Trial Outcomes & Findings for Duration of hSBA Response After a Primary Series of Bivalent rLP2086 Followed by a Booster Dose (NCT NCT01543087)

Last Updated: 2020-03-27

Results Overview

For immunogenicity assessment, serum bactericidal assay using human complement (hSBA) was performed with 4 primary Neisseria meningitidis serogroup B (MnB) test strains. 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). Participants who received bivalent rLP2086 in primary study B1971012, entered in this study at Month 12 (Visit 2). Hence, no participants enrolled from primary study B1971012 had serology results at Month 6.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

698 participants

Primary outcome timeframe

Month 6 (Visit 1 of study B1971033)

Results posted on

2020-03-27

Participant Flow

Total 698 participants enrolled in this extension study, who were enrolled in any 1 of the primary studies B1971010 (NCT01323270), B1971012 (NCT01299480), and B1971015 (NCT01461980).

This study consisted of 2 stages: Stage 1 and Booster stage. Only participants from primary studies B1971010 and B1971012 who received bivalent rLP2086 in the primary study and completed Stage 1 in this study, were eligible to participate in the booster stage.

Participant milestones

Participant milestones
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) Participants received quadrivalent meningococcal polysaccharide conjugate (MCV4) tetanus + acellular pertussis (Tdap) +Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 2: rLP2086 (0-, 1-, and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0-, 1-, and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 micrograms (mcg) of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 3: rLP2086 (0-, 2-, and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, B1971012 and B1971015 were included in this group, and were followed up for 48 months during the stage 1 of this study. Only participants from B1971010 and B1971012 studies received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 4: rLP2086 (0-and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Stage 1 (48 Months) STARTED	70	103	277	116	86	46
Stage 1 (48 Months) Safety Population	70	101	277	116	86	46
Stage 1 (48 Months) COMPLETED	56	93	237	108	83	46
Stage 1 (48 Months) NOT COMPLETED	14	10	40	8	3	0
Booster Stage (26 Months) STARTED	0	60	92	64	56	32
Booster Stage (26 Months) Vaccinated	0	59	92	64	54	32
Booster Stage (26 Months) COMPLETED	0	59	91	64	54	32
Booster Stage (26 Months) NOT COMPLETED	0	1	1	0	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) Participants received quadrivalent meningococcal polysaccharide conjugate (MCV4) tetanus + acellular pertussis (Tdap) +Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 2: rLP2086 (0-, 1-, and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0-, 1-, and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 micrograms (mcg) of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 3: rLP2086 (0-, 2-, and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, B1971012 and B1971015 were included in this group, and were followed up for 48 months during the stage 1 of this study. Only participants from B1971010 and B1971012 studies received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 4: rLP2086 (0-and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Stage 1 (48 Months) Lost to Follow-up	3	4	12	0	0
Stage 1 (48 Months) No longer met eligibility criteria	1	0	1	2	0
Stage 1 (48 Months) No longer willing to participate	5	3	18	6	3
Stage 1 (48 Months) Other than specified	5	0	9	0	0
Stage 1 (48 Months) Protocol Violation	0	3	0	0	0
Booster Stage (26 Months) Withdrawal before booster vaccination	0	1	0	0	2
Booster Stage (26 Months) Lost to Follow-up	0	0	1	0	0

Baseline Characteristics

Duration of hSBA Response After a Primary Series of Bivalent rLP2086 Followed by a Booster Dose

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=70 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 2: rLP2086 (0-, 1-, and 6-Month Schedule) n=103 Participants Participants who received bivalent rLP2086 vaccine on 0-, 1-, and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 micrograms (mcg) of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 3: rLP2086 (0-, 2-, and 6-Month Schedule) n=277 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, B1971012 and B1971015 were included in this group, and were followed up for 48 months during the stage 1 of this study. Only participants from B1971010 and B1971012 studies received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 4: rLP2086 (0-and 6-Month Schedule) n=116 Participants Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) n=86 Participants Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) n=46 Participants Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Total n=698 Participants Total of all reporting groups
Age, Continuous	11.7 years STANDARD_DEVIATION 0.7 • n=93 Participants	15.9 years STANDARD_DEVIATION 2.2 • n=4 Participants	14.3 years STANDARD_DEVIATION 2.8 • n=27 Participants	15.8 years STANDARD_DEVIATION 2.1 • n=483 Participants	16.1 years STANDARD_DEVIATION 2.4 • n=36 Participants	15.9 years STANDARD_DEVIATION 2.1 • n=10 Participants	14.8 years STANDARD_DEVIATION 2.7 • n=115 Participants
Sex: Female, Male Female	32 Participants n=93 Participants	55 Participants n=4 Participants	144 Participants n=27 Participants	67 Participants n=483 Participants	38 Participants n=36 Participants	26 Participants n=10 Participants	362 Participants n=115 Participants
Sex: Female, Male Male	38 Participants n=93 Participants	48 Participants n=4 Participants	133 Participants n=27 Participants	49 Participants n=483 Participants	48 Participants n=36 Participants	20 Participants n=10 Participants	336 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=93 Participants	0 Participants n=4 Participants	25 Participants n=27 Participants	1 Participants n=483 Participants	2 Participants n=36 Participants	0 Participants n=10 Participants	44 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=93 Participants	103 Participants n=4 Participants	252 Participants n=27 Participants	115 Participants n=483 Participants	84 Participants n=36 Participants	46 Participants n=10 Participants	654 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race/Ethnicity, Customized White	59 Participants n=93 Participants	103 Participants n=4 Participants	256 Participants n=27 Participants	115 Participants n=483 Participants	85 Participants n=36 Participants	46 Participants n=10 Participants	664 Participants n=115 Participants
Race/Ethnicity, Customized Black	9 Participants n=93 Participants	0 Participants n=4 Participants	12 Participants n=27 Participants	1 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	22 Participants n=115 Participants
Race/Ethnicity, Customized Other	2 Participants n=93 Participants	0 Participants n=4 Participants	8 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	0 Participants n=10 Participants	11 Participants n=115 Participants
Race/Ethnicity, Customized Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants

PRIMARY outcome

Timeframe: Month 6 (Visit 1 of study B1971033)

Population: Modified intent-to-treat (mITT) population included participants who had at least 1 valid and determinate assay result in Stage 1 of Study B1971033. Here, 'Number analyzed' signifies number of participants with valid and determinate hSBA titers for the given strain.

Outcome measures

Outcome measures
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=70 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) n=40 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=123 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 4: rLP2086 (0-and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 6 (Visit 1) After Primary Vaccinations PMB2948 (B24)	0.0 percentage of participants Interval 0.0 to 41.0	36.8 percentage of participants Interval 21.8 to 54.0	35.3 percentage of participants Interval 14.2 to 61.7	—	—	—	—	—
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 6 (Visit 1) After Primary Vaccinations PMB2707 (B44)	0.0 percentage of participants Interval 0.0 to 41.0	64.9 percentage of participants Interval 47.5 to 79.8	56.3 percentage of participants Interval 29.9 to 80.2	—	—	—	—	—
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 6 (Visit 1) After Primary Vaccinations PMB80 (A22)	14.3 percentage of participants Interval 0.4 to 57.9	86.5 percentage of participants Interval 71.2 to 95.5	83.3 percentage of participants Interval 58.6 to 96.4	—	—	—	—	—
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 6 (Visit 1) After Primary Vaccinations PMB2001 (A56)	16.7 percentage of participants Interval 0.4 to 64.1	72.2 percentage of participants Interval 54.8 to 85.8	88.9 percentage of participants Interval 65.3 to 98.6	—	—	—	—	—

PRIMARY outcome

Timeframe: Month 12 (Visit 2 of study B1971033)

Population: mITT population included participants who had at least 1 valid and determinate assay result in Stage 1 of Study B1971033. Here, 'Number analyzed' signifies number of participants with valid and determinate hSBA titers for the given strain.

Outcome measures

Outcome measures
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=70 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) n=101 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=40 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) n=114 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=123 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 4: rLP2086 (0-and 6-Month Schedule) n=116 Participants Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) n=86 Participants Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) n=46 Participants Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations PMB80 (A22)	29.0 percentage of participants Interval 18.7 to 41.2	41.4 percentage of participants Interval 31.6 to 51.8	69.2 percentage of participants Interval 52.4 to 83.0	45.0 percentage of participants Interval 35.6 to 54.8	61.5 percentage of participants Interval 52.2 to 70.1	36.3 percentage of participants Interval 27.4 to 45.9	44.0 percentage of participants Interval 33.2 to 55.3	41.3 percentage of participants Interval 27.0 to 56.8
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations PMB2001 (A56)	17.4 percentage of participants Interval 9.3 to 28.4	73.5 percentage of participants Interval 63.6 to 81.9	66.7 percentage of participants Interval 49.8 to 80.9	76.1 percentage of participants Interval 67.0 to 83.8	63.1 percentage of participants Interval 53.4 to 72.0	60.4 percentage of participants Interval 50.4 to 69.7	69.0 percentage of participants Interval 58.0 to 78.7	71.4 percentage of participants Interval 55.4 to 84.3
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations PMB2948 (B24)	1.4 percentage of participants Interval 0.0 to 7.7	40.8 percentage of participants Interval 31.0 to 51.2	37.5 percentage of participants Interval 22.7 to 54.2	49.1 percentage of participants Interval 39.3 to 58.9	24.0 percentage of participants Interval 16.7 to 32.6	36.9 percentage of participants Interval 27.6 to 47.0	41.5 percentage of participants Interval 30.7 to 52.9	37.0 percentage of participants Interval 23.2 to 52.5
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 12 (Visit 2) After Primary Vaccinations PMB2707 (B44)	1.4 percentage of participants Interval 0.0 to 7.7	24.0 percentage of participants Interval 16.0 to 33.6	47.5 percentage of participants Interval 31.5 to 63.9	22.5 percentage of participants Interval 15.1 to 31.4	32.5 percentage of participants Interval 24.2 to 41.7	16.5 percentage of participants Interval 10.3 to 24.6	21.2 percentage of participants Interval 13.1 to 31.4	22.2 percentage of participants Interval 11.2 to 37.1

PRIMARY outcome

Timeframe: Month 18 (Visit 3 of study B1971033)

Outcome measures

Outcome measures
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=70 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) n=101 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=40 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) n=114 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=123 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 4: rLP2086 (0-and 6-Month Schedule) n=116 Participants Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) n=86 Participants Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) n=46 Participants Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations PMB80 (A22)	23.2 percentage of participants Interval 13.9 to 34.9	37.1 percentage of participants Interval 27.5 to 47.5	57.9 percentage of participants Interval 40.8 to 73.7	44.6 percentage of participants Interval 35.2 to 54.3	51.3 percentage of participants Interval 41.9 to 60.6	47.7 percentage of participants Interval 38.2 to 57.4	47.1 percentage of participants Interval 36.1 to 58.2	51.1 percentage of participants Interval 35.8 to 66.3
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations PMB2001 (A56)	11.9 percentage of participants Interval 5.3 to 22.2	64.9 percentage of participants Interval 54.4 to 74.5	56.4 percentage of participants Interval 39.6 to 72.2	72.6 percentage of participants Interval 63.1 to 80.9	53.5 percentage of participants Interval 43.9 to 62.9	57.8 percentage of participants Interval 47.7 to 67.6	62.7 percentage of participants Interval 51.3 to 73.0	62.8 percentage of participants Interval 46.7 to 77.0
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations PMB2948 (B24)	5.8 percentage of participants Interval 1.6 to 14.2	45.8 percentage of participants Interval 35.6 to 56.3	39.5 percentage of participants Interval 24.0 to 56.6	46.8 percentage of participants Interval 37.2 to 56.6	23.9 percentage of participants Interval 16.4 to 32.8	31.4 percentage of participants Interval 22.7 to 41.2	39.5 percentage of participants Interval 28.8 to 51.0	50.0 percentage of participants Interval 34.6 to 65.4
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 18 (Visit 3) After Primary Vaccinations PMB2707 (B44)	0.0 percentage of participants Interval 0.0 to 5.2	26.5 percentage of participants Interval 18.1 to 36.4	31.6 percentage of participants Interval 17.5 to 48.7	18.2 percentage of participants Interval 11.5 to 26.7	29.6 percentage of participants Interval 21.4 to 38.8	15.9 percentage of participants Interval 9.7 to 24.0	24.4 percentage of participants Interval 15.8 to 34.9	28.3 percentage of participants Interval 16.0 to 43.5

PRIMARY outcome

Timeframe: Month 24 (Visit 4 of study B1971033)

Outcome measures

Outcome measures
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=70 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) n=101 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=40 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) n=114 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=123 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 4: rLP2086 (0-and 6-Month Schedule) n=116 Participants Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) n=86 Participants Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) n=46 Participants Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations PMB80 (A22)	17.6 percentage of participants Interval 9.5 to 28.8	34.7 percentage of participants Interval 25.4 to 45.0	50.0 percentage of participants Interval 33.4 to 66.6	40.2 percentage of participants Interval 30.8 to 50.1	49.6 percentage of participants Interval 40.1 to 59.0	42.2 percentage of participants Interval 32.8 to 52.0	44.0 percentage of participants Interval 33.2 to 55.3	39.1 percentage of participants Interval 25.1 to 54.6
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations PMB2001 (A56)	3.0 percentage of participants Interval 0.4 to 10.5	69.2 percentage of participants Interval 58.7 to 78.5	57.9 percentage of participants Interval 40.8 to 73.7	68.6 percentage of participants Interval 58.7 to 77.5	36.4 percentage of participants Interval 27.4 to 46.1	53.8 percentage of participants Interval 43.8 to 63.7	58.8 percentage of participants Interval 47.2 to 69.6	60.0 percentage of participants Interval 44.3 to 74.3
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations PMB2948 (B24)	4.4 percentage of participants Interval 0.9 to 12.4	43.0 percentage of participants Interval 32.8 to 53.7	39.5 percentage of participants Interval 24.0 to 56.6	43.0 percentage of participants Interval 33.5 to 52.9	25.9 percentage of participants Interval 18.1 to 35.0	31.8 percentage of participants Interval 23.3 to 41.4	37.3 percentage of participants Interval 27.0 to 48.7	51.1 percentage of participants Interval 35.8 to 66.3
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 24 (Visit 4) After Primary Vaccinations PMB2707 (B44)	3.0 percentage of participants Interval 0.4 to 10.4	23.7 percentage of participants Interval 15.7 to 33.4	38.5 percentage of participants Interval 23.4 to 55.4	18.3 percentage of participants Interval 11.6 to 26.9	27.2 percentage of participants Interval 19.3 to 36.3	15.7 percentage of participants Interval 9.4 to 24.0	22.9 percentage of participants Interval 14.4 to 33.4	28.3 percentage of participants Interval 16.0 to 43.5

PRIMARY outcome

Timeframe: Month 36 (Visit 5 of study B1971033)

Outcome measures

Outcome measures
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=70 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) n=101 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=40 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) n=114 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=123 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 4: rLP2086 (0-and 6-Month Schedule) n=116 Participants Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) n=86 Participants Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) n=46 Participants Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations PMB80 (A22)	27.6 percentage of participants Interval 16.7 to 40.9	41.7 percentage of participants Interval 31.7 to 52.2	60.5 percentage of participants Interval 43.4 to 76.0	39.2 percentage of participants Interval 29.7 to 49.4	49.5 percentage of participants Interval 39.7 to 59.4	42.6 percentage of participants Interval 33.1 to 52.5	42.7 percentage of participants Interval 31.8 to 54.1	34.1 percentage of participants Interval 20.5 to 49.9
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations PMB2707 (B44)	1.7 percentage of participants Interval 0.0 to 9.1	21.6 percentage of participants Interval 13.9 to 31.2	33.3 percentage of participants Interval 19.1 to 50.2	16.5 percentage of participants Interval 9.9 to 25.1	24.3 percentage of participants Interval 16.4 to 33.7	20.2 percentage of participants Interval 13.1 to 28.9	21.7 percentage of participants Interval 13.4 to 32.1	18.2 percentage of participants Interval 8.2 to 32.7
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations PMB2001 (A56)	7.0 percentage of participants Interval 1.9 to 17.0	58.5 percentage of participants Interval 47.9 to 68.6	54.1 percentage of participants Interval 36.9 to 70.5	67.4 percentage of participants Interval 56.8 to 76.8	35.0 percentage of participants Interval 25.8 to 45.0	58.6 percentage of participants Interval 48.2 to 68.4	59.3 percentage of participants Interval 47.8 to 70.1	50.0 percentage of participants Interval 34.2 to 65.8
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 36 (Visit 5) After Primary Vaccinations PMB2948 (B24)	3.4 percentage of participants Interval 0.4 to 11.7	41.9 percentage of participants Interval 31.8 to 52.6	38.9 percentage of participants Interval 23.1 to 56.5	42.0 percentage of participants Interval 32.2 to 52.3	30.1 percentage of participants Interval 21.5 to 39.9	33.6 percentage of participants Interval 24.8 to 43.4	48.1 percentage of participants Interval 36.9 to 59.5	41.9 percentage of participants Interval 27.0 to 57.9

PRIMARY outcome

Timeframe: Month 48 (Visit 6 of study B1971033)

Outcome measures

Outcome measures
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=70 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) n=101 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=40 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) n=114 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=123 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 4: rLP2086 (0-and 6-Month Schedule) n=116 Participants Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) n=86 Participants Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) n=46 Participants Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations PMB2707 (B44)	3.6 percentage of participants Interval 0.4 to 12.3	20.7 percentage of participants Interval 12.9 to 30.4	41.2 percentage of participants Interval 24.6 to 59.3	18.0 percentage of participants Interval 11.0 to 26.9	23.0 percentage of participants Interval 15.2 to 32.5	18.9 percentage of participants Interval 11.9 to 27.6	24.4 percentage of participants Interval 15.6 to 35.1	23.9 percentage of participants Interval 12.6 to 38.8
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations PMB80 (A22)	16.4 percentage of participants Interval 7.8 to 28.8	41.1 percentage of participants Interval 30.8 to 52.0	51.4 percentage of participants Interval 34.0 to 68.6	43.0 percentage of participants Interval 33.1 to 53.3	34.7 percentage of participants Interval 25.5 to 44.8	39.6 percentage of participants Interval 30.0 to 49.8	45.7 percentage of participants Interval 34.6 to 57.1	41.3 percentage of participants Interval 27.0 to 56.8
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations PMB2001 (A56)	2.0 percentage of participants Interval 0.0 to 10.4	47.1 percentage of participants Interval 36.1 to 58.2	42.4 percentage of participants Interval 25.5 to 60.8	58.6 percentage of participants Interval 48.2 to 68.4	30.9 percentage of participants Interval 21.7 to 41.2	57.6 percentage of participants Interval 47.2 to 67.5	61.3 percentage of participants Interval 49.4 to 72.4	47.8 percentage of participants Interval 32.9 to 63.1
Percentage of Participants in Stage 1 Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains at Month 48 (Visit 6) After Primary Vaccinations PMB2948 (B24)	7.1 percentage of participants Interval 2.0 to 17.3	41.1 percentage of participants Interval 30.8 to 52.0	50.0 percentage of participants Interval 32.4 to 67.6	40.8 percentage of participants Interval 31.0 to 51.2	23.8 percentage of participants Interval 15.9 to 33.3	30.5 percentage of participants Interval 21.9 to 40.2	45.1 percentage of participants Interval 34.1 to 56.5	42.2 percentage of participants Interval 27.7 to 57.8

PRIMARY outcome

Timeframe: 1 month after last vaccination in primary study

Population: Evaluable population:eligible participants who received scheduled investigational products, received no prohibited vaccines or treatment, had pre and post vaccination blood drawn with valid,determinate assay results and had no important protocol deviation. 'Number analyzed'=number of participants with valid,determinate hSBA titers for given strain.

Outcome measures

Outcome measures
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=59 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) n=31 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=58 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) n=62 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=54 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 4: rLP2086 (0-and 6-Month Schedule) n=32 Participants Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study PMB80 (A22)	89.8 percentage of participants Interval 79.2 to 96.2	100.0 percentage of participants Interval 88.8 to 100.0	91.2 percentage of participants Interval 80.7 to 97.1	98.4 percentage of participants Interval 91.2 to 100.0	77.8 percentage of participants Interval 64.4 to 88.0	84.4 percentage of participants Interval 67.2 to 94.7	—	—
Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study PMB2001 (A56)	100.0 percentage of participants Interval 93.8 to 100.0	100.0 percentage of participants Interval 88.8 to 100.0	98.2 percentage of participants Interval 90.6 to 100.0	98.4 percentage of participants Interval 91.3 to 100.0	100.0 percentage of participants Interval 93.4 to 100.0	96.9 percentage of participants Interval 83.8 to 99.9	—	—
Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study PMB2948 (B24)	88.1 percentage of participants Interval 77.1 to 95.1	93.5 percentage of participants Interval 78.6 to 99.2	91.4 percentage of participants Interval 81.0 to 97.1	85.0 percentage of participants Interval 73.4 to 92.9	71.2 percentage of participants Interval 56.9 to 82.9	79.3 percentage of participants Interval 60.3 to 92.0	—	—
Percentage of Booster Stage Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After Last Vaccination in Primary Study PMB2707 (B44)	86.2 percentage of participants Interval 74.6 to 93.9	96.8 percentage of participants Interval 83.3 to 99.9	89.5 percentage of participants Interval 78.5 to 96.0	81.7 percentage of participants Interval 69.6 to 90.5	73.1 percentage of participants Interval 59.0 to 84.4	87.5 percentage of participants Interval 71.0 to 96.5	—	—

PRIMARY outcome

Timeframe: Visit 6 of study B1971033 (48 months after last vaccination in primary study)

Population: Evaluable population:eligible participants who received scheduled investigational products, received no prohibited vaccines or treatment, had pre and post vaccination blood drawn with valid, determinate assay results and had no important protocol deviation. 'Number analyzed'=number of participants with valid,determinatehSBA titers for given strain.

Outcome measures

Outcome measures
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=59 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) n=31 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=58 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) n=62 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=54 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 4: rLP2086 (0-and 6-Month Schedule) n=32 Participants Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) PMB2948 (B24)	40.7 percentage of participants Interval 28.1 to 54.3	46.7 percentage of participants Interval 28.3 to 65.7	49.1 percentage of participants Interval 35.6 to 62.7	40.3 percentage of participants Interval 28.1 to 53.6	46.3 percentage of participants Interval 32.6 to 60.4	45.2 percentage of participants Interval 27.3 to 64.0	—	—
Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) PMB2707 (B44)	36.8 percentage of participants Interval 24.4 to 50.7	33.3 percentage of participants Interval 17.3 to 52.8	35.1 percentage of participants Interval 22.9 to 48.9	12.9 percentage of participants Interval 5.7 to 23.9	37.7 percentage of participants Interval 24.8 to 52.1	34.4 percentage of participants Interval 18.6 to 53.2	—	—
Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) PMB80 (A22)	49.2 percentage of participants Interval 35.9 to 62.5	48.4 percentage of participants Interval 30.2 to 66.9	56.1 percentage of participants Interval 42.4 to 69.3	55.7 percentage of participants Interval 42.4 to 68.5	57.4 percentage of participants Interval 43.2 to 70.8	48.4 percentage of participants Interval 30.2 to 66.9	—	—
Percentage of Booster Stage Participants Achieving hSBA Titer Level (>=) Lower Limit of Quantitation for Each of the 4 Primary Strains Before Booster Vaccination (48 Months After Last Vaccination in Primary Study [Visit 6]) PMB2001 (A56)	43.4 percentage of participants Interval 29.8 to 57.7	41.4 percentage of participants Interval 23.5 to 61.1	56.4 percentage of participants Interval 42.3 to 69.7	43.5 percentage of participants Interval 31.0 to 56.7	51.9 percentage of participants Interval 37.6 to 66.0	43.3 percentage of participants Interval 25.5 to 62.6	—	—

PRIMARY outcome

Timeframe: Visit 8 (1 month following the booster vaccination on Month 49)

Population: Evaluable population:eligible participants who received scheduled investigational products, received no prohibited vaccines or treatment, had pre and post vaccination blood drawn with valid, determinate assay results and had no important protocol deviation. 'Number analyzed'=number of participants with valid,determinatehSBA titers for given strain.

Outcome measures

Outcome measures
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=59 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) n=31 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=58 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) n=62 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=54 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 4: rLP2086 (0-and 6-Month Schedule) n=32 Participants Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) PMB80 (A22)	100.0 percentage of participants Interval 93.9 to 100.0	96.8 percentage of participants Interval 83.3 to 99.9	100.0 percentage of participants Interval 93.8 to 100.0	96.7 percentage of participants Interval 88.5 to 99.6	98.1 percentage of participants Interval 89.9 to 100.0	100.0 percentage of participants Interval 89.1 to 100.0	—	—
Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) PMB2001 (A56)	100.0 percentage of participants Interval 93.7 to 100.0	100.0 percentage of participants Interval 88.4 to 100.0	100.0 percentage of participants Interval 93.6 to 100.0	98.4 percentage of participants Interval 91.3 to 100.0	100.0 percentage of participants Interval 93.0 to 100.0	100.0 percentage of participants Interval 89.1 to 100.0	—	—
Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) PMB2948 (B24)	100.0 percentage of participants Interval 93.8 to 100.0	96.8 percentage of participants Interval 83.3 to 99.9	100.0 percentage of participants Interval 93.7 to 100.0	96.8 percentage of participants Interval 88.8 to 99.6	94.4 percentage of participants Interval 84.6 to 98.8	100.0 percentage of participants Interval 89.1 to 100.0	—	—
Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 1 Month After the Booster Vaccination (Visit 8) PMB2707 (B44)	100.0 percentage of participants Interval 93.9 to 100.0	100.0 percentage of participants Interval 88.8 to 100.0	100.0 percentage of participants Interval 93.8 to 100.0	93.4 percentage of participants Interval 84.1 to 98.2	100.0 percentage of participants Interval 93.3 to 100.0	100.0 percentage of participants Interval 89.1 to 100.0	—	—

PRIMARY outcome

Timeframe: Visit 10 (12 months following the booster vaccination on Month 60)

Population: Evaluable population:eligible participants who received scheduled investigational products, received no prohibited vaccines or treatment, had pre and post vaccination blood drawn with valid, determinate assay results and had no important protocol deviation. 'Number analyzed'=number of participants with valid,determinatehSBA titers for given strain.

Outcome measures

Outcome measures
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=59 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) n=31 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=58 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) n=62 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=54 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 4: rLP2086 (0-and 6-Month Schedule) n=32 Participants Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) PMB80 (A22)	74.1 percentage of participants Interval 61.0 to 84.7	89.3 percentage of participants Interval 71.8 to 97.7	77.8 percentage of participants Interval 64.4 to 88.0	80.0 percentage of participants Interval 67.7 to 89.2	82.4 percentage of participants Interval 69.1 to 91.6	96.8 percentage of participants Interval 83.3 to 99.9	—	—
Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) PMB2001 (A56)	90.9 percentage of participants Interval 80.0 to 97.0	87.5 percentage of participants Interval 67.6 to 97.3	89.1 percentage of participants Interval 77.8 to 95.9	81.4 percentage of participants Interval 69.1 to 90.3	74.0 percentage of participants Interval 59.7 to 85.4	100.0 percentage of participants Interval 89.1 to 100.0	—	—
Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) PMB2948 (B24)	65.5 percentage of participants Interval 51.9 to 77.5	66.7 percentage of participants Interval 47.2 to 82.7	74.1 percentage of participants Interval 60.3 to 85.0	77.4 percentage of participants Interval 65.0 to 87.1	65.3 percentage of participants Interval 50.4 to 78.3	84.4 percentage of participants Interval 67.2 to 94.7	—	—
Percentage of Participants Achieving hSBATiter Level Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 12 Months After the Booster Vaccination(Visit 10) PMB2707 (B44)	75.0 percentage of participants Interval 61.6 to 85.6	76.7 percentage of participants Interval 57.7 to 90.1	81.1 percentage of participants Interval 68.0 to 90.6	59.0 percentage of participants Interval 45.7 to 71.4	78.8 percentage of participants Interval 65.3 to 88.9	93.3 percentage of participants Interval 77.9 to 99.2	—	—

PRIMARY outcome

Timeframe: Visit 11 (26 months following the booster vaccination on Month 74)

Population: Evaluable population:eligible participants who received scheduled investigational products, received no prohibited vaccines or treatment, had pre and post vaccination blood drawn with valid, determinate assay results and had no important protocol deviation. 'Number analyzed'=number of participants with valid,determinatehSBA titers for given strain.

For immunogenicity assessment, hSBA was performed with 4 primary MnB test strains. 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). Participants of Group 3c (participants from primary study B1971015) were not continued in booster stage. only participants who received bivalent rLP2086 in primary study B1971010 were not analysed for this endpoint. Only participants who received bivalent rLP2086 in primary study B1971012 on a 0-, 2-, and 6-month or a 0- and 6-month vaccination schedule were eligible to be followed for 26 months after booster vaccination

Outcome measures

Outcome measures
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=58 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) n=62 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 4: rLP2086 (0-and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to(>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 26 Months After the Booster Vaccination(Visit 11) PMB80 (A22)	73.5 percentage of participants Interval 55.6 to 87.1	61.9 percentage of participants Interval 45.6 to 76.4	—	—	—	—	—	—
Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to(>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 26 Months After the Booster Vaccination(Visit 11) PMB2001 (A56)	82.8 percentage of participants Interval 64.2 to 94.2	57.5 percentage of participants Interval 40.9 to 73.0	—	—	—	—	—	—
Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to(>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 26 Months After the Booster Vaccination(Visit 11) PMB2948 (B24)	78.8 percentage of participants Interval 61.1 to 91.0	59.5 percentage of participants Interval 43.3 to 74.4	—	—	—	—	—	—
Percentage of Participants Achieving hSBA Titer Level Greater Than or Equal to(>=) Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Strains 26 Months After the Booster Vaccination(Visit 11) PMB2707 (B44)	66.7 percentage of participants Interval 48.2 to 82.0	62.8 percentage of participants Interval 46.7 to 77.0	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Within 7 days after booster vaccination on Month 48

Population: Booster stage safety population included all participants who had received the booster vaccination (Bivalent rLP2086) and for whom safety data was available.

Local reactions were collected by using an e-diary and included pain at injection site, redness and swelling. Redness and swelling were graded as: none (0-2.0 centimetre \[cm\]), mild (2.5-5.0 cm), moderate (greater than \[\>\] 5.0-10.0 cm) and severe (\>10.0 cm). Pain was graded as: mild (does not interfere with activity), moderate (Interferes with activity) and severe (prevents daily activity).

Outcome measures

Outcome measures
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=59 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) n=92 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=64 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) n=54 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=32 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 4: rLP2086 (0-and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination Swelling:Severe	0.0 percentage of participants Interval 0.0 to 6.1	1.1 percentage of participants Interval 0.0 to 5.9	0.0 percentage of participants Interval 0.0 to 5.6	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 10.9	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination Pain at injection site:Any	91.5 percentage of participants Interval 81.3 to 97.2	93.5 percentage of participants Interval 86.3 to 97.6	89.1 percentage of participants Interval 78.8 to 95.5	88.9 percentage of participants Interval 77.4 to 95.8	84.4 percentage of participants Interval 67.2 to 94.7	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination Pain at injection site:Mild	37.3 percentage of participants Interval 25.0 to 50.9	29.3 percentage of participants Interval 20.3 to 39.8	28.1 percentage of participants Interval 17.6 to 40.8	35.2 percentage of participants Interval 22.7 to 49.4	25.0 percentage of participants Interval 11.5 to 43.4	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination Pain at injection site:Moderate	40.7 percentage of participants Interval 28.1 to 54.3	54.3 percentage of participants Interval 43.6 to 64.8	51.6 percentage of participants Interval 38.7 to 64.2	44.4 percentage of participants Interval 30.9 to 58.6	46.9 percentage of participants Interval 29.1 to 65.3	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination Pain at injection site:Severe	13.6 percentage of participants Interval 6.0 to 25.0	9.8 percentage of participants Interval 4.6 to 17.8	9.4 percentage of participants Interval 3.5 to 19.3	9.3 percentage of participants Interval 3.1 to 20.3	12.5 percentage of participants Interval 3.5 to 29.0	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination Redness:Any	20.3 percentage of participants Interval 11.0 to 32.8	20.7 percentage of participants Interval 12.9 to 30.4	20.3 percentage of participants Interval 11.3 to 32.2	27.8 percentage of participants Interval 16.5 to 41.6	6.3 percentage of participants Interval 0.8 to 20.8	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination Redness:Mild	6.8 percentage of participants Interval 1.9 to 16.5	5.4 percentage of participants Interval 1.8 to 12.2	10.9 percentage of participants Interval 4.5 to 21.2	5.6 percentage of participants Interval 1.2 to 15.4	3.1 percentage of participants Interval 0.1 to 16.2	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination Redness:Moderate	11.9 percentage of participants Interval 4.9 to 22.9	10.9 percentage of participants Interval 5.3 to 19.1	7.8 percentage of participants Interval 2.6 to 17.3	16.7 percentage of participants Interval 7.9 to 29.3	3.1 percentage of participants Interval 0.1 to 16.2	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination Redness:Severe	1.7 percentage of participants Interval 0.0 to 9.1	4.3 percentage of participants Interval 1.2 to 10.8	1.6 percentage of participants Interval 0.0 to 8.4	5.6 percentage of participants Interval 1.2 to 15.4	0.0 percentage of participants Interval 0.0 to 10.9	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination Swelling:Any	18.6 percentage of participants Interval 9.7 to 30.9	20.7 percentage of participants Interval 12.9 to 30.4	17.2 percentage of participants Interval 8.9 to 28.7	14.8 percentage of participants Interval 6.6 to 27.1	9.4 percentage of participants Interval 2.0 to 25.0	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination Swelling:Mild	11.9 percentage of participants Interval 4.9 to 22.9	8.7 percentage of participants Interval 3.8 to 16.4	10.9 percentage of participants Interval 4.5 to 21.2	3.7 percentage of participants Interval 0.5 to 12.7	9.4 percentage of participants Interval 2.0 to 25.0	—	—	—
Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Vaccination Swelling:Moderate	6.8 percentage of participants Interval 1.9 to 16.5	10.9 percentage of participants Interval 5.3 to 19.1	6.3 percentage of participants Interval 1.7 to 15.2	11.1 percentage of participants Interval 4.2 to 22.6	0.0 percentage of participants Interval 0.0 to 10.9	—	—	—

PRIMARY outcome

Timeframe: Within 7 days after booster vaccination on Month 48

Population: Booster stage safety population included all participants who had received the booster vaccination (Bivalent rLP2086) and for whom safety data was available.

Systemic reactions included: fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site and joint pain, all other systemic reactions were recorded by using an e-diary. Fever was categorized as: 38.0 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \> 40.0 degree C. Vomiting was graded as: mild (1 to 2 times in 24 hours \[hrs\]), moderate (\>2 times in 24 hrs) and severe (requires intravenous \[IV\] hydration); Diarrhea was graded as: mild (2 to 3 loose stools in 24 hrs), moderate (4 to 5 loose stools in 24 hrs) and severe (6 or more loose stools in 24 hrs); Headache, fatigue, chills, muscle pain and joint pain was graded as: mild (does not interfere with daily activities), moderate (some interference with activity) and severe (prevents daily routine activity).

Outcome measures

Outcome measures
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=59 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) n=92 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=64 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) n=54 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=32 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 4: rLP2086 (0-and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Chills:Any	23.7 percentage of participants Interval 13.6 to 36.6	31.5 percentage of participants Interval 22.2 to 42.0	20.3 percentage of participants Interval 11.3 to 32.2	18.5 percentage of participants Interval 9.3 to 31.4	28.1 percentage of participants Interval 13.7 to 46.7	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Chills:Mild	13.6 percentage of participants Interval 6.0 to 25.0	20.7 percentage of participants Interval 12.9 to 30.4	12.5 percentage of participants Interval 5.6 to 23.2	9.3 percentage of participants Interval 3.1 to 20.3	18.8 percentage of participants Interval 7.2 to 36.4	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Chills:Moderate	10.2 percentage of participants Interval 3.8 to 20.8	9.8 percentage of participants Interval 4.6 to 17.8	7.8 percentage of participants Interval 2.6 to 17.3	7.4 percentage of participants Interval 2.1 to 17.9	9.4 percentage of participants Interval 2.0 to 25.0	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Muscle pain: Mild	16.9 percentage of participants Interval 8.4 to 29.0	15.2 percentage of participants Interval 8.6 to 24.2	7.8 percentage of participants Interval 2.6 to 17.3	14.8 percentage of participants Interval 6.6 to 27.1	6.3 percentage of participants Interval 0.8 to 20.8	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Muscle pain:Severe	0.0 percentage of participants Interval 0.0 to 6.1	1.1 percentage of participants Interval 0.0 to 5.9	3.1 percentage of participants Interval 0.4 to 10.8	3.7 percentage of participants Interval 0.5 to 12.7	0.0 percentage of participants Interval 0.0 to 10.9	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Joint pain:Any	11.9 percentage of participants Interval 4.9 to 22.9	16.3 percentage of participants Interval 9.4 to 25.5	14.1 percentage of participants Interval 6.6 to 25.0	18.5 percentage of participants Interval 9.3 to 31.4	21.9 percentage of participants Interval 9.3 to 40.0	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Joint pain:Mild	8.5 percentage of participants Interval 2.8 to 18.7	9.8 percentage of participants Interval 4.6 to 17.8	7.8 percentage of participants Interval 2.6 to 17.3	7.4 percentage of participants Interval 2.1 to 17.9	12.5 percentage of participants Interval 3.5 to 29.0	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Fever >=38 degrees C	5.1 percentage of participants Interval 1.1 to 14.1	1.1 percentage of participants Interval 0.0 to 5.9	4.7 percentage of participants Interval 1.0 to 13.1	1.9 percentage of participants Interval 0.0 to 9.9	3.1 percentage of participants Interval 0.1 to 16.2	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Fever 38.0 to <38.5 degrees C	5.1 percentage of participants Interval 1.1 to 14.1	1.1 percentage of participants Interval 0.0 to 5.9	3.1 percentage of participants Interval 0.4 to 10.8	0.0 percentage of participants Interval 0.0 to 6.6	3.1 percentage of participants Interval 0.1 to 16.2	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Fever 38.5 to <39.0 degrees C	0.0 percentage of participants Interval 0.0 to 6.1	0.0 percentage of participants Interval 0.0 to 3.9	1.6 percentage of participants Interval 0.0 to 8.4	1.9 percentage of participants Interval 0.0 to 9.9	0.0 percentage of participants Interval 0.0 to 10.9	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Fever 39.0 to 40.0 degrees C	0.0 percentage of participants Interval 0.0 to 6.1	0.0 percentage of participants Interval 0.0 to 3.9	0.0 percentage of participants Interval 0.0 to 5.6	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 10.9	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Fever >40.0 degrees C	0.0 percentage of participants Interval 0.0 to 6.1	0.0 percentage of participants Interval 0.0 to 3.9	0.0 percentage of participants Interval 0.0 to 5.6	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 10.9	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Vomiting:Any	1.7 percentage of participants Interval 0.0 to 9.1	3.3 percentage of participants Interval 0.7 to 9.2	3.1 percentage of participants Interval 0.4 to 10.8	1.9 percentage of participants Interval 0.0 to 9.9	0.0 percentage of participants Interval 0.0 to 10.9	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Vomiting:Mild	1.7 percentage of participants Interval 0.0 to 9.1	3.3 percentage of participants Interval 0.7 to 9.2	1.6 percentage of participants Interval 0.0 to 8.4	1.9 percentage of participants Interval 0.0 to 9.9	0.0 percentage of participants Interval 0.0 to 10.9	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Vomiting:Moderate	0.0 percentage of participants Interval 0.0 to 6.1	0.0 percentage of participants Interval 0.0 to 3.9	1.6 percentage of participants Interval 0.0 to 8.4	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 10.9	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Vomiting:Severe	0.0 percentage of participants Interval 0.0 to 6.1	0.0 percentage of participants Interval 0.0 to 3.9	0.0 percentage of participants Interval 0.0 to 5.6	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 10.9	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Diarrhea:Any	10.2 percentage of participants Interval 3.8 to 20.8	13.0 percentage of participants Interval 6.9 to 21.7	4.7 percentage of participants Interval 1.0 to 13.1	5.6 percentage of participants Interval 1.2 to 15.4	18.8 percentage of participants Interval 7.2 to 36.4	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Diarrhea:Mild	8.5 percentage of participants Interval 2.8 to 18.7	12.0 percentage of participants Interval 6.1 to 20.4	3.1 percentage of participants Interval 0.4 to 10.8	5.6 percentage of participants Interval 1.2 to 15.4	18.8 percentage of participants Interval 7.2 to 36.4	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Diarrhea:Moderate	1.7 percentage of participants Interval 0.0 to 9.1	1.1 percentage of participants Interval 0.0 to 5.9	1.6 percentage of participants Interval 0.0 to 8.4	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 10.9	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Diarrhea:Severe	0.0 percentage of participants Interval 0.0 to 6.1	0.0 percentage of participants Interval 0.0 to 3.9	0.0 percentage of participants Interval 0.0 to 5.6	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 10.9	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Headache:Any	50.8 percentage of participants Interval 37.5 to 64.1	47.8 percentage of participants Interval 37.3 to 58.5	56.3 percentage of participants Interval 43.3 to 68.6	48.1 percentage of participants Interval 34.3 to 62.2	37.5 percentage of participants Interval 21.1 to 56.3	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Headache:Mild	30.5 percentage of participants Interval 19.2 to 43.9	28.3 percentage of participants Interval 19.4 to 38.6	35.9 percentage of participants Interval 24.3 to 48.9	22.2 percentage of participants Interval 12.0 to 35.6	25.0 percentage of participants Interval 11.5 to 43.4	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Headache:Moderate	20.3 percentage of participants Interval 11.0 to 32.8	18.5 percentage of participants Interval 11.1 to 27.9	20.3 percentage of participants Interval 11.3 to 32.2	25.9 percentage of participants Interval 15.0 to 39.7	12.5 percentage of participants Interval 3.5 to 29.0	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Headache:Severe	0.0 percentage of participants Interval 0.0 to 6.1	1.1 percentage of participants Interval 0.0 to 5.9	0.0 percentage of participants Interval 0.0 to 5.6	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 10.9	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Fatigue:Any	62.7 percentage of participants Interval 49.1 to 75.0	60.9 percentage of participants Interval 50.1 to 70.9	62.5 percentage of participants Interval 49.5 to 74.3	51.9 percentage of participants Interval 37.8 to 65.7	65.6 percentage of participants Interval 46.8 to 81.4	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Fatigue:Mild	27.1 percentage of participants Interval 16.4 to 40.3	27.2 percentage of participants Interval 18.4 to 37.4	35.9 percentage of participants Interval 24.3 to 48.9	24.1 percentage of participants Interval 13.5 to 37.6	31.3 percentage of participants Interval 16.1 to 50.0	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Fatigue:Moderate	32.2 percentage of participants Interval 20.6 to 45.6	31.5 percentage of participants Interval 22.2 to 42.0	23.4 percentage of participants Interval 13.8 to 35.7	24.1 percentage of participants Interval 13.5 to 37.6	31.3 percentage of participants Interval 16.1 to 50.0	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Fatigue:Severe	3.4 percentage of participants Interval 0.4 to 11.7	2.2 percentage of participants Interval 0.3 to 7.6	3.1 percentage of participants Interval 0.4 to 10.8	3.7 percentage of participants Interval 0.5 to 12.7	3.1 percentage of participants Interval 0.1 to 16.2	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Chills:Severe	0.0 percentage of participants Interval 0.0 to 6.1	1.1 percentage of participants Interval 0.0 to 5.9	0.0 percentage of participants Interval 0.0 to 5.6	1.9 percentage of participants Interval 0.0 to 9.9	0.0 percentage of participants Interval 0.0 to 10.9	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Muscle pain:Any	22.0 percentage of participants Interval 12.3 to 34.7	29.3 percentage of participants Interval 20.3 to 39.8	18.8 percentage of participants Interval 10.1 to 30.5	24.1 percentage of participants Interval 13.5 to 37.6	15.6 percentage of participants Interval 5.3 to 32.8	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Muscle pain:Moderate	5.1 percentage of participants Interval 1.1 to 14.1	13.0 percentage of participants Interval 6.9 to 21.7	7.8 percentage of participants Interval 2.6 to 17.3	5.6 percentage of participants Interval 1.2 to 15.4	9.4 percentage of participants Interval 2.0 to 25.0	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Joint pain:Moderate	3.4 percentage of participants Interval 0.4 to 11.7	6.5 percentage of participants Interval 2.4 to 13.7	4.7 percentage of participants Interval 1.0 to 13.1	9.3 percentage of participants Interval 3.1 to 20.3	9.4 percentage of participants Interval 2.0 to 25.0	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Joint pain:Severe	0.0 percentage of participants Interval 0.0 to 6.1	0.0 percentage of participants Interval 0.0 to 3.9	1.6 percentage of participants Interval 0.0 to 8.4	1.9 percentage of participants Interval 0.0 to 9.9	0.0 percentage of participants Interval 0.0 to 10.9	—	—	—
Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination Use of antipyretic medication	10.2 percentage of participants Interval 3.8 to 20.8	14.1 percentage of participants Interval 7.7 to 23.0	7.8 percentage of participants Interval 2.6 to 17.3	13.0 percentage of participants Interval 5.4 to 24.9	6.3 percentage of participants Interval 0.8 to 20.8	—	—	—

PRIMARY outcome

Timeframe: From Visit 7 (Month 48) to Visit 8 (Month 49) in Booster stage

Population: Booster stage safety population included all participants who had received the booster vaccination (Bivalent rLP2086) and for whom safety data was available.

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both non-serious AEs and serious adverse events (SAEs). An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC. An MAE was defined as a non serious AE (AE other than SAE) that resulted in an evaluation at a medical facility.

Outcome measures

Outcome measures
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=59 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) n=92 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=64 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) n=54 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=32 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 4: rLP2086 (0-and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) AE	6.8 percentage of participants Interval 1.9 to 16.5	8.7 percentage of participants Interval 3.8 to 16.4	12.5 percentage of participants Interval 5.6 to 23.2	3.7 percentage of participants Interval 0.5 to 12.7	12.5 percentage of participants Interval 3.5 to 29.0	—	—	—
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) SAE	0.0 percentage of participants Interval 0.0 to 6.1	1.1 percentage of participants Interval 0.0 to 5.9	0.0 percentage of participants Interval 0.0 to 5.6	1.9 percentage of participants Interval 0.0 to 9.9	0.0 percentage of participants Interval 0.0 to 10.9	—	—	—
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) NDCMC	0.0 percentage of participants Interval 0.0 to 6.1	0.0 percentage of participants Interval 0.0 to 3.9	0.0 percentage of participants Interval 0.0 to 5.6	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 10.9	—	—	—
Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Medically Attended Adverse Event (MAE) From Booster Vaccination Phase (Visit 7 to Visit 8) MAE	5.1 percentage of participants Interval 1.1 to 14.1	4.3 percentage of participants Interval 1.2 to 10.8	4.7 percentage of participants Interval 1.0 to 13.1	0.0 percentage of participants Interval 0.0 to 6.6	3.1 percentage of participants Interval 0.1 to 16.2	—	—	—

PRIMARY outcome

Timeframe: Visit 8 (Month 49) to Visit 9 (Month 54) in Booster stage

Population: Booster stage safety population included all participants who had received the booster vaccination (Bivalent rLP2086) and for whom safety data was available.

Outcome measures

Outcome measures
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=59 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) n=92 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=64 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) n=54 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=32 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 4: rLP2086 (0-and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Follow-Up Phase (Visit 8 to Visit 9) SAE	1.7 percentage of participants Interval 0.0 to 9.1	0.0 percentage of participants Interval 0.0 to 3.9	3.1 percentage of participants Interval 0.4 to 10.8	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 10.9	—	—	—
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Follow-Up Phase (Visit 8 to Visit 9) MAE	28.8 percentage of participants Interval 17.8 to 42.1	12.0 percentage of participants Interval 6.1 to 20.4	10.9 percentage of participants Interval 4.5 to 21.2	11.1 percentage of participants Interval 4.2 to 22.6	21.9 percentage of participants Interval 9.3 to 40.0	—	—	—

PRIMARY outcome

Timeframe: From Visit 7 (time of booster vaccination, Month 48) to Visit 9 (6 months after booster vaccination, Month 54)

Population: Booster stage safety population included all participants who had received the booster vaccination (Bivalent rLP2086) and for whom safety data was available.

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Serious adverse event (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. An MAE was defined as a nonserious AE (AE other than SAE) that resulted in an evaluation at a medical facility.

Outcome measures

Outcome measures
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=59 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) n=92 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=64 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) n=54 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=32 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 4: rLP2086 (0-and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 to Visit 9) MAE	32.2 percentage of participants Interval 20.6 to 45.6	15.2 percentage of participants Interval 8.6 to 24.2	15.6 percentage of participants Interval 7.8 to 26.9	11.1 percentage of participants Interval 4.2 to 22.6	25.0 percentage of participants Interval 11.5 to 43.4	—	—	—
Percentage of Participants With at Least 1 Serious Adverse Event (SAE) and Medically Attended Adverse Event (MAE) From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 to Visit 9) SAE	1.7 percentage of participants Interval 0.0 to 9.1	1.1 percentage of participants Interval 0.0 to 5.9	3.1 percentage of participants Interval 0.4 to 10.8	1.9 percentage of participants Interval 0.0 to 9.9	0.0 percentage of participants Interval 0.0 to 10.9	—	—	—

PRIMARY outcome

Timeframe: Visit 1 of B1971033 (6-month safety telephone call after last dose in primary study) to Visit 6 of B1971033 (6 months after last primary dose to 48 months after last primary dose in primary study)

Population: Stage 1 safety population included all participants who had at least 1 blood draw in the study.

Outcome measures

Outcome measures
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=70 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) n=101 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=277 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) n=116 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=86 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 4: rLP2086 (0-and 6-Month Schedule) n=46 Participants Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Percentage of Participants With Newly Diagnosed Chronic Medical Condition;(NDCMC) From the 6-Month Safety Telephone Call in the Primary Study Through 48 Months After the Last Dose in the Primary Study (Visit 6 in Stage 1)	5.7 percentage of participants Interval 1.6 to 14.0	5.0 percentage of participants Interval 1.6 to 11.2	2.2 percentage of participants Interval 0.8 to 4.7	2.6 percentage of participants Interval 0.5 to 7.4	2.3 percentage of participants Interval 0.3 to 8.1	2.2 percentage of participants Interval 0.1 to 11.5	—	—

PRIMARY outcome

Timeframe: From Visit 8 (1 month after booster vaccination, Month 49) to Visit 10 (12 months after booster vaccination, Month 60)

Population: Booster stage safety population included all participants who had received the booster vaccination (bivalent rLP2086) and for whom safety data was available.

Outcome measures

Outcome measures
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=59 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) n=92 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=64 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) n=54 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=32 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 4: rLP2086 (0-and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Booster Vaccination Through 12 Months After Booster Vaccination (Visit 8 to Visit 10)	1.7 percentage of participants Interval 0.0 to 9.1	2.2 percentage of participants Interval 0.3 to 7.6	0.0 percentage of participants Interval 0.0 to 5.6	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 10.9	—	—	—

PRIMARY outcome

Timeframe: From Visit 7 (time of booster vaccination, Month 48) to Visit 10 (12 months after booster vaccination, Month 60)

Population: Booster stage safety population included all participants who had received the booster vaccination (bivalent rLP2086) and for whom safety data was available.

Outcome measures

Outcome measures
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=59 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) n=92 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=64 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) n=54 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=32 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 4: rLP2086 (0-and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) From Booster Stage Vaccination Through 12 Months After Booster Vaccination (Visit 7 to Visit 10)	1.7 percentage of participants Interval 0.0 to 9.1	2.2 percentage of participants Interval 0.3 to 7.6	0.0 percentage of participants Interval 0.0 to 5.6	0.0 percentage of participants Interval 0.0 to 6.6	0.0 percentage of participants Interval 0.0 to 10.9	—	—	—

PRIMARY outcome

Timeframe: From Visit 8 (1 month after booster vaccination, Month 49) to Visit 11 (26 months after booster vaccination, Month 74)

Population: Booster stage safety population included all participants who had received the booster vaccination (bivalent rLP2086) and for whom safety data was available. Here, "Overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

An NDCMC was defined as a disease or medical condition, that was not identified previously and that was expected to be persistent or otherwise long-lasting in its effects. The investigator determined if the AE was an NDCMC. Participants who received bivalent rLP2086 in primary study B1971012 on a 0-, 2-, and 6-month or a 0- and 6-month vaccination schedule were eligible to be follow up for 26 months after booster vaccination.

Outcome measures

Outcome measures
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=37 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) n=49 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 4: rLP2086 (0-and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Booster Vaccination Through 26 Months After Booster Vaccination (Visit 8 to Visit 11)	5.4 percentage of participants Interval 0.7 to 18.2	0.0 percentage of participants Interval 0.0 to 7.3	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From Visit 7 (time of booster vaccination, Month 48) to Visit 11 (26 months after booster vaccination, Month 74)

Outcome measures

Outcome measures
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=37 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) n=49 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 4: rLP2086 (0-and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) From Booster Vaccine Through 26 Months After Booster Vaccination (Visit 7 to Visit 11)	5.4 percentage of participants Interval 0.7 to 18.2	0.0 percentage of participants Interval 0.0 to 7.3	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Within 30 minutes after Booster Vaccination in Month 48

Population: Booster stage safety population included all participants who had received the booster vaccination (bivalent rLP2086) and for whom safety data was available.

Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration. 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:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=59 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) n=92 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=64 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) n=54 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=32 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 4: rLP2086 (0-and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Percentage of Participants With at Least 1 Immediate Adverse Event (AE) After Booster 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	—	—	—

PRIMARY outcome

Timeframe: From Visit 7 (time of booster vaccination, Month 48) Through Visit 9 (6 months after booster vaccination, Month 54)

Population: Booster stage safety population included all participants who had received the booster vaccination (bivalent rLP2086) and for whom safety data was available. Here, "Overall number of subjects analyzed" signifies those subjects who were evaluable for this outcome measure.

An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Number of days participants missed work or school due to AE occurred following booster vaccination were reported here.

Outcome measures

Outcome measures
Measure	Group 1:MCV4+Tdap+Saline (0-, 2-, and 6-Month Schedule) n=12 Participants Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Group 3a: rLP2086 (0-, 2-, and 6-Month Schedule) n=8 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=8 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 3b: rLP2086 (0-, 2-, and 6-Month Schedule) n=3 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971012, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately Month 48) in booster stage of study B1971033.	Group 3c: rLP2086 (0-, 2-, and 6-Month Schedule)) n=6 Participants Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971015.	Group 4: rLP2086 (0-and 6-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 5: rLP2086 (0- and 2-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Group 6: rLP2086 (0- and 4-Month Schedule) Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study, and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Number of Days Participants Missed Work or School Due to AE From Booster Vaccination Through 6 Months After Booster Vaccination (Visit 7 Through Visit 9)	17.5 days Standard Deviation 28.14	12.4 days Standard Deviation 9.72	10.1 days Standard Deviation 9.14	3.0 days Standard Deviation 2.65	4.8 days Standard Deviation 2.56	—	—	—

Adverse Events

Stage1,Group 1:MCV4+Tdap+Saline (0-,2-,and 6-Month Schedule):

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Stage 1, Group 2: rLP2086 (0-, 1-, and 6-Month Schedule):

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Stage 1, Group 3: rLP2086 (0-, 2-, and 6-Month Schedule):

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Stage 1, Group 4: rLP2086 (0-and 6-Month Schedule):

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Stage 1, Group 5: rLP2086 (0- and 2-Month Schedule):

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Stage 1,Group 6: rLP2086 (0- and 4-Month Schedule):

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Stage 2, Group 2: rLP2086 (0-, 1-, and 6-Month Schedule)

Serious events: 1 serious events

Other events: 56 other events

Deaths: 0 deaths

Stage 2, Group 3: rLP2086 (0-, 2-, and 6-Month Schedule)

Serious events: 1 serious events

Other events: 90 other events

Deaths: 0 deaths

Stage 2, Group 4: rLP2086 (0-and 6-Month Schedule)

Serious events: 2 serious events

Other events: 62 other events

Deaths: 0 deaths

Stage 2, Group 5: rLP2086 (0- and 2-Month Schedule)

Serious events: 1 serious events

Other events: 53 other events

Deaths: 0 deaths

Stage 2, Group 6: rLP2086 (0- and 4-Month Schedule)

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Stage1,Group 1:MCV4+Tdap+Saline (0-,2-,and 6-Month Schedule): n=70 participants at risk Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Stage 1, Group 2: rLP2086 (0-, 1-, and 6-Month Schedule): n=101 participants at risk Participants who received bivalent rLP2086 vaccine on 0-, 1-, and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study.	Stage 1, Group 3: rLP2086 (0-, 2-, and 6-Month Schedule): n=277 participants at risk Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, B1971012 and B1971015 were included in this group, and were followed up for 48 months during the stage 1 of this study.	Stage 1, Group 4: rLP2086 (0-and 6-Month Schedule): n=116 participants at risk Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study.	Stage 1, Group 5: rLP2086 (0- and 2-Month Schedule): n=86 participants at risk Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study.	Stage 1,Group 6: rLP2086 (0- and 4-Month Schedule): n=46 participants at risk Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study.	Stage 2, Group 2: rLP2086 (0-, 1-, and 6-Month Schedule) n=59 participants at risk Participants who received bivalent rLP2086 vaccine on 0-, 1-, and 6-month schedule in primary study B1971012 and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Stage 2, Group 3: rLP2086 (0-, 2-, and 6-Month Schedule) n=92 participants at risk Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, B1971012 and B1971015 were included in this group. Only participants from B1971010 and B1971012 studies received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Stage 2, Group 4: rLP2086 (0-and 6-Month Schedule) n=64 participants at risk Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Stage 2, Group 5: rLP2086 (0- and 2-Month Schedule) n=54 participants at risk Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Stage 2, Group 6: rLP2086 (0- and 4-Month Schedule) n=32 participants at risk Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
General disorders Influenza like illness	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.9% 1/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Pyelonephritis	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.6% 1/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Injury, poisoning and procedural complications Meniscus injury	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Psychiatric disorders Depression	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.6% 1/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Psychiatric disorders Suicide attempt	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	— 0/0 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.

Other adverse events

Other adverse events
Measure	Stage1,Group 1:MCV4+Tdap+Saline (0-,2-,and 6-Month Schedule): n=70 participants at risk Participants received MCV4+Tdap+Saline at Month 0, Saline only at Month 2 and 6 schedule in primary study B1971015 and were followed up for 48 months during the stage 1 of this study.	Stage 1, Group 2: rLP2086 (0-, 1-, and 6-Month Schedule): n=101 participants at risk Participants who received bivalent rLP2086 vaccine on 0-, 1-, and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study.	Stage 1, Group 3: rLP2086 (0-, 2-, and 6-Month Schedule): n=277 participants at risk Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, B1971012 and B1971015 were included in this group, and were followed up for 48 months during the stage 1 of this study.	Stage 1, Group 4: rLP2086 (0-and 6-Month Schedule): n=116 participants at risk Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study.	Stage 1, Group 5: rLP2086 (0- and 2-Month Schedule): n=86 participants at risk Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study.	Stage 1,Group 6: rLP2086 (0- and 4-Month Schedule): n=46 participants at risk Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and were followed up for 48 months during the stage 1 of this study.	Stage 2, Group 2: rLP2086 (0-, 1-, and 6-Month Schedule) n=59 participants at risk Participants who received bivalent rLP2086 vaccine on 0-, 1-, and 6-month schedule in primary study B1971012 and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Stage 2, Group 3: rLP2086 (0-, 2-, and 6-Month Schedule) n=92 participants at risk Participants who received bivalent rLP2086 vaccine on 0-, 2-, and 6-month schedule in primary study B1971010, B1971012 and B1971015 were included in this group. Only participants from B1971010 and B1971012 studies received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Stage 2, Group 4: rLP2086 (0-and 6-Month Schedule) n=64 participants at risk Participants who received bivalent rLP2086 vaccine on 0- and 6-month schedule in primary study B1971012 and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Stage 2, Group 5: rLP2086 (0- and 2-Month Schedule) n=54 participants at risk Participants who received bivalent rLP2086 vaccine on 0- and 2-month schedule in primary study B1971012 and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.	Stage 2, Group 6: rLP2086 (0- and 4-Month Schedule) n=32 participants at risk Participants who received bivalent rLP2086 vaccine on 0- and 4-month schedule in primary study B1971012 and received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine at Visit 7 (approximately at Month 48) in booster stage of study B1971033.
Blood and lymphatic system disorders Anaemia	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Cardiac disorders Bradycardia	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Cardiac disorders Cardiac arrest	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Eye disorders Myopia	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	3.4% 2/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Gastrointestinal disorders Constipation	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Gastrointestinal disorders Gastric ulcer	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Gastrointestinal disorders Nausea	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
General disorders Influenza like illness	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	3.1% 1/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Immune system disorders Mite allergy	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Immune system disorders Seasonal allergy	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.2% 1/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Body tinea	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Bronchitis	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.6% 1/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Cervicitis	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.9% 1/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Chlamydial infection	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.9% 1/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Conjunctivitis	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Cystitis	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.2% 1/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.9% 1/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Gastroenteritis	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.6% 1/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.9% 1/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	3.1% 1/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Genitourinary chlamydia infection	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Impetigo	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.6% 1/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.9% 1/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Infection	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Influenza	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	3.1% 1/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Laryngitis	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Lower respiratory tract infection viral	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Nasopharyngitis	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	5.1% 3/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	2.2% 2/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	7.8% 5/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.9% 1/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Oral candidiasis	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Oral herpes	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/3 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Otitis media acute	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	3.1% 1/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Pharyngitis	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	5.1% 3/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.6% 1/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	3.1% 1/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Pneumonia	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Rhinitis	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Sinusitis	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Tonsillitis	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	3.1% 2/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	6.2% 2/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Tooth infection	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.9% 1/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Tracheitis	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	5.1% 3/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	3.1% 1/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Urinary tract infection	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	2.2% 2/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	33.3% 1/3 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Injury, poisoning and procedural complications Animal bite	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Injury, poisoning and procedural complications Fall	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	3.7% 2/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Injury, poisoning and procedural complications Head injury	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.6% 1/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Injury, poisoning and procedural complications Joint injury	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.6% 1/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.9% 1/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Injury, poisoning and procedural complications Laceration	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Injury, poisoning and procedural complications Limb injury	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	3.1% 1/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Injury, poisoning and procedural complications Muscle injury	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	3.1% 1/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Injury, poisoning and procedural complications Neck injury	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Injury, poisoning and procedural complications Vasoplegia syndrome	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	3.7% 2/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Investigations Borrelia test positive	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Metabolism and nutrition disorders Vitamin K deficiency	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.9% 1/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Nervous system disorders Brain injury	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Nervous system disorders Disturbance in attention	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Nervous system disorders Dizziness	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Nervous system disorders Migraine	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.9% 1/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	3.1% 1/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Nervous system disorders Syncope	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Psychiatric disorders Depression	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Psychiatric disorders Gastrointestinal somatic symptom disorder	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Psychiatric disorders Generalised anxiety disorder	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Psychiatric disorders Insomnia	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Psychiatric disorders Persistent depressive disorder	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Renal and urinary disorders Acute kidney injury	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Reproductive system and breast disorders Testicular pain	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Skin and subcutaneous tissue disorders Acne	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	3.1% 1/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.6% 1/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Skin and subcutaneous tissue disorders Rash	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.6% 1/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Vascular disorders Hypertension	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Vascular disorders Hypotension	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Vascular disorders Peripheral artery thrombosis	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
General disorders Withdrawal syndrome	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Infections and infestations Infectious mononucleosis	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Gastrointestinal disorders Diarrhoea	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	10.2% 6/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	13.0% 12/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	4.7% 3/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	5.6% 3/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	18.8% 6/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Gastrointestinal disorders Vomiting	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.7% 1/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	3.3% 3/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	3.1% 2/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.9% 1/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
General disorders Chills	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	23.7% 14/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	31.5% 29/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	20.3% 13/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	18.5% 10/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	28.1% 9/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
General disorders Fatigue	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	62.7% 37/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	60.9% 56/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	62.5% 40/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	51.9% 28/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	65.6% 21/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
General disorders Injection site erythema (redness)	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	20.3% 12/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	20.7% 19/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	20.3% 13/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	27.8% 15/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	6.2% 2/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
General disorders Injection site pain (tenderness at injection site)	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	91.5% 54/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	93.5% 86/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	89.1% 57/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	88.9% 48/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	84.4% 27/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
General disorders Injection site swelling (swelling)	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	18.6% 11/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	20.7% 19/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	17.2% 11/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	14.8% 8/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	9.4% 3/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
General disorders Pyrexia (fever)	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	5.1% 3/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.1% 1/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	4.7% 3/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	1.9% 1/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	3.1% 1/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	11.9% 7/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	16.3% 15/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	14.1% 9/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	18.5% 10/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	21.9% 7/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	22.0% 13/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	29.3% 27/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	18.8% 12/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	24.1% 13/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	15.6% 5/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Nervous system disorders Headache	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	50.8% 30/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	47.8% 44/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	56.2% 36/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	48.1% 26/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	37.5% 12/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Eye disorders Hypermetropia	0.00% 0/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	2.2% 1/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Gastrointestinal disorders Irritable bowel syndrome	1.4% 1/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Endocrine disorders Autoimmune thyroiditis	1.4% 1/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.36% 1/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Musculoskeletal and connective tissue disorders Osteochondrosis	1.4% 1/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.
Nervous system disorders Orthostatic intolerance	1.4% 1/70 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/101 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/277 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/116 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/86 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/46 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/59 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/92 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/64 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/54 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.	0.00% 0/32 • SAEs and Non SAEs: Visit 7 (Booster vaccination, Month 48) to Visit 11 (Month 74) [26 months]. Local reactions and systemic events: Recorded by participants in e-diary from Day 1 to Day 7 after booster vaccination in Month 48. AEs were reported only for those participants who had received the booster vaccination (bivalent rLP2086) and for whom safety information was available for disclosure. SAEs were not collected for stage 1 of the study.

Additional Information

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Phone: 1-800-718-1021

Email: [email protected]

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
Publication restrictions are in place

Restriction type: OTHER