5 percentage of Participants Interval 0.0 to 8.2	3.0 percentage of Participants Interval 0.8 to 7.6
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Any Vaccination MAE	22.7 percentage of Participants Interval 7.8 to 45.4	40.9 percentage of Participants Interval 20.7 to 63.6	31.8 percentage of Participants Interval 18.6 to 47.6	32.7 percentage of Participants Interval 24.1 to 42.3	40.0 percentage of Participants Interval 30.8 to 49.8	36.4 percentage of Participants Interval 30.0 to 43.1	31.8 percentage of Participants Interval 20.9 to 44.4	39.4 percentage of Participants Interval 27.6 to 52.2	35.6 percentage of Participants Interval 27.5 to 44.4
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Any Vaccination NDCMC	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	0.0 percentage of Participants Interval 0.0 to 3.3	0.0 percentage of Participants Interval 0.0 to 3.3	0.0 percentage of Participants Interval 0.0 to 1.7	0.0 percentage of Participants Interval 0.0 to 5.4	0.0 percentage of Participants Interval 0.0 to 5.4	0.0 percentage of Participants Interval 0.0 to 2.8

PRIMARY outcome

Timeframe: From the Vaccination 1 up to 1 month after Vaccination 3

Population: Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=22 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=22 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=44 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=110 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=110 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=220 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=66 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=66 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 n=132 Participants Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase NDCMC	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 8.0	0.0 percentage of Participants Interval 0.0 to 3.3	0.0 percentage of Participants Interval 0.0 to 5.0	0.5 percentage of Participants Interval 0.0 to 2.5	0.0 percentage of Participants Interval 0.0 to 5.4	0.0 percentage of Participants Interval 0.0 to 5.4	0.0 percentage of Participants Interval 0.0 to 2.8
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase AE	54.5 percentage of Participants Interval 32.2 to 75.6	77.3 percentage of Participants Interval 54.6 to 92.2	65.9 percentage of Participants Interval 50.1 to 79.5	68.2 percentage of Participants Interval 58.6 to 76.7	71.8 percentage of Participants Interval 62.4 to 80.0	70.0 percentage of Participants Interval 63.5 to 76.0	65.2 percentage of Participants Interval 52.4 to 76.5	63.6 percentage of Participants Interval 50.9 to 75.1	64.4 percentage of Participants Interval 55.6 to 72.5
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase SAE	0.0 percentage of Participants Interval 0.0 to 15.4	9.1 percentage of Participants Interval 1.1 to 29.2	4.5 percentage of Participants Interval 0.6 to 15.5	10.9 percentage of Participants Interval 5.8 to 18.3	3.6 percentage of Participants Interval 1.0 to 9.0	7.3 percentage of Participants Interval 4.2 to 11.5	4.5 percentage of Participants Interval 0.9 to 12.7	6.1 percentage of Participants Interval 1.7 to 14.8	5.3 percentage of Participants Interval 2.2 to 10.6
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase MAE	36.4 percentage of Participants Interval 17.2 to 59.3	45.5 percentage of Participants Interval 24.4 to 67.8	40.9 percentage of Participants Interval 26.3 to 56.8	47.3 percentage of Participants Interval 37.7 to 57.0	54.5 percentage of Participants Interval 44.8 to 64.1	50.9 percentage of Participants Interval 44.1 to 57.7	42.4 percentage of Participants Interval 30.3 to 55.2	43.9 percentage of Participants Interval 31.7 to 56.7	43.2 percentage of Participants Interval 34.6 to 52.1

PRIMARY outcome

Timeframe: From 1 month after Vaccination 3 up to 6 months after Vaccination 3

Population: Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. Here "N" signifies number of participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=22 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=22 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=44 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=108 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=107 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=215 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=65 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=63 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 n=128 Participants Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Follow up Phase SAE	4.5 percentage of Participants Interval 0.1 to 22.8	9.1 percentage of Participants Interval 1.1 to 29.2	6.8 percentage of Participants Interval 1.4 to 18.7	0.9 percentage of Participants Interval 0.0 to 5.1	3.7 percentage of Participants Interval 1.0 to 9.3	2.3 percentage of Participants Interval 0.8 to 5.3	1.5 percentage of Participants Interval 0.0 to 8.3	1.6 percentage of Participants Interval 0.0 to 8.5	1.6 percentage of Participants Interval 0.2 to 5.5
Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Follow up Phase MAE	22.7 percentage of Participants Interval 7.8 to 45.4	40.9 percentage of Participants Interval 20.7 to 63.6	31.8 percentage of Participants Interval 18.6 to 47.6	29.6 percentage of Participants Interval 21.2 to 39.2	32.7 percentage of Participants Interval 24.0 to 42.5	31.2 percentage of Participants Interval 25.0 to 37.8	30.8 percentage of Participants Interval 19.9 to 43.4	28.6 percentage of Participants Interval 17.9 to 41.3	29.7 percentage of Participants Interval 21.9 to 38.4
Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Follow up Phase NDCMC	4.5 percentage of Participants Interval 0.1 to 22.8	0.0 percentage of Participants Interval 0.0 to 15.4	2.3 percentage of Participants Interval 0.1 to 12.0	0.0 percentage of Participants Interval 0.0 to 3.4	0.0 percentage of Participants Interval 0.0 to 3.4	0.0 percentage of Participants Interval 0.0 to 1.7	0.0 percentage of Participants Interval 0.0 to 5.5	0.0 percentage of Participants Interval 0.0 to 5.7	0.0 percentage of Participants Interval 0.0 to 2.8

PRIMARY outcome

Timeframe: From Vaccination 1 up to 6 months after Vaccination 3

Population: Safety population: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=22 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=22 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=44 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=110 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=110 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=220 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=66 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=66 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 n=132 Participants Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) From Vaccination 1 up to 6 Months After Vaccination 3 SAE	4.5 percentage of Participants Interval 0.1 to 22.8	13.6 percentage of Participants Interval 2.9 to 34.9	9.1 percentage of Participants Interval 2.5 to 21.7	10.9 percentage of Participants Interval 5.8 to 18.3	6.4 percentage of Participants Interval 2.6 to 12.7	8.6 percentage of Participants Interval 5.3 to 13.2	6.1 percentage of Participants Interval 1.7 to 14.8	6.1 percentage of Participants Interval 1.7 to 14.8	6.1 percentage of Participants Interval 2.7 to 11.6
Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) From Vaccination 1 up to 6 Months After Vaccination 3 MAE	54.5 percentage of Participants Interval 32.2 to 75.6	68.2 percentage of Participants Interval 45.1 to 86.1	61.4 percentage of Participants Interval 45.5 to 75.6	54.5 percentage of Participants Interval 44.8 to 64.1	62.7 percentage of Participants Interval 53.0 to 71.8	58.6 percentage of Participants Interval 51.8 to 65.2	59.1 percentage of Participants Interval 46.3 to 71.0	53.0 percentage of Participants Interval 40.3 to 65.4	56.1 percentage of Participants Interval 42.7 to 64.7
Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) From Vaccination 1 up to 6 Months After Vaccination 3 NDCMC	4.5 percentage of Participants Interval 0.1 to 22.8	0.0 percentage of Participants Interval 0.0 to 15.4	2.3 percentage of Participants Interval 0.1 to 12.0	0.0 percentage of Participants Interval 0.0 to 3.3	0.9 percentage of Participants Interval 0.0 to 5.0	0.5 percentage of Participants Interval 0.0 to 2.5	0.0 percentage of Participants Interval 0.0 to 5.4	0.0 percentage of Participants Interval 0.0 to 5.4	0.0 percentage of Participants Interval 0.0 to 2.8

SECONDARY outcome

Timeframe: 1, 6, 12, 24 months after Vaccination 3

Population: Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. Here N signifies number of participants evaluable for this outcome measure and "number analyzed" (n) signifies participants evaluable at specific rows.

Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44).

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=21 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=97 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=60 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3 PMB80 (A22) 1 Month after Vaccination 3	90.0 percentage of Participants Interval 68.3 to 98.8	89.6 percentage of Participants Interval 81.7 to 94.9	5.0 percentage of Participants Interval 1.0 to 13.9	—	—	—	—	—	—
Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3 PMB80 (A22): 6 Months after Vaccination 3	10.0 percentage of Participants Interval 1.2 to 31.7	12.4 percentage of Participants Interval 6.6 to 20.6	3.4 percentage of Participants Interval 0.4 to 11.9	—	—	—	—	—	—
Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3 PMB80 (A22): 12 Months after Vaccination 3	14.3 percentage of Participants Interval 3.0 to 36.3	6.3 percentage of Participants Interval 2.4 to 13.2	1.8 percentage of Participants Interval 0.0 to 9.7	—	—	—	—	—	—
Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3 PMB80 (A22): 24 Months after Vaccination 3	0.0 percentage of Participants Interval 0.0 to 17.6	3.7 percentage of Participants Interval 0.8 to 10.4	—	—	—	—	—	—	—
Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3 PMB2001 (A56): 1 Month after Vaccination 3	100.0 percentage of Participants Interval 82.4 to 100.0	100.0 percentage of Participants Interval 96.2 to 100.0	1.9 percentage of Participants Interval 0.0 to 9.9	—	—	—	—	—	—
Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3 PMB2001 (A56): 6 months after Vaccination 3	61.1 percentage of Participants Interval 35.7 to 82.7	59.1 percentage of Participants Interval 48.1 to 69.5	3.8 percentage of Participants Interval 0.5 to 13.2	—	—	—	—	—	—
Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3 PMB2001 (A56): 12 months after Vaccination 3	56.3 percentage of Participants Interval 29.9 to 80.2	38.7 percentage of Participants Interval 28.8 to 49.4	5.7 percentage of Participants Interval 1.2 to 15.7	—	—	—	—	—	—
Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3 PMB2001 (A56): 24 months after Vaccination 3	41.2 percentage of Participants Interval 18.4 to 67.1	22.8 percentage of Participants Interval 14.1 to 33.6	—	—	—	—	—	—	—
Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3 PMB2948 (B24): 1 Month after Vaccination 3	85.0 percentage of Participants Interval 62.1 to 96.8	71.6 percentage of Participants Interval 61.4 to 80.4	5.0 percentage of Participants Interval 1.0 to 13.9	—	—	—	—	—	—
Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3 PMB2948 (B24): 6 month after Vaccination 3	15.0 percentage of Participants Interval 3.2 to 37.9	10.3 percentage of Participants Interval 5.1 to 18.1	3.4 percentage of Participants Interval 0.4 to 11.9	—	—	—	—	—	—
Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3 PMB2948 (B24): 12 month after Vaccination 3	9.5 percentage of Participants Interval 1.2 to 30.4	3.2 percentage of Participants Interval 0.7 to 9.1	3.6 percentage of Participants Interval 0.4 to 12.5	—	—	—	—	—	—
Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3 PMB2948 (B24): 24 month after Vaccination 3	5.3 percentage of Participants Interval 0.1 to 26.0	3.7 percentage of Participants Interval 0.8 to 10.3	—	—	—	—	—	—	—
Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3 PMB2707 (B44): 1 Month after Vaccination 3	89.5 percentage of Participants Interval 66.9 to 98.7	86.2 percentage of Participants Interval 77.5 to 92.4	0.0 percentage of Participants Interval 0.0 to 6.6	—	—	—	—	—	—
Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3 PMB2707 (B44): 6 month after Vaccination 3	25.0 percentage of Participants Interval 7.3 to 52.4	40.4 percentage of Participants Interval 30.2 to 51.4	1.9 percentage of Participants Interval 0.0 to 10.1	—	—	—	—	—	—
Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3 PMB2707 (B44): 12 month after Vaccination 3	12.5 percentage of Participants Interval 1.6 to 38.3	17.8 percentage of Participants Interval 10.5 to 27.3	2.0 percentage of Participants Interval 0.0 to 10.4	—	—	—	—	—	—
Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3 PMB2707 (B44): 24 month after Vaccination 3	11.8 percentage of Participants Interval 1.5 to 36.4	12.5 percentage of Participants Interval 6.2 to 21.8	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 1 month (Mon) after Vaccination (Vac) 2

Population: Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. Here "N" signifies number of participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=10 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=10 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=19 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=47 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=50 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=95 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=30 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=29 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 n=59 Participants Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2 1 Mon after Vac2: PMB80[A22]	90.0 percentage of Participants Interval 55.5 to 99.7	66.7 percentage of Participants Interval 29.9 to 92.5	78.9 percentage of Participants Interval 54.4 to 93.9	64.4 percentage of Participants Interval 48.8 to 78.1	84.0 percentage of Participants Interval 70.9 to 92.8	74.7 percentage of Participants Interval 64.8 to 83.1	0.0 percentage of Participants Interval 0.0 to 11.6	3.4 percentage of Participants Interval 0.1 to 17.8	1.7 percentage of Participants Interval 0.0 to 9.1
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2 1Mon after Vac2:PMB2001[A56]	100.0 percentage of Participants Interval 66.4 to 100.0	90.0 percentage of Participants Interval 55.5 to 99.7	94.7 percentage of Participants Interval 74.0 to 99.9	100.0 percentage of Participants Interval 92.5 to 100.0	100.0 percentage of Participants Interval 92.6 to 100.0	100.0 percentage of Participants Interval 96.2 to 100.0	0.0 percentage of Participants Interval 0.0 to 14.8	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.8
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2 1Mon after Vac2:PMB2948[B24]	70.0 percentage of Participants Interval 34.8 to 93.3	44.4 percentage of Participants Interval 13.7 to 78.8	57.9 percentage of Participants Interval 33.5 to 79.7	23.8 percentage of Participants Interval 12.1 to 39.5	43.2 percentage of Participants Interval 28.3 to 59.0	33.7 percentage of Participants Interval 23.9 to 44.7	0.0 percentage of Participants Interval 0.0 to 11.6	3.4 percentage of Participants Interval 0.1 to 17.8	1.7 percentage of Participants Interval 0.0 to 9.1
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2 1Mon after Vac2:PMB2707[B44]	77.8 percentage of Participants Interval 40.0 to 97.2	60.0 percentage of Participants Interval 26.2 to 87.8	68.4 percentage of Participants Interval 43.4 to 87.4	72.3 percentage of Participants Interval 57.4 to 84.4	63.8 percentage of Participants Interval 48.5 to 77.3	68.1 percentage of Participants Interval 57.7 to 77.3	0.0 percentage of Participants Interval 0.0 to 14.8	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.8

SECONDARY outcome

Timeframe: Before Vaccination 1 (T1), 1 month after Vaccination 2 (T2), 1 month after Vaccination 3 (T3), 6 months after Vaccination 3 (T4), 12 months after Vaccination 3 (T5) and 24 months after Vaccination 3 (T6)

Population: Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. Here N signifies number of participants evaluable for this outcome measure and n signifies participants evaluable at specific rows.

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=10 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=11 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=21 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=47 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=51 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=97 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=31 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=30 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 n=61 Participants Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB2948 (B24)-1:128	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 28.5	0.0 percentage of Participants Interval 0.0 to 16.1	0.0 percentage of Participants Interval 0.0 to 7.7	0.0 percentage of Participants Interval 0.0 to 7.0	0.0 percentage of Participants Interval 0.0 to 3.7	0.0 percentage of Participants Interval 0.0 to 11.2	0.0 percentage of Participants Interval 0.0 to 11.6	0.0 percentage of Participants Interval 0.0 to 5.9
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB2707 (B44): 1:16	0.0 percentage of Participants Interval 0.0 to 33.6	14.3 percentage of Participants Interval 0.4 to 57.9	6.3 percentage of Participants Interval 0.2 to 30.2	16.3 percentage of Participants Interval 6.8 to 30.7	8.5 percentage of Participants Interval 2.4 to 20.4	12.2 percentage of Participants Interval 6.3 to 20.8	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 7.0
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB2707 (B44): 1:128	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 41.0	0.0 percentage of Participants Interval 0.0 to 20.6	0.0 percentage of Participants Interval 0.0 to 8.2	0.0 percentage of Participants Interval 0.0 to 7.5	0.0 percentage of Participants Interval 0.0 to 4.0	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 7.0
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T2: PMB2948 (B24)-1:64	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 17.6	2.4 percentage of Participants Interval 0.1 to 12.6	4.5 percentage of Participants Interval 0.6 to 15.5	3.5 percentage of Participants Interval 0.7 to 9.9	0.0 percentage of Participants Interval 0.0 to 11.6	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.1
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T2: PMB2948 (B24)-1:128	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 17.6	2.4 percentage of Participants Interval 0.1 to 12.6	0.0 percentage of Participants Interval 0.0 to 8.0	1.2 percentage of Participants Interval 0.0 to 6.3	0.0 percentage of Participants Interval 0.0 to 11.6	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.1
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T2: PMB2707 (B44)-1:4	77.8 percentage of Participants Interval 40.0 to 97.2	70.0 percentage of Participants Interval 34.8 to 93.3	73.7 percentage of Participants Interval 48.8 to 90.9	72.3 percentage of Participants Interval 57.4 to 84.4	63.8 percentage of Participants Interval 48.5 to 77.3	68.1 percentage of Participants Interval 57.7 to 77.3	0.0 percentage of Participants Interval 0.0 to 14.8	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.8
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T2: PMB2707 (B44)-1:16	77.8 percentage of Participants Interval 40.0 to 97.2	60.0 percentage of Participants Interval 26.2 to 87.8	68.4 percentage of Participants Interval 43.4 to 87.4	72.3 percentage of Participants Interval 57.4 to 84.4	61.7 percentage of Participants Interval 46.4 to 75.5	67.0 percentage of Participants Interval 56.6 to 76.4	0.0 percentage of Participants Interval 0.0 to 14.8	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.8
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T2: PMB2707 (B44)-1:32	55.6 percentage of Participants Interval 21.2 to 86.3	60.0 percentage of Participants Interval 26.2 to 87.8	57.9 percentage of Participants Interval 33.5 to 79.7	61.7 percentage of Participants Interval 46.4 to 75.5	51.1 percentage of Participants Interval 36.1 to 65.9	56.4 percentage of Participants Interval 45.8 to 66.6	0.0 percentage of Participants Interval 0.0 to 14.8	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.8
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T2: PMB2707 (B44)-1:64	33.3 percentage of Participants Interval 7.5 to 70.1	30.0 percentage of Participants Interval 6.7 to 65.2	31.6 percentage of Participants Interval 12.6 to 56.6	27.7 percentage of Participants Interval 15.6 to 42.6	21.3 percentage of Participants Interval 10.7 to 35.7	24.5 percentage of Participants Interval 16.2 to 34.4	0.0 percentage of Participants Interval 0.0 to 14.8	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.8
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T2: PMB2707 (B44)-1:128	11.1 percentage of Participants Interval 0.3 to 48.2	10.0 percentage of Participants Interval 0.3 to 44.5	10.5 percentage of Participants Interval 1.3 to 33.1	10.6 percentage of Participants Interval 3.5 to 23.1	10.6 percentage of Participants Interval 3.5 to 23.1	10.6 percentage of Participants Interval 5.2 to 18.7	0.0 percentage of Participants Interval 0.0 to 14.8	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.8
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T3: PMB80 (A22)-1:4	88.9 percentage of Participants Interval 51.8 to 99.7	90.9 percentage of Participants Interval 58.7 to 99.8	90.0 percentage of Participants Interval 68.3 to 98.8	91.1 percentage of Participants Interval 78.8 to 97.5	88.2 percentage of Participants Interval 76.1 to 95.6	89.6 percentage of Participants Interval 81.7 to 94.9	6.5 percentage of Participants Interval 0.8 to 21.4	6.9 percentage of Participants Interval 0.8 to 22.8	6.7 percentage of Participants Interval 1.8 to 16.2
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T3: PMB80 (A22)-1:8	88.9 percentage of Participants Interval 51.8 to 99.7	90.9 percentage of Participants Interval 58.7 to 99.8	90.0 percentage of Participants Interval 68.3 to 98.8	91.1 percentage of Participants Interval 78.8 to 97.5	88.2 percentage of Participants Interval 76.1 to 95.6	89.6 percentage of Participants Interval 81.7 to 94.9	6.5 percentage of Participants Interval 0.8 to 21.4	6.9 percentage of Participants Interval 0.8 to 22.8	6.7 percentage of Participants Interval 1.8 to 16.2
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T3: PMB80 (A22)-1:32	88.9 percentage of Participants Interval 51.8 to 99.7	81.8 percentage of Participants Interval 48.2 to 97.7	85.0 percentage of Participants Interval 62.1 to 96.8	82.2 percentage of Participants Interval 67.9 to 92.0	86.3 percentage of Participants Interval 73.7 to 94.3	84.4 percentage of Participants Interval 75.5 to 91.0	3.2 percentage of Participants Interval 0.1 to 16.7	3.4 percentage of Participants Interval 0.1 to 17.8	3.3 percentage of Participants Interval 0.4 to 11.5
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T3: PMB80 (A22)-1:64	66.7 percentage of Participants Interval 29.9 to 92.5	72.7 percentage of Participants Interval 39.0 to 94.0	70.0 percentage of Participants Interval 45.7 to 88.1	60.0 percentage of Participants Interval 44.3 to 74.3	72.5 percentage of Participants Interval 58.3 to 84.1	66.7 percentage of Participants Interval 56.3 to 76.0	3.2 percentage of Participants Interval 0.1 to 16.7	0.0 percentage of Participants Interval 0.0 to 11.9	1.7 percentage of Participants Interval 0.0 to 8.9
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T3: PMB80 (A22)-1:128	44.4 percentage of Participants Interval 13.7 to 78.8	54.5 percentage of Participants Interval 23.4 to 83.3	50.0 percentage of Participants Interval 27.2 to 72.8	37.8 percentage of Participants Interval 23.8 to 53.5	49.0 percentage of Participants Interval 34.8 to 63.4	43.8 percentage of Participants Interval 33.6 to 54.3	0.0 percentage of Participants Interval 0.0 to 11.2	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.0
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T3: PMB2001 (A56)-1:4	100.0 percentage of Participants Interval 66.4 to 100.0	100.0 percentage of Participants Interval 69.2 to 100.0	100.0 percentage of Participants Interval 82.4 to 100.0	100.0 percentage of Participants Interval 92.5 to 100.0	100.0 percentage of Participants Interval 92.6 to 100.0	100.0 percentage of Participants Interval 96.2 to 100.0	8.3 percentage of Participants Interval 1.0 to 27.0	10.0 percentage of Participants Interval 2.1 to 26.5	9.3 percentage of Participants Interval 3.1 to 20.3
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T3: PMB2001 (A56)-1:16	100.0 percentage of Participants Interval 66.4 to 100.0	100.0 percentage of Participants Interval 69.2 to 100.0	100.0 percentage of Participants Interval 82.4 to 100.0	97.9 percentage of Participants Interval 88.7 to 99.9	100.0 percentage of Participants Interval 92.6 to 100.0	98.9 percentage of Participants Interval 94.3 to 100.0	0.0 percentage of Participants Interval 0.0 to 14.2	3.3 percentage of Participants Interval 0.1 to 7.2	1.9 percentage of Participants Interval 0.0 to 9.9
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T3: PMB2001 (A56)-1:32	100.0 percentage of Participants Interval 66.4 to 100.0	90.0 percentage of Participants Interval 55.5 to 99.7	94.7 percentage of Participants Interval 74.0 to 99.9	97.9 percentage of Participants Interval 88.7 to 99.9	93.8 percentage of Participants Interval 82.8 to 98.7	95.8 percentage of Participants Interval 89.6 to 98.8	0.0 percentage of Participants Interval 0.0 to 14.2	3.3 percentage of Participants Interval 0.1 to 17.2	1.9 percentage of Participants Interval 0.0 to 9.9
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T3: PMB2001 (A56)-1:64	100.0 percentage of Participants Interval 66.4 to 100.0	80.0 percentage of Participants Interval 44.4 to 97.5	89.5 percentage of Participants Interval 66.9 to 98.7	93.6 percentage of Participants Interval 82.5 to 98.7	85.4 percentage of Participants Interval 72.2 to 93.9	89.5 percentage of Participants Interval 81.5 to 94.8	0.0 percentage of Participants Interval 0.0 to 14.2	0.0 percentage of Participants Interval 0.0 to 11.6	0.0 percentage of Participants Interval 0.0 to 6.6
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T3: PMB2001 (A56)-1:128	55.6 percentage of Participants Interval 21.2 to 86.3	80.0 percentage of Participants Interval 44.4 to 97.5	68.4 percentage of Participants Interval 43.4 to 87.4	89.4 percentage of Participants Interval 76.9 to 96.5	77.1 percentage of Participants Interval 62.7 to 88.0	83.2 percentage of Participants Interval 74.1 to 90.1	0.0 percentage of Participants Interval 0.0 to 14.2	0.0 percentage of Participants Interval 0.0 to 11.6	0.0 percentage of Participants Interval 0.0 to 6.6
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T3:PMB2948 (B24)-1:4	88.9 percentage of Participants Interval 51.8 to 99.7	81.8 percentage of Participants Interval 48.2 to 97.7	85.0 percentage of Participants Interval 62.1 to 96.8	71.1 percentage of Participants Interval 55.7 to 83.6	72.0 percentage of Participants Interval 57.5 to 83.8	71.6 percentage of Participants Interval 61.4 to 80.4	3.2 percentage of Participants Interval 0.1 to 16.7	6.9 percentage of Participants Interval 0.8 to 22.8	5.0 percentage of Participants Interval 1.0 to 13.9
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T3:PMB2948 (B24)-1:16	88.9 percentage of Participants Interval 51.8 to 99.7	63.6 percentage of Participants Interval 30.8 to 89.1	75.0 percentage of Participants Interval 50.9 to 91.3	66.7 percentage of Participants Interval 51.0 to 80.0	68.0 percentage of Participants Interval 53.3 to 80.5	67.4 percentage of Participants Interval 57.0 to 76.6	3.2 percentage of Participants Interval 0.1 to 16.7	6.9 percentage of Participants Interval 0.8 to 22.8	5.0 percentage of Participants Interval 1.0 to 13.9
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T3:PMB2948 (B24)-1:32	44.4 percentage of Participants Interval 13.7 to 78.8	36.4 percentage of Participants Interval 10.9 to 69.2	40.0 percentage of Participants Interval 19.1 to 63.9	37.8 percentage of Participants Interval 23.8 to 53.5	34.0 percentage of Participants Interval 21.2 to 48.8	35.8 percentage of Participants Interval 26.2 to 46.3	3.2 percentage of Participants Interval 0.1 to 16.7	0.0 percentage of Participants Interval 0.0 to 11.9	1.7 percentage of Participants Interval 0.0 to 8.9
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T3:PMB2948 (B24)-1:64	11.1 percentage of Participants Interval 0.3 to 48.2	18.2 percentage of Participants Interval 2.3 to 51.8	15.0 percentage of Participants Interval 3.2 to 37.9	17.8 percentage of Participants Interval 8.0 to 32.1	10.0 percentage of Participants Interval 3.3 to 21.8	13.7 percentage of Participants Interval 7.5 to 22.3	0.0 percentage of Participants Interval 0.0 to 11.2	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.0
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T3:PMB2948 (B24)-1:128	0.0 percentage of Participants Interval 0.0 to 33.6	9.1 percentage of Participants Interval 0.2 to 41.3	5.0 percentage of Participants Interval 0.1 to 24.9	2.2 percentage of Participants Interval 0.1 to 11.8	2.0 percentage of Participants Interval 0.1 to 10.6	2.1 percentage of Participants Interval 0.3 to 7.4	0.0 percentage of Participants Interval 0.0 to 11.2	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.0
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T3:PMB2707 (B44)-1:4	88.9 percentage of Participants Interval 51.8 to 99.7	90.0 percentage of Participants Interval 55.5 to 99.7	89.5 percentage of Participants Interval 66.9 to 98.7	87.2 percentage of Participants Interval 74.3 to 95.2	87.2 percentage of Participants Interval 74.3 to 95.2	87.2 percentage of Participants Interval 78.8 to 93.2	0.0 percentage of Participants Interval 0.0 to 14.2	0.0 percentage of Participants Interval 0.0 to 11.6	0.0 percentage of Participants Interval 0.0 to 6.6
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T3:PMB2707 (B44)-1:16	77.8 percentage of Participants Interval 40.0 to 97.2	90.0 percentage of Participants Interval 55.5 to 99.7	84.2 percentage of Participants Interval 60.4 to 96.6	87.2 percentage of Participants Interval 74.3 to 95.2	85.1 percentage of Participants Interval 71.7 to 93.8	86.2 percentage of Participants Interval 77.5 to 92.4	0.0 percentage of Participants Interval 0.0 to 14.2	0.0 percentage of Participants Interval 0.0 to 11.6	0.0 percentage of Participants Interval 0.0 to 6.6
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T3:PMB2707 (B44)-1:32	55.6 percentage of Participants Interval 21.2 to 86.3	70.0 percentage of Participants Interval 34.8 to 93.3	63.2 percentage of Participants Interval 38.4 to 83.7	74.5 percentage of Participants Interval 59.7 to 86.1	78.7 percentage of Participants Interval 64.3 to 89.3	76.6 percentage of Participants Interval 66.7 to 84.7	0.0 percentage of Participants Interval 0.0 to 14.2	0.0 percentage of Participants Interval 0.0 to 11.6	0.0 percentage of Participants Interval 0.0 to 6.6
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T3:PMB2707 (B44)-1:64	44.4 percentage of Participants Interval 13.7 to 78.8	30.0 percentage of Participants Interval 6.7 to 65.2	36.8 percentage of Participants Interval 16.3 to 61.6	57.4 percentage of Participants Interval 42.2 to 71.7	59.6 percentage of Participants Interval 44.3 to 73.6	58.5 percentage of Participants Interval 47.9 to 68.6	0.0 percentage of Participants Interval 0.0 to 14.2	0.0 percentage of Participants Interval 0.0 to 11.6	0.0 percentage of Participants Interval 0.0 to 6.6
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T3:PMB2707 (B44)-1:128	22.2 percentage of Participants Interval 2.8 to 60.0	20.0 percentage of Participants Interval 2.5 to 55.6	21.1 percentage of Participants Interval 6.1 to 45.6	29.8 percentage of Participants Interval 17.3 to 44.9	34.0 percentage of Participants Interval 20.9 to 49.3	31.9 percentage of Participants Interval 22.7 to 42.3	0.0 percentage of Participants Interval 0.0 to 14.2	0.0 percentage of Participants Interval 0.0 to 11.6	0.0 percentage of Participants Interval 0.0 to 6.6
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB80 (A22): 1: 4	20.0 percentage of Participants Interval 2.5 to 55.6	0.0 percentage of Participants Interval 0.0 to 30.8	10.0 percentage of Participants Interval 1.2 to 31.7	17.4 percentage of Participants Interval 7.8 to 31.4	7.8 percentage of Participants Interval 2.2 to 18.9	12.4 percentage of Participants Interval 6.6 to 20.6	0.0 percentage of Participants Interval 0.0 to 11.6	7.1 percentage of Participants Interval 0.9 to 23.5	3.4 percentage of Participants Interval 0.4 to 11.9
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB80 (A22): 1: 8	20.0 percentage of Participants Interval 2.5 to 55.6	0.0 percentage of Participants Interval 0.0 to 30.8	10.0 percentage of Participants Interval 1.2 to 31.7	17.4 percentage of Participants Interval 7.8 to 31.4	7.8 percentage of Participants Interval 2.2 to 18.9	12.4 percentage of Participants Interval 6.6 to 20.6	0.0 percentage of Participants Interval 0.0 to 11.6	7.1 percentage of Participants Interval 0.9 to 23.5	3.4 percentage of Participants Interval 0.4 to 11.9
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB80 (A22): 1: 16	20.0 percentage of Participants Interval 2.5 to 55.6	0.0 percentage of Participants Interval 0.0 to 30.8	10.0 percentage of Participants Interval 1.2 to 31.7	17.4 percentage of Participants Interval 7.8 to 31.4	7.8 percentage of Participants Interval 2.2 to 18.9	12.4 percentage of Participants Interval 6.6 to 20.6	0.0 percentage of Participants Interval 0.0 to 11.6	7.1 percentage of Participants Interval 0.9 to 23.5	3.4 percentage of Participants Interval 0.4 to 11.9
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB80 (A22): 1: 32	10.0 percentage of Participants Interval 0.3 to 44.5	0.0 percentage of Participants Interval 0.0 to 30.8	5.0 percentage of Participants Interval 0.1 to 24.9	15.2 percentage of Participants Interval 6.3 to 28.9	5.9 percentage of Participants Interval 1.2 to 16.2	10.3 percentage of Participants Interval 5.1 to 18.1	0.0 percentage of Participants Interval 0.0 to 11.6	3.6 percentage of Participants Interval 0.1 to 18.3	1.7 percentage of Participants Interval 0.0 to 9.2
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB80 (A22): 1: 64	10.0 percentage of Participants Interval 0.3 to 44.5	0.0 percentage of Participants Interval 0.0 to 30.8	5.0 percentage of Participants Interval 0.1 to 24.9	6.5 percentage of Participants Interval 1.4 to 17.9	2.0 percentage of Participants Interval 0.0 to 10.4	4.1 percentage of Participants Interval 1.1 to 10.2	0.0 percentage of Participants Interval 0.0 to 11.6	3.6 percentage of Participants Interval 0.1 to 18.3	1.7 percentage of Participants Interval 0.0 to 9.2
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB80 (A22): 1: 128	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 16.8	2.2 percentage of Participants Interval 0.1 to 11.5	2.0 percentage of Participants Interval 0.0 to 10.4	2.1 percentage of Participants Interval 0.3 to 7.3	0.0 percentage of Participants Interval 0.0 to 11.6	0.0 percentage of Participants Interval 0.0 to 12.3	0.0 percentage of Participants Interval 0.0 to 6.2
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB2001 (A56): 1:4	62.5 percentage of Participants Interval 24.5 to 91.5	80.0 percentage of Participants Interval 44.4 to 97.5	72.2 percentage of Participants Interval 46.5 to 90.3	65.9 percentage of Participants Interval 49.4 to 79.9	63.8 percentage of Participants Interval 48.5 to 77.3	64.8 percentage of Participants Interval 53.9 to 74.7	4.2 percentage of Participants Interval 0.1 to 21.1	3.6 percentage of Participants Interval 0.1 to 18.3	3.8 percentage of Participants Interval 0.5 to 13.2
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB2001 (A56): 1:8	37.5 percentage of Participants Interval 8.5 to 75.5	80.0 percentage of Participants Interval 44.4 to 97.5	61.1 percentage of Participants Interval 35.7 to 82.7	61.0 percentage of Participants Interval 44.5 to 75.8	57.4 percentage of Participants Interval 42.2 to 71.7	59.1 percentage of Participants Interval 48.1 to 69.5	4.2 percentage of Participants Interval 0.1 to 21.1	3.6 percentage of Participants Interval 0.1 to 18.3	3.8 percentage of Participants Interval 0.5 to 13.2
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB2001 (A56): 1:16	25.0 percentage of Participants Interval 3.2 to 65.1	80.0 percentage of Participants Interval 44.4 to 97.5	55.6 percentage of Participants Interval 30.8 to 78.5	58.5 percentage of Participants Interval 42.1 to 73.7	44.7 percentage of Participants Interval 30.2 to 59.9	51.1 percentage of Participants Interval 40.2 to 61.9	0.0 percentage of Participants Interval 0.0 to 14.2	3.6 percentage of Participants Interval 0.1 to 18.3	1.9 percentage of Participants Interval 0.0 to 10.3
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB2001 (A56): 1:32	25.0 percentage of Participants Interval 3.2 to 65.1	60.0 percentage of Participants Interval 26.2 to 87.8	44.5 percentage of Participants Interval 21.5 to 69.2	34.1 percentage of Participants Interval 20.1 to 50.6	31.9 percentage of Participants Interval 19.1 to 47.1	33.0 percentage of Participants Interval 23.3 to 43.8	0.0 percentage of Participants Interval 0.0 to 14.2	3.6 percentage of Participants Interval 0.1 to 18.3	1.9 percentage of Participants Interval 0.0 to 10.3
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB2001 (A56): 1:64	0.0 percentage of Participants Interval 0.0 to 36.9	40.0 percentage of Participants Interval 12.2 to 73.8	22.2 percentage of Participants Interval 6.4 to 47.6	14.6 percentage of Participants Interval 5.6 to 29.2	21.3 percentage of Participants Interval 10.7 to 35.7	18.2 percentage of Participants Interval 10.8 to 27.8	0.0 percentage of Participants Interval 0.0 to 14.2	3.6 percentage of Participants Interval 0.1 to 18.3	1.9 percentage of Participants Interval 0.0 to 10.3
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB2001 (A56): 1:128	0.0 percentage of Participants Interval 0.0 to 36.9	20.0 percentage of Participants Interval 2.5 to 55.6	11.1 percentage of Participants Interval 1.4 to 34.7	4.9 percentage of Participants Interval 0.6 to 16.5	8.5 percentage of Participants Interval 2.4 to 20.4	6.8 percentage of Participants Interval 2.5 to 14.3	0.0 percentage of Participants Interval 0.0 to 14.2	3.6 percentage of Participants Interval 0.1 to 18.3	1.9 percentage of Participants Interval 0.0 to 10.3
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB2948 (B24): 1: 4	20.0 percentage of Participants Interval 2.5 to 55.6	10.0 percentage of Participants Interval 0.3 to 44.5	15.0 percentage of Participants Interval 3.2 to 37.9	10.9 percentage of Participants Interval 3.6 to 23.6	15.7 percentage of Participants Interval 7.0 to 28.6	13.4 percentage of Participants Interval 7.3 to 21.8	3.3 percentage of Participants Interval 0.1 to 17.2	3.6 percentage of Participants Interval 0.1 to 18.3	3.4 percentage of Participants Interval 0.4 to 11.9
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB2948 (B24): 1: 8	20.0 percentage of Participants Interval 2.5 to 55.6	10.0 percentage of Participants Interval 0.3 to 44.5	15.0 percentage of Participants Interval 3.2 to 37.9	8.7 percentage of Participants Interval 2.4 to 20.8	11.8 percentage of Participants Interval 4.4 to 23.9	10.3 percentage of Participants Interval 5.1 to 18.1	3.3 percentage of Participants Interval 0.1 to 17.2	3.6 percentage of Participants Interval 0.1 to 18.3	3.4 percentage of Participants Interval 0.4 to 11.9
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB2948 (B24): 1: 16	10.0 percentage of Participants Interval 0.3 to 44.5	10.0 percentage of Participants Interval 0.3 to 44.5	10.0 percentage of Participants Interval 1.2 to 31.7	6.5 percentage of Participants Interval 1.4 to 17.9	11.8 percentage of Participants Interval 4.4 to 23.9	9.3 percentage of Participants Interval 4.3 to 16.9	0.0 percentage of Participants Interval 0.0 to 11.6	3.6 percentage of Participants Interval 0.1 to 18.3	1.7 percentage of Participants Interval 0.0 to 9.2
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB2948 (B24): 1: 32	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 16.8	0.0 percentage of Participants Interval 0.0 to 7.7	3.9 percentage of Participants Interval 0.5 to 13.5	2.1 percentage of Participants Interval 0.3 to 7.3	0.0 percentage of Participants Interval 0.0 to 11.6	3.6 percentage of Participants Interval 0.1 to 18.3	1.7 percentage of Participants Interval 0.0 to 9.2
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB2948 (B24): 1: 64	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 16.8	0.0 percentage of Participants Interval 0.0 to 7.7	2.0 percentage of Participants Interval 0.0 to 10.4	1.0 percentage of Participants Interval 0.0 to 5.6	0.0 percentage of Participants Interval 0.0 to 11.6	0.0 percentage of Participants Interval 0.0 to 12.3	0.0 percentage of Participants Interval 0.0 to 6.2
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB2948 (B24): 1: 128	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 16.8	0.0 percentage of Participants Interval 0.0 to 7.7	0.0 percentage of Participants Interval 0.0 to 7.0	0.0 percentage of Participants Interval 0.0 to 3.7	0.0 percentage of Participants Interval 0.0 to 11.6	0.0 percentage of Participants Interval 0.0 to 12.3	0.0 percentage of Participants Interval 0.0 to 6.2
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB2707 (B44): 1: 4	12.5 percentage of Participants Interval 0.3 to 52.7	37.5 percentage of Participants Interval 8.5 to 75.5	25.0 percentage of Participants Interval 7.3 to 52.4	44.2 percentage of Participants Interval 29.1 to 60.1	47.8 percentage of Participants Interval 32.9 to 63.1	46.1 percentage of Participants Interval 35.4 to 57.0	4.2 percentage of Participants Interval 0.1 to 21.1	0.0 percentage of Participants Interval 0.0 to 11.9	1.9 percentage of Participants Interval 0.0 to 10.1
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB2707 (B44): 1: 8	12.5 percentage of Participants Interval 0.3 to 52.7	37.5 percentage of Participants Interval 8.5 to 75.5	25.0 percentage of Participants Interval 7.3 to 52.4	39.5 percentage of Participants Interval 25.0 to 55.6	41.3 percentage of Participants Interval 27.0 to 56.8	40.4 percentage of Participants Interval 30.2 to 51.4	4.2 percentage of Participants Interval 0.1 to 21.1	0.0 percentage of Participants Interval 0.0 to 11.9	1.9 percentage of Participants Interval 0.0 to 10.1
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB2707 (B44): 1: 16	12.5 percentage of Participants Interval 0.3 to 52.7	25.0 percentage of Participants Interval 3.2 to 65.1	18.8 percentage of Participants Interval 4.0 to 45.6	34.9 percentage of Participants Interval 21.0 to 50.9	32.6 percentage of Participants Interval 19.5 to 48.0	33.7 percentage of Participants Interval 24.0 to 44.5	0.0 percentage of Participants Interval 0.0 to 14.2	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.7
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB2707 (B44): 1: 32	0.0 percentage of Participants Interval 0.0 to 36.9	12.5 percentage of Participants Interval 0.3 to 52.7	6.3 percentage of Participants Interval 0.2 to 30.2	11.6 percentage of Participants Interval 3.9 to 25.1	10.9 percentage of Participants Interval 3.6 to 23.6	11.2 percentage of Participants Interval 5.5 to 19.7	0.0 percentage of Participants Interval 0.0 to 14.2	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.7
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB2707 (B44): 1: 64	0.0 percentage of Participants Interval 0.0 to 36.9	12.5 percentage of Participants Interval 0.3 to 52.7	6.3 percentage of Participants Interval 0.2 to 30.2	9.3 percentage of Participants Interval 2.6 to 22.1	2.2 percentage of Participants Interval 0.1 to 11.5	5.6 percentage of Participants Interval 1.8 to 12.6	0.0 percentage of Participants Interval 0.0 to 14.2	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.7
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T4: PMB2707 (B44): 1: 128	0.0 percentage of Participants Interval 0.0 to 36.9	12.5 percentage of Participants Interval 0.3 to 52.7	6.3 percentage of Participants Interval 0.2 to 30.2	2.3 percentage of Participants Interval 0.1 to 12.3	0.0 percentage of Participants Interval 0.0 to 7.7	1.1 percentage of Participants Interval 0.0 to 6.1	0.0 percentage of Participants Interval 0.0 to 14.2	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.7
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB80 (A22): 1:4	10.0 percentage of Participants Interval 0.3 to 44.5	18.2 percentage of Participants Interval 2.3 to 51.8	14.3 percentage of Participants Interval 3.0 to 36.3	13.3 percentage of Participants Interval 5.1 to 26.8	6.0 percentage of Participants Interval 1.3 to 16.5	9.5 percentage of Participants Interval 4.4 to 17.2	3.7 percentage of Participants Interval 0.1 to 19.0	3.6 percentage of Participants Interval 0.1 to 18.3	3.6 percentage of Participants Interval 0.4 to 12.5
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB80 (A22): 1: 8	10.0 percentage of Participants Interval 0.3 to 44.5	18.2 percentage of Participants Interval 2.3 to 51.8	14.3 percentage of Participants Interval 3.0 to 36.3	11.1 percentage of Participants Interval 3.7 to 24.1	4.0 percentage of Participants Interval 0.5 to 13.7	7.4 percentage of Participants Interval 3.0 to 14.6	3.7 percentage of Participants Interval 0.1 to 19.0	0.0 percentage of Participants Interval 0.0 to 12.3	1.8 percentage of Participants Interval 0.0 to 9.7
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB80 (A22): 1: 16	10.0 percentage of Participants Interval 0.3 to 44.5	18.2 percentage of Participants Interval 2.3 to 51.8	14.3 percentage of Participants Interval 3.0 to 36.3	8.9 percentage of Participants Interval 2.5 to 21.2	4.0 percentage of Participants Interval 0.5 to 13.7	6.3 percentage of Participants Interval 2.4 to 13.22	3.7 percentage of Participants Interval 0.1 to 19.0	0.0 percentage of Participants Interval 0.0 to 12.3	1.8 percentage of Participants Interval 0.0 to 9.7
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB80 (A22): 1: 32	0.0 percentage of Participants Interval 0.0 to 30.8	9.1 percentage of Participants Interval 0.2 to 41.3	4.8 percentage of Participants Interval 0.1 to 23.8	4.4 percentage of Participants Interval 0.5 to 15.1	4.0 percentage of Participants Interval 0.5 to 13.7	4.2 percentage of Participants Interval 1.2 to 10.4	0.0 percentage of Participants Interval 0.0 to 12.8	0.0 percentage of Participants Interval 0.0 to 12.3	0.0 percentage of Participants Interval 0.0 to 6.5
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB80 (A22): 1: 64	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 28.5	0.0 percentage of Participants Interval 0.0 to 16.1	2.2 percentage of Participants Interval 0.1 to 11.8	2.0 percentage of Participants Interval 0.1 to 10.6	2.1 percentage of Participants Interval 0.3 to 7.4	0.0 percentage of Participants Interval 0.0 to 12.8	0.0 percentage of Participants Interval 0.0 to 12.3	0.0 percentage of Participants Interval 0.0 to 6.5
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB80 (A22): 1: 128	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 28.5	0.0 percentage of Participants Interval 0.0 to 16.1	0.0 percentage of Participants Interval 0.0 to 7.9	0.0 percentage of Participants Interval 0.0 to 7.1	0.0 percentage of Participants Interval 0.0 to 3.8	0.0 percentage of Participants Interval 0.0 to 12.8	0.0 percentage of Participants Interval 0.0 to 12.3	0.0 percentage of Participants Interval 0.0 to 6.5
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB2001 (A56): 1: 4	33.3 percentage of Participants Interval 7.5 to 70.1	85.7 percentage of Participants Interval 42.1 to 99.6	56.3 percentage of Participants Interval 29.9 to 80.2	53.3 percentage of Participants Interval 37.9 to 68.3	52.1 percentage of Participants Interval 37.2 to 66.7	52.7 percentage of Participants Interval 42.1 to 63.1	8.7 percentage of Participants Interval 1.1 to 28.0	10.0 percentage of Participants Interval 2.1 to 26.5	9.4 percentage of Participants Interval 3.1 to 20.7
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB2001 (A56): 1: 8	33.3 percentage of Participants Interval 7.5 to 70.1	85.7 percentage of Participants Interval 42.1 to 99.6	56.3 percentage of Participants Interval 29.9 to 80.2	40.0 percentage of Participants Interval 25.7 to 55.7	37.5 percentage of Participants Interval 24.0 to 52.6	38.7 percentage of Participants Interval 28.8 to 49.4	0.0 percentage of Participants Interval 0.0 to 14.8	10.0 percentage of Participants Interval 2.1 to 26.5	5.7 percentage of Participants Interval 1.2 to 15.7
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB2001 (A56): 1: 16	33.3 percentage of Participants Interval 7.5 to 70.1	85.7 percentage of Participants Interval 42.1 to 99.6	56.3 percentage of Participants Interval 29.9 to 80.2	26.7 percentage of Participants Interval 14.6 to 41.9	31.3 percentage of Participants Interval 18.7 to 46.3	29.0 percentage of Participants Interval 20.1 to 39.4	0.0 percentage of Participants Interval 0.0 to 14.8	10.0 percentage of Participants Interval 2.1 to 26.5	5.7 percentage of Participants Interval 1.2 to 15.7
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB2001 (A56): 1: 32	22.2 percentage of Participants Interval 2.8 to 60.0	71.4 percentage of Participants Interval 29.0 to 96.3	43.8 percentage of Participants Interval 19.8 to 70.1	17.8 percentage of Participants Interval 8.0 to 32.1	20.8 percentage of Participants Interval 10.5 to 35.0	19.4 percentage of Participants Interval 11.9 to 28.9	0.0 percentage of Participants Interval 0.0 to 14.8	10.0 percentage of Participants Interval 2.1 to 26.5	5.7 percentage of Participants Interval 1.2 to 15.7
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB2001 (A56): 1: 64	22.2 percentage of Participants Interval 2.8 to 60.0	42.9 percentage of Participants Interval 9.9 to 81.6	31.3 percentage of Participants Interval 11.0 to 58.7	8.9 percentage of Participants Interval 2.5 to 21.2	12.5 percentage of Participants Interval 4.7 to 25.2	10.8 percentage of Participants Interval 5.3 to 18.9	0.0 percentage of Participants Interval 0.0 to 14.8	6.7 percentage of Participants Interval 0.8 to 22.1	3.8 percentage of Participants Interval 0.5 to 13.0
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB2001 (A56): 1: 128	0.0 percentage of Participants Interval 0.0 to 33.6	28.6 percentage of Participants Interval 3.7 to 71.0	12.5 percentage of Participants Interval 1.6 to 38.3	4.4 percentage of Participants Interval 0.5 to 15.1	0.0 percentage of Participants Interval 0.0 to 7.4	2.2 percentage of Participants Interval 0.3 to 7.6	0.0 percentage of Participants Interval 0.0 to 14.8	3.3 percentage of Participants Interval 0.1 to 17.2	1.9 percentage of Participants Interval 0.0 to 10.1
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB2948 (B24): 1: 4	0.0 percentage of Participants Interval 0.0 to 30.8	27.3 percentage of Participants Interval 6.0 to 61.0	14.3 percentage of Participants Interval 3.0 to 36.3	2.3 percentage of Participants Interval 0.1 to 12.0	6.1 percentage of Participants Interval 1.3 to 16.9	4.3 percentage of Participants Interval 1.2 to 10.6	0.0 percentage of Participants Interval 0.0 to 12.8	7.1 percentage of Participants Interval 0.9 to 23.5	3.6 percentage of Participants Interval 0.4 to 12.5
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB2948 (B24): 1: 8	0.0 percentage of Participants Interval 0.0 to 30.8	18.2 percentage of Participants Interval 2.3 to 51.8	9.5 percentage of Participants Interval 1.2 to 30.4	2.3 percentage of Participants Interval 0.1 to 12.0	4.1 percentage of Participants Interval 0.5 to 14.0	3.2 percentage of Participants Interval 0.7 to 9.1	0.0 percentage of Participants Interval 0.0 to 12.8	7.1 percentage of Participants Interval 0.9 to 23.5	3.6 percentage of Participants Interval 0.4 to 12.5
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB2948 (B24): 1: 16	0.0 percentage of Participants Interval 0.0 to 30.8	18.2 percentage of Participants Interval 2.3 to 51.8	9.5 percentage of Participants Interval 1.2 to 30.4	0.0 percentage of Participants Interval 0.0 to 8.0	2.0 percentage of Participants Interval 0.1 to 10.9	1.1 percentage of Participants Interval 0.0 to 5.8	0.0 percentage of Participants Interval 0.0 to 12.8	7.1 percentage of Participants Interval 0.9 to 23.5	3.6 percentage of Participants Interval 0.4 to 12.5
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB2948 (B24): 1: 32	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 28.5	0.0 percentage of Participants Interval 0.0 to 16.1	0.0 percentage of Participants Interval 0.0 to 8.0	2.0 percentage of Participants Interval 0.1 to 10.9	1.1 percentage of Participants Interval 0.0 to 5.8	0.0 percentage of Participants Interval 0.0 to 12.8	3.6 percentage of Participants Interval 0.1 to 18.3	1.8 percentage of Participants Interval 0.0 to 9.7
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB2948 (B24): 1: 64	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 28.5	0.0 percentage of Participants Interval 0.0 to 16.1	0.0 percentage of Participants Interval 0.0 to 8.0	2.0 percentage of Participants Interval 0.1 to 10.9	1.1 percentage of Participants Interval 0.0 to 5.8	0.0 percentage of Participants Interval 0.0 to 12.8	3.6 percentage of Participants Interval 0.1 to 18.3	1.8 percentage of Participants Interval 0.0 to 9.7
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB2948 (B24): 1: 128	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 28.5	0.0 percentage of Participants Interval 0.0 to 16.1	0.0 percentage of Participants Interval 0.0 to 8.0	2.0 percentage of Participants Interval 0.1 to 10.9	1.1 percentage of Participants Interval 0.0 to 5.8	0.0 percentage of Participants Interval 0.0 to 12.8	0.0 percentage of Participants Interval 0.0 to 12.3	0.0 percentage of Participants Interval 0.0 to 6.5
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB2707 (B44): 1:4	11.1 percentage of Participants Interval 0.3 to 48.2	14.3 percentage of Participants Interval 0.4 to 57.9	12.5 percentage of Participants Interval 1.6 to 38.3	20.9 percentage of Participants Interval 10.0 to 36.0	21.3 percentage of Participants Interval 10.7 to 35.7	21.1 percentage of Participants Interval 13.2 to 31.0	4.5 percentage of Participants Interval 0.1 to 22.8	3.4 percentage of Participants Interval 0.1 to 17.8	3.9 percentage of Participants Interval 0.5 to 13.5
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB2707 (B44): 1:8	11.1 percentage of Participants Interval 0.3 to 48.2	14.3 percentage of Participants Interval 0.4 to 57.9	12.5 percentage of Participants Interval 1.6 to 38.3	18.6 percentage of Participants Interval 8.4 to 33.4	17.0 percentage of Participants Interval 7.6 to 30.8	17.8 percentage of Participants Interval 10.5 to 27.3	0.0 percentage of Participants Interval 0.0 to 15.4	3.4 percentage of Participants Interval 0.1 to 17.8	2.0 percentage of Participants Interval 0.0 to 10.4
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB2707 (B44): 1:32	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 41.0	0.0 percentage of Participants Interval 0.0 to 20.6	4.7 percentage of Participants Interval 0.6 to 15.8	4.3 percentage of Participants Interval 0.5 to 14.5	4.4 percentage of Participants Interval 1.2 to 11.0	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 7.0
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T5: PMB2707 (B44): 1:64	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 41.0	0.0 percentage of Participants Interval 0.0 to 20.6	2.3 percentage of Participants Interval 0.1 to 12.3	2.1 percentage of Participants Interval 0.1 to 11.3	2.2 percentage of Participants Interval 0.3 to 7.8	0.0 percentage of Participants Interval 0.0 to 15.4	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 7.0
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB80 (A22): 1:4	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 17.6	8.8 percentage of Participants Interval 1.9 to 23.7	2.1 percentage of Participants Interval 0.1 to 11.3	4.9 percentage of Participants Interval 1.4 to 12.2	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB80 (A22): 1:8	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 17.6	5.9 percentage of Participants Interval 0.7 to 19.7	2.1 percentage of Participants Interval 0.1 to 11.3	3.7 percentage of Participants Interval 0.8 to 10.4	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB80 (A22): 1:16	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 17.6	5.9 percentage of Participants Interval 0.7 to 19.7	2.1 percentage of Participants Interval 0.1 to 11.3	3.7 percentage of Participants Interval 0.8 to 10.4	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB80 (A22): 1:32	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 17.6	5.9 percentage of Participants Interval 0.7 to 19.7	2.1 percentage of Participants Interval 0.1 to 11.3	3.7 percentage of Participants Interval 0.8 to 10.4	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB80 (A22): 1:64	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 17.6	2.9 percentage of Participants Interval 0.1 to 15.3	2.1 percentage of Participants Interval 0.1 to 11.3	2.5 percentage of Participants Interval 0.3 to 8.6	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB80 (A22): 1:128	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 17.6	0.0 percentage of Participants Interval 0.0 to 10.3	0.0 percentage of Participants Interval 0.0 to 7.5	0.0 percentage of Participants Interval 0.0 to 4.5	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB2001 (A56): 1:4	22.2 percentage of Participants Interval 2.8 to 60.0	75.0 percentage of Participants Interval 34.9 to 96.8	47.1 percentage of Participants Interval 23.0 to 72.2	20.5 percentage of Participants Interval 9.3 to 36.5	30.0 percentage of Participants Interval 16.6 to 46.5	25.3 percentage of Participants Interval 16.2 to 36.4	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB2001 (A56): 1:8	11.1 percentage of Participants Interval 0.3 to 48.2	75.0 percentage of Participants Interval 34.9 to 96.8	41.2 percentage of Participants Interval 18.4 to 67.1	15.4 percentage of Participants Interval 5.9 to 30.5	30.0 percentage of Participants Interval 16.6 to 46.5	22.8 percentage of Participants Interval 14.1 to 33.6	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB2001 (A56): 1:16	11.1 percentage of Participants Interval 0.3 to 48.2	75.0 percentage of Participants Interval 34.9 to 96.8	41.2 percentage of Participants Interval 18.4 to 67.1	10.3 percentage of Participants Interval 2.9 to 24.2	27.5 percentage of Participants Interval 14.6 to 43.9	19.0 percentage of Participants Interval 11.0 to 29.4	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB2001 (A56): 1:32	11.1 percentage of Participants Interval 0.3 to 48.2	50.0 percentage of Participants Interval 15.7 to 84.3	29.4 percentage of Participants Interval 10.3 to 56.0	2.6 percentage of Participants Interval 0.1 to 13.5	12.5 percentage of Participants Interval 4.2 to 26.8	7.6 percentage of Participants Interval 2.8 to 15.8	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB2001 (A56): 1:64	11.1 percentage of Participants Interval 0.3 to 48.2	0.0 percentage of Participants Interval 0.0 to 36.9	5.9 percentage of Participants Interval 0.1 to 28.7	2.6 percentage of Participants Interval 0.1 to 13.5	7.5 percentage of Participants Interval 1.6 to 20.4	5.1 percentage of Participants Interval 1.4 to 12.5	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB2001 (A56): 1:128	11.1 percentage of Participants Interval 0.3 to 48.2	0.0 percentage of Participants Interval 0.0 to 36.9	5.9 percentage of Participants Interval 0.1 to 28.7	2.6 percentage of Participants Interval 0.1 to 13.5	5.0 percentage of Participants Interval 0.6 to 16.9	3.8 percentage of Participants Interval 0.8 to 10.7	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB2948 (B24): 1: 4	0.0 percentage of Participants Interval 0.0 to 30.8	11.1 percentage of Participants Interval 0.3 to 48.2	5.3 percentage of Participants Interval 0.1 to 26.0	8.8 percentage of Participants Interval 1.9 to 23.7	0.0 percentage of Participants Interval 0.0 to 7.4	3.7 percentage of Participants Interval 0.8 to 10.3	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB2948 (B24): 1: 8	0.0 percentage of Participants Interval 0.0 to 30.8	11.1 percentage of Participants Interval 0.3 to 48.2	5.3 percentage of Participants Interval 0.1 to 26.0	8.8 percentage of Participants Interval 1.9 to 23.7	0.0 percentage of Participants Interval 0.0 to 7.4	3.7 percentage of Participants Interval 0.8 to 10.3	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB2948 (B24): 1: 16	0.0 percentage of Participants Interval 0.0 to 30.8	11.1 percentage of Participants Interval 0.3 to 48.2	5.3 percentage of Participants Interval 0.1 to 26.0	5.9 percentage of Participants Interval 0.7 to 19.7	0.0 percentage of Participants Interval 0.0 to 7.4	2.4 percentage of Participants Interval 0.3 to 8.5	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB2948 (B24): 1: 32	0.0 percentage of Participants Interval 0.0 to 30.8	11.1 percentage of Participants Interval 0.3 to 48.2	5.3 percentage of Participants Interval 0.1 to 26.0	5.9 percentage of Participants Interval 0.7 to 19.7	0.0 percentage of Participants Interval 0.0 to 7.4	2.4 percentage of Participants Interval 0.3 to 8.5	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB2948 (B24): 1: 64	0.0 percentage of Participants Interval 0.0 to 30.8	11.1 percentage of Participants Interval 0.3 to 48.2	5.3 percentage of Participants Interval 0.1 to 26.0	5.9 percentage of Participants Interval 0.7 to 19.7	0.0 percentage of Participants Interval 0.0 to 7.4	2.4 percentage of Participants Interval 0.3 to 8.5	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB2948 (B24): 1: 128	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 17.6	2.9 percentage of Participants Interval 0.1 to 15.3	0.0 percentage of Participants Interval 0.0 to 7.4	1.2 percentage of Participants Interval 0.0 to 6.6	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB2707 (B44): 1: 4	0.0 percentage of Participants Interval 0.0 to 33.6	25.0 percentage of Participants Interval 3.2 to 65.1	11.8 percentage of Participants Interval 1.5 to 36.4	15.4 percentage of Participants Interval 5.9 to 30.5	12.2 percentage of Participants Interval 4.1 to 26.2	13.8 percentage of Participants Interval 7.1 to 23.3	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB80 [A22] - 1:4	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 28.5	0.0 percentage of Participants Interval 0.0 to 16.8	4.3 percentage of Participants Interval 0.5 to 14.8	3.9 percentage of Participants Interval 0.5 to 13.5	4.1 percentage of Participants Interval 1.1 to 10.2	0.0 percentage of Participants Interval 0.0 to 11.2	3.3 percentage of Participants Interval 0.1 to 17.2	1.6 percentage of Participants Interval 0.0 to 8.8
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB80 [A22] - 1:8	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 28.5	0.0 percentage of Participants Interval 0.0 to 16.8	2.2 percentage of Participants Interval 0.1 to 11.5	3.9 percentage of Participants Interval 0.5 to 13.5	3.1 percentage of Participants Interval 0.6 to 8.8	0.0 percentage of Participants Interval 0.0 to 11.2	3.3 percentage of Participants Interval 0.1 to 17.2	1.6 percentage of Participants Interval 0.0 to 8.8
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB80 [A22] - 1:16	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 28.5	0.0 percentage of Participants Interval 0.0 to 16.8	2.2 percentage of Participants Interval 0.1 to 11.5	3.9 percentage of Participants Interval 0.5 to 13.5	3.1 percentage of Participants Interval 0.6 to 8.8	0.0 percentage of Participants Interval 0.0 to 11.2	3.3 percentage of Participants Interval 0.1 to 17.2	1.6 percentage of Participants Interval 0.0 to 8.8
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB80 [A22] - 1:32	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 28.5	0.0 percentage of Participants Interval 0.0 to 16.8	2.2 percentage of Participants Interval 0.1 to 11.5	2.0 percentage of Participants Interval 0.0 to 10.4	2.1 percentage of Participants Interval 0.3 to 7.3	0.0 percentage of Participants Interval 0.0 to 11.2	0.0 percentage of Participants Interval 0.0 to 11.6	0.0 percentage of Participants Interval 0.0 to 5.9
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB80 [A22] - 1:64	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 28.5	0.0 percentage of Participants Interval 0.0 to 16.8	2.2 percentage of Participants Interval 0.1 to 11.5	0.0 percentage of Participants Interval 0.0 to 7.0	1.0 percentage of Participants Interval 0.0 to 5.6	0.0 percentage of Participants Interval 0.0 to 11.2	0.0 percentage of Participants Interval 0.0 to 11.6	0.0 percentage of Participants Interval 0.0 to 5.9
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB80 [A22] - 1:128	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 28.5	0.0 percentage of Participants Interval 0.0 to 16.8	2.2 percentage of Participants Interval 0.1 to 11.5	0.0 percentage of Participants Interval 0.0 to 7.0	1.0 percentage of Participants Interval 0.0 to 5.6	0.0 percentage of Participants Interval 0.0 to 11.2	0.0 percentage of Participants Interval 0.0 to 11.6	0.0 percentage of Participants Interval 0.0 to 5.9
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB2001 (A56)-1:4	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 17.6	0.0 percentage of Participants Interval 0.0 to 7.7	4.1 percentage of Participants Interval 0.5 to 14.0	2.1 percentage of Participants Interval 0.3 to 7.4	4.2 percentage of Participants Interval 0.1 to 21.1	0.0 percentage of Participants Interval 0.0 to 11.9	1.9 percentage of Participants Interval 0.0 to 10.1
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB2001 (A56)-1:8	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 17.6	0.0 percentage of Participants Interval 0.0 to 7.7	2.0 percentage of Participants Interval 0.1 to 10.9	1.1 percentage of Participants Interval 0.0 to 5.7	0.0 percentage of Participants Interval 0.0 to 14.2	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.7
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB2001 (A56)-1:16	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 17.6	0.0 percentage of Participants Interval 0.0 to 7.7	2.0 percentage of Participants Interval 0.1 to 10.9	1.1 percentage of Participants Interval 0.0 to 5.7	0.0 percentage of Participants Interval 0.0 to 14.2	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.7
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB2001 (A56)-1:32	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 17.6	0.0 percentage of Participants Interval 0.0 to 7.7	2.0 percentage of Participants Interval 0.1 to 10.9	1.1 percentage of Participants Interval 0.0 to 5.7	0.0 percentage of Participants Interval 0.0 to 14.2	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.7
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB2001 (A56)-1:64	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 17.6	0.0 percentage of Participants Interval 0.0 to 7.7	0.0 percentage of Participants Interval 0.0 to 7.3	0.0 percentage of Participants Interval 0.0 to 3.8	0.0 percentage of Participants Interval 0.0 to 14.2	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.7
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB2001 (A56)-1:128	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 17.6	0.0 percentage of Participants Interval 0.0 to 7.7	0.0 percentage of Participants Interval 0.0 to 7.3	0.0 percentage of Participants Interval 0.0 to 3.8	0.0 percentage of Participants Interval 0.0 to 14.2	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.7
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB2948 (B24)-1:4	0.0 percentage of Participants Interval 0.0 to 30.8	9.1 percentage of Participants Interval 0.2 to 41.3	4.8 percentage of Participants Interval 0.1 to 23.8	2.2 percentage of Participants Interval 0.1 to 11.5	2.0 percentage of Participants Interval 0.0 to 10.4	2.1 percentage of Participants Interval 0.3 to 7.3	0.0 percentage of Participants Interval 0.0 to 11.2	3.3 percentage of Participants Interval 0.1 to 17.2	1.6 percentage of Participants Interval 0.0 to 8.8
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB2948 (B24)-1:8	0.0 percentage of Participants Interval 0.0 to 30.8	9.1 percentage of Participants Interval 0.2 to 41.3	4.8 percentage of Participants Interval 0.1 to 23.8	2.2 percentage of Participants Interval 0.1 to 11.5	2.0 percentage of Participants Interval 0.0 to 10.4	2.1 percentage of Participants Interval 0.3 to 7.3	0.0 percentage of Participants Interval 0.0 to 11.2	3.3 percentage of Participants Interval 0.1 to 17.2	1.6 percentage of Participants Interval 0.0 to 8.8
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB2948 (B24)-1:16	0.0 percentage of Participants Interval 0.0 to 30.8	9.1 percentage of Participants Interval 0.2 to 41.3	4.8 percentage of Participants Interval 0.1 to 23.8	2.2 percentage of Participants Interval 0.1 to 11.5	2.0 percentage of Participants Interval 0.0 to 10.4	2.1 percentage of Participants Interval 0.3 to 7.3	0.0 percentage of Participants Interval 0.0 to 11.2	3.3 percentage of Participants Interval 0.1 to 17.2	1.6 percentage of Participants Interval 0.0 to 8.8
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB2948 (B24)-1:32	0.0 percentage of Participants Interval 0.0 to 30.8	9.1 percentage of Participants Interval 0.2 to 14.3	4.8 percentage of Participants Interval 0.1 to 23.8	0.0 percentage of Participants Interval 0.0 to 7.7	0.0 percentage of Participants Interval 0.0 to 7.0	0.0 percentage of Participants Interval 0.0 to 3.7	0.0 percentage of Participants Interval 0.0 to 11.2	3.3 percentage of Participants Interval 0.1 to 17.2	1.6 percentage of Participants Interval 0.0 to 8.8
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB2948 (B24)-1:64	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 28.5	0.0 percentage of Participants Interval 0.0 to 16.1	0.0 percentage of Participants Interval 0.0 to 7.7	0.0 percentage of Participants Interval 0.0 to 7.0	0.0 percentage of Participants Interval 0.0 to 3.7	0.0 percentage of Participants Interval 0.0 to 11.2	3.3 percentage of Participants Interval 0.1 to 17.2	1.6 percentage of Participants Interval 0.0 to 8.8
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB2707 (B44)-1:4	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 17.6	2.2 percentage of Participants Interval 0.1 to 11.5	0.0 percentage of Participants Interval 0.0 to 7.3	1.1 percentage of Participants Interval 0.0 to 5.7	0.0 percentage of Participants Interval 0.0 to 14.2	0.0 percentage of Participants Interval 0.0 to 11.6	0.0 percentage of Participants Interval 0.0 to 6.6
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB2707 (B44)-1:8	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 17.6	2.2 percentage of Participants Interval 0.1 to 11.5	0.0 percentage of Participants Interval 0.0 to 7.3	1.1 percentage of Participants Interval 0.0 to 5.7	0.0 percentage of Participants Interval 0.0 to 14.2	0.0 percentage of Participants Interval 0.0 to 11.6	0.0 percentage of Participants Interval 0.0 to 6.6
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB2707 (B44)-1:16	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 17.6	0.0 percentage of Participants Interval 0.0 to 7.7	0.0 percentage of Participants Interval 0.0 to 7.3	0.0 percentage of Participants Interval 0.0 to 3.8	0.0 percentage of Participants Interval 0.0 to 14.2	0.0 percentage of Participants Interval 0.0 to 11.6	0.0 percentage of Participants Interval 0.0 to 6.6
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB2707 (B44)-1:32	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 17.6	0.0 percentage of Participants Interval 0.0 to 7.7	0.0 percentage of Participants Interval 0.0 to 7.3	0.0 percentage of Participants Interval 0.0 to 3.8	0.0 percentage of Participants Interval 0.0 to 14.2	0.0 percentage of Participants Interval 0.0 to 11.6	0.0 percentage of Participants Interval 0.0 to 6.6
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB2707 (B44)-1:64	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 17.6	0.0 percentage of Participants Interval 0.0 to 7.7	0.0 percentage of Participants Interval 0.0 to 7.3	0.0 percentage of Participants Interval 0.0 to 3.8	0.0 percentage of Participants Interval 0.0 to 14.2	0.0 percentage of Participants Interval 0.0 to 11.6	0.0 percentage of Participants Interval 0.0 to 6.6
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T1: PMB2707 (B44)-1:128	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 30.8	0.0 percentage of Participants Interval 0.0 to 17.6	0.0 percentage of Participants Interval 0.0 to 7.7	0.0 percentage of Participants Interval 0.0 to 7.3	0.0 percentage of Participants Interval 0.0 to 3.8	0.0 percentage of Participants Interval 0.0 to 14.2	0.0 percentage of Participants Interval 0.0 to 11.6	0.0 percentage of Participants Interval 0.0 to 6.6
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T2: PMB80 [A22] - 1:4	90.0 percentage of Participants Interval 55.5 to 99.7	66.7 percentage of Participants Interval 29.9 to 92.5	78.9 percentage of Participants Interval 54.4 to 93.9	64.4 percentage of Participants Interval 48.8 to 78.1	86.0 percentage of Participants Interval 73.3 to 94.2	75.8 percentage of Participants Interval 65.9 to 84.0	0.0 percentage of Participants Interval 0.0 to 11.6	3.4 percentage of Participants Interval 0.1 to 17.8	1.7 percentage of Participants Interval 0.0 to 9.1
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T2: PMB80 [A22] - 1:8	90.0 percentage of Participants Interval 55.5 to 99.7	66.7 percentage of Participants Interval 29.9 to 92.5	78.9 percentage of Participants Interval 54.4 to 93.9	64.4 percentage of Participants Interval 48.8 to 78.1	86.0 percentage of Participants Interval 73.3 to 94.2	75.8 percentage of Participants Interval 65.9 to 84.0	0.0 percentage of Participants Interval 0.0 to 11.6	3.4 percentage of Participants Interval 0.1 to 17.8	1.7 percentage of Participants Interval 0.0 to 9.1
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T2: PMB80 [A22] - 1:32	80.0 percentage of Participants Interval 44.4 to 97.5	44.4 percentage of Participants Interval 13.7 to 78.8	63.2 percentage of Participants Interval 38.4 to 83.7	51.1 percentage of Participants Interval 35.8 to 66.3	66.0 percentage of Participants Interval 51.2 to 78.8	58.9 percentage of Participants Interval 48.4 to 68.9	0.0 percentage of Participants Interval 0.0 to 11.6	3.4 percentage of Participants Interval 0.1 to 17.8	1.7 percentage of Participants Interval 0.0 to 9.1
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB2707 (B44): 1: 8	0.0 percentage of Participants Interval 0.0 to 33.6	25.0 percentage of Participants Interval 3.2 to 65.1	11.8 percentage of Participants Interval 1.5 to 36.4	12.8 percentage of Participants Interval 4.3 to 27.4	12.2 percentage of Participants Interval 4.1 to 26.2	12.5 percentage of Participants Interval 6.2 to 21.8	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB2707 (B44): 1: 16	0.0 percentage of Participants Interval 0.0 to 33.6	12.5 percentage of Participants Interval 0.3 to 52.7	5.9 percentage of Participants Interval 0.1 to 28.7	7.7 percentage of Participants Interval 1.6 to 20.9	9.8 percentage of Participants Interval 2.7 to 23.1	8.8 percentage of Participants Interval 3.6 to 17.2	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB2707 (B44): 1: 32	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 36.9	0.0 percentage of Participants Interval 0.0 to 19.5	5.1 percentage of Participants Interval 0.6 to 17.3	2.4 percentage of Participants Interval 0.1 to 12.9	3.8 percentage of Participants Interval 0.8 to 10.6	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB2707 (B44): 1: 64	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 36.9	0.0 percentage of Participants Interval 0.0 to 19.5	0.0 percentage of Participants Interval 0.0 to 9.0	2.4 percentage of Participants Interval 0.1 to 12.9	1.3 percentage of Participants Interval 0.0 to 6.8	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T6: PMB2707 (B44): 1: 128	0.0 percentage of Participants Interval 0.0 to 33.6	0.0 percentage of Participants Interval 0.0 to 36.9	0.0 percentage of Participants Interval 0.0 to 19.5	0.0 percentage of Participants Interval 0.0 to 9.0	2.4 percentage of Participants Interval 0.1 to 12.9	1.3 percentage of Participants Interval 0.0 to 6.8	—	—	—
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T2: PMB80 [A22] - 1:64	50.0 percentage of Participants Interval 18.7 to 81.3	22.2 percentage of Participants Interval 2.8 to 60.0	36.8 percentage of Participants Interval 16.3 to 61.6	28.9 percentage of Participants Interval 16.4 to 44.3	40.0 percentage of Participants Interval 26.4 to 54.8	34.7 percentage of Participants Interval 25.3 to 45.2	0.0 percentage of Participants Interval 0.0 to 11.6	3.4 percentage of Participants Interval 0.1 to 17.8	1.7 percentage of Participants Interval 0.0 to 9.1
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T2: PMB80 [A22] - 1:128	20.0 percentage of Participants Interval 2.5 to 55.6	22.2 percentage of Participants Interval 2.8 to 60.0	21.1 percentage of Participants Interval 6.1 to 45.6	11.1 percentage of Participants Interval 3.7 to 24.1	16.0 percentage of Participants Interval 7.2 to 29.1	13.7 percentage of Participants Interval 7.5 to 22.3	0.0 percentage of Participants Interval 0.0 to 11.6	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.1
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T2: PMB2001 [A56]- 1:4	100.0 percentage of Participants Interval 66.4 to 100.0	100.0 percentage of Participants Interval 69.2 to 100.0	100.0 percentage of Participants Interval 82.4 to 100.0	100.0 percentage of Participants Interval 92.5 to 100.0	100.0 percentage of Participants Interval 92.6 to 100.0	100.0 percentage of Participants Interval 96.2 to 100.0	4.3 percentage of Participants Interval 0.1 to 21.9	0.0 percentage of Participants Interval 0.0 to 11.9	1.9 percentage of Participants Interval 0.0 to 10.3
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T2: PMB2001 [A56]- 1:16	100.0 percentage of Participants Interval 66.4 to 100.0	90.0 percentage of Participants Interval 55.5 to 99.7	94.7 percentage of Participants Interval 74.0 to 99.9	100.0 percentage of Participants Interval 92.5 to 100.0	100.0 percentage of Participants Interval 92.6 to 100.0	100.0 percentage of Participants Interval 96.2 to 100.0	0.0 percentage of Participants Interval 0.0 to 14.8	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.8
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T2: PMB2001 [A56]- 1:32	100.0 percentage of Participants Interval 66.4 to 100.0	90.0 percentage of Participants Interval 55.5 to 99.7	94.7 percentage of Participants Interval 74.0 to 99.9	95.7 percentage of Participants Interval 85.5 to 99.5	95.8 percentage of Participants Interval 85.7 to 99.5	95.8 percentage of Participants Interval 89.6 to 98.8	0.0 percentage of Participants Interval 0.0 to 14.8	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.8
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T2:PMB2001 [A56]- 1:64	100.0 percentage of Participants Interval 66.4 to 100.0	70.0 percentage of Participants Interval 34.8 to 93.3	84.2 percentage of Participants Interval 60.4 to 96.6	87.2 percentage of Participants Interval 74.3 to 95.2	85.4 percentage of Participants Interval 72.2 to 93.9	86.3 percentage of Participants Interval 77.7 to 92.5	0.0 percentage of Participants Interval 0.0 to 14.8	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.8
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T2:PMB2001 [A56]-1:128	44.4 percentage of Participants Interval 13.7 to 78.8	50.0 percentage of Participants Interval 18.7 to 81.3	47.4 percentage of Participants Interval 24.4 to 71.1	59.6 percentage of Participants Interval 44.3 to 73.6	54.2 percentage of Participants Interval 39.2 to 68.8	56.8 percentage of Participants Interval 46.3 to 67.0	0.0 percentage of Participants Interval 0.0 to 14.8	0.0 percentage of Participants Interval 0.0 to 11.9	0.0 percentage of Participants Interval 0.0 to 6.8
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T2: PMB2948 (B24)-1:4	70.0 percentage of Participants Interval 34.8 to 93.3	44.4 percentage of Participants Interval 13.7 to 78.8	57.9 percentage of Participants Interval 33.5 to 79.7	28.6 percentage of Participants Interval 15.7 to 44.6	43.2 percentage of Participants Interval 28.3 to 59.0	36.0 percentage of Participants Interval 26.0 to 47.1	0.0 percentage of Participants Interval 0.0 to 11.6	3.4 percentage of Participants Interval 0.1 to 17.8	1.7 percentage of Participants Interval 0.0 to 9.1
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T2: PMB2948 (B24)-1:16	60.0 percentage of Participants Interval 26.2 to 87.8	33.3 percentage of Participants Interval 7.5 to 70.1	47.4 percentage of Participants Interval 24.4 to 71.7	21.4 percentage of Participants Interval 10.3 to 36.8	43.2 percentage of Participants Interval 28.3 to 59.0	32.6 percentage of Participants Interval 22.8 to 43.5	0.0 percentage of Participants Interval 0.0 to 11.6	3.4 percentage of Participants Interval 0.1 to 17.8	1.7 percentage of Participants Interval 0.0 to 9.1
Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains T2: PMB2948 (B24)-1:32	10.0 percentage of Participants Interval 0.3 to 44.5	0.0 percentage of Participants Interval 0.0 to 33.6	5.3 percentage of Participants Interval 0.1 to 26.0	9.5 percentage of Participants Interval 2.7 to 22.6	18.2 percentage of Participants Interval 8.2 to 32.7	14.0 percentage of Participants Interval 7.4 to 23.1	0.0 percentage of Participants Interval 0.0 to 11.6	3.4 percentage of Participants Interval 0.1 to 17.8	1.7 percentage of Participants Interval 0.0 to 9.1

SECONDARY outcome

Population: Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. Here N signifies number of participants evaluable for this outcome measure and n signifies participants evaluable at specific rows.

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=10 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=11 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=21 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) n=47 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=51 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=97 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) n=31 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) n=30 Participants Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 n=61 Participants Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T4: PMB2948 (B24)	4.9 titer Interval 3.5 to 6.9	4.6 titer Interval 3.4 to 6.3	4.8 titer Interval 3.9 to 5.9	4.4 titer Interval 4.0 to 4.9	4.9 titer Interval 4.2 to 5.8	4.7 titer Interval 4.2 to 5.2	4.1 titer Interval 3.9 to 4.3	4.3 titer Interval 3.7 to 5.0	4.2 titer Interval 3.9 to 4.5
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T5: PMB2707 (B44)	4.3 titer Interval 3.6 to 5.2	4.9 titer Interval 3.0 to 7.9	4.6 titer Interval 3.7 to 5.6	5.3 titer Interval 4.4 to 6.6	5.0 titer Interval 4.2 to 5.9	5.2 titer Interval 4.5 to 5.9	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.1 titer Interval 3.9 to 4.3	4.1 titer Interval 3.9 to 4.2
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T2: PMB2001 (A56)	101.6 titer Interval 64.0 to 161.2	68.6 titer Interval 28.2 to 166.8	82.6 titer Interval 51.4 to 129.9	117.2 titer Interval 89.7 to 153.0	104.6 titer Interval 80.4 to 136.0	110.6 titer Interval 92.0 to 133.0	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.0 titer CI was not estimable due to the lack of variability of geometric means.
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T4: PMB2707 (B44)	4.8 titer Interval 3.2 to 7.2	8.7 titer Interval 2.6 to 29.5	6.4 titer Interval 3.6 to 11.5	7.9 titer Interval 5.8 to 10.6	7.3 titer Interval 5.7 to 9.3	7.6 titer Interval 6.3 to 9.1	4.1 titer Interval 3.9 to 4.4	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.1 titer Interval 3.9 to 4.2
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T5: PMB80 (A22)	8.6 titer Interval 7.3 to 10.0	9.7 titer Interval 7.2 to 13.1	9.1 titer Interval 7.8 to 10.7	8.9 titer Interval 7.9 to 10.0	8.6 titer Interval 7.8 to 9.5	8.7 titer Interval 8.1 to 9.4	8.2 titer Interval 7.8 to 8.7	8.0 titer CI was not estimable due to the lack of variability of geometric means.	8.1 titer Interval 7.9 to 8.3
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T5: PMB2001 (A56)	8.6 titer Interval 3.4 to 22.1	35.3 titer Interval 11.3 to 110.1	16.0 titer Interval 7.6 to 33.5	7.9 titer Interval 5.8 to 10.7	8.1 titer Interval 6.0 to 11.0	8.0 titer Interval 6.5 to 9.9	4.0 titer CI was not estimable due to the lack of variability of geometric means.	5.3 titer Interval 3.8 to 7.3	4.7 titer Interval 3.9 to 5.6
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T5: PMB2948 (B24)	4.0 titer CI was not estimable due to the lack of variability of geometric means.	5.1 titer Interval 3.5 to 7.5	4.6 titer Interval 3.8 to 5.5	4.1 titer Interval 3.9 to 4.2	4.4 titer Interval 3.8 to 5.0	4.2 titer Interval 3.9 to 4.5	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.6 titer Interval 3.7 to 5.8	4.3 titer Interval 3.9 to 4.8
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T1:PMB80 (A22)	8.0 titer CI was not estimable due to the lack of variability of geometric means.	8.0 titer CI was not estimable due to the lack of variability of geometric means.	8.0 titer CI was not estimable due to the lack of variability of geometric means.	8.5 titer Interval 7.5 to 9.6	8.3 titer Interval 7.8 to 8.9	8.4 titer Interval 7.9 to 9.0	8.0 titer CI was not estimable due to the lack of variability of geometric means.	8.2 titer Interval 7.8 to 8.6	8.1 titer Interval 7.9 to 8.3
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T1: PMB2001 (A56)	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.2 titer Interval 3.8 to 4.5	4.1 titer Interval 3.9 to 4.3	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.0 titer CI was not estimable due to the lack of variability of geometric means.
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T1: PMB2948 (B24)	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.8 titer Interval 3.2 to 7.4	4.4 titer Interval 3.6 to 5.4	4.1 titer Interval 3.9 to 4.4	4.1 titer Interval 3.9 to 4.3	4.1 titer Interval 4.0 to 4.3	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.4 titer Interval 3.6 to 5.3	4.2 titer Interval 3.8 to 4.6
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T1: PMB2707 (B44)	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.1 titer Interval 3.9 to 4.2	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.0 titer Interval 4.0 to 4.1	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.0 titer CI was not estimable due to the lack of variability of geometric means.
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T2: PMB80 (A22)	42.2 titer Interval 22.6 to 79.1	23.5 titer Interval 10.1 to 54.9	32.0 titer Interval 19.7 to 52.0	24.6 titer Interval 17.8 to 34.2	36.8 titer Interval 26.9 to 50.3	30.4 titer Interval 24.3 to 38.1	8.0 titer CI was not estimable due to the lack of variability of geometric means.	8.6 titer Interval 7.4 to 10.0	8.3 titer Interval 7.7 to 8.9
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T2: PMB2948 (B24)	10.6 titer Interval 6.2 to 18.0	6.9 titer Interval 4.1 to 11.5	8.6 titer Interval 6.1 to 12.2	6.0 titer Interval 4.7 to 7.8	8.5 titer Interval 6.4 to 11.3	7.2 titer Interval 5.9 to 8.7	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.3 titer Interval 3.7 to 5.0	4.1 titer Interval 3.9 to 4.4
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T2: PMB2707 (B44)	23.5 titer Interval 9.3 to 59.4	21.1 titer Interval 6.5 to 68.3	22.2 titer Interval 11.2 to 43.9	22.1 titer Interval 15.5 to 31.6	17.0 titer Interval 11.8 to 24.4	19.4 titer Interval 15.1 to 24.9	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.0 titer CI was not estimable due to the lack of variability of geometric means.	40 titer CI was not estimable due to the lack of variability of geometric means.
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T3: PMB80 (A22)	80.6 titer Interval 30.9 to 210.7	82.3 titer Interval 36.5 to 185.8	81.6 titer Interval 46.6 to 142.8	63.0 titer Interval 44.5 to 89.3	71.4 titer Interval 52.7 to 96.6	67.3 titer Interval 53.7 to 84.3	8.6 titer Interval 7.5 to 9.8	8.6 titer Interval 7.7 to 9.6	8.6 titer Interval 7.9 to 9.3
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T3: PMB2001 (A56)	109.7 titer Interval 70.4 to 171.1	181.0 titer Interval 68.6 to 477.9	142.8 titer Interval 85.5 to 238.6	190.6 titer Interval 146.9 to 247.4	154.4 titer Interval 116.3 to 205.1	171.4 titer Interval 141.6 to 207.4	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.3 titer Interval 3.7 to 4.9	4.2 titer Interval 3.8 to 4.5
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T3: PMB2948 (B24)	20.2 titer Interval 11.1 to 36.6	17.0 titer Interval 8.2 to 35.5	18.4 titer Interval 11.8 to 28.6	15.8 titer Interval 11.4 to 21.8	14.5 titer Interval 11.1 to 19.1	15.1 titer Interval 12.3 to 18.6	4.3 titer Interval 3.7 to 4.9	4.4 titer Interval 3.8 to 5.0	4.3 titer Interval 3.9 to 4.8
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T3: PMB2707 (B44)	29.6 titer Interval 11.6 to 75.8	34.3 titer Interval 15.0 to 78.2	32.0 titer Interval 18.3 to 55.8	46.3 titer Interval 31.6 to 67.8	44.9 titer Interval 31.3 to 64.5	45.6 titer Interval 35.2 to 59.0	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.0 titer CI was not estimable due to the lack of variability of geometric means.
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T4: PMB80 (A22)	10.6 titer Interval 6.5 to 17.0	8.0 titer CI was not estimable due to the lack of variability of geometric means.	9.2 titer Interval 7.3 to 11.5	10.8 titer Interval 8.7 to 13.5	9.0 titer Interval 7.9 to 10.2	9.8 titer Interval 8.7 to 11.1	8.0 titer CI was not estimable due to the lack of variability of geometric means.	8.8 titer Interval 7.5 to 10.4	8.4 titer Interval 7.8 to 9.0
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T4: PMB2001 (A56)	7.3 titer Interval 3.3 to 16.1	27.9 titer Interval 11.3 to 68.5	15.4 titer Interval 8.1 to 29.3	13.7 titer Interval 9.4 to 20.1	12.5 titer Interval 8.7 to 17.9	13.0 titer Interval 10.1 to 16.9	4.1 titer Interval 3.9 to 4.4	4.6 titer Interval 3.4 to 6.3	4.4 titer Interval 3.7 to 5.2
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T6: PMB80 (A22)	8.0 titer CI was not estimable due to the lack of variability of geometric means.	8.0 titer CI was not estimable due to the lack of variability of geometric means.	8.0 titer CI was not estimable due to the lack of variability of geometric means.	8.9 titer Interval 7.6 to 10.3	8.4 titer Interval 7.6 to 9.1	8.6 titer Interval 7.9 to 9.3	—	—	—
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T6: PMB2001 (A56)	6.9 titer Interval 2.0 to 23.8	16.0 titer Interval 7.5 to 34.2	10.2 titer Interval 5.1 to 20.6	5.1 titer Interval 4.0 to 6.6	7.3 titer Interval 5.1 to 10.5	6.1 titer Interval 4.9 to 7.6	—	—	—
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T6: PMB2948 (B24)	4.0 titer CI was not estimable due to the lack of variability of geometric means.	5.4 titer Interval 2.7 to 11.1	4.6 titer Interval 3.4 to 6.3	4.9 titer Interval 3.8 to 6.4	4.0 titer CI was not estimable due to the lack of variability of geometric means.	4.4 titer Interval 3.9 to 4.8	—	—	—
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T6: PMB2707 (B44)	4.0 titer CI was not estimable due to the lack of variability of geometric means.	5.2 titer Interval 3.4 to 8.0	4.5 titer Interval 3.7 to 5.5	4.8 titer Interval 4.0 to 5.7	5.0 titer Interval 4.0 to 6.3	4.9 titer Interval 4.2 to 5.6	—	—	—

SECONDARY outcome

Timeframe: Within 7 days after booster vaccination

Population: Booster safety population included all participants who received the booster dose at 23 months after vaccination 3 (Visit 12), and for whom safety information was available.

Local reactions included pain at injection site, swelling and redness collected by using an e-diary. Pain at injection site was graded as: mild (does not interfere with activity), moderate (interferes with activity) and severe (prevents daily activity). A caliper was used to measure the redness or swelling area. Caliper units were converted to centimeters (cm) according to 1 caliper unit = 0.5 cm. Redness and swelling were graded as: none (0 cm) mild (0.5-2.0 cm), moderate (\>=2.0 to 7.0 cm) and severe (\>7.0 cm).

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=147 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Booster Vaccination Pain at injection site: mild	30.6 percentage of participants Interval 23.3 to 38.7	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Booster Vaccination Pain at injection site: moderate	29.3 percentage of participants Interval 22.0 to 37.3	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Booster Vaccination Pain at injection site: severe	10.2 percentage of participants Interval 5.8 to 16.3	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Booster Vaccination Redness: mild	22.4 percentage of participants Interval 16.0 to 30.1	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Booster Vaccination Redness: moderate	21.1 percentage of participants Interval 14.8 to 28.6	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Booster Vaccination Redness: severe	4.8 percentage of participants Interval 1.9 to 9.6	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Booster Vaccination Swelling: mild	18.4 percentage of participants Interval 12.5 to 25.6	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Booster Vaccination Swelling: moderate	15.0 percentage of participants Interval 9.6 to 21.8	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Booster Vaccination Swelling: severe	0.0 percentage of participants Interval 0.0 to 2.5	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 7 days after booster vaccination

Population: Booster safety population included all participants who received the booster dose at 23 months after Vaccination 3 (Visit 12), and for whom safety information was available.

Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle pain and joint pain were recorded by using an e-diary. Fever was defined as a temperature of greater than or equal to (\>=) 38.0 degree Celsius and was graded as 38.0 degree Celsius (C) to 38.4 degree C, 38.5 degree C to 38.9 degree C, 39.0 degree C to 39.4 degree C, 39.5 degree C to 40.0 degree C, \>40.0 degree C. Vomiting was graded as mild (1 to 2 times in 24 hours), moderate (\>2 times in 24 hours) and severe (requires IV hydration). Diarrhea was graded as mild (2 to 3 loose stools in 24 hours), moderate (4 to 5 loose stools in 24 hours), and severe (6 or more loose stools in 24 hours). Fatigue, headache, muscle pain and joint pain were graded as: mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). The use and type of antipyretic medication was also recorded in the e-diary daily.

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=147 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Fever >=38 degree C	10.2 percentage of participants Interval 5.8 to 16.3	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Fever 38 to <38.5 degree C	6.1 percentage of participants Interval 2.8 to 11.3	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Fever 38.5 to <39 degree C	3.4 percentage of participants Interval 1.1 to 7.8	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Fever 39 to <39.5 degree C	0.7 percentage of participants Interval 0.0 to 3.7	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Fever 39.5 to <=40 degree C	0.0 percentage of participants Interval 0.0 to 2.5	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Fever >40 degree C	0.0 percentage of participants Interval 0.0 to 2.5	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Vomiting: mild	4.8 percentage of participants Interval 1.9 to 9.6	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Vomiting: moderate	1.4 percentage of participants Interval 0.2 to 4.8	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Vomiting: severe	0.0 percentage of participants Interval 0.0 to 2.5	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Diarrhea: mild	4.8 percentage of participants Interval 1.9 to 9.6	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Diarrhea: moderate	0.7 percentage of participants Interval 0.0 to 3.7	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Diarrhea: severe	0.0 percentage of participants Interval 0.0 to 2.5	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Headache: mild	7.5 percentage of participants Interval 3.8 to 13.0	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Headache: moderate	10.2 percentage of participants Interval 5.8 to 16.3	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Headache: severe	1.4 percentage of participants Interval 0.2 to 4.8	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Fatigue: mild	17.0 percentage of participants Interval 11.3 to 24.1	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Fatigue: moderate	22.4 percentage of participants Interval 16.0 to 30.1	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Fatigue: severe	6.8 percentage of participants Interval 3.3 to 12.2	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Muscle pain : mild	6.1 percentage of participants Interval 2.8 to 11.3	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Muscle pain : moderate	8.2 percentage of participants Interval 4.3 to 13.8	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Muscle pain : severe	2.0 percentage of participants Interval 0.4 to 5.4	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Joint pain: mild	4.1 percentage of participants Interval 1.5 to 8.7	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Joint pain: moderate	6.1 percentage of participants Interval 2.8 to 11.3	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Joint pain: severe	0.0 percentage of participants Interval 0.0 to 2.5	—	—	—	—	—	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Antipyretic medication use	34.7 percentage of participants Interval 27.0 to 43.0	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Booster vaccination to 1 month after booster vaccination (T1), 1 month after booster vaccination to 6 months after booster vaccination (T2) and booster vaccination through 6 months after booster vaccination (T3)

Population: Booster safety population included all participants who received the booster dose at 23 months after Vaccination 3 (Visit 12), and for whom safety information was available.

SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=147 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Percentage of Participants With SAE, MAE, NDCMC From Booster Vaccination to 1 Month After Booster Vaccination, 1 Month After Booster Vaccination to 6 Months After Booster Vaccination and Booster Vaccination Through 6 Months After Booster Vaccination SAE: T1	0.7 percentage of participants Interval 0.0 to 3.7	—	—	—	—	—	—	—	—
Percentage of Participants With SAE, MAE, NDCMC From Booster Vaccination to 1 Month After Booster Vaccination, 1 Month After Booster Vaccination to 6 Months After Booster Vaccination and Booster Vaccination Through 6 Months After Booster Vaccination SAE: T2	0.7 percentage of participants Interval 0.0 to 3.7	—	—	—	—	—	—	—	—
Percentage of Participants With SAE, MAE, NDCMC From Booster Vaccination to 1 Month After Booster Vaccination, 1 Month After Booster Vaccination to 6 Months After Booster Vaccination and Booster Vaccination Through 6 Months After Booster Vaccination SAE: T3	1.4 percentage of participants Interval 0.2 to 4.8	—	—	—	—	—	—	—	—
Percentage of Participants With SAE, MAE, NDCMC From Booster Vaccination to 1 Month After Booster Vaccination, 1 Month After Booster Vaccination to 6 Months After Booster Vaccination and Booster Vaccination Through 6 Months After Booster Vaccination MAE: T1	4.8 percentage of participants Interval 1.9 to 9.6	—	—	—	—	—	—	—	—
Percentage of Participants With SAE, MAE, NDCMC From Booster Vaccination to 1 Month After Booster Vaccination, 1 Month After Booster Vaccination to 6 Months After Booster Vaccination and Booster Vaccination Through 6 Months After Booster Vaccination MAE: T2	2.7 percentage of participants Interval 0.7 to 6.8	—	—	—	—	—	—	—	—
Percentage of Participants With SAE, MAE, NDCMC From Booster Vaccination to 1 Month After Booster Vaccination, 1 Month After Booster Vaccination to 6 Months After Booster Vaccination and Booster Vaccination Through 6 Months After Booster Vaccination MAE: T3	7.5 percentage of participants Interval 3.8 to 13.0	—	—	—	—	—	—	—	—
Percentage of Participants With SAE, MAE, NDCMC From Booster Vaccination to 1 Month After Booster Vaccination, 1 Month After Booster Vaccination to 6 Months After Booster Vaccination and Booster Vaccination Through 6 Months After Booster Vaccination NDCMC: T1	0.0 percentage of participants Interval 0.0 to 2.5	—	—	—	—	—	—	—	—
Percentage of Participants With SAE, MAE, NDCMC From Booster Vaccination to 1 Month After Booster Vaccination, 1 Month After Booster Vaccination to 6 Months After Booster Vaccination and Booster Vaccination Through 6 Months After Booster Vaccination NDCMC: T2	0.0 percentage of participants Interval 0.0 to 2.5	—	—	—	—	—	—	—	—
Percentage of Participants With SAE, MAE, NDCMC From Booster Vaccination to 1 Month After Booster Vaccination, 1 Month After Booster Vaccination to 6 Months After Booster Vaccination and Booster Vaccination Through 6 Months After Booster Vaccination NDCMC: T3	0.0 percentage of participants Interval 0.0 to 2.5	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Booster vaccination up to 1 month after booster vaccination

Population: Booster safety population included all participants who received the booster dose at 23 months after Vaccination 3 (Visit 12), and for whom safety information was available.

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=147 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Percentage of Participants With at Least 1 Adverse Event (AE) From Booster Vaccination to 1 Month After Booster Vaccination	13.6 percentage of participants Interval 8.5 to 20.2	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Within 30 minutes after booster vaccination

Population: Booster safety population included all participants who received the booster dose at 23 months after vaccination 3 (Visit 12), and for whom safety information was available.

Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=147 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Percentage of Participants With Immediate Adverse Event (IAE) After Booster Vaccination	0.0 percentage of participants Interval 0.0 to 2.5	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Before booster vaccination and 1 month after booster vaccination

Population: Booster evaluable immunogenicity population: participants eligible for study, randomized to 120 mcg bivalent rLP2086 during stage 1, received scheduled investigational products, had blood drawn prior to booster vaccination dose and post-booster vaccination blood drawn (Visit 13) within 28-42 days from booster vaccination (Visit 12) and had no important protocol deviation. N=number of participants evaluable for this outcome measure and number analyzed=participants evaluable at specific rows.

Percentage of participants achieving hSBA titer \>= LLOQ were computed along with corresponding 2-sided 95 % CIs. The LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44.

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=69 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Percentage of Participants With hSBA Titer >=LLOQ >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains Before Booster Vaccination, and 1 Month After Booster Vaccination PMB80 (A22): before booster vaccination	2.9 percentage of participants Interval 0.4 to 10.1	—	—	—	—	—	—	—	—
Percentage of Participants With hSBA Titer >=LLOQ >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains Before Booster Vaccination, and 1 Month After Booster Vaccination PMB80 (A22):1 month after booster vaccination	92.6 percentage of participants Interval 83.7 to 97.6	—	—	—	—	—	—	—	—
Percentage of Participants With hSBA Titer >=LLOQ >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains Before Booster Vaccination, and 1 Month After Booster Vaccination PMB2001 (A56):before booster vaccination	15.2 percentage of participants Interval 7.5 to 26.1	—	—	—	—	—	—	—	—
Percentage of Participants With hSBA Titer >=LLOQ >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains Before Booster Vaccination, and 1 Month After Booster Vaccination PMB2001 (A56):1 month after booster vaccination	100.0 percentage of participants Interval 94.7 to 100.0	—	—	—	—	—	—	—	—
Percentage of Participants With hSBA Titer >=LLOQ >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains Before Booster Vaccination, and 1 Month After Booster Vaccination PMB2948 (B24): before booster vaccination	7.2 percentage of participants Interval 2.4 to 16.1	—	—	—	—	—	—	—	—
Percentage of Participants With hSBA Titer >=LLOQ >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains Before Booster Vaccination, and 1 Month After Booster Vaccination PMB2948 (B24):1 month after booster vaccination	92.8 percentage of participants Interval 83.9 to 97.6	—	—	—	—	—	—	—	—
Percentage of Participants With hSBA Titer >=LLOQ >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains Before Booster Vaccination, and 1 Month After Booster Vaccination PMB2707 (B44): before booster vaccination	9.0 percentage of participants Interval 3.4 to 18.5	—	—	—	—	—	—	—	—
Percentage of Participants With hSBA Titer >=LLOQ >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains Before Booster Vaccination, and 1 Month After Booster Vaccination PMB2707 (B44): 1 month after booster vaccination	95.7 percentage of participants Interval 87.8 to 99.1	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Before booster vaccination and 1 month after booster vaccination

The LLOQ was 1:16 for A22, 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5\*LLOQ for analysis. Titers were expressed in terms of 1/dilution.

Outcome measures

Outcome measures
Measure	Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months) n=69 Participants Participants from \>=12 months to \<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <18 Months) Participants from \>=12 months to \<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=18 Months to <24 Months) Participants from \>=18 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 MnB Primary Test Strains at Before Booster Vaccination and 1 Month After Booster Vaccination PMB80 (A22): before booster vaccination	8.4 titer Interval 7.8 to 9.0	—	—	—	—	—	—	—	—
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 MnB Primary Test Strains at Before Booster Vaccination and 1 Month After Booster Vaccination PMB80 (A22):1 month after booster vaccination	112.1 titer Interval 87.2 to 144.2	—	—	—	—	—	—	—	—
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 MnB Primary Test Strains at Before Booster Vaccination and 1 Month After Booster Vaccination PMB2001 (A56):before booster vaccination	5.2 titer Interval 4.4 to 6.2	—	—	—	—	—	—	—	—
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 MnB Primary Test Strains at Before Booster Vaccination and 1 Month After Booster Vaccination PMB2001 (A56):1 month after booster vaccination	248.3 titer Interval 192.7 to 319.9	—	—	—	—	—	—	—	—
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 MnB Primary Test Strains at Before Booster Vaccination and 1 Month After Booster Vaccination PMB2948 (B24): before booster vaccination	4.5 titer Interval 4.0 to 5.1	—	—	—	—	—	—	—	—
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 MnB Primary Test Strains at Before Booster Vaccination and 1 Month After Booster Vaccination PMB2948 (B24):1 month after booster vaccination	48.3 titer Interval 37.6 to 62.0	—	—	—	—	—	—	—	—
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 MnB Primary Test Strains at Before Booster Vaccination and 1 Month After Booster Vaccination PMB2707 (B44): before booster vaccination	4.4 titer Interval 4.1 to 4.9	—	—	—	—	—	—	—	—
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 MnB Primary Test Strains at Before Booster Vaccination and 1 Month After Booster Vaccination PMB2707 (B44): 1 month after booster vaccination	98.6 titer Interval 71.4 to 136.2	—	—	—	—	—	—	—	—

Adverse Events

Group 1: 60- Microgram (mcg) Bivalent rLP2086 (>=12 Months to <24 Months): Stage 1

Serious events: 4 serious events

Other events: 43 other events

Deaths: 0 deaths

Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months):Stage 1

Serious events: 19 serious events

Other events: 209 other events

Deaths: 0 deaths

Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1

Serious events: 8 serious events

Other events: 113 other events

Deaths: 0 deaths

120-mcg Bivalent rLP2086: Stage 2 Booster Phase

Serious events: 2 serious events

Other events: 121 other events

Deaths: 0 deaths

Group 1: 60-mcg Bivalent rLP2086 (>=12 Months to <24 Months): Follow up

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months): Follow up

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 3: HAV/Saline (>=12 Months to <24 Months): Follow up

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1: 60- Microgram (mcg) Bivalent rLP2086 (>=12 Months to <24 Months): Stage 1 n=44 participants at risk Participants from greater than or equal to (\>=) 12 months to less than (\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3).	Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months):Stage 1 n=220 participants at risk Participants from \>=12 months to \<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3). All eligible participants (who received 3 doses of bivalent rLP2086 in stage 1 at the 120 mcg dose level) received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 months of vaccination 3 (visit 12) in stage 2. Participants were followed up approximately 6 months after the booster vaccination.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 n=132 participants at risk Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.	120-mcg Bivalent rLP2086: Stage 2 Booster Phase n=147 participants at risk Participants who were randomly assigned to bivalent rLP2086 (irrespective of dose level) were eligible for booster vaccination. Participants received intramuscular injection of 120-mcg of bivalent rLP2086 vaccine after 23 months of visit 3.	Group 1: 60-mcg Bivalent rLP2086 (>=12 Months to <24 Months): Follow up n=44 participants at risk Participants from \>=12 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3).	Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months): Follow up n=220 participants at risk Participants from \>=12 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3).	Group 3: HAV/Saline (>=12 Months to <24 Months): Follow up n=132 participants at risk Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3).
Eye disorders Eyelid ptosis	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.45% 1/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Gastrointestinal disorders Enteritis	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.76% 1/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Gastrointestinal disorders Inguinal hernia	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.76% 1/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Gastrointestinal disorders Nausea	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.45% 1/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
General disorders Crying	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.45% 1/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
General disorders Pyrexia	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.45% 1/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Bronchiolitis	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.91% 2/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Bronchitis	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.45% 1/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.5% 2/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Croup infectious	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.76% 1/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Enterovirus infection	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.76% 1/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Gastroenteritis	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.4% 3/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.76% 1/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Otitis media	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.91% 2/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Otitis media chronic	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Pneumonia	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.4% 3/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.45% 1/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Respiratory tract infection viral	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.45% 1/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Tonsillitis	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.91% 2/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Urinary tract infection	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.45% 1/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Viral tonsillitis	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.91% 2/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Viral upper respiratory tract infection	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.76% 1/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Injury, poisoning and procedural complications Accidental exposure to product	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.76% 1/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Injury, poisoning and procedural complications Head injury	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.45% 1/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Nervous system disorders Balance disorder	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.45% 1/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Nervous system disorders Cerebellar ataxia	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Psychiatric disorders Irritability	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.45% 1/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Psychiatric disorders Polydipsia psychogenic	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.45% 1/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Gastrointestinal disorders Constipation	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.68% 1/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Rhinovirus infection	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.68% 1/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Cellulitis	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.45% 1/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.45% 1/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Influenza	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.45% 1/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).

Other adverse events

Other adverse events
Measure	Group 1: 60- Microgram (mcg) Bivalent rLP2086 (>=12 Months to <24 Months): Stage 1 n=44 participants at risk Participants from greater than or equal to (\>=) 12 months to less than (\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3).	Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months):Stage 1 n=220 participants at risk Participants from \>=12 months to \<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3). All eligible participants (who received 3 doses of bivalent rLP2086 in stage 1 at the 120 mcg dose level) received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 months of vaccination 3 (visit 12) in stage 2. Participants were followed up approximately 6 months after the booster vaccination.	Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1 n=132 participants at risk Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.	120-mcg Bivalent rLP2086: Stage 2 Booster Phase n=147 participants at risk Participants who were randomly assigned to bivalent rLP2086 (irrespective of dose level) were eligible for booster vaccination. Participants received intramuscular injection of 120-mcg of bivalent rLP2086 vaccine after 23 months of visit 3.	Group 1: 60-mcg Bivalent rLP2086 (>=12 Months to <24 Months): Follow up n=44 participants at risk Participants from \>=12 months to \<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3).	Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months): Follow up n=220 participants at risk Participants from \>=12 months to \<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3).	Group 3: HAV/Saline (>=12 Months to <24 Months): Follow up n=132 participants at risk Participants from \>=12 months to \<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3).
Ear and labyrinth disorders Eustachian tube disorder	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.45% 1/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.76% 1/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Ear and labyrinth disorders Middle ear effusion	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	3.6% 8/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	2.3% 3/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Eye disorders Anisometropia	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Eye disorders Astigmatism	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Eye disorders Conjunctivitis allergic	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Eye disorders Hypermetropia	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.45% 1/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Gastrointestinal disorders Aphthous ulcer	6.8% 3/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.45% 1/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Gastrointestinal disorders Diarrhoea	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	5.4% 8/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Gastrointestinal disorders Enteritis	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Gastrointestinal disorders Flatulence	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Gastrointestinal disorders Teething	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	3.6% 8/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	3.0% 4/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Gastrointestinal disorders Vomiting	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	6.1% 9/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
General disorders Chills	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.4% 3/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
General disorders Injection site erythema (redness)	68.2% 30/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	62.3% 137/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	21.2% 28/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	48.3% 71/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
General disorders Injection site erythema	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
General disorders Injection site pain (tenderness at injection site)	79.5% 35/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	72.7% 160/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	31.1% 41/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
General disorders Injection site pain	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	70.1% 103/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
General disorders Injection site swelling (swelling)	38.6% 17/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	46.8% 103/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	15.2% 20/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	33.3% 49/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
General disorders Pyrexia (fever)	36.4% 16/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	37.3% 82/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	15.2% 20/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	10.2% 15/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
General disorders Pyrexia	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	8.2% 18/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	4.5% 6/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
General disorders Vaccination site pain	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.91% 2/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.76% 1/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
General disorders Vessel puncture site bruise	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Immune system disorders Food allergy	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Bronchiolitis	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.4% 3/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.5% 2/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Bronchitis	11.4% 5/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	10.0% 22/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	8.3% 11/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Cellulitis	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.91% 2/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Conjunctivitis	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	10.0% 22/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	9.8% 13/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Croup infectious	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	4.1% 9/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.5% 2/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.4% 2/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Enterobiasis	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.91% 2/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.5% 2/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Exanthema subitum	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.4% 3/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Gastroenteritis viral	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	4.5% 10/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	2.3% 3/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Gastroenteritis	9.1% 4/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	13.2% 29/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	8.3% 11/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Hand-foot-and-mouth disease	4.5% 2/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	4.5% 10/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	4.5% 6/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Impetigo	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.4% 3/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	2.3% 3/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Infected bite	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.91% 2/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Laryngitis	4.5% 2/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.4% 3/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	3.8% 5/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Lower respiratory tract infection	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.8% 4/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.5% 2/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Molluscum contagiosum	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Nasopharyngitis	15.9% 7/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.4% 3/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	5.3% 7/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Otitis externa	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.5% 2/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Otitis media acute	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.91% 2/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.5% 2/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Otitis media	6.8% 3/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	12.3% 27/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	15.2% 20/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Pharyngitis streptococcal	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.45% 1/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.5% 2/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Pharyngitis	13.6% 6/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	8.2% 18/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	11.4% 15/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.4% 2/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Pharyngotonsillitis	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Pneumonia	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	3.2% 7/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.5% 2/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Respiratory tract infection viral	4.5% 2/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.4% 3/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.76% 1/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Respiratory tract infection	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.8% 4/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.76% 1/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Rhinitis	6.8% 3/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	3.6% 8/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	2.3% 3/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Skin candida	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Tonsillitis	9.1% 4/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	2.7% 6/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	6.8% 9/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Tracheitis	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.45% 1/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	3.8% 5/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Upper respiratory tract infection	13.6% 6/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	26.4% 58/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	25.8% 34/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	2.0% 3/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Urinary tract infection	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	3.2% 7/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	2.3% 3/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Varicella	4.5% 2/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	2.3% 5/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	2.3% 3/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Viral infection	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.4% 3/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.5% 2/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Viral pharyngitis	4.5% 2/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.76% 1/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Viral tonsillitis	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.91% 2/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Infections and infestations Viral upper respiratory tract infection	11.4% 5/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	20.5% 45/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	17.4% 23/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	3.4% 5/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.4% 3/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.76% 1/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Injury, poisoning and procedural complications Arthropod sting	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Injury, poisoning and procedural complications Concussion	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	2.3% 3/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Injury, poisoning and procedural complications Contusion	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	2.3% 5/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.5% 2/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.5% 2/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Injury, poisoning and procedural complications Excoriation	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.76% 1/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Injury, poisoning and procedural complications Face injury	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.5% 2/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Injury, poisoning and procedural complications Fall	4.5% 2/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	2.3% 5/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	5.3% 7/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Injury, poisoning and procedural complications Hand fracture	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Injury, poisoning and procedural complications Laceration	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.8% 4/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Injury, poisoning and procedural complications Lip injury	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.4% 3/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Metabolism and nutrition disorders Decreased appetite (loss of appetite)	50.0% 22/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	64.5% 142/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	37.9% 50/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Metabolism and nutrition disorders Decreased appetite	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.45% 1/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.5% 2/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.4% 2/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.5% 2/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Nervous system disorders Headache	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	19.0% 28/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Nervous system disorders Somnolence (drowsiness)	52.3% 23/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	57.7% 127/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	30.3% 40/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Nervous system disorders Somnolence	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.4% 3/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.5% 2/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Psychiatric disorders Irritability	70.5% 31/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	80.0% 176/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	52.3% 69/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Respiratory, thoracic and mediastinal disorders Cough	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	3.6% 8/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	2.3% 3/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.91% 2/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	4.5% 2/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	5.0% 11/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.5% 2/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Skin and subcutaneous tissue disorders Dermatitis allergic	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.8% 4/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.5% 2/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.8% 4/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.76% 1/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Skin and subcutaneous tissue disorders Dermatitis diaper	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.4% 3/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Skin and subcutaneous tissue disorders Eczema	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.8% 4/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	3.0% 4/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Skin and subcutaneous tissue disorders Miliaria	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.45% 1/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.76% 1/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Skin and subcutaneous tissue disorders Rash generalised	2.3% 1/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Skin and subcutaneous tissue disorders Rash	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.4% 3/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.76% 1/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.8% 4/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.5% 2/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	1.4% 3/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	2.3% 3/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
General disorders Fatigue	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	46.3% 68/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	10.2% 15/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	16.3% 24/147 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/44 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/220 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/132 • Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).

Additional Information

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Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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