Trial Outcomes & Findings for A Study to Describe the Immunogenicity, Safety, and Tolerability of Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Subjects Aged ≥24 Months to <10 Years (NCT NCT02531698)

Last Updated: 2020-10-26

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

400 participants

Primary outcome timeframe

1 month after Vaccination 3

Results posted on

2020-10-26

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) Participants from greater than or equal to (\>=) 24 months to less than (\<) 10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
Overall Study STARTED	294	106
Overall Study COMPLETED	283	104
Overall Study NOT COMPLETED	11	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) Participants from greater than or equal to (\>=) 24 months to less than (\<) 10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
Overall Study Adverse Event	2	1
Overall Study Withdrawal by Subject	6	1
Overall Study Protocol Violation	2	0
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

A Study to Describe the Immunogenicity, Safety, and Tolerability of Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Subjects Aged ≥24 Months to <10 Years

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Total n=400 Participants Total of all reporting groups
Age, Continuous	4.3 years STANDARD_DEVIATION 2.24 • n=5 Participants	4.2 years STANDARD_DEVIATION 2.15 • n=7 Participants	4.3 years STANDARD_DEVIATION 2.21 • n=5 Participants
Sex: Female, Male Female	146 Participants n=5 Participants	62 Participants n=7 Participants	208 Participants n=5 Participants
Sex: Female, Male Male	148 Participants n=5 Participants	44 Participants n=7 Participants	192 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	294 Participants n=5 Participants	106 Participants n=7 Participants	400 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	291 Participants n=5 Participants	104 Participants n=7 Participants	395 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month 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.

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=136 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=138 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=52 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=45 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) Participants from \>=4 years to \<10 years 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 PMB2707 [B44]	80.0 Percentage of participants Interval 68.2 to 88.9	78.3 Percentage of participants Interval 66.7 to 87.3	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.2	—	—
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 PMB80 [A22]	83.8 Percentage of participants Interval 72.9 to 91.6	91.0 Percentage of participants Interval 81.5 to 96.6	4.0 Percentage of participants Interval 0.1 to 20.4	10.0 Percentage of participants Interval 1.2 to 31.7	—	—
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 94.7 to 100.0	100.0 Percentage of participants Interval 94.9 to 100.0	4.2 Percentage of participants Interval 0.1 to 21.1	42.1 Percentage of participants Interval 20.3 to 66.5	—	—
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]	85.7 Percentage of participants Interval 74.6 to 93.3	92.1 Percentage of participants Interval 82.4 to 97.4	7.7 Percentage of participants Interval 0.9 to 25.1	0.0 Percentage of participants Interval 0.0 to 16.8	—	—

PRIMARY outcome

Timeframe: Within 7 Days after Vaccination 1

Population: Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0).

Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity) and severe (prevented daily activity). 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 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=145 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=149 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=55 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=51 Participants Participants from \>=4 years to \<10 years 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 Pain at injection site: Any	66.0 Percentage of participants Interval 60.3 to 71.4	51.7 Percentage of participants Interval 43.3 to 60.1	79.9 Percentage of participants Interval 72.5 to 86.0	22.6 Percentage of participants Interval 15.1 to 31.8	10.9 Percentage of participants Interval 4.1 to 22.2	35.3 Percentage of participants Interval 22.4 to 49.9
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 Pain at injection site: Mild	32.3 Percentage of participants Interval 27.0 to 38.0	24.1 Percentage of participants Interval 17.4 to 31.9	40.3 Percentage of participants Interval 32.3 to 48.6	17.9 Percentage of participants Interval 11.2 to 26.6	9.1 Percentage of participants Interval 3.0 to 20.0	27.5 Percentage of participants Interval 15.9 to 41.7
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 Pain at injection site: Moderate	30.3 Percentage of participants Interval 25.1 to 35.9	24.8 Percentage of participants Interval 18.0 to 32.7	35.6 Percentage of participants Interval 27.9 to 43.8	4.7 Percentage of participants Interval 1.5 to 10.7	1.8 Percentage of participants Interval 0.0 to 9.7	7.8 Percentage of participants Interval 2.2 to 18.9
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 Pain at injection site: Severe	3.4 Percentage of participants Interval 1.6 to 6.2	2.8 Percentage of participants Interval 0.8 to 6.9	4.0 Percentage of participants Interval 1.5 to 8.6	0.0 Percentage of participants Interval 0.0 to 3.4	0.0 Percentage of participants Interval 0.0 to 6.5	0.0 Percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 Redness: Any	40.8 Percentage of participants Interval 35.1 to 46.7	42.1 Percentage of participants Interval 33.9 to 50.5	39.6 Percentage of participants Interval 31.7 to 47.9	9.4 Percentage of participants Interval 4.6 to 16.7	10.9 Percentage of participants Interval 4.1 to 22.2	7.8 Percentage of participants Interval 2.2 to 18.9
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 Redness: Mild	17.7 Percentage of participants Interval 13.5 to 22.5	22.1 Percentage of participants Interval 15.6 to 29.7	13.4 Percentage of participants Interval 8.4 to 20.0	5.7 Percentage of participants Interval 2.1 to 11.9	7.3 Percentage of participants Interval 2.0 to 17.6	3.9 Percentage of participants Interval 0.5 to 13.5
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 Redness: Moderate	18.7 Percentage of participants Interval 14.4 to 23.6	18.6 Percentage of participants Interval 12.6 to 25.9	18.8 Percentage of participants Interval 12.9 to 26.0	3.8 Percentage of participants Interval 1.0 to 9.4	3.6 Percentage of participants Interval 0.4 to 12.5	3.9 Percentage of participants Interval 0.5 to 13.5
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 Redness: Severe	4.4 Percentage of participants Interval 2.4 to 7.4	1.4 Percentage of participants Interval 0.2 to 4.9	7.4 Percentage of participants Interval 3.7 to 12.8	0.0 Percentage of participants Interval 0.0 to 3.4	0.0 Percentage of participants Interval 0.0 to 6.5	0.0 Percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 Swelling: Any	31.3 Percentage of participants Interval 26.0 to 36.9	27.6 Percentage of participants Interval 20.5 to 35.6	34.9 Percentage of participants Interval 27.3 to 43.1	5.7 Percentage of participants Interval 2.1 to 11.9	5.5 Percentage of participants Interval 1.1 to 15.1	5.9 Percentage of participants Interval 1.2 to 16.2
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 Swelling: Mild	12.2 Percentage of participants Interval 8.7 to 16.5	11.0 Percentage of participants Interval 6.4 to 17.3	13.4 Percentage of participants Interval 8.4 to 20.0	3.8 Percentage of participants Interval 1.0 to 9.4	3.6 Percentage of participants Interval 0.4 to 12.5	3.9 Percentage of participants Interval 0.5 to 13.5
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 Swelling: Moderate	17.3 Percentage of participants Interval 13.2 to 22.2	16.6 Percentage of participants Interval 10.9 to 23.6	18.1 Percentage of participants Interval 12.3 to 25.3	1.9 Percentage of participants Interval 0.2 to 6.6	1.8 Percentage of participants Interval 0.0 to 9.7	2.0 Percentage of participants Interval 0.0 to 10.4
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1 Swelling: Severe	1.7 Percentage of participants Interval 0.6 to 3.9	0.0 Percentage of participants Interval 0.0 to 2.5	3.4 Percentage of participants Interval 1.1 to 7.7	0.0 Percentage of participants Interval 0.0 to 3.4	0.0 Percentage of participants Interval 0.0 to 6.5	0.0 Percentage of participants Interval 0.0 to 7.0

PRIMARY outcome

Timeframe: Within 7 Days after Vaccination 2

Population: Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit. Here "number of participants analyzed (N)" signifies number of participants evaluable for this outcome measure.

Local reactions included pain at injection site, swelling and redness collected by using an e-diary. Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity) and severe (prevented daily activity). 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 Bivalent rLP2086 (>=24 Months to <10 Years) n=291 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=143 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=148 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=103 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=54 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=49 Participants Participants from \>=4 years to \<10 years 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 Pain at injection site: Mild	40.2 Percentage of participants Interval 34.5 to 46.1	40.6 Percentage of participants Interval 32.4 to 49.1	39.9 Percentage of participants Interval 31.9 to 48.2	9.7 Percentage of participants Interval 4.8 to 17.1	5.6 Percentage of participants Interval 1.2 to 15.4	14.3 Percentage of participants Interval 5.9 to 27.2
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 Pain at injection site: Any	70.8 Percentage of participants Interval 65.2 to 76.0	63.6 Percentage of participants Interval 55.2 to 71.5	77.7 Percentage of participants Interval 70.1 to 84.1	12.6 Percentage of participants Interval 6.9 to 20.6	5.6 Percentage of participants Interval 1.2 to 15.4	20.4 Percentage of participants Interval 10.2 to 34.3
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 Pain at injection site: Moderate	28.5 Percentage of participants Interval 23.4 to 34.1	20.3 Percentage of participants Interval 14.0 to 27.8	36.5 Percentage of participants Interval 28.7 to 44.8	2.9 Percentage of participants Interval 0.6 to 8.3	0.0 Percentage of participants Interval 0.0 to 6.6	6.1 Percentage of participants Interval 1.3 to 16.9
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 Pain at injection site: Severe	2.1 Percentage of participants Interval 0.8 to 4.4	2.8 Percentage of participants Interval 0.8 to 7.0	1.4 Percentage of participants Interval 0.2 to 4.8	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.3
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 Redness: Any	37.1 Percentage of participants Interval 31.5 to 42.9	36.4 Percentage of participants Interval 28.5 to 44.8	37.8 Percentage of participants Interval 30.0 to 46.2	5.8 Percentage of participants Interval 2.2 to 12.2	5.6 Percentage of participants Interval 1.2 to 15.4	6.1 Percentage of participants Interval 1.3 to 16.9
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 Redness: Mild	16.5 Percentage of participants Interval 12.4 to 21.3	15.4 Percentage of participants Interval 9.9 to 22.4	17.6 Percentage of participants Interval 11.8 to 24.7	5.8 Percentage of participants Interval 2.2 to 12.2	5.6 Percentage of participants Interval 1.2 to 15.4	6.1 Percentage of participants Interval 1.3 to 16.9
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 Redness: Moderate	18.2 Percentage of participants Interval 14.0 to 23.1	20.3 Percentage of participants Interval 14.0 to 27.8	16.2 Percentage of participants Interval 10.7 to 23.2	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.3
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 Redness: Severe	2.4 Percentage of participants Interval 1.0 to 4.9	0.7 Percentage of participants Interval 0.0 to 3.8	4.1 Percentage of participants Interval 1.5 to 8.6	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.3
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 Swelling: Any	28.5 Percentage of participants Interval 23.4 to 34.1	27.3 Percentage of participants Interval 20.2 to 35.3	29.7 Percentage of participants Interval 22.5 to 37.8	1.0 Percentage of participants Interval 0.0 to 5.3	0.0 Percentage of participants Interval 0.0 to 6.6	2.0 Percentage of participants Interval 0.1 to 10.9
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 Swelling: Mild	11.7 Percentage of participants Interval 8.2 to 15.9	11.9 Percentage of participants Interval 7.1 to 18.4	11.5 Percentage of participants Interval 6.8 to 17.8	1.0 Percentage of participants Interval 0.0 to 5.3	0.0 Percentage of participants Interval 0.0 to 6.6	2.0 Percentage of participants Interval 0.1 to 10.9
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 Swelling: Moderate	16.2 Percentage of participants Interval 12.1 to 20.9	14.7 Percentage of participants Interval 9.3 to 21.6	17.6 Percentage of participants Interval 11.8 to 24.7	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.3
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2 Swelling: Severe	0.7 Percentage of participants Interval 0.1 to 2.5	0.7 Percentage of participants Interval 0.0 to 3.8	0.7 Percentage of participants Interval 0.0 to 3.7	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.3

PRIMARY outcome

Timeframe: Within 7 Days after Vaccination 3

Population: Vaccination 3 safety population: all participants who received the third dose of investigational product (rLP2086 or HAV vaccine) on Month 6 visit. Here "N" signifies number of participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=285 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=139 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=146 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=104 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=54 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=50 Participants Participants from \>=4 years to \<10 years 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 Swelling: Moderate	14.7 Percentage of participants Interval 10.8 to 19.4	15.1 Percentage of participants Interval 9.6 to 22.2	14.4 Percentage of participants Interval 9.1 to 21.1	1.0 Percentage of participants Interval 0.0 to 5.2	1.9 Percentage of participants Interval 0.0 to 9.9	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 Pain at injection site: Any	68.4 Percentage of participants Interval 62.7 to 73.8	54.7 Percentage of participants Interval 46.0 to 63.1	81.5 Percentage of participants Interval 74.2 to 87.4	15.4 Percentage of participants Interval 9.1 to 23.8	9.3 Percentage of participants Interval 3.1 to 20.3	22.0 Percentage of participants Interval 11.5 to 36.0
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 Pain at injection site: Mild	38.2 Percentage of participants Interval 32.6 to 44.2	26.6 Percentage of participants Interval 19.5 to 34.8	49.3 Percentage of participants Interval 41.0 to 57.7	10.6 Percentage of participants Interval 5.4 to 18.1	7.4 Percentage of participants Interval 2.1 to 17.9	14.0 Percentage of participants Interval 5.8 to 26.7
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 Pain at injection site: Moderate	27.0 Percentage of participants Interval 21.9 to 32.6	25.2 Percentage of participants Interval 18.2 to 33.2	28.8 Percentage of participants Interval 21.6 to 36.8	4.8 Percentage of participants Interval 1.6 to 10.9	1.9 Percentage of participants Interval 0.0 to 9.9	8.0 Percentage of participants Interval 2.2 to 19.2
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 Pain at injection site: Severe	3.2 Percentage of participants Interval 1.5 to 5.9	2.9 Percentage of participants Interval 0.8 to 7.2	3.4 Percentage of participants Interval 1.1 to 7.8	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 Redness: Any	35.1 Percentage of participants Interval 29.6 to 40.9	34.5 Percentage of participants Interval 26.7 to 43.1	35.6 Percentage of participants Interval 27.9 to 44.0	9.6 Percentage of participants Interval 4.7 to 17.0	9.3 Percentage of participants Interval 3.1 to 20.3	10.0 Percentage of participants Interval 3.3 to 21.8
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 Redness: Mild	16.5 Percentage of participants Interval 12.4 to 21.3	15.8 Percentage of participants Interval 10.2 to 23.0	17.1 Percentage of participants Interval 11.4 to 24.2	8.7 Percentage of participants Interval 4.0 to 15.8	7.4 Percentage of participants Interval 2.1 to 17.9	10.0 Percentage of participants Interval 3.3 to 21.8
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 Redness: Moderate	14.7 Percentage of participants Interval 10.8 to 19.4	17.3 Percentage of participants Interval 11.4 to 24.6	12.3 Percentage of participants Interval 7.5 to 18.8	1.0 Percentage of participants Interval 0.0 to 5.2	1.9 Percentage of participants Interval 0.0 to 9.9	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 Redness: Severe	3.9 Percentage of participants Interval 1.9 to 6.8	1.4 Percentage of participants Interval 0.2 to 5.1	6.2 Percentage of participants Interval 2.9 to 11.4	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 Swelling: Any	27.4 Percentage of participants Interval 22.3 to 32.9	24.5 Percentage of participants Interval 17.6 to 32.5	30.1 Percentage of participants Interval 22.8 to 38.3	4.8 Percentage of participants Interval 1.6 to 10.9	3.7 Percentage of participants Interval 0.5 to 12.7	6.0 Percentage of participants Interval 1.3 to 16.5
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 Swelling: Mild	11.9 Percentage of participants Interval 8.4 to 16.3	9.4 Percentage of participants Interval 5.1 to 15.5	14.4 Percentage of participants Interval 9.1 to 21.1	3.8 Percentage of participants Interval 1.1 to 9.6	1.9 Percentage of participants Interval 0.0 to 9.9	6.0 Percentage of participants Interval 1.3 to 16.5
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3 Swelling: Severe	0.7 Percentage of participants Interval 0.1 to 2.5	0.0 Percentage of participants Interval 0.0 to 2.6	1.4 Percentage of participants Interval 0.2 to 4.9	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.1

PRIMARY outcome

Timeframe: Within 7 Days after Vaccination 1

Population: Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0).

Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and 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. Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevented daily activity).

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=145 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=149 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=55 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=51 Participants Participants from \>=4 years to \<10 years 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 Headache: Moderate	8.5 Percentage of participants Interval 5.6 to 12.3	4.8 Percentage of participants Interval 2.0 to 9.7	12.1 Percentage of participants Interval 7.3 to 18.4	3.8 Percentage of participants Interval 1.0 to 9.4	1.8 Percentage of participants Interval 0.0 to 9.7	5.9 Percentage of participants Interval 1.2 to 16.2
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Headache: Severe	0.3 Percentage of participants Interval 0.0 to 1.9	0.0 Percentage of participants Interval 0.0 to 2.5	0.7 Percentage of participants Interval 0.0 to 3.7	0.9 Percentage of participants Interval 0.0 to 5.1	0.0 Percentage of participants Interval 0.0 to 6.5	2.0 Percentage of participants Interval 0.0 to 10.4
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Fatigue: Any	49.0 Percentage of participants Interval 43.1 to 54.8	55.9 Percentage of participants Interval 47.4 to 64.1	42.3 Percentage of participants Interval 34.2 to 50.6	25.5 Percentage of participants Interval 17.5 to 34.9	20.0 Percentage of participants Interval 10.4 to 33.0	31.4 Percentage of participants Interval 19.1 to 45.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Fatigue: Mild	21.8 Percentage of participants Interval 17.2 to 26.9	24.1 Percentage of participants Interval 17.4 to 31.9	19.5 Percentage of participants Interval 13.4 to 26.7	14.2 Percentage of participants Interval 8.1 to 22.3	9.1 Percentage of participants Interval 3.0 to 20.0	19.6 Percentage of participants Interval 9.8 to 33.1
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Fatigue: Moderate	23.5 Percentage of participants Interval 18.7 to 28.7	27.6 Percentage of participants Interval 20.5 to 35.6	19.5 Percentage of participants Interval 13.4 to 26.7	8.5 Percentage of participants Interval 4.0 to 15.5	5.5 Percentage of participants Interval 1.1 to 15.1	11.8 Percentage of participants Interval 4.4 to 23.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Fatigue: Severe	3.7 Percentage of participants Interval 1.9 to 6.6	4.1 Percentage of participants Interval 1.5 to 8.8	3.4 Percentage of participants Interval 1.1 to 7.7	2.8 Percentage of participants Interval 0.6 to 8.0	5.5 Percentage of participants Interval 1.1 to 15.1	0.0 Percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Muscle pain : Any	16.3 Percentage of participants Interval 12.3 to 21.1	13.1 Percentage of participants Interval 8.1 to 19.7	19.5 Percentage of participants Interval 13.4 to 26.7	5.7 Percentage of participants Interval 2.1 to 11.9	1.8 Percentage of participants Interval 0.0 to 9.7	9.8 Percentage of participants Interval 3.3 to 21.4
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Muscle pain : Mild	8.8 Percentage of participants Interval 5.9 to 12.7	6.2 Percentage of participants Interval 2.9 to 11.5	11.4 Percentage of participants Interval 6.8 to 17.6	4.7 Percentage of participants Interval 1.5 to 10.7	1.8 Percentage of participants Interval 0.0 to 9.7	7.8 Percentage of participants Interval 2.2 to 18.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Muscle pain : Moderate	6.1 Percentage of participants Interval 3.7 to 9.5	4.8 Percentage of participants Interval 2.0 to 9.7	7.4 Percentage of participants Interval 3.7 to 12.8	0.9 Percentage of participants Interval 0.0 to 5.1	0.0 Percentage of participants Interval 0.0 to 6.5	2.0 Percentage of participants Interval 0.0 to 10.4
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Joint pain: Any	6.5 Percentage of participants Interval 3.9 to 9.9	6.2 Percentage of participants Interval 2.9 to 11.5	6.7 Percentage of participants Interval 3.3 to 12.0	4.7 Percentage of participants Interval 1.5 to 10.7	1.8 Percentage of participants Interval 0.0 to 9.7	7.8 Percentage of participants Interval 2.2 to 18.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Muscle pain : Severe	1.4 Percentage of participants Interval 0.4 to 3.4	2.1 Percentage of participants Interval 0.4 to 5.9	0.7 Percentage of participants Interval 0.0 to 3.7	0.0 Percentage of participants Interval 0.0 to 3.4	0.0 Percentage of participants Interval 0.0 to 6.5	0.0 Percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Joint pain: Severe	0.0 Percentage of participants Interval 0.0 to 1.2	0.0 Percentage of participants Interval 0.0 to 2.5	0.0 Percentage of participants Interval 0.0 to 2.4	0.0 Percentage of participants Interval 0.0 to 3.4	0.0 Percentage of participants Interval 0.0 to 6.5	0.0 Percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Diarrhea: Mild	7.1 Percentage of participants Interval 4.5 to 10.7	9.0 Percentage of participants Interval 4.9 to 14.8	5.4 Percentage of participants Interval 2.3 to 10.3	6.6 Percentage of participants Interval 2.7 to 13.1	7.3 Percentage of participants Interval 2.0 to 17.6	5.9 Percentage of participants Interval 1.2 to 16.2
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Diarrhea: Moderate	1.7 Percentage of participants Interval 0.6 to 3.9	2.1 Percentage of participants Interval 0.4 to 5.9	1.3 Percentage of participants Interval 0.2 to 4.8	0.0 Percentage of participants Interval 0.0 to 3.4	0.0 Percentage of participants Interval 0.0 to 6.5	0.0 Percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Diarrhea: Severe	0.3 Percentage of participants Interval 0.0 to 1.9	0.7 Percentage of participants Interval 0.0 to 3.8	0.0 Percentage of participants Interval 0.0 to 2.4	0.0 Percentage of participants Interval 0.0 to 3.4	0.0 Percentage of participants Interval 0.0 to 6.5	0.0 Percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Headache: Any	18.4 Percentage of participants Interval 14.1 to 23.3	8.3 Percentage of participants Interval 4.3 to 14.0	28.2 Percentage of participants Interval 21.1 to 36.1	11.3 Percentage of participants Interval 6.0 to 18.9	3.6 Percentage of participants Interval 0.4 to 12.5	19.6 Percentage of participants Interval 9.8 to 33.1
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Headache: Mild	9.5 Percentage of participants Interval 6.4 to 13.5	3.4 Percentage of participants Interval 1.1 to 7.9	15.4 Percentage of participants Interval 10.0 to 22.3	6.6 Percentage of participants Interval 2.7 to 13.1	1.8 Percentage of participants Interval 0.0 to 9.7	11.8 Percentage of participants Interval 4.4 to 23.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Joint pain: Mild	3.4 Percentage of participants Interval 1.6 to 6.2	3.4 Percentage of participants Interval 1.1 to 7.9	3.4 Percentage of participants Interval 1.1 to 7.7	4.7 Percentage of participants Interval 1.5 to 10.7	1.8 Percentage of participants Interval 0.0 to 9.7	7.8 Percentage of participants Interval 2.2 to 18.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Joint pain: Moderate	3.1 Percentage of participants Interval 1.4 to 5.7	2.8 Percentage of participants Interval 0.8 to 6.9	3.4 Percentage of participants Interval 1.1 to 7.7	0.0 Percentage of participants Interval 0.0 to 3.4	0.0 Percentage of participants Interval 0.0 to 6.5	0.0 Percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Fever >=38 degrees C	16.3 Percentage of participants Interval 12.3 to 21.1	21.4 Percentage of participants Interval 15.0 to 29.0	11.4 Percentage of participants Interval 6.8 to 17.6	6.6 Percentage of participants Interval 2.7 to 13.1	10.9 Percentage of participants Interval 4.1 to 22.2	2.0 Percentage of participants Interval 0.0 to 10.4
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Fever 38 to <38.5 degrees C	6.1 Percentage of participants Interval 3.7 to 9.5	6.9 Percentage of participants Interval 3.4 to 12.3	5.4 Percentage of participants Interval 2.3 to 10.3	4.7 Percentage of participants Interval 1.5 to 10.7	7.3 Percentage of participants Interval 2.0 to 17.6	2.0 Percentage of participants Interval 0.0 to 10.4
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Fever 38.5 to <39 degrees C	6.1 Percentage of participants Interval 3.7 to 9.5	7.6 Percentage of participants Interval 3.8 to 13.2	4.7 Percentage of participants Interval 1.9 to 9.4	1.9 Percentage of participants Interval 0.2 to 6.6	3.6 Percentage of participants Interval 0.4 to 12.5	0.0 Percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Fever 39 to <39.5 degrees C	2.4 Percentage of participants Interval 1.0 to 4.8	3.4 Percentage of participants Interval 1.1 to 7.9	1.3 Percentage of participants Interval 0.2 to 4.8	0.0 Percentage of participants Interval 0.0 to 3.4	0.0 Percentage of participants Interval 0.0 to 6.5	0.0 Percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Fever 39.5 to 40 degrees C	1.4 Percentage of participants Interval 0.4 to 3.4	2.8 Percentage of participants Interval 0.8 to 6.9	0.0 Percentage of participants Interval 0.0 to 2.4	0.0 Percentage of participants Interval 0.0 to 3.4	0.0 Percentage of participants Interval 0.0 to 6.5	0.0 Percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Fever >40 degrees C	0.3 Percentage of participants Interval 0.0 to 1.9	0.7 Percentage of participants Interval 0.0 to 3.8	0.0 Percentage of participants Interval 0.0 to 2.4	0.0 Percentage of participants Interval 0.0 to 3.4	0.0 Percentage of participants Interval 0.0 to 6.5	0.0 Percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Vomiting: Any	5.4 Percentage of participants Interval 3.1 to 8.7	9.0 Percentage of participants Interval 4.9 to 14.8	2.0 Percentage of participants Interval 0.4 to 5.8	3.8 Percentage of participants Interval 1.0 to 9.4	5.5 Percentage of participants Interval 1.1 to 15.1	2.0 Percentage of participants Interval 0.0 to 10.4
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Vomiting: Mild	4.4 Percentage of participants Interval 2.4 to 7.4	7.6 Percentage of participants Interval 3.8 to 13.2	1.3 Percentage of participants Interval 0.2 to 4.8	2.8 Percentage of participants Interval 0.6 to 8.0	5.5 Percentage of participants Interval 1.1 to 15.1	0.0 Percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Vomiting: Moderate	1.0 Percentage of participants Interval 0.2 to 3.0	1.4 Percentage of participants Interval 0.2 to 4.9	0.7 Percentage of participants Interval 0.0 to 3.7	0.9 Percentage of participants Interval 0.0 to 5.1	0.0 Percentage of participants Interval 0.0 to 6.5	2.0 Percentage of participants Interval 0.0 to 10.4
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Vomiting: Severe	0.0 Percentage of participants Interval 0.0 to 1.2	0.0 Percentage of participants Interval 0.0 to 2.5	0.0 Percentage of participants Interval 0.0 to 2.4	0.0 Percentage of participants Interval 0.0 to 3.4	0.0 Percentage of participants Interval 0.0 to 6.5	0.0 Percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Diarrhea: Any	9.2 Percentage of participants Interval 6.1 to 13.1	11.7 Percentage of participants Interval 7.0 to 18.1	6.7 Percentage of participants Interval 3.3 to 12.0	6.6 Percentage of participants Interval 2.7 to 13.1	7.3 Percentage of participants Interval 2.0 to 17.6	5.9 Percentage of participants Interval 1.2 to 16.2
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1 Antipyretic Medication Use	37.1 Percentage of participants Interval 31.5 to 42.9	42.8 Percentage of participants Interval 34.6 to 51.2	31.5 Percentage of participants Interval 24.2 to 39.7	16.0 Percentage of participants Interval 9.6 to 24.4	14.5 Percentage of participants Interval 6.5 to 26.7	17.6 Percentage of participants Interval 8.4 to 30.9

PRIMARY outcome

Timeframe: Within 7 Days after Vaccination 2

Population: Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit. Here "N" signifies number of participants evaluable for this outcome measure.

Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and 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. Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevented daily activity).

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=291 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=143 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=148 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=103 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=54 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=49 Participants Participants from \>=4 years to \<10 years 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 Muscle pain: Moderate	5.8 Percentage of participants Interval 3.4 to 9.2	7.0 Percentage of participants Interval 3.4 to 12.5	4.7 Percentage of participants Interval 1.9 to 9.5	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.3
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Joint pain: Severe	1.0 Percentage of participants Interval 0.2 to 3.0	2.1 Percentage of participants Interval 0.4 to 6.0	0.0 Percentage of participants Interval 0.0 to 2.5	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.3
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Antipyretic Medication Use	29.9 Percentage of participants Interval 24.7 to 35.5	32.9 Percentage of participants Interval 25.2 to 41.2	27.0 Percentage of participants Interval 20.1 to 34.9	5.8 Percentage of participants Interval 2.2 to 12.2	1.9 Percentage of participants Interval 0.0 to 9.9	10.2 Percentage of participants Interval 3.4 to 22.2
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Diarrhea: Moderate	0.3 Percentage of participants Interval 0.0 to 1.9	0.7 Percentage of participants Interval 0.0 to 3.8	0.0 Percentage of participants Interval 0.0 to 2.5	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.3
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Diarrhea: Severe	0.3 Percentage of participants Interval 0.0 to 1.9	0.7 Percentage of participants Interval 0.0 to 3.8	0.0 Percentage of participants Interval 0.0 to 2.5	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.3
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Fever >=38 degrees C	12.0 Percentage of participants Interval 8.5 to 16.3	15.4 Percentage of participants Interval 9.9 to 22.4	8.8 Percentage of participants Interval 4.8 to 14.6	2.9 Percentage of participants Interval 0.6 to 8.3	3.7 Percentage of participants Interval 0.5 to 12.7	2.0 Percentage of participants Interval 0.1 to 10.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Fever 38 to <38.5 degrees C	6.5 Percentage of participants Interval 4.0 to 10.0	7.7 Percentage of participants Interval 3.9 to 13.3	5.4 Percentage of participants Interval 2.4 to 10.4	1.9 Percentage of participants Interval 0.2 to 6.8	3.7 Percentage of participants Interval 0.5 to 12.7	0.0 Percentage of participants Interval 0.0 to 7.3
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Fever 38.5 to <39 degrees C	1.7 Percentage of participants Interval 0.6 to 4.0	2.8 Percentage of participants Interval 0.8 to 7.0	0.7 Percentage of participants Interval 0.0 to 3.7	1.0 Percentage of participants Interval 0.0 to 5.3	0.0 Percentage of participants Interval 0.0 to 6.6	2.0 Percentage of participants Interval 0.1 to 10.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Fever 39 to <39.5 degrees C	1.7 Percentage of participants Interval 0.6 to 4.0	1.4 Percentage of participants Interval 0.2 to 5.0	2.0 Percentage of participants Interval 0.4 to 5.8	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.3
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Fever 39.5 to 40 degrees C	1.7 Percentage of participants Interval 0.6 to 4.0	2.8 Percentage of participants Interval 0.8 to 7.0	0.7 Percentage of participants Interval 0.0 to 3.7	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.3
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Fever >40 degrees C	0.3 Percentage of participants Interval 0.0 to 1.9	0.7 Percentage of participants Interval 0.0 to 3.8	0.0 Percentage of participants Interval 0.0 to 2.5	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.3
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Vomiting: Any	5.2 Percentage of participants Interval 2.9 to 8.4	5.6 Percentage of participants Interval 2.4 to 10.7	4.7 Percentage of participants Interval 1.9 to 9.5	4.9 Percentage of participants Interval 1.6 to 11.0	3.7 Percentage of participants Interval 0.5 to 12.7	6.1 Percentage of participants Interval 1.3 to 16.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Vomiting: Mild	3.4 Percentage of participants Interval 1.7 to 6.2	4.2 Percentage of participants Interval 1.6 to 8.9	2.7 Percentage of participants Interval 0.7 to 6.8	3.9 Percentage of participants Interval 1.1 to 9.6	1.9 Percentage of participants Interval 0.0 to 9.9	6.1 Percentage of participants Interval 1.3 to 16.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Vomiting: Moderate	1.7 Percentage of participants Interval 0.6 to 4.0	1.4 Percentage of participants Interval 0.2 to 5.0	2.0 Percentage of participants Interval 0.4 to 5.8	1.0 Percentage of participants Interval 0.0 to 5.3	1.9 Percentage of participants Interval 0.0 to 9.9	0.0 Percentage of participants Interval 0.0 to 7.3
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Vomiting: Severe	0.0 Percentage of participants Interval 0.0 to 1.3	0.0 Percentage of participants Interval 0.0 to 2.5	0.0 Percentage of participants Interval 0.0 to 2.5	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.3
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Diarrhea: Any	8.2 Percentage of participants Interval 5.4 to 12.0	9.8 Percentage of participants Interval 5.5 to 15.9	6.8 Percentage of participants Interval 3.3 to 12.1	5.8 Percentage of participants Interval 2.2 to 12.2	5.6 Percentage of participants Interval 1.2 to 15.4	6.1 Percentage of participants Interval 1.3 to 16.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Headache: Any	18.2 Percentage of participants Interval 14.0 to 23.1	11.2 Percentage of participants Interval 6.5 to 17.5	25.0 Percentage of participants Interval 18.3 to 32.8	11.7 Percentage of participants Interval 6.2 to 19.5	1.9 Percentage of participants Interval 0.0 to 9.9	22.4 Percentage of participants Interval 11.8 to 36.6
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Headache: Mild	10.3 Percentage of participants Interval 7.1 to 14.4	7.7 Percentage of participants Interval 3.9 to 13.3	12.8 Percentage of participants Interval 7.9 to 19.3	9.7 Percentage of participants Interval 4.8 to 17.1	1.9 Percentage of participants Interval 0.0 to 9.9	18.4 Percentage of participants Interval 8.8 to 32.0
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Headache: Moderate	7.6 Percentage of participants Interval 4.8 to 11.2	3.5 Percentage of participants Interval 1.1 to 8.0	11.5 Percentage of participants Interval 6.8 to 17.8	1.0 Percentage of participants Interval 0.0 to 5.3	0.0 Percentage of participants Interval 0.0 to 6.6	2.0 Percentage of participants Interval 0.1 to 10.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Headache: Severe	0.3 Percentage of participants Interval 0.0 to 1.9	0.0 Percentage of participants Interval 0.0 to 2.5	0.7 Percentage of participants Interval 0.0 to 3.7	1.0 Percentage of participants Interval 0.0 to 5.3	0.0 Percentage of participants Interval 0.0 to 6.6	2.0 Percentage of participants Interval 0.1 to 10.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Fatigue: Any	43.3 Percentage of participants Interval 37.5 to 49.2	45.5 Percentage of participants Interval 37.1 to 54.0	41.2 Percentage of participants Interval 33.2 to 49.6	13.6 Percentage of participants Interval 7.6 to 21.8	13.0 Percentage of participants Interval 5.4 to 24.9	14.3 Percentage of participants Interval 5.9 to 27.2
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Fatigue: Mild	21.0 Percentage of participants Interval 16.4 to 26.1	22.4 Percentage of participants Interval 15.8 to 30.1	19.6 Percentage of participants Interval 13.5 to 26.9	7.8 Percentage of participants Interval 3.4 to 14.7	7.4 Percentage of participants Interval 2.1 to 17.9	8.2 Percentage of participants Interval 2.3 to 19.6
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Fatigue: Moderate	19.6 Percentage of participants Interval 15.2 to 24.6	19.6 Percentage of participants Interval 13.4 to 27.0	19.6 Percentage of participants Interval 13.5 to 26.9	5.8 Percentage of participants Interval 2.2 to 12.2	5.6 Percentage of participants Interval 1.2 to 15.4	6.1 Percentage of participants Interval 1.3 to 16.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Diarrhea: Mild	7.6 Percentage of participants Interval 4.8 to 11.2	8.4 Percentage of participants Interval 4.4 to 14.2	6.8 Percentage of participants Interval 3.3 to 12.1	5.8 Percentage of participants Interval 2.2 to 12.2	5.6 Percentage of participants Interval 1.2 to 15.4	6.1 Percentage of participants Interval 1.3 to 16.9
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Fatigue: Severe	2.7 Percentage of participants Interval 1.2 to 5.3	3.5 Percentage of participants Interval 1.1 to 8.0	2.0 Percentage of participants Interval 0.4 to 5.8	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.3
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Muscle pain: Any	13.1 Percentage of participants Interval 9.4 to 17.5	11.2 Percentage of participants Interval 6.5 to 17.5	14.9 Percentage of participants Interval 9.6 to 21.6	1.9 Percentage of participants Interval 0.2 to 6.8	0.0 Percentage of participants Interval 0.0 to 6.6	4.1 Percentage of participants Interval 0.5 to 14.0
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Muscle pain: Mild	6.9 Percentage of participants Interval 4.2 to 10.4	3.5 Percentage of participants Interval 1.1 to 8.0	10.1 Percentage of participants Interval 5.8 to 16.2	1.9 Percentage of participants Interval 0.2 to 6.8	0.0 Percentage of participants Interval 0.0 to 6.6	4.1 Percentage of participants Interval 0.5 to 14.0
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Muscle pain: Severe	0.3 Percentage of participants Interval 0.0 to 1.9	0.7 Percentage of participants Interval 0.0 to 3.8	0.0 Percentage of participants Interval 0.0 to 2.5	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.3
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Joint pain: Any	7.2 Percentage of participants Interval 4.5 to 10.8	5.6 Percentage of participants Interval 2.4 to 10.7	8.8 Percentage of participants Interval 4.8 to 14.6	3.9 Percentage of participants Interval 1.1 to 9.6	0.0 Percentage of participants Interval 0.0 to 6.6	8.2 Percentage of participants Interval 2.3 to 19.6
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Joint pain: Mild	2.7 Percentage of participants Interval 1.2 to 5.3	1.4 Percentage of participants Interval 0.2 to 5.0	4.1 Percentage of participants Interval 1.5 to 8.6	3.9 Percentage of participants Interval 1.1 to 9.6	0.0 Percentage of participants Interval 0.0 to 6.6	8.2 Percentage of participants Interval 2.3 to 19.6
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2 Joint pain: Moderate	3.4 Percentage of participants Interval 1.7 to 6.2	2.1 Percentage of participants Interval 0.4 to 6.0	4.7 Percentage of participants Interval 1.9 to 9.5	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.3

PRIMARY outcome

Timeframe: Within 7 Days after Vaccination 3

Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain (other than at the injection site) and 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. Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevented daily activity).

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=285 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=139 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=146 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=104 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=54 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=50 Participants Participants from \>=4 years to \<10 years 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 Diarrhea: Any	6.3 Percentage of participants Interval 3.8 to 9.8	6.5 Percentage of participants Interval 3.0 to 11.9	6.2 Percentage of participants Interval 2.9 to 11.4	2.9 Percentage of participants Interval 0.6 to 8.2	3.7 Percentage of participants Interval 0.5 to 12.7	2.0 Percentage of participants Interval 0.1 to 10.6
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Muscle pain: Any	12.3 Percentage of participants Interval 8.7 to 16.7	12.9 Percentage of participants Interval 7.9 to 19.7	11.6 Percentage of participants Interval 6.9 to 18.0	4.8 Percentage of participants Interval 1.6 to 10.9	5.6 Percentage of participants Interval 1.2 to 15.4	4.0 Percentage of participants Interval 0.5 to 13.7
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Headache: Mild	10.5 Percentage of participants Interval 7.2 to 14.7	5.8 Percentage of participants Interval 2.5 to 11.0	15.1 Percentage of participants Interval 9.7 to 21.9	3.8 Percentage of participants Interval 1.1 to 9.6	0.0 Percentage of participants Interval 0.0 to 6.6	8.0 Percentage of participants Interval 2.2 to 19.2
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Headache: Moderate	3.5 Percentage of participants Interval 1.7 to 6.4	1.4 Percentage of participants Interval 0.2 to 5.1	5.5 Percentage of participants Interval 2.4 to 10.5	2.9 Percentage of participants Interval 0.6 to 8.2	1.9 Percentage of participants Interval 0.0 to 9.9	4.0 Percentage of participants Interval 0.5 to 13.7
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Headache: Severe	0.0 Percentage of participants Interval 0.0 to 1.3	0.0 Percentage of participants Interval 0.0 to 2.6	0.0 Percentage of participants Interval 0.0 to 2.5	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Fatigue: Any	33.3 Percentage of participants Interval 27.9 to 39.1	36.0 Percentage of participants Interval 28.0 to 44.5	30.8 Percentage of participants Interval 23.5 to 39.0	17.3 Percentage of participants Interval 10.6 to 26.0	18.5 Percentage of participants Interval 9.3 to 31.4	16.0 Percentage of participants Interval 7.2 to 29.1
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Fatigue: Mild	18.2 Percentage of participants Interval 13.9 to 23.2	16.5 Percentage of participants Interval 10.8 to 23.8	19.9 Percentage of participants Interval 13.7 to 27.3	11.5 Percentage of participants Interval 6.1 to 19.3	11.1 Percentage of participants Interval 4.2 to 22.6	12.0 Percentage of participants Interval 4.5 to 24.3
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Fatigue: Moderate	14.0 Percentage of participants Interval 10.2 to 18.6	18.0 Percentage of participants Interval 12.0 to 25.4	10.3 Percentage of participants Interval 5.9 to 16.4	5.8 Percentage of participants Interval 2.1 to 12.1	7.4 Percentage of participants Interval 2.1 to 17.9	4.0 Percentage of participants Interval 0.5 to 13.7
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Fatigue: Severe	1.1 Percentage of participants Interval 0.2 to 3.0	1.4 Percentage of participants Interval 0.2 to 5.1	0.7 Percentage of participants Interval 0.0 to 3.8	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Muscle pain: Mild	6.3 Percentage of participants Interval 3.8 to 9.8	7.2 Percentage of participants Interval 3.5 to 12.8	5.5 Percentage of participants Interval 2.4 to 10.5	2.9 Percentage of participants Interval 0.6 to 8.2	1.9 Percentage of participants Interval 0.0 to 9.9	4.0 Percentage of participants Interval 0.5 to 13.7
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Fever >=38 degrees C	6.7 Percentage of participants Interval 4.1 to 10.2	11.5 Percentage of participants Interval 6.7 to 18.0	2.1 Percentage of participants Interval 0.4 to 5.9	5.8 Percentage of participants Interval 2.1 to 12.1	9.3 Percentage of participants Interval 3.1 to 20.3	2.0 Percentage of participants Interval 0.1 to 10.6
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Fever 38 to <38.5 degrees C	3.5 Percentage of participants Interval 1.7 to 6.4	5.0 Percentage of participants Interval 2.0 to 10.1	2.1 Percentage of participants Interval 0.4 to 5.9	2.9 Percentage of participants Interval 0.6 to 8.2	3.7 Percentage of participants Interval 0.5 to 12.7	2.0 Percentage of participants Interval 0.1 to 10.6
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Fever 38.5 to <39 degrees C	1.8 Percentage of participants Interval 0.6 to 4.0	3.6 Percentage of participants Interval 1.2 to 8.2	0.0 Percentage of participants Interval 0.0 to 2.5	1.9 Percentage of participants Interval 0.2 to 6.8	3.7 Percentage of participants Interval 0.5 to 12.7	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Fever 39 to <39.5 degrees C	1.1 Percentage of participants Interval 0.2 to 3.0	2.2 Percentage of participants Interval 0.4 to 6.2	0.0 Percentage of participants Interval 0.0 to 2.5	1.0 Percentage of participants Interval 0.0 to 5.2	1.9 Percentage of participants Interval 0.0 to 9.9	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Fever 39.5 to 40 degrees C	0.4 Percentage of participants Interval 0.0 to 1.9	0.7 Percentage of participants Interval 0.0 to 3.9	0.0 Percentage of participants Interval 0.0 to 2.5	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.1
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 1.3	0.0 Percentage of participants Interval 0.0 to 2.6	0.0 Percentage of participants Interval 0.0 to 2.5	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Muscle pain: Moderate	5.6 Percentage of participants Interval 3.2 to 9.0	5.0 Percentage of participants Interval 2.0 to 10.1	6.2 Percentage of participants Interval 2.9 to 11.4	1.9 Percentage of participants Interval 0.2 to 6.8	3.7 Percentage of participants Interval 0.5 to 12.7	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Vomiting: Any	3.2 Percentage of participants Interval 1.5 to 5.9	4.3 Percentage of participants Interval 1.6 to 9.2	2.1 Percentage of participants Interval 0.4 to 5.9	3.8 Percentage of participants Interval 1.1 to 9.6	5.6 Percentage of participants Interval 1.2 to 15.4	2.0 Percentage of participants Interval 0.1 to 10.6
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Vomiting: Mild	2.1 Percentage of participants Interval 0.8 to 4.5	2.9 Percentage of participants Interval 0.8 to 7.2	1.4 Percentage of participants Interval 0.2 to 4.9	1.9 Percentage of participants Interval 0.2 to 6.8	3.7 Percentage of participants Interval 0.5 to 12.7	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Vomiting: Moderate	1.1 Percentage of participants Interval 0.2 to 3.0	1.4 Percentage of participants Interval 0.2 to 5.1	0.7 Percentage of participants Interval 0.0 to 3.8	1.9 Percentage of participants Interval 0.2 to 6.8	1.9 Percentage of participants Interval 0.0 to 9.9	2.0 Percentage of participants Interval 0.1 to 10.6
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Vomiting: Severe	0.0 Percentage of participants Interval 0.0 to 1.3	0.0 Percentage of participants Interval 0.0 to 2.6	0.0 Percentage of participants Interval 0.0 to 2.5	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Muscle pain: Severe	0.4 Percentage of participants Interval 0.0 to 1.9	0.7 Percentage of participants Interval 0.0 to 3.9	0.0 Percentage of participants Interval 0.0 to 2.5	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Joint pain: Any	7.4 Percentage of participants Interval 4.6 to 11.0	7.2 Percentage of participants Interval 3.5 to 12.8	7.5 Percentage of participants Interval 3.8 to 13.1	2.9 Percentage of participants Interval 0.6 to 8.2	0.0 Percentage of participants Interval 0.0 to 6.6	6.0 Percentage of participants Interval 1.3 to 16.5
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Joint pain: Mild	3.9 Percentage of participants Interval 1.9 to 6.8	2.9 Percentage of participants Interval 0.8 to 7.2	4.8 Percentage of participants Interval 1.9 to 9.6	2.9 Percentage of participants Interval 0.6 to 8.2	0.0 Percentage of participants Interval 0.0 to 6.6	6.0 Percentage of participants Interval 1.3 to 16.5
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Joint pain: Moderate	3.2 Percentage of participants Interval 1.5 to 5.9	3.6 Percentage of participants Interval 1.2 to 8.2	2.7 Percentage of participants Interval 0.8 to 6.9	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Joint pain: Severe	0.4 Percentage of participants Interval 0.0 to 1.9	0.7 Percentage of participants Interval 0.0 to 3.9	0.0 Percentage of participants Interval 0.0 to 2.5	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Antipyretic Medication Use	26.3 Percentage of participants Interval 21.3 to 31.8	25.2 Percentage of participants Interval 18.2 to 33.2	27.4 Percentage of participants Interval 20.3 to 35.4	10.6 Percentage of participants Interval 5.4 to 18.1	13.0 Percentage of participants Interval 5.4 to 24.9	8.0 Percentage of participants Interval 2.2 to 19.2
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Diarrhea: Mild	5.3 Percentage of participants Interval 3.0 to 8.5	5.8 Percentage of participants Interval 2.5 to 11.0	4.8 Percentage of participants Interval 1.9 to 9.6	2.9 Percentage of participants Interval 0.6 to 8.2	3.7 Percentage of participants Interval 0.5 to 12.7	2.0 Percentage of participants Interval 0.1 to 10.6
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Diarrhea: Moderate	0.7 Percentage of participants Interval 0.1 to 2.5	0.7 Percentage of participants Interval 0.0 to 3.9	0.7 Percentage of participants Interval 0.0 to 3.8	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Diarrhea: Severe	0.4 Percentage of participants Interval 0.0 to 1.9	0.0 Percentage of participants Interval 0.0 to 2.6	0.7 Percentage of participants Interval 0.0 to 3.8	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.1
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3 Headache: Any	14.0 Percentage of participants Interval 10.2 to 18.6	7.2 Percentage of participants Interval 3.5 to 12.8	20.5 Percentage of participants Interval 14.3 to 28.0	6.7 Percentage of participants Interval 2.7 to 13.4	1.9 Percentage of participants Interval 0.0 to 9.9	12.0 Percentage of participants Interval 4.5 to 24.3

PRIMARY outcome

Timeframe: Within 30 Days after Vaccination 1

Population: Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0).

SAE was an adverse event (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. 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 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=145 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=149 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=55 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=51 Participants Participants from \>=4 years to \<10 years 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) Within 30 Days After Vaccination 1	0.3 Percentage of participants Interval 0.0 to 1.9	0.7 Percentage of participants Interval 0.0 to 3.8	0.0 Percentage of participants Interval 0.0 to 2.4	0.9 Percentage of participants Interval 0.0 to 5.1	1.8 Percentage of participants Interval 0.0 to 9.7	0.0 Percentage of participants Interval 0.0 to 7.0

PRIMARY outcome

Timeframe: Within 30 Days after Vaccination 2

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. 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 Bivalent rLP2086 (>=24 Months to <10 Years) n=291 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=143 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=148 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=104 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=54 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=50 Participants Participants from \>=4 years to \<10 years 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) Within 30 Days After Vaccination 2	0.7 Percentage of participants Interval 0.1 to 2.5	1.4 Percentage of participants Interval 0.2 to 5.0	0.0 Percentage of participants Interval 0.0 to 2.5	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.1

PRIMARY outcome

Timeframe: Within 30 Days after Vaccination 3

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=287 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=140 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=147 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=104 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=54 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=50 Participants Participants from \>=4 years to \<10 years 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) Within 30 Days After Vaccination 3	0.0 Percentage of participants Interval 0.0 to 1.3	0.0 Percentage of participants Interval 0.0 to 2.6	0.0 Percentage of participants Interval 0.0 to 2.5	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.1

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 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=145 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=149 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=55 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=51 Participants Participants from \>=4 years to \<10 years 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) Within 30 Days After Any Vaccination	1.0 Percentage of participants Interval 0.2 to 3.0	2.1 Percentage of participants Interval 0.4 to 5.9	0.0 Percentage of participants Interval 0.0 to 2.4	0.9 Percentage of participants Interval 0.0 to 5.1	1.8 Percentage of participants Interval 0.0 to 9.7	0.0 Percentage of participants Interval 0.0 to 7.0

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 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=145 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=149 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=55 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=51 Participants Participants from \>=4 years to \<10 years 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) During the Vaccination Phase	1.4 Percentage of participants Interval 0.4 to 3.4	2.1 Percentage of participants Interval 0.4 to 5.9	0.7 Percentage of participants Interval 0.0 to 3.7	0.9 Percentage of participants Interval 0.0 to 5.1	1.8 Percentage of participants Interval 0.0 to 9.7	0.0 Percentage of participants Interval 0.0 to 7.0

PRIMARY outcome

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

Population: Safety population: all participants who had at least 1 dose of investigational product (rLP2086 or HAV/saline) and had safety data available from after post third-vaccination blood draw to 6 months after last study vaccination. Here "N" signifies number of participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=284 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=137 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=147 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=104 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=54 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=50 Participants Participants from \>=4 years to \<10 years 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) During the Follow-up Phase	0.4 Percentage of participants Interval 0.0 to 1.9	0.0 Percentage of participants Interval 0.0 to 2.7	0.7 Percentage of participants Interval 0.0 to 3.7	0.0 Percentage of participants Interval 0.0 to 3.5	0.0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.1

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 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=145 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=149 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=55 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=51 Participants Participants from \>=4 years to \<10 years 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) Throughout the Study	1.7 Percentage of participants Interval 0.6 to 3.9	2.1 Percentage of participants Interval 0.4 to 5.9	1.3 Percentage of participants Interval 0.2 to 4.8	0.9 Percentage of participants Interval 0.0 to 5.1	1.8 Percentage of participants Interval 0.0 to 9.7	0.0 Percentage of participants Interval 0.0 to 7.0

PRIMARY outcome

Timeframe: Within 30 Days after Vaccination 1

Population: Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0).

A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=145 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=149 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=55 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=51 Participants Participants from \>=4 years to \<10 years 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 Medically Attended Adverse Event (AE) Within 30 Days After Vaccination 1	13.3 Percentage of participants Interval 9.6 to 17.7	18.6 Percentage of participants Interval 12.6 to 25.9	8.1 Percentage of participants Interval 4.2 to 13.6	13.2 Percentage of participants Interval 7.4 to 21.2	16.4 Percentage of participants Interval 7.8 to 28.8	9.8 Percentage of participants Interval 3.3 to 21.4

PRIMARY outcome

Timeframe: Within 30 Days after Vaccination 2

A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=291 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=143 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=148 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=104 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=54 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=50 Participants Participants from \>=4 years to \<10 years 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 Medically Attended Adverse Event (AE) Within 30 Days After Vaccination 2	12.0 Percentage of participants Interval 8.5 to 16.3	10.5 Percentage of participants Interval 6.0 to 16.7	13.5 Percentage of participants Interval 8.5 to 20.1	11.5 Percentage of participants Interval 6.1 to 19.3	14.8 Percentage of participants Interval 6.6 to 27.1	8.0 Percentage of participants Interval 2.2 to 19.2

PRIMARY outcome

Timeframe: Within 30 Days after Vaccination 3

A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=287 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=140 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=147 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=104 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=54 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=50 Participants Participants from \>=4 years to \<10 years 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 Medically Attended Adverse Event (AE) Within 30 Days After Vaccination 3	5.6 Percentage of participants Interval 3.2 to 8.9	6.4 Percentage of participants Interval 3.0 to 11.9	4.8 Percentage of participants Interval 1.9 to 9.6	4.8 Percentage of participants Interval 1.6 to 10.9	5.6 Percentage of participants Interval 1.2 to 15.4	4.0 Percentage of participants Interval 0.5 to 13.7

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.

A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=145 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=149 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=55 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=51 Participants Participants from \>=4 years to \<10 years 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 Medically Attended Adverse Event (AE) Within 30 Days After Any Vaccination	25.9 Percentage of participants Interval 20.9 to 31.3	29.0 Percentage of participants Interval 21.7 to 37.1	22.8 Percentage of participants Interval 16.3 to 30.4	26.4 Percentage of participants Interval 18.3 to 35.9	30.9 Percentage of participants Interval 19.1 to 44.8	21.6 Percentage of participants Interval 11.3 to 35.3

PRIMARY outcome

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

A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=145 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=149 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=55 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=51 Participants Participants from \>=4 years to \<10 years 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 Medically Attended Adverse Event (AE) During the Vaccination Phase	43.2 Percentage of participants Interval 37.5 to 49.1	45.5 Percentage of participants Interval 37.2 to 54.0	40.9 Percentage of participants Interval 33.0 to 49.3	46.2 Percentage of participants Interval 36.5 to 56.2	41.8 Percentage of participants Interval 28.7 to 55.9	51.0 Percentage of participants Interval 36.6 to 65.2

PRIMARY outcome

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

A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=284 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=137 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=147 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=104 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=54 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=50 Participants Participants from \>=4 years to \<10 years 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 Medically Attended Adverse Event (AE) During the Follow-up Phase	18.3 Percentage of participants Interval 14.0 to 23.3	20.4 Percentage of participants Interval 14.0 to 28.2	16.3 Percentage of participants Interval 10.7 to 23.3	12.5 Percentage of participants Interval 6.8 to 20.4	13.0 Percentage of participants Interval 5.4 to 24.9	12.0 Percentage of participants Interval 4.5 to 24.3

PRIMARY outcome

Timeframe: From the Vaccination 1 up to 6 months after the 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.

A medically attended AE was defined as a non-serious AE that resulted in an evaluation at a medical facility.

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=145 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=149 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=55 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=51 Participants Participants from \>=4 years to \<10 years 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 Medically Attended Adverse Event (AE) Throughout the Study	48.6 Percentage of participants Interval 42.8 to 54.5	49.0 Percentage of participants Interval 40.6 to 57.4	48.3 Percentage of participants Interval 40.1 to 56.6	50.0 Percentage of participants Interval 40.1 to 59.9	47.3 Percentage of participants Interval 33.7 to 61.2	52.9 Percentage of participants Interval 38.5 to 67.1

PRIMARY outcome

Timeframe: Within 30 Days after Vaccination 1

Population: Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0).

A newly diagnosed chronic medical condition 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 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=145 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=149 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=55 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=51 Participants Participants from \>=4 years to \<10 years 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 Newly Diagnosed Chronic Medical Condition Within 30 Days After Vaccination 1	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: Within 30 Days after Vaccination 2

Population: Vaccination 2 safety population: all participants who received the second dose of investigational products (rLP2086 or saline) on Month 2 visit.

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=145 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=149 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=55 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=51 Participants Participants from \>=4 years to \<10 years 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 Newly Diagnosed Chronic Medical Condition Within 30 Days After Vaccination 2	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: Within 30 Days after Vaccination 3

Population: Vaccination 3 safety population: all participants who received the third dose of investigational product (rLP2086 or HAV vaccine) on Month 6 visit.

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=145 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=149 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=55 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=51 Participants Participants from \>=4 years to \<10 years 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 Newly Diagnosed Chronic Medical Condition Within 30 Days After Vaccination 3	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0

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 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=145 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=149 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=55 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=51 Participants Participants from \>=4 years to \<10 years 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 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: From the Vaccination 1 up to 1 month after the 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 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=145 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=149 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=55 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=51 Participants Participants from \>=4 years to \<10 years 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 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=145 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=149 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=55 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=51 Participants Participants from \>=4 years to \<10 years 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 Newly Diagnosed Chronic Medical Condition During the Follow-up Phase	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: From the Vaccination 1 up to 6 months after the 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 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=145 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=149 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=55 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=51 Participants Participants from \>=4 years to \<10 years 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 Newly Diagnosed Chronic Medical Condition Throughout the Study	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0	0.0 Percentage of participants Interval 0.0 to 0.0

PRIMARY outcome

Timeframe: Within 30 Days after Vaccination 1

Population: Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0).

AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=145 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=149 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=55 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=51 Participants Participants from \>=4 years to \<10 years 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) Within 30 Days After Vaccination 1	24.1 Percentage of participants Interval 19.4 to 29.5	29.0 Percentage of participants Interval 21.7 to 37.1	19.5 Percentage of participants Interval 13.4 to 26.7	17.9 Percentage of participants Interval 11.2 to 26.6	21.8 Percentage of participants Interval 11.8 to 35.0	13.7 Percentage of participants Interval 5.7 to 26.3

PRIMARY outcome

Timeframe: Within 30 Days after Vaccination 2

AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=291 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=143 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=148 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=104 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=54 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=50 Participants Participants from \>=4 years to \<10 years 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) Within 30 Days After Vaccination 2	23.0 Percentage of participants Interval 18.3 to 28.3	19.6 Percentage of participants Interval 13.4 to 27.0	26.4 Percentage of participants Interval 19.5 to 34.2	22.1 Percentage of participants Interval 14.6 to 31.3	27.8 Percentage of participants Interval 16.5 to 41.6	16.0 Percentage of participants Interval 7.2 to 29.1

PRIMARY outcome

Timeframe: Within 30 Days after Vaccination 3

AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=287 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=140 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=147 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=104 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=54 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=50 Participants Participants from \>=4 years to \<10 years 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) Within 30 Days After Vaccination 3	14.3 Percentage of participants Interval 10.5 to 18.9	12.9 Percentage of participants Interval 7.8 to 19.6	15.6 Percentage of participants Interval 10.2 to 22.5	9.6 Percentage of participants Interval 4.7 to 17.0	11.1 Percentage of participants Interval 4.2 to 22.6	8.0 Percentage of participants Interval 2.2 to 19.2

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.

AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=145 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=149 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=55 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=51 Participants Participants from \>=4 years to \<10 years 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) Within 30 Days After Any Vaccination	44.2 Percentage of participants Interval 38.5 to 50.1	44.8 Percentage of participants Interval 36.6 to 53.3	43.6 Percentage of participants Interval 35.5 to 52.0	39.6 Percentage of participants Interval 30.3 to 49.6	49.1 Percentage of participants Interval 35.4 to 62.9	29.4 Percentage of participants Interval 17.5 to 43.8

PRIMARY outcome

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

AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=145 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=149 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=55 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=51 Participants Participants from \>=4 years to \<10 years 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) During the Vaccination Phase	62.6 Percentage of participants Interval 56.8 to 68.1	62.1 Percentage of participants Interval 53.6 to 70.0	63.1 Percentage of participants Interval 54.8 to 70.8	63.2 Percentage of participants Interval 53.3 to 72.4	63.6 Percentage of participants Interval 49.6 to 76.2	62.7 Percentage of participants Interval 48.1 to 75.9

PRIMARY outcome

Timeframe: Within 30 minutes after Vaccination 1

Population: Vaccination 1 safety population: all participants who received the first dose of investigational products (rLP2086 or HAV vaccine) on Day 1 (Month 0).

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

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=145 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=149 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=55 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=51 Participants Participants from \>=4 years to \<10 years 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 Immediate Adverse Event (AE) After Vaccination 1	0 Percentage of participants Interval 0.0 to 1.2	0 Percentage of participants Interval 0.0 to 2.5	0 Percentage of participants Interval 0.0 to 2.4	0 Percentage of participants Interval 0.0 to 3.4	0 Percentage of participants Interval 0.0 to 6.5	0 Percentage of participants Interval 0.0 to 7.0

PRIMARY outcome

Timeframe: Within 30 minutes after Vaccination 2

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

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=291 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=143 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=148 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=104 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=54 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=50 Participants Participants from \>=4 years to \<10 years 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 Immediate Adverse Event (AE) After Vaccination 2	0 Percentage of participants Interval 0.0 to 1.3	0 Percentage of participants Interval 0.0 to 2.5	0 Percentage of participants Interval 0.0 to 2.5	0 Percentage of participants Interval 0.0 to 3.5	0 Percentage of participants Interval 0.0 to 6.6	0 Percentage of participants Interval 0.0 to 7.1

PRIMARY outcome

Timeframe: Within 30 minutes after Vaccination 3

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

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=287 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=140 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=147 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=104 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=54 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=50 Participants Participants from \>=4 years to \<10 years 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 Immediate Adverse Event (AE) After Vaccination 3	0.3 Percentage of participants Interval 0.0 to 1.9	0.0 Percentage of participants Interval 0.0 to 2.6	0.7 Percentage of participants Interval 0.0 to 3.7	0 Percentage of participants Interval 0.0 to 3.5	0 Percentage of participants Interval 0.0 to 6.6	0.0 Percentage of participants Interval 0.0 to 7.1

PRIMARY outcome

Timeframe: From the Vaccination 1 up to 1 month after the 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 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=145 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=149 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=55 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=51 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
Number of Days Participant's Missed School Due to Adverse Event (AE) During the Vaccination Phase	4.7 Days Standard Deviation 3.1	7.0 Days Standard Deviation 3.7	4.0 Days Standard Deviation 2.6	4.6 Days Standard Deviation 2.6	7.3 Days Standard Deviation 2.3	4.2 Days Standard Deviation 2.5

SECONDARY outcome

Timeframe: 1 month after Vaccination 3

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 Bivalent rLP2086 (>=24 Months to <10 Years) n=274 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=97 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) Participants from \>=4 years to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.
Percentage of Participants Aged >=24 Months to <10 Years With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 3 PMB80 [A22]	87.4 Percentage of participants Interval 80.6 to 92.5	6.7 Percentage of participants Interval 1.4 to 18.3	—	—	—	—
Percentage of Participants Aged >=24 Months to <10 Years With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 3 PMB2001 [A56]	100.0 Percentage of participants Interval 97.4 to 100.0	20.9 Percentage of participants Interval 10.0 to 36.0	—	—	—	—
Percentage of Participants Aged >=24 Months to <10 Years With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 3 PMB2948 [B24]	88.9 Percentage of participants Interval 82.1 to 93.8	4.3 Percentage of participants Interval 0.5 to 14.8	—	—	—	—
Percentage of Participants Aged >=24 Months to <10 Years With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 3 PMB2707 [B44]	79.1 Percentage of participants Interval 71.2 to 85.6	0.0 Percentage of participants Interval 0.0 to 7.1	—	—	—	—

SECONDARY outcome

Timeframe: 1 month after Vaccination 2 and 6 months after Vaccination 3

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=274 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=136 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=138 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=97 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=52 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=45 Participants Participants from \>=4 years to \<10 years 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 and 6 Months After Vaccination 3 1 Month after Vaccination 2: PMB80 [A22]	69.2 Percentage of participants Interval 60.5 to 77.0	59.4 Percentage of participants Interval 46.4 to 71.5	78.8 Percentage of participants Interval 67.0 to 87.9	4.4 Percentage of participants Interval 0.5 to 15.1	0.0 Percentage of participants Interval 0.0 to 14.2	9.5 Percentage of participants Interval 1.2 to 30.4
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2 and 6 Months After Vaccination 3 6 Months after Vaccination 3: PMB80 [A22]	32.5 Percentage of participants Interval 24.5 to 41.5	19.0 Percentage of participants Interval 10.2 to 30.9	46.0 Percentage of participants Interval 33.4 to 59.1	8.5 Percentage of participants Interval 2.4 to 20.4	7.7 Percentage of participants Interval 0.9 to 25.1	9.5 Percentage of participants Interval 1.2 to 30.4
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2 and 6 Months After Vaccination 3 1 Month after Vaccination 2: PMB2001 [A56]	100.0 Percentage of participants Interval 97.3 to 100.0	100.0 Percentage of participants Interval 94.6 to 100.0	100.0 Percentage of participants Interval 94.6 to 100.0	16.3 Percentage of participants Interval 6.8 to 30.7	9.5 Percentage of participants Interval 1.2 to 30.4	22.7 Percentage of participants Interval 7.8 to 45.4
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2 and 6 Months After Vaccination 3 6 Months after Vaccination 3: PMB2001 [A56]	82.4 Percentage of participants Interval 74.8 to 88.5	80.3 Percentage of participants Interval 68.2 to 89.4	84.3 Percentage of participants Interval 73.6 to 91.9	19.6 Percentage of participants Interval 9.4 to 33.9	16.7 Percentage of participants Interval 4.7 to 37.4	22.7 Percentage of participants Interval 7.8 to 45.4
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2 and 6 Months After Vaccination 3 1 Month after Vaccination 2: PMB2948 [B24]	57.0 Percentage of participants Interval 48.0 to 65.7	49.2 Percentage of participants Interval 36.6 to 61.9	65.1 Percentage of participants Interval 52.0 to 76.7	8.9 Percentage of participants Interval 2.5 to 21.2	8.3 Percentage of participants Interval 1.0 to 27.0	9.5 Percentage of participants Interval 1.2 to 30.4
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2 and 6 Months After Vaccination 3 6 Months after Vaccination 3: PMB2948 [B24]	15.5 Percentage of participants Interval 9.7 to 22.9	9.2 Percentage of participants Interval 3.5 to 19.0	21.9 Percentage of participants Interval 12.5 to 34.0	0.0 Percentage of participants Interval 0.0 to 7.5	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 16.1
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2 and 6 Months After Vaccination 3 1 Month after Vaccination 2: PMB2707 [B44]	48.5 Percentage of participants Interval 39.6 to 57.4	57.1 Percentage of participants Interval 44.0 to 69.5	40.3 Percentage of participants Interval 28.5 to 53.0	0.0 Percentage of participants Interval 0.0 to 7.1	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.2
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2 and 6 Months After Vaccination 3 6 Months after Vaccination 3: PMB2707 [B44]	10.4 Percentage of participants Interval 5.8 to 16.8	12.1 Percentage of participants Interval 5.4 to 22.5	8.7 Percentage of participants Interval 3.3 to 18.0	0.0 Percentage of participants Interval 0.0 to 7.3	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.8

SECONDARY outcome

Timeframe: Before Vaccination 1, 1 month after Vaccination 2, 1 month after Vaccination 3 and 6 months after Vaccination 3

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=274 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=136 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=138 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=97 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=52 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=45 Participants Participants from \>=4 years to \<10 years 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 1 month after Vaccination 2: PMB80 [A22] - 1:8	72.3 Percentage of participants Interval 63.8 to 79.8	62.5 Percentage of participants Interval 49.5 to 74.3	81.8 Percentage of participants Interval 70.4 to 90.2	8.9 Percentage of participants Interval 2.5 to 21.2	8.3 Percentage of participants Interval 1.0 to 27.0	9.5 Percentage of participants Interval 1.2 to 30.4
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 1 month after Vaccination 2: PMB80 [A22] - 1:32	41.5 Percentage of participants Interval 33.0 to 50.5	35.9 Percentage of participants Interval 24.3 to 48.9	47.0 Percentage of participants Interval 34.6 to 59.7	4.4 Percentage of participants Interval 0.5 to 15.1	0.0 Percentage of participants Interval 0.0 to 14.2	9.5 Percentage of participants Interval 1.2 to 30.4
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 1 month after Vaccination 2: PMB80 [A22] - 1:64	16.9 Percentage of participants Interval 10.9 to 24.5	14.1 Percentage of participants Interval 6.6 to 25.0	19.7 Percentage of participants Interval 10.9 to 31.3	2.2 Percentage of participants Interval 0.1 to 11.8	0.0 Percentage of participants Interval 0.0 to 14.2	4.8 Percentage of participants Interval 0.1 to 23.8
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 1 month after Vaccination 2: PMB80 [A22] - 1:128	4.6 Percentage of participants Interval 1.7 to 9.8	1.6 Percentage of participants Interval 0.0 to 8.4	7.6 Percentage of participants Interval 2.5 to 16.8	0.0 Percentage of participants Interval 0.0 to 7.9	0.0 Percentage of participants Interval 0.0 to 14.2	0.0 Percentage of participants Interval 0.0 to 16.1
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 1 month after Vaccination 3: PMB80 [A22] - 1:4	92.6 Percentage of participants Interval 86.8 to 96.4	86.8 Percentage of participants Interval 76.4 to 93.8	98.5 Percentage of participants Interval 92.0 to 100.0	11.1 Percentage of participants Interval 3.7 to 24.1	8.0 Percentage of participants Interval 1.0 to 26.0	15.0 Percentage of participants Interval 3.2 to 37.9
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] - 1:8	92.6 Percentage of participants Interval 86.8 to 96.4	86.8 Percentage of participants Interval 76.4 to 93.8	98.5 Percentage of participants Interval 92.0 to 100.0	11.1 Percentage of participants Interval 3.7 to 24.1	8.0 Percentage of participants Interval 1.0 to 26.0	15.0 Percentage of participants Interval 3.2 to 37.9
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] - 1:32	67.4 Percentage of participants Interval 58.8 to 75.2	63.2 Percentage of participants Interval 50.7 to 74.6	71.6 Percentage of participants Interval 59.3 to 82.0	4.4 Percentage of participants Interval 0.5 to 15.1	4.0 Percentage of participants Interval 0.1 to 20.4	5.0 Percentage of participants Interval 0.1 to 24.9
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: PMB2707 [B44] - 1:128	33.6 Percentage of participants Interval 25.7 to 42.2	36.9 Percentage of participants Interval 25.3 to 49.8	30.4 Percentage of participants Interval 19.9 to 42.7	0.0 Percentage of participants Interval 0.0 to 7.1	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.2
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	13.3 Percentage of participants Interval 8.1 to 20.3	13.6 Percentage of participants Interval 6.4 to 24.3	13.0 Percentage of participants Interval 6.1 to 23.3	0.0 Percentage of participants Interval 0.0 to 7.3	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.8
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 Before Vaccination 1: PMB80 [A22] - 1:4	12.7 Percentage of participants Interval 7.6 to 19.5	5.9 Percentage of participants Interval 1.6 to 14.4	19.7 Percentage of participants Interval 10.9 to 31.3	6.4 Percentage of participants Interval 1.3 to 17.5	3.8 Percentage of participants Interval 0.1 to 19.6	9.5 Percentage of participants Interval 1.2 to 30.4
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 Before Vaccination 1: PMB80 [A22] - 1:8	11.9 Percentage of participants Interval 7.0 to 18.7	5.9 Percentage of participants Interval 1.6 to 14.4	18.2 Percentage of participants Interval 9.8 to 29.6	6.4 Percentage of participants Interval 1.3 to 17.5	3.8 Percentage of participants Interval 0.1 to 19.6	9.5 Percentage of participants Interval 1.2 to 30.4
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 Before Vaccination 1: PMB80 [A22] - 1:16	9.0 Percentage of participants Interval 4.7 to 15.1	4.4 Percentage of participants Interval 0.9 to 12.4	13.6 Percentage of participants Interval 6.4 to 24.3	6.4 Percentage of participants Interval 1.3 to 17.5	3.8 Percentage of participants Interval 0.1 to 19.6	9.5 Percentage of participants Interval 1.2 to 30.4
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 Before Vaccination 1: PMB80 [A22] - 1:32	3.0 Percentage of participants Interval 0.8 to 7.5	1.5 Percentage of participants Interval 0.0 to 7.9	4.5 Percentage of participants Interval 0.9 to 12.7	4.3 Percentage of participants Interval 0.5 to 14.5	0.0 Percentage of participants Interval 0.0 to 13.2	9.5 Percentage of participants Interval 1.2 to 30.4
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 Before Vaccination 1: PMB80 [A22] - 1:64	0.0 Percentage of participants Interval 0.0 to 2.7	0.0 Percentage of participants Interval 0.0 to 5.3	0.0 Percentage of participants Interval 0.0 to 5.4	2.1 Percentage of participants Interval 0.1 to 11.3	0.0 Percentage of participants Interval 0.0 to 13.2	4.8 Percentage of participants Interval 0.1 to 23.8
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 Before Vaccination 1: PMB80 [A22] - 1:128	0.0 Percentage of participants Interval 0.0 to 2.7	0.0 Percentage of participants Interval 0.0 to 5.3	0.0 Percentage of participants Interval 0.0 to 5.4	2.1 Percentage of participants Interval 0.1 to 11.3	0.0 Percentage of participants Interval 0.0 to 13.2	4.8 Percentage of participants Interval 0.1 to 23.8
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 1 month after Vaccination 2: PMB80 [A22] - 1:4	74.6 Percentage of participants Interval 66.2 to 81.8	65.6 Percentage of participants Interval 52.7 to 77.1	83.3 Percentage of participants Interval 72.1 to 91.4	11.1 Percentage of participants Interval 3.7 to 24.1	8.3 Percentage of participants Interval 1.0 to 27.0	14.3 Percentage of participants Interval 3.0 to 36.3
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: PMB80 [A22] - 1:64	39.3 Percentage of participants Interval 31.0 to 48.0	38.2 Percentage of participants Interval 26.7 to 50.8	40.3 Percentage of participants Interval 28.5 to 53.0	2.2 Percentage of participants Interval 0.1 to 11.8	4.0 Percentage of participants Interval 0.1 to 20.4	0.0 Percentage of participants Interval 0.0 to 16.8
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] - 1:128	15.6 Percentage of participants Interval 9.9 to 22.8	14.7 Percentage of participants Interval 7.3 to 25.4	16.4 Percentage of participants Interval 8.5 to 27.5	0.0 Percentage of participants Interval 0.0 to 7.9	0.0 Percentage of participants Interval 0.0 to 13.7	0.0 Percentage of participants Interval 0.0 to 16.8
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 T4: PMB80 [A22] - 1:4	40.5 Percentage of participants Interval 31.8 to 49.6	25.4 Percentage of participants Interval 15.3 to 37.9	55.6 Percentage of participants Interval 42.5 to 68.1	10.6 Percentage of participants Interval 3.5 to 23.1	11.5 Percentage of participants Interval 2.4 to 30.2	9.5 Percentage of participants Interval 1.2 to 30.4
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 T4: PMB80 [A22] - 1:8	38.9 Percentage of participants Interval 30.3 to 48.0	22.2 Percentage of participants Interval 12.7 to 34.5	55.6 Percentage of participants Interval 42.5 to 68.1	8.5 Percentage of participants Interval 2.4 to 20.4	7.7 Percentage of participants Interval 0.9 to 25.1	9.5 Percentage of participants Interval 1.2 to 30.4
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 T4: PMB80 [A22] - 1:32	19.8 Percentage of participants Interval 13.3 to 27.9	14.3 Percentage of participants Interval 6.7 to 25.4	25.4 Percentage of participants Interval 15.3 to 37.9	2.1 Percentage of participants Interval 0.1 to 11.3	0.0 Percentage of participants Interval 0.0 to 13.2	4.8 Percentage of participants Interval 0.1 to 23.8
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 T4: PMB80 [A22] - 1:64	7.9 Percentage of participants Interval 3.9 to 14.1	4.8 Percentage of participants Interval 1.0 to 13.3	11.1 Percentage of participants Interval 4.6 to 21.6	2.1 Percentage of participants Interval 0.1 to 11.3	0.0 Percentage of participants Interval 0.0 to 13.2	4.8 Percentage of participants Interval 0.1 to 23.8
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 T4: PMB80 [A22] - 1:128	2.4 Percentage of participants Interval 0.5 to 6.8	4.8 Percentage of participants Interval 1.0 to 13.3	0.0 Percentage of participants Interval 0.0 to 5.7	0.0 Percentage of participants Interval 0.0 to 7.5	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 16.1
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] - 1:4	10.6 Percentage of participants Interval 5.9 to 17.2	3.0 Percentage of participants Interval 0.4 to 10.4	18.5 Percentage of participants Interval 9.9 to 30.0	19.1 Percentage of participants Interval 9.1 to 33.3	16.7 Percentage of participants Interval 4.7 to 37.4	21.7 Percentage of participants Interval 7.5 to 43.7
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] - 1:8	8.3 Percentage of participants Interval 4.2 to 14.4	1.5 Percentage of participants Interval 0.0 to 8.0	15.4 Percentage of participants Interval 7.6 to 26.5	14.9 Percentage of participants Interval 6.2 to 28.3	8.3 Percentage of participants Interval 1.0 to 27.0	21.7 Percentage of participants Interval 7.5 to 43.7
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	8.3 Percentage of participants Interval 4.2 to 14.4	1.5 Percentage of participants Interval 0.0 to 8.0	15.4 Percentage of participants Interval 7.6 to 26.5	14.9 Percentage of participants Interval 6.2 to 28.3	8.3 Percentage of participants Interval 1.0 to 27.0	21.7 Percentage of participants Interval 7.5 to 43.7
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	6.8 Percentage of participants Interval 3.2 to 12.5	0.0 Percentage of participants Interval 0.0 to 5.4	13.8 Percentage of participants Interval 6.5 to 24.7	12.8 Percentage of participants Interval 4.8 to 25.7	8.3 Percentage of participants Interval 1.0 to 27.0	17.4 Percentage of participants Interval 5.0 to 38.8
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: PMB2001 [A56] - 1:64	3.8 Percentage of participants Interval 1.2 to 8.6	0.0 Percentage of participants Interval 0.0 to 5.4	7.7 Percentage of participants Interval 2.5 to 17.0	6.4 Percentage of participants Interval 1.3 to 17.5	4.2 Percentage of participants Interval 0.1 to 21.1	8.7 Percentage of participants Interval 1.1 to 28.0
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 T1: PMB2001 [A56] -1:128	0.8 Percentage of participants Interval 0.0 to 4.1	0.0 Percentage of participants Interval 0.0 to 5.4	1.5 Percentage of participants Interval 0.0 to 8.3	0.0 Percentage of participants Interval 0.0 to 7.5	0.0 Percentage of participants Interval 0.0 to 14.2	0.0 Percentage of participants Interval 0.0 to 14.8
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] - 1:4	100.0 Percentage of participants Interval 97.3 to 100.0	100.0 Percentage of participants Interval 94.6 to 100.0	100.0 Percentage of participants Interval 94.6 to 100.0	16.3 Percentage of participants Interval 6.8 to 30.7	9.5 Percentage of participants Interval 1.2 to 30.4	22.7 Percentage of participants Interval 7.8 to 45.4
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 T2: PMB2001 [A56] - 1:16	99.2 Percentage of participants Interval 95.9 to 100.0	100.0 Percentage of participants Interval 94.6 to 100.0	98.5 Percentage of participants Interval 92.0 to 100.0	16.3 Percentage of participants Interval 6.8 to 30.7	9.5 Percentage of participants Interval 1.2 to 30.4	22.7 Percentage of participants Interval 7.8 to 45.4
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 T2: PMB2001 [A56] - 1:32	94.7 Percentage of participants Interval 89.5 to 97.9	97.0 Percentage of participants Interval 89.5 to 99.6	92.5 Percentage of participants Interval 83.4 to 97.5	11.6 Percentage of participants Interval 3.9 to 25.1	9.5 Percentage of participants Interval 1.2 to 30.4	13.6 Percentage of participants Interval 2.9 to 34.9
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 T2: PMB2001 [A56] - 1:64	81.2 Percentage of participants Interval 73.5 to 87.5	80.3 Percentage of participants Interval 68.7 to 89.1	82.1 Percentage of participants Interval 70.8 to 90.4	7.0 Percentage of participants Interval 1.5 to 19.1	4.8 Percentage of participants Interval 0.1 to 23.8	9.1 Percentage of participants Interval 1.1 to 29.2
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 T2: PMB2001 [A56] - 1:128	54.1 Percentage of participants Interval 45.3 to 62.8	62.1 Percentage of participants Interval 49.3 to 73.8	46.3 Percentage of participants Interval 34.0 to 58.9	2.3 Percentage of participants Interval 0.1 to 12.3	0.0 Percentage of participants Interval 0.0 to 16.1	4.5 Percentage of participants Interval 0.1 to 22.8
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: PMB2001 [A56] - 1:4	100.0 Percentage of participants Interval 97.4 to 100.0	100.0 Percentage of participants Interval 94.7 to 100.0	100.0 Percentage of participants Interval 94.9 to 100.0	23.3 Percentage of participants Interval 11.8 to 38.6	4.2 Percentage of participants Interval 0.1 to 21.1	47.4 Percentage of participants Interval 24.4 to 71.1
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 T3: PMB2001 [A56] - 1:16	100.0 Percentage of participants Interval 97.4 to 100.0	100.0 Percentage of participants Interval 94.7 to 100.0	100.0 Percentage of participants Interval 94.9 to 100.0	20.9 Percentage of participants Interval 10.0 to 36.0	4.2 Percentage of participants Interval 0.1 to 21.1	42.1 Percentage of participants Interval 20.3 to 66.5
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: PMB2001 [A56] - 1:32	98.6 Percentage of participants Interval 94.9 to 99.8	97.1 Percentage of participants Interval 89.8 to 99.6	100.0 Percentage of participants Interval 94.9 to 100.0	11.6 Percentage of participants Interval 3.9 to 25.1	4.2 Percentage of participants Interval 0.1 to 21.1	21.1 Percentage of participants Interval 6.1 to 45.6
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] - 1:64	93.5 Percentage of participants Interval 88.1 to 97.0	92.6 Percentage of participants Interval 83.7 to 97.6	94.4 Percentage of participants Interval 86.2 to 98.4	4.7 Percentage of participants Interval 0.6 to 15.8	4.2 Percentage of participants Interval 0.1 to 21.1	5.3 Percentage of participants Interval 0.1 to 26.0
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] - 1:128	77.0 Percentage of participants Interval 69.1 to 83.7	76.5 Percentage of participants Interval 64.6 to 85.9	77.5 Percentage of participants Interval 66.0 to 86.5	0.0 Percentage of participants Interval 0.0 to 8.2	0.0 Percentage of participants Interval 0.0 to 14.2	0.0 Percentage of participants Interval 0.0 to 17.6
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: PMB2001 [A56] - 1:4	84.0 Percentage of participants Interval 76.5 to 89.8	82.0 Percentage of participants Interval 70.0 to 90.6	85.7 Percentage of participants Interval 75.3 to 92.9	21.7 Percentage of participants Interval 10.9 to 36.4	20.8 Percentage of participants Interval 7.1 to 42.2	22.7 Percentage of participants Interval 7.8 to 45.4
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 T4: PMB2001 [A56] - 1:16	80.2 Percentage of participants Interval 72.3 to 86.6	77.0 Percentage of participants Interval 64.5 to 86.8	82.9 Percentage of participants Interval 72.0 to 90.8	19.6 Percentage of participants Interval 9.4 to 33.9	16.7 Percentage of participants Interval 4.7 to 37.4	22.7 Percentage of participants Interval 7.8 to 45.4
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 T4: PMB2001 [A56] - 1:32	65.6 Percentage of participants Interval 56.9 to 73.7	59.0 Percentage of participants Interval 45.7 to 71.4	71.4 Percentage of participants Interval 59.4 to 81.6	13.0 Percentage of participants Interval 4.9 to 26.3	16.7 Percentage of participants Interval 4.7 to 37.4	9.1 Percentage of participants Interval 1.1 to 29.2
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] - 1:64	44.3 Percentage of participants Interval 35.6 to 53.2	39.3 Percentage of participants Interval 27.1 to 52.7	48.6 Percentage of participants Interval 36.4 to 60.8	6.5 Percentage of participants Interval 1.4 to 17.9	8.3 Percentage of participants Interval 1.0 to 27.0	4.5 Percentage of participants Interval 0.1 to 22.8
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 T4: PMB2001 [A56] - 1:128	19.1 Percentage of participants Interval 12.7 to 26.9	16.4 Percentage of participants Interval 8.2 to 28.1	21.4 Percentage of participants Interval 12.5 to 32.9	0.0 Percentage of participants Interval 0.0 to 7.7	0.0 Percentage of participants Interval 0.0 to 14.2	0.0 Percentage of participants Interval 0.0 to 15.4
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 T1: PMB2948 [B24] - 1:4	6.7 Percentage of participants Interval 3.1 to 12.4	4.5 Percentage of participants Interval 0.9 to 12.5	9.0 Percentage of participants Interval 3.4 to 18.5	4.3 Percentage of participants Interval 0.5 to 14.5	3.8 Percentage of participants Interval 0.1 to 19.6	4.8 Percentage of participants Interval 0.1 to 23.8
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	5.2 Percentage of participants Interval 2.1 to 10.5	3.0 Percentage of participants Interval 0.4 to 10.4	7.5 Percentage of participants Interval 2.5 to 16.6	4.3 Percentage of participants Interval 0.5 to 14.5	3.8 Percentage of participants Interval 0.1 to 19.6	4.8 Percentage of participants Interval 0.1 to 23.8
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	4.5 Percentage of participants Interval 1.7 to 9.5	3.0 Percentage of participants Interval 0.4 to 10.4	6.0 Percentage of participants Interval 1.7 to 14.6	4.3 Percentage of participants Interval 0.5 to 14.3	3.8 Percentage of participants Interval 0.1 to 19.6	4.8 Percentage of participants Interval 0.1 to 23.8
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	3.0 Percentage of participants Interval 0.8 to 7.5	1.5 Percentage of participants Interval 0.0 to 8.0	4.5 Percentage of participants Interval 0.9 to 12.5	4.3 Percentage of participants Interval 0.5 to 14.3	3.8 Percentage of participants Interval 0.1 to 19.6	4.8 Percentage of participants Interval 0.1 to 23.8
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	1.5 Percentage of participants Interval 0.2 to 5.3	1.5 Percentage of participants Interval 0.0 to 8.0	1.5 Percentage of participants Interval 0.0 to 8.0	0.0 Percentage of participants Interval 0.0 to 7.5	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 16.1
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: PMB2948 [B24] - 1:128	0.7 Percentage of participants Interval 0.0 to 4.1	1.5 Percentage of participants Interval 0.0 to 8.0	0.0 Percentage of participants Interval 0.0 to 5.4	0.0 Percentage of participants Interval 0.0 to 7.5	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 16.1
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] - 1:4	60.9 Percentage of participants Interval 51.9 to 69.4	53.8 Percentage of participants Interval 41.0 to 66.3	68.3 Percentage of participants Interval 55.3 to 79.4	8.9 Percentage of participants Interval 2.5 to 21.2	8.3 Percentage of participants Interval 1.1 to 27.0	9.5 Percentage of participants Interval 1.2 to 30.4
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 T2: PMB2948 [B24] - 1:16	50.8 Percentage of participants Interval 41.8 to 59.7	43.1 Percentage of participants Interval 30.8 to 56.0	58.7 Percentage of participants Interval 45.6 to 71.0	8.9 Percentage of participants Interval 2.5 to 21.2	8.3 Percentage of participants Interval 1.0 to 27.0	9.5 Percentage of participants Interval 1.2 to 30.4
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 T2: PMB2948 [B24] - 1:32	22.7 Percentage of participants Interval 15.7 to 30.9	15.4 Percentage of participants Interval 7.6 to 26.5	30.2 Percentage of participants Interval 19.2 to 43.0	4.4 Percentage of participants Interval 0.5 to 15.1	4.2 Percentage of participants Interval 0.1 to 21.1	4.8 Percentage of participants Interval 0.1 to 23.8
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] - 1:64	9.4 Percentage of participants Interval 4.9 to 15.8	3.1 Percentage of participants Interval 0.4 to 10.7	15.9 Percentage of participants Interval 7.9 to 27.3	4.4 Percentage of participants Interval 0.5 to 15.1	4.2 Percentage of participants Interval 0.1 to 21.1	4.8 Percentage of participants Interval 0.1 to 23.8
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] - 1:128	4.7 Percentage of participants Interval 1.7 to 9.9	1.5 Percentage of participants Interval 0.0 to 8.3	7.9 Percentage of participants Interval 2.6 to 17.6	0.0 Percentage of participants Interval 0.0 to 7.9	0.0 Percentage of participants Interval 0.0 to 14.2	0.0 Percentage of participants Interval 0.0 to 16.1
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 T3: PMB2948 [B24] - 1:4	92.9 Percentage of participants Interval 86.9 to 96.7	90.5 Percentage of participants Interval 80.4 to 96.4	95.2 Percentage of participants Interval 86.7 to 99.0	6.5 Percentage of participants Interval 1.4 to 17.9	11.5 Percentage of participants Interval 2.4 to 30.2	0.0 Percentage of participants Interval 0.0 to 16.8
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: PMB2948 [B24] - 1:16	84.9 Percentage of participants Interval 77.5 to 90.7	81.0 Percentage of participants Interval 69.1 to 89.8	88.9 Percentage of participants Interval 78.4 to 95.4	4.3 Percentage of participants Interval 0.5 to 14.8	7.7 Percentage of participants Interval 0.9 to 25.1	0.0 Percentage of participants Interval 0.0 to 16.8
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: PMB2948 [B24] - 1:32	46.8 Percentage of participants Interval 37.9 to 55.9	38.1 Percentage of participants Interval 26.1 to 51.2	55.6 Percentage of participants Interval 42.5 to 68.1	2.2 Percentage of participants Interval 0.1 to 11.5	3.8 Percentage of participants Interval 0.1 to 19.6	0.0 Percentage of participants Interval 0.0 to 16.8
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: PMB2948 [B24] - 1:64	18.3 Percentage of participants Interval 11.9 to 26.1	9.5 Percentage of participants Interval 3.6 to 19.6	27.0 Percentage of participants Interval 16.6 to 39.7	0.0 Percentage of participants Interval 0.0 to 7.7	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 16.8
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: PMB2948 [B24] - 1:128	7.1 Percentage of participants Interval 3.3 to 13.1	4.8 Percentage of participants Interval 1.0 to 13.3	9.5 Percentage of participants Interval 3.6 to 19.6	0.0 Percentage of participants Interval 0.0 to 7.7	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 16.8
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 T4: PMB2948 [B24] - 1:4	20.2 Percentage of participants Interval 13.6 to 28.1	13.8 Percentage of participants Interval 6.5 to 24.7	26.6 Percentage of participants Interval 16.3 to 39.1	2.1 Percentage of participants Interval 0.1 to 11.3	0.0 Percentage of participants Interval 0.0 to 13.2	4.8 Percentage of participants Interval 0.1 to 23.8
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 T4: PMB2948 [B24] - 1:16	14.7 Percentage of participants Interval 9.1 to 22.0	9.2 Percentage of participants Interval 3.5 to 19.0	20.3 Percentage of participants Interval 11.3 to 32.2	0.0 Percentage of participants Interval 0.0 to 7.5	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 16.1
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: PMB2948 [B24] - 1:32	9.3 Percentage of participants Interval 4.9 to 15.7	6.2 Percentage of participants Interval 1.7 to 15.0	12.5 Percentage of participants Interval 5.6 to 23.2	0.0 Percentage of participants Interval 0.0 to 7.5	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 16.1
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: PMB2948 [B24] - 1:64	4.7 Percentage of participants Interval 1.7 to 9.8	4.6 Percentage of participants Interval 1.0 to 12.9	4.7 Percentage of participants Interval 1.0 to 13.1	0.0 Percentage of participants Interval 0.0 to 7.5	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 16.1
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: PMB2948 [B24] - 1:128	3.1 Percentage of participants Interval 0.9 to 7.7	3.1 Percentage of participants Interval 0.4 to 10.7	3.1 Percentage of participants Interval 0.4 to 10.8	0.0 Percentage of participants Interval 0.0 to 7.5	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 16.1
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: PMB2707 [B44] - 1:4	0.7 Percentage of participants Interval 0.0 to 4.0	0.0 Percentage of participants Interval 0.0 to 5.4	1.4 Percentage of participants Interval 0.0 to 7.6	0.0 Percentage of participants Interval 0.0 to 7.1	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.2
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 T1: PMB2707 [B44] - 1:8	0.0 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 5.1	0.0 Percentage of participants Interval 0.0 to 7.1	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.2
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 T1: PMB2707 [B44] - 1:16	0.0 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 5.1	0.0 Percentage of participants Interval 0.0 to 7.1	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.2
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 T1: PMB2707 [B44] - 1:32	0.0 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 5.1	0.0 Percentage of participants Interval 0.0 to 7.1	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.2
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 T1: PMB2707 [B44] - 1:64	0.0 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 5.1	0.0 Percentage of participants Interval 0.0 to 7.1	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.2
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 T1: PMB2707 [B44] - 1:128	0.0 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 5.1	0.0 Percentage of participants Interval 0.0 to 7.1	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.2
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 T2: PMB2707 [B44] - 1:4	57.7 Percentage of participants Interval 48.7 to 63.3	66.7 Percentage of participants Interval 53.7 to 78.0	49.3 Percentage of participants Interval 36.8 to 61.8	0.0 Percentage of participants Interval 0.0 to 7.1	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.2
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 T2: PMB2707 [B44] - 1:16	43.1 Percentage of participants Interval 34.4 to 52.0	55.6 Percentage of participants Interval 42.5 to 68.1	31.3 Percentage of participants Interval 20.6 to 43.8	0.0 Percentage of participants Interval 0.0 to 7.1	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.2
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 T2: PMB2707 [B44] - 1:32	30.0 Percentage of participants Interval 22.3 to 38.7	46.0 Percentage of participants Interval 33.4 to 59.1	14.9 Percentage of participants Interval 7.4 to 25.7	0.0 Percentage of participants Interval 0.0 to 7.1	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.2
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 T2: PMB2707 [B44] - 1:64	17.7 Percentage of participants Interval 11.6 to 25.4	27.0 Percentage of participants Interval 16.6 to 39.7	9.0 Percentage of participants Interval 3.4 to 18.5	0.0 Percentage of participants Interval 0.0 to 7.1	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.2
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 T2: PMB2707 [B44] - 1:128	10.0 Percentage of participants Interval 5.4 to 16.5	15.9 Percentage of participants Interval 7.9 to 27.3	4.5 Percentage of participants Interval 0.9 to 12.5	0.0 Percentage of participants Interval 0.0 to 7.1	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.2
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: PMB2707 [B44] - 1:4	82.1 Percentage of participants Interval 74.5 to 88.2	81.5 Percentage of participants Interval 70.0 to 90.1	82.6 Percentage of participants Interval 71.6 to 90.7	0.0 Percentage of participants Interval 0.0 to 7.1	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.2
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: PMB2707 [B44] - 1:16	77.6 Percentage of participants Interval 69.6 to 84.4	80.0 Percentage of participants Interval 68.2 to 88.9	75.4 Percentage of participants Interval 63.5 to 84.9	0.0 Percentage of participants Interval 0.0 to 7.1	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.2
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: PMB2707 [B44] - 1:32	65.7 Percentage of participants Interval 57.0 to 73.7	67.7 Percentage of participants Interval 54.9 to 78.8	63.8 Percentage of participants Interval 51.3 to 75.0	0.0 Percentage of participants Interval 0.0 to 7.1	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.2
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: PMB2707 [B44] - 1:64	52.2 Percentage of participants Interval 43.4 to 60.9	55.4 Percentage of participants Interval 42.5 to 67.7	49.3 Percentage of participants Interval 37.0 to 61.6	0.0 Percentage of participants Interval 0.0 to 7.1	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.2
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] - 1:16	8.1 Percentage of participants Interval 4.1 to 14.1	9.1 Percentage of participants Interval 3.4 to 18.7	7.2 Percentage of participants Interval 2.4 to 16.1	0.0 Percentage of participants Interval 0.0 to 7.3	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.8
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 T4: PMB2707 [B44] - 1:32	6.7 Percentage of participants Interval 3.1 to 12.3	6.1 Percentage of participants Interval 1.7 to 14.8	7.2 Percentage of participants Interval 2.4 to 16.1	0.0 Percentage of participants Interval 0.0 to 7.3	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.8
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 T4: PMB2707 [B44] - 1:64	5.2 Percentage of participants Interval 2.1 to 10.4	6.1 Percentage of participants Interval 1.7 to 14.8	4.3 Percentage of participants Interval 0.9 to 12.2	0.0 Percentage of participants Interval 0.0 to 7.3	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.8
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 T4: PMB2707 [B44] - 1:128	3.0 Percentage of participants Interval 0.8 to 7.4	3.0 Percentage of participants Interval 0.4 to 10.5	2.9 Percentage of participants Interval 0.4 to 10.1	0.0 Percentage of participants Interval 0.0 to 7.3	0.0 Percentage of participants Interval 0.0 to 13.2	0.0 Percentage of participants Interval 0.0 to 14.8

SECONDARY outcome

Timeframe: Before Vaccination 1, 1 month after Vaccination 2, 1 month after Vaccination 3 and 6 months after Vaccination 3

Outcome measures

Outcome measures
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=274 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=24 Months to <4 Years) n=136 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 1 Bivalent rLP2086 (>=4 Years to <10 Years) n=138 Participants Participants from \>=4 years to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=97 Participants Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <4 Years) n=52 Participants Participants from \>=24 months to \<4 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.	Group 2 HAV/Saline (>=4 Years to <10 Years) n=45 Participants Participants from \>=4 years to \<10 years 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: PMB2707 [B44]	5.1 titers Interval 4.4 to 5.9	5.2 titers Interval 4.2 to 6.4	5.0 titers Interval 4.1 to 6.2	4.0 titers CI was not estimable due to the lack of variability of geometric means.	4.0 titers CI was not estimable due to the lack of variability of geometric means.	4.0 titers 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 Before Vaccination 1: PMB80 [A22]	8.7 titers Interval 8.3 to 9.1	8.3 titers Interval 7.9 to 8.8	9.1 titers Interval 8.3 to 9.9	8.9 titers Interval 7.8 to 10.1	8.2 titers Interval 7.8 to 8.7	9.8 titers Interval 7.2 to 13.2
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains 1 month after Vaccination 2: PMB80 [A22]	20.1 titers Interval 17.4 to 23.2	17.4 titers Interval 14.2 to 21.4	23.1 titers Interval 18.9 to 28.3	8.6 titers Interval 7.7 to 9.7	8.0 titers CI was not estimable due to the lack of variability of geometric means.	9.4 titers Interval 7.4 to 12.0
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains 1 month after Vaccination 3: PMB80 [A22]	35.8 titers Interval 30.5 to 42.2	33.7 titers Interval 26.4 to 42.9	38.2 titers Interval 30.6 to 47.6	8.8 titers Interval 7.8 to 9.8	8.7 titers Interval 7.3 to 10.3	8.9 titers Interval 7.6 to 10.4
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains 6 months after Vaccination 3: PMB80 [A22]	12.4 titers Interval 10.9 to 14.2	10.9 titers Interval 9.0 to 13.1	14.2 titers Interval 11.8 to 17.0	8.7 titers Interval 7.9 to 9.7	8.4 titers Interval 7.8 to 9.1	9.1 titers Interval 7.4 to 11.3
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains Before Vaccination 1: PMB2001 [A56]	4.9 titers Interval 4.3 to 5.5	4.1 titers Interval 3.9 to 4.3	5.8 titers Interval 4.6 to 7.3	5.6 titers Interval 4.4 to 7.2	4.9 titers Interval 3.7 to 6.6	6.5 titers Interval 4.3 to 9.8
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains 1 month after Vaccination 2: PMB2001 [A56]	96.6 titers Interval 83.0 to 112.5	103.8 titers Interval 84.2 to 127.9	90.0 titers Interval 71.9 to 112.7	5.8 titers Interval 4.4 to 7.6	5.0 titers Interval 3.6 to 7.1	6.6 titers Interval 4.2 to 10.5
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains 1 month after Vaccination 3: PMB2001 [A56]	183.3 titers Interval 156.7 to 214.4	175.6 titers Interval 139.1 to 221.6	191.0 titers Interval 153.9 to 237.1	6.0 titers Interval 4.6 to 7.7	4.5 titers Interval 3.5 to 5.7	8.6 titers Interval 5.4 to 13.8
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains 6 months after Vaccination 3: PMB2001 [A56]	31.3 titers Interval 25.3 to 38.7	27.0 titers Interval 19.7 to 36.9	35.7 titers Interval 26.6 to 47.8	6.0 titers Interval 4.6 to 7.8	6.0 titers Interval 4.0 to 8.9	6.0 titers Interval 4.2 to 8.7
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains Before Vaccination 1: PMB2948 [B24]	4.5 titers Interval 4.1 to 4.9	4.3 titers Interval 3.8 to 4.9	4.6 titers Interval 4.0 to 5.2	4.4 titers Interval 3.9 to 4.9	4.3 titers Interval 3.7 to 5.1	4.4 titers Interval 3.6 to 5.4
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains 1 month after Vaccination 2: PMB2948 [B24]	11.1 titers Interval 9.2 to 13.5	9.1 titers Interval 7.0 to 11.9	13.7 titers Interval 10.3 to 18.2	4.8 titers Interval 4.0 to 5.8	4.8 titers Interval 3.7 to 6.2	4.9 titers Interval 3.6 to 6.6
Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains T3: PMB2948 [B24]	22.6 titers Interval 19.1 to 26.8	19.1 titers Interval 14.9 to 24.5	26.8 titers Interval 21.3 to 33.9	4.3 titers Interval 3.9 to 4.8	4.6 titers Interval 3.8 to 5.6	4.0 titers 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: PMB2948 [B24]	5.6 titers Interval 4.8 to 6.5	5.1 titers Interval 4.1 to 6.3	6.2 titers Interval 4.9 to 7.7	4.0 titers CI was not estimable due to the lack of variability of geometric means.	4.0 titers CI was not estimable due to the lack of variability of geometric means.	4.0 titers 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: PMB2707 [B44]	4.0 titers CI was not estimable due to the lack of variability of geometric means.	4.0 titers CI was not estimable due to the lack of variability of geometric means.	4.0 titers CI was not estimable due to the lack of variability of geometric means.	4.0 titers CI was not estimable due to the lack of variability of geometric means.	4.0 titers CI was not estimable due to the lack of variability of geometric means.	4.0 titers 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: PMB2707 [B44]	11.7 titers Interval 9.3 to 14.7	17.1 titers Interval 11.8 to 24.8	8.2 titers Interval 6.3 to 10.6	4.0 titers CI was not estimable due to the lack of variability of geometric means.	4.0 titers CI was not estimable due to the lack of variability of geometric means.	4.0 titers 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: PMB2707 [B44]	39.8 titers Interval 30.6 to 51.6	43.6 titers Interval 29.9 to 63.6	36.5 titers Interval 25.2 to 52.7	4.0 titers CI was not estimable due to the lack of variability of geometric means.	4.0 titers CI was not estimable due to the lack of variability of geometric means.	4.0 titers CI was not estimable due to the lack of variability of geometric means.

Adverse Events

Group 1 Bivalent rLP2086 (>=24 Months to <10 Years)

Serious events: 5 serious events

Other events: 281 other events

Deaths: 0 deaths

Group 2 HAV/Saline (>=24 Months to <10 Years)

Serious events: 1 serious events

Other events: 87 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 Bivalent rLP2086 (>=24 Months to <10 Years) n=294 participants at risk Participants from \>=24 months to \<10 years of age, received intramuscular injection of rLP2086 vaccine on a 0-, 2-, 6- month schedule.	Group 2 HAV/Saline (>=24 Months to <10 Years) n=106 participants at risk Participants from \>=24 months to \<10 years of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule
Infections and infestations Bronchitis	0.00% 0/294 • AEs/SAEs: Recorded from first vaccination through 6 months after third vaccination. Participants recorded local reactions and systemic events in e-diary within 7 days after first, second and third vaccination. SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.94% 1/106 • AEs/SAEs: Recorded from first vaccination through 6 months after third vaccination. Participants recorded local reactions and systemic events in e-diary within 7 days after first, second and third vaccination. SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs 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 rotavirus	0.34% 1/294 • AEs/SAEs: Recorded from first vaccination through 6 months after third vaccination. Participants recorded local reactions and systemic events in e-diary within 7 days after first, second and third vaccination. SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/106 • AEs/SAEs: Recorded from first vaccination through 6 months after third vaccination. Participants recorded local reactions and systemic events in e-diary within 7 days after first, second and third vaccination. SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs 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 salmonella	0.34% 1/294 • AEs/SAEs: Recorded from first vaccination through 6 months after third vaccination. Participants recorded local reactions and systemic events in e-diary within 7 days after first, second and third vaccination. SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/106 • AEs/SAEs: Recorded from first vaccination through 6 months after third vaccination. Participants recorded local reactions and systemic events in e-diary within 7 days after first, second and third vaccination. SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs 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	0.34% 1/294 • AEs/SAEs: Recorded from first vaccination through 6 months after third vaccination. Participants recorded local reactions and systemic events in e-diary within 7 days after first, second and third vaccination. SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/106 • AEs/SAEs: Recorded from first vaccination through 6 months after third vaccination. Participants recorded local reactions and systemic events in e-diary within 7 days after first, second and third vaccination. SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs 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 Subcutaneous abscess	0.34% 1/294 • AEs/SAEs: Recorded from first vaccination through 6 months after third vaccination. Participants recorded local reactions and systemic events in e-diary within 7 days after first, second and third vaccination. SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/106 • AEs/SAEs: Recorded from first vaccination through 6 months after third vaccination. Participants recorded local reactions and systemic events in e-diary within 7 days after first, second and third vaccination. SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs 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 papular	0.34% 1/294 • AEs/SAEs: Recorded from first vaccination through 6 months after third vaccination. Participants recorded local reactions and systemic events in e-diary within 7 days after first, second and third vaccination. SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/106 • AEs/SAEs: Recorded from first vaccination through 6 months after third vaccination. Participants recorded local reactions and systemic events in e-diary within 7 days after first, second and third vaccination. SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs 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	0.34% 1/294 • AEs/SAEs: Recorded from first vaccination through 6 months after third vaccination. Participants recorded local reactions and systemic events in e-diary within 7 days after first, second and third vaccination. SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/106 • AEs/SAEs: Recorded from first vaccination through 6 months after third vaccination. Participants recorded local reactions and systemic events in e-diary within 7 days after first, second and third vaccination. SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs 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

Additional Information

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Results disclosure agreements

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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