Trial Outcomes & Findings for A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age. (NCT NCT03135834)

NCT ID: NCT03135834

Last Updated: 2023-08-08

Results Overview

Percentage of participants who achieved an hSBA titer \>= LLOQ for all 4 primary MenB test strains combined (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome. Analysis for this outcome measure was planned for combined Group 2 and 4.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1610 participants
• Primary outcome timeframe: 1 month after Vaccination 2
• Results posted on: 2023-08-08

Participant Flow

The study had 2 stages: 1 and 2. Study was conducted at 68 sites in Stage 1, with 39 of those sites participating in Stage 2. Participants were randomized as ACWY-naive and ACWY-experienced (received 1 prior dose of a vaccine containing 1 or more ACWY groups greater than or equal to [>=] 4 years prior to randomization).

A total of 1610 participants were randomized in this study, out of which 10 withdrew before vaccination.

Participant milestones

Measure	Group 1: MenABCWY + Saline (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants had blood drawn for antibody persistence at Month 18, 30, 42. There was a blood draw at Month 0, Month 6 and Month 54 before Vaccination 1, 2 and Booster vaccination. Post vaccination blood draw happened at 1 month after Vaccination 1, 2 and Booster vaccination. Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54. There was a safety follow-up 6 months after Vaccination 2 in Stage 1 (Visit 5) and 6 months after Booster Vaccination in Stage 2 (Visit 12).	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants had blood drawn for antibody persistence at Month 18, 30, 42. There was a blood draw at Month 0, Month 6 and Month 54 before Vaccination 1, 2 and Booster vaccination. Post vaccination blood draw happened at 1 month after Vaccination 1, 2 and Booster vaccination. Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54. There was a safety follow-up 6 months after Vaccination 2 in Stage 1 (Visit 5) and 6 months after Booster Vaccination in Stage 2 (Visit 12).	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants had blood drawn for antibody persistence at Month 18, 30, 42. There was a blood draw at Month 0, Month 6 and Month 54 before Vaccination 1, 2 and Booster vaccination. Post vaccination blood draw happened at 1 month after Vaccination 1, 2 and Booster vaccination. Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54. There was a safety follow-up 6 months after Vaccination 2 in Stage 1 (Visit 5) and 6 months after Booster Vaccination in Stage 2 (Visit 12).	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants had blood drawn for antibody persistence at Month 18, 30, 42. There was a blood draw at Month 0, Month 6 and Month 54 before Vaccination 1, 2 and Booster vaccination. Post vaccination blood draw happened at 1 month after Vaccination 1, 2 and Booster vaccination. Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54. There was a safety follow-up 6 months after Vaccination 2 in Stage 1 (Visit 5) and 6 months after Booster Vaccination in Stage 2 (Visit 12).
Stage 1 STARTED	272	537	272	529
Stage 1 Vaccination 1 at Month 0	272	534	271	523
Stage 1 Vaccination 2 at Month 6	242	469	244	477
Stage 1 COMPLETED	233	462	232	463
Stage 1 NOT COMPLETED	39	75	40	66
Stage 2 STARTED	114	65	101	73
Stage 2 Antibody Persistence: Blood Draw Month18	114	63	53	23
Stage 2 Antibody Persistence: Blood Draw Month 30	104	61	96	71
Stage 2 Antibody Persistence: Blood Draw Month 42	97	55	97	68
Stage 2 Received Booster Vaccination	67	40	77	58
Stage 2 COMPLETED	67	38	77	58
Stage 2 NOT COMPLETED	47	27	24	15

Reasons for withdrawal

Measure	Group 1: MenABCWY + Saline (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants had blood drawn for antibody persistence at Month 18, 30, 42. There was a blood draw at Month 0, Month 6 and Month 54 before Vaccination 1, 2 and Booster vaccination. Post vaccination blood draw happened at 1 month after Vaccination 1, 2 and Booster vaccination. Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54. There was a safety follow-up 6 months after Vaccination 2 in Stage 1 (Visit 5) and 6 months after Booster Vaccination in Stage 2 (Visit 12).	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants had blood drawn for antibody persistence at Month 18, 30, 42. There was a blood draw at Month 0, Month 6 and Month 54 before Vaccination 1, 2 and Booster vaccination. Post vaccination blood draw happened at 1 month after Vaccination 1, 2 and Booster vaccination. Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54. There was a safety follow-up 6 months after Vaccination 2 in Stage 1 (Visit 5) and 6 months after Booster Vaccination in Stage 2 (Visit 12).	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants had blood drawn for antibody persistence at Month 18, 30, 42. There was a blood draw at Month 0, Month 6 and Month 54 before Vaccination 1, 2 and Booster vaccination. Post vaccination blood draw happened at 1 month after Vaccination 1, 2 and Booster vaccination. Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54. There was a safety follow-up 6 months after Vaccination 2 in Stage 1 (Visit 5) and 6 months after Booster Vaccination in Stage 2 (Visit 12).	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants had blood drawn for antibody persistence at Month 18, 30, 42. There was a blood draw at Month 0, Month 6 and Month 54 before Vaccination 1, 2 and Booster vaccination. Post vaccination blood draw happened at 1 month after Vaccination 1, 2 and Booster vaccination. Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54. There was a safety follow-up 6 months after Vaccination 2 in Stage 1 (Visit 5) and 6 months after Booster Vaccination in Stage 2 (Visit 12).
Stage 1 Adverse Event	1	2	2	1
Stage 1 Death	1	0	0	0
Stage 1 Lost to Follow-up	17	24	21	38
Stage 1 No longer met eligibility criteria	1	6	2	5
Stage 1 Other	0	2	1	0
Stage 1 Physician Decision	0	1	0	0
Stage 1 Pregnancy	0	4	2	4
Stage 1 Protocol Violation	1	1	2	1
Stage 1 Withdrawal by parent/guardian	2	10	2	1
Stage 1 Withdrawal by Subject	16	22	7	10
Stage 1 Randomized but not Vaccinated	0	3	1	6
Stage 2 Lost to Follow-up	0	1	0	0
Stage 2 Withdrawal by Subject	0	1	0	0
Stage 2 Withdrawn Before Booster Vaccination	46	24	24	15
Stage 2 Did not receive Booster Vaccination	1	1	0	0

Baseline Characteristics

Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).

Baseline characteristics by cohort

Measure	Group 1: MenABCWY + Saline (ACWY-Naive) n=272 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants had blood drawn for antibody persistence at Month 18, 30, 42. There was a blood draw at Month 0, Month 6 and Month 54 before Vaccination 1, 2 and Booster vaccination. Post vaccination blood draw happened at 1 month after Vaccination 1, 2 and Booster vaccination. Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54. There was a safety follow-up 6 months after Vaccination 2 in Stage 1 (Visit 5) and 6 months after Booster Vaccination in Stage 2 (Visit 12).	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=534 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants had blood drawn for antibody persistence at Month 18, 30, 42. There was a blood draw at Month 0, Month 6 and Month 54 before Vaccination 1, 2 and Booster vaccination. Post vaccination blood draw happened at 1 month after Vaccination 1, 2 and Booster vaccination. Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54. There was a safety follow-up 6 months after Vaccination 2 in Stage 1 (Visit 5) and 6 months after Booster Vaccination in Stage 2 (Visit 12).	Group 3: MenABCWY + Saline (ACWY-Experienced) n=271 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants had blood drawn for antibody persistence at Month 18, 30, 42. There was a blood draw at Month 0, Month 6 and Month 54 before Vaccination 1, 2 and Booster vaccination. Post vaccination blood draw happened at 1 month after Vaccination 1, 2 and Booster vaccination. Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54. There was a safety follow-up 6 months after Vaccination 2 in Stage 1 (Visit 5) and 6 months after Booster Vaccination in Stage 2 (Visit 12).	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=523 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants had blood drawn for antibody persistence at Month 18, 30, 42. There was a blood draw at Month 0, Month 6 and Month 54 before Vaccination 1, 2 and Booster vaccination. Post vaccination blood draw happened at 1 month after Vaccination 1, 2 and Booster vaccination. Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54. There was a safety follow-up 6 months after Vaccination 2 in Stage 1 (Visit 5) and 6 months after Booster Vaccination in Stage 2 (Visit 12).	Total n=1600 Participants Total of all reporting groups
Age, Continuous Stage 1	16.0 Years STANDARD_DEVIATION 5.67 • n=272 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	16.5 Years STANDARD_DEVIATION 5.81 • n=534 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	17.7 Years STANDARD_DEVIATION 3.57 • n=271 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	17.8 Years STANDARD_DEVIATION 3.66 • n=523 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	17.1 Years STANDARD_DEVIATION 4.87 • n=1600 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Age, Continuous Stage 2	19.1 Years STANDARD_DEVIATION 5.36 • n=67 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	18.5 Years STANDARD_DEVIATION 5.51 • n=40 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	20.8 Years STANDARD_DEVIATION 3.73 • n=77 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	21.1 Years STANDARD_DEVIATION 4.11 • n=56 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	20.4 Years STANDARD_DEVIATION 4.72 • n=240 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Sex: Female, Male Stage 1 · Female	144 Participants n=272 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	333 Participants n=534 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	152 Participants n=271 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	289 Participants n=523 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	918 Participants n=1600 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Sex: Female, Male Stage 1 · Male	128 Participants n=272 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	201 Participants n=534 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	119 Participants n=271 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	234 Participants n=523 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	682 Participants n=1600 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Sex: Female, Male Stage 2 · Female	28 Participants n=67 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	26 Participants n=40 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	47 Participants n=77 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	29 Participants n=56 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	130 Participants n=240 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Sex: Female, Male Stage 2 · Male	39 Participants n=67 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	14 Participants n=40 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	30 Participants n=77 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	27 Participants n=56 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	110 Participants n=240 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Ethnicity (NIH/OMB) Stage 1 · Hispanic or Latino	35 Participants n=272 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	73 Participants n=534 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	24 Participants n=271 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	61 Participants n=523 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	193 Participants n=1600 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Ethnicity (NIH/OMB) Stage 1 · Not Hispanic or Latino	236 Participants n=272 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	461 Participants n=534 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	246 Participants n=271 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	461 Participants n=523 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	1404 Participants n=1600 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Ethnicity (NIH/OMB) Stage 1 · Unknown or Not Reported	1 Participants n=272 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=534 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	1 Participants n=271 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	1 Participants n=523 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	3 Participants n=1600 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Ethnicity (NIH/OMB) Stage 2 · Hispanic or Latino	6 Participants n=67 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	3 Participants n=40 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	3 Participants n=77 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	1 Participants n=56 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	13 Participants n=240 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Ethnicity (NIH/OMB) Stage 2 · Not Hispanic or Latino	61 Participants n=67 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	37 Participants n=40 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	74 Participants n=77 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	55 Participants n=56 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	227 Participants n=240 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Ethnicity (NIH/OMB) Stage 2 · Unknown or Not Reported	0 Participants n=67 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=40 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=77 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=56 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=240 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Race (NIH/OMB) Stage 1 · American Indian or Alaska Native	10 Participants n=272 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	13 Participants n=534 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	6 Participants n=271 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	20 Participants n=523 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	49 Participants n=1600 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Race (NIH/OMB) Stage 1 · Asian	1 Participants n=272 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	4 Participants n=534 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	3 Participants n=271 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	8 Participants n=523 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	16 Participants n=1600 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Race (NIH/OMB) Stage 1 · Native Hawaiian or Other Pacific Islander	0 Participants n=272 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=534 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=271 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=523 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=1600 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Race (NIH/OMB) Stage 1 · Black or African American	27 Participants n=272 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	53 Participants n=534 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	25 Participants n=271 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	60 Participants n=523 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	165 Participants n=1600 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Race (NIH/OMB) Stage 1 · White	234 Participants n=272 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	464 Participants n=534 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	237 Participants n=271 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	435 Participants n=523 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	1370 Participants n=1600 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Race (NIH/OMB) Stage 1 · More than one race	0 Participants n=272 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=534 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=271 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=523 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=1600 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Race (NIH/OMB) Stage 1 · Unknown or Not Reported	0 Participants n=272 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=534 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=271 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=523 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=1600 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Race (NIH/OMB) Stage 2 · American Indian or Alaska Native	0 Participants n=67 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=40 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=77 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=56 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=240 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Race (NIH/OMB) Stage 2 · Asian	0 Participants n=67 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=40 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=77 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	1 Participants n=56 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	1 Participants n=240 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Race (NIH/OMB) Stage 2 · Native Hawaiian or Other Pacific Islander	0 Participants n=67 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=40 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=77 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=56 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=240 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Race (NIH/OMB) Stage 2 · Black or African American	5 Participants n=67 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	3 Participants n=40 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	4 Participants n=77 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	2 Participants n=56 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	14 Participants n=240 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Race (NIH/OMB) Stage 2 · White	59 Participants n=67 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	37 Participants n=40 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	72 Participants n=77 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	53 Participants n=56 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	221 Participants n=240 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Race (NIH/OMB) Stage 2 · More than one race	0 Participants n=67 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=40 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=77 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=56 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=240 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).
Race (NIH/OMB) Stage 2 · Unknown or Not Reported	3 Participants n=67 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=40 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	1 Participants n=77 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	0 Participants n=56 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).	4 Participants n=240 Participants • Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).

PRIMARY outcome

Timeframe: 1 month after Vaccination 2

Population: Stage 1 evaluable immunogenicity population(EIP)=all participants randomized to study group of interest,received all investigational products as randomized,had blood drawn for assay testing in required time frames at Months 0 and 7,had valid and determinate assay results,received no prohibited vaccines/treatment,had no major protocol violation determined by medical monitor.'Number of Participants Analyzed'=participants with valid and determinate hSBA results on all 4 strains at given time point.

Percentage of participants who achieved an hSBA titer >= LLOQ for all 4 primary MenB test strains combined (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome. Analysis for this outcome measure was planned for combined Group 2 and 4.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=814 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= Lower Limit of Quantitation (LLOQ) for All 4 Primary Test Strains Combined 1 Month After Vaccination 2 (Group 2 and 4 Combined)	74.3 Percentage of participants Interval 71.2 to 77.3	—	—	—

PRIMARY outcome

Timeframe: From Baseline (blood draw prior to Vaccination 1) to 1 month after Vaccination 2

Population: Stage 1 EIP analyzed. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table but may not have evaluable data for every row. "Number Analyzed": participants with valid and determinate hSBA titers for given strain at both specified time point and baseline.

The 4-fold increase: a) participants with baseline hSBA titer below limit of detection (LOD or an hSBA titer <1:4), response was defined as hSBA titer >=1:16 or LLOQ (whichever titer is higher); b) Participants with baseline hSBA titer >= LOD and < LLOQ, response was defined as hSBA titer >= 4 times the LLOQ; c) participants with baseline hSBA titer >= LLOQ, response was defined as hSBA titer >=4 times baseline titer. Four primary MenB test strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Analysis for this outcome measure was planned for combined Group 2 and 4.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=864 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With Fold Rise >=4 in hSBA for Each of the 4 Primary MenB Test Strains From Baseline to 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB80 (A22)	73.8 Percentage of participants Interval 70.6 to 76.7	—	—	—
Stage1: Percentage of Participants With Fold Rise >=4 in hSBA for Each of the 4 Primary MenB Test Strains From Baseline to 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2001 (A56)	95.0 Percentage of participants Interval 93.3 to 96.4	—	—	—
Stage1: Percentage of Participants With Fold Rise >=4 in hSBA for Each of the 4 Primary MenB Test Strains From Baseline to 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2948 (B24)	67.4 Percentage of participants Interval 64.1 to 70.6	—	—	—
Stage1: Percentage of Participants With Fold Rise >=4 in hSBA for Each of the 4 Primary MenB Test Strains From Baseline to 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2707 (B44)	86.4 Percentage of participants Interval 83.9 to 88.6	—	—	—

PRIMARY outcome

Timeframe: 7 days after Vaccination 1

Population: Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Here, 'Overall Number of participants Analyzed' signifies number of participants with known values. Analysis was planned for combined Group 2 and 4.

Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm) and severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=1044 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Redness: Any	16.9 Percentage of participants Interval 14.6 to 19.3	—	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Redness: Mild	6.8 Percentage of participants Interval 5.3 to 8.5	—	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Redness: Moderate	8.0 Percentage of participants Interval 6.5 to 9.9	—	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Redness: Severe	2.0 Percentage of participants Interval 1.2 to 3.1	—	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Swelling: Any	17.0 Percentage of participants Interval 14.7 to 19.4	—	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Swelling: Mild	9.8 Percentage of participants Interval 8.0 to 11.7	—	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Swelling: Moderate	6.9 Percentage of participants Interval 5.4 to 8.6	—	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Swelling: Severe	0.3 Percentage of participants Interval 0.1 to 0.8	—	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Pain at injection site: Any	85.0 Percentage of participants Interval 82.6 to 87.1	—	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Pain at injection site: Mild	41.2 Percentage of participants Interval 38.2 to 44.2	—	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Pain at injection site: Moderate	39.1 Percentage of participants Interval 36.1 to 42.1	—	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Pain at injection site: Severe	4.7 Percentage of participants Interval 3.5 to 6.2	—	—	—

PRIMARY outcome

Timeframe: 7 days after Vaccination 2

Population: Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Here, 'Overall Number of Participants Analyzed' signifies number of participants with known values. Analysis was planned for combined Group 2 and 4.

Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm) and severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=903 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Redness: Any	14.7 Percentage of participants Interval 12.5 to 17.2	—	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Redness: Mild	5.2 Percentage of participants Interval 3.8 to 6.9	—	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Redness: Moderate	8.4 Percentage of participants Interval 6.7 to 10.4	—	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Redness: Severe	1.1 Percentage of participants Interval 0.5 to 2.0	—	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Swelling: Any	14.3 Percentage of participants Interval 12.1 to 16.7	—	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Swelling: Mild	6.4 Percentage of participants Interval 4.9 to 8.2	—	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Swelling: Moderate	7.5 Percentage of participants Interval 5.9 to 9.4	—	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Swelling: Severe	0.3 Percentage of participants Interval 0.1 to 1.0	—	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Pain at injection site: Any	82.2 Percentage of participants Interval 79.5 to 84.6	—	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Pain at injection site: Mild	38.9 Percentage of participants Interval 35.7 to 42.1	—	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Pain at injection site: Moderate	37.9 Percentage of participants Interval 34.7 to 41.1	—	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Pain at injection site: Severe	5.4 Percentage of participants Interval 4.0 to 7.1	—	—	—

PRIMARY outcome

Timeframe: 7 days after Vaccination 1

Population: Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Here, "Overall Number of Participants Analyzed": number of participants with known values. Analysis was planned for combined Group 2 and 4.

Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site, and joint pain were recorded by using an e-diary. Fever was defined as >=38.0 degree Celsius (C) and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 in 24 hours).

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=1044 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Fever: >= 38.0 degree C	6.7 Percentage of participants Interval 5.3 to 8.4	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Fever: 38.0 to 38.4 degree C	4.0 Percentage of participants Interval 2.9 to 5.4	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Fever: 38.5 to 38.9 degree C	2.1 Percentage of participants Interval 1.3 to 3.2	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Fever: 39.0 to 40.0 degree C	0.6 Percentage of participants Interval 0.2 to 1.2	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Fever: > 40.0 degree C	0.0 Percentage of participants Interval 0.0 to 0.4	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Fatigue: Any	51.9 Percentage of participants Interval 48.8 to 55.0	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Fatigue: Mild	25.4 Percentage of participants Interval 22.8 to 28.1	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Fatigue: Moderate	23.7 Percentage of participants Interval 21.1 to 26.4	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Fatigue: Severe	2.9 Percentage of participants Interval 1.9 to 4.1	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Headache: Any	46.5 Percentage of participants Interval 43.4 to 49.5	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Headache: Mild	25.1 Percentage of participants Interval 22.5 to 27.8	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Headache: Moderate	19.0 Percentage of participants Interval 16.6 to 21.5	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Headache: Severe	2.4 Percentage of participants Interval 1.6 to 3.5	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Chills: Any	18.5 Percentage of participants Interval 16.2 to 21.0	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Chills: Mild	11.5 Percentage of participants Interval 9.6 to 13.6	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Chills: Moderate	5.7 Percentage of participants Interval 4.4 to 7.3	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Chills: Severe	1.2 Percentage of participants Interval 0.7 to 2.1	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Vomiting: Any	3.7 Percentage of participants Interval 2.7 to 5.1	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Vomiting: Mild	2.9 Percentage of participants Interval 1.9 to 4.1	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Vomiting: Moderate	0.9 Percentage of participants Interval 0.4 to 1.6	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Vomiting: severe	0.0 Percentage of participants Interval 0.0 to 0.4	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Diarrhea: Any	14.1 Percentage of participants Interval 12.0 to 16.3	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Diarrhea: Mild	10.7 Percentage of participants Interval 8.9 to 12.8	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Diarrhea: Moderate	3.3 Percentage of participants Interval 2.3 to 4.5	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Diarrhea: Severe	0.1 Percentage of participants Interval 0.0 to 0.5	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Muscle pain: Any	28.4 Percentage of participants Interval 25.7 to 31.3	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Muscle pain: Mild	15.8 Percentage of participants Interval 13.6 to 18.2	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Muscle pain: Moderate	11.6 Percentage of participants Interval 9.7 to 13.7	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Muscle pain: Severe	1.1 Percentage of participants Interval 0.5 to 1.9	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Joint pain: Any	19.6 Percentage of participants Interval 17.3 to 22.2	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Joint pain: Mild	10.2 Percentage of participants Interval 8.5 to 12.3	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Joint pain: Moderate	8.6 Percentage of participants Interval 7.0 to 10.5	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) Joint pain: Severe	0.8 Percentage of participants Interval 0.3 to 1.5	—	—	—

PRIMARY outcome

Timeframe: 7 days after Vaccination 2

Population: Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Here, "Overall Number of Participants Analyzed": number of participants with known values. Analysis was planned for combined Group 2 and 4.

Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site, and joint pain were recorded by using an e-diary. Fever was defined as >=38.0 degree C and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 in 24 hours).

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=903 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Fever: >= 38.0 degree C	3.2 Percentage of participants Interval 2.2 to 4.6	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Fever: 38.0 to 38.4 degree C	1.9 Percentage of participants Interval 1.1 to 3.0	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Fever: 38.5 to 38.9 degree C	0.7 Percentage of participants Interval 0.2 to 1.4	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Fever: 39.0 to 40.0 degree C	0.7 Percentage of participants Interval 0.2 to 1.4	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Fever: > 40.0 degree C	0.0 Percentage of participants Interval 0.0 to 0.4	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Fatigue: Any	45.2 Percentage of participants Interval 41.9 to 48.5	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Fatigue: Mild	23.0 Percentage of participants Interval 20.3 to 25.9	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Fatigue: Moderate	19.2 Percentage of participants Interval 16.6 to 21.9	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Fatigue: Severe	3.0 Percentage of participants Interval 2.0 to 4.3	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Headache: Any	41.6 Percentage of participants Interval 38.4 to 44.9	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Headache: Mild	23.1 Percentage of participants Interval 20.4 to 26.0	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Headache: Moderate	16.5 Percentage of participants Interval 14.1 to 19.1	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Headache: Severe	2.0 Percentage of participants Interval 1.2 to 3.1	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Chills: Any	18.5 Percentage of participants Interval 16.0 to 21.2	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Chills: Mild	11.6 Percentage of participants Interval 9.6 to 13.9	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Chills: Moderate	6.2 Percentage of participants Interval 4.7 to 8.0	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Chills: Severe	0.7 Percentage of participants Interval 0.2 to 1.4	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Vomiting: Any	2.8 Percentage of participants Interval 1.8 to 4.1	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Vomiting: Mild	2.0 Percentage of participants Interval 1.2 to 3.1	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Vomiting: Moderate	0.8 Percentage of participants Interval 0.3 to 1.6	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Vomiting: Severe	0.0 Percentage of participants Interval 0.0 to 0.4	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Diarrhea: Any	10.6 Percentage of participants Interval 8.7 to 12.8	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Diarrhea: Mild	7.6 Percentage of participants Interval 6.0 to 9.6	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Diarrhea: Moderate	2.5 Percentage of participants Interval 1.6 to 3.8	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Diarrhea: Severe	0.4 Percentage of participants Interval 0.1 to 1.1	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Muscle pain: Any	21.4 Percentage of participants Interval 18.7 to 24.2	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Muscle pain: Mild	11.5 Percentage of participants Interval 9.5 to 13.8	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Muscle pain: Moderate	7.8 Percentage of participants Interval 6.1 to 9.7	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Muscle pain: Severe	2.1 Percentage of participants Interval 1.3 to 3.3	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Joint pain: Any	18.7 Percentage of participants Interval 16.2 to 21.4	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Joint pain: Mild	11.2 Percentage of participants Interval 9.2 to 13.4	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Joint pain: Moderate	6.5 Percentage of participants Interval 5.0 to 8.3	—	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) Joint pain: Severe	1.0 Percentage of participants Interval 0.5 to 1.9	—	—	—

PRIMARY outcome

Timeframe: 7 days after Vaccination 1

Population: Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Here, "Overall Number of Participants Analyzed": number of participants with known values. Analysis was planned for combined Group 2 and 4.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=1044 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Vaccination 1 (Group 2 and 4 Combined)	18.6 Percentage of participants Interval 16.3 to 21.1	—	—	—

PRIMARY outcome

Timeframe: 7 days after Vaccination 2

Population: Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Here, "Overall Number of participants Analyzed": number of participants with known values. Analysis was planned for combined Group 2 and 4.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=903 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Vaccination 2 (Group 2 and 4 Combined)	14.4 Percentage of participants Interval 12.2 to 16.9	—	—	—

PRIMARY outcome

Timeframe: 30 days after Vaccination 1

Population: Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for combined Group 2 and 4.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=1057 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)	0.0 Percentage of participants Interval 0.0 to 0.3	—	—	—

PRIMARY outcome

Timeframe: 30 days after Vaccination 2

Population: Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Analysis was planned for combined Group 2 and 4.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=946 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)	0.0 Percentage of participants Interval 0.0 to 0.4	—	—	—

PRIMARY outcome

Timeframe: 30 days after any vaccination

Population: Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=1057 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Any Vaccination (Group 2 and 4 Combined)	0.0 Percentage of participants Interval 0.0 to 0.3	—	—	—

PRIMARY outcome

Timeframe: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

Population: Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=1057 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)	0.8 Percentage of participants Interval 0.3 to 1.5	—	—	—

PRIMARY outcome

Timeframe: Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)

Population: Stage 1 Follow-up Safety population: participants who received at least 1 dose of investigational product and for whom safety information was available from after Visit 4 (Month 7) up to and including Visit 5 (Month 12). Analysis was planned for combined Group 2 and 4. Here overall number of participants analysed included those participants who met criteria for Stage 1 Follow-up safety population.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. There was one participant who did not meet criteria for Stage 1 follow-up safety population. The subject's SAE happened in the follow-up phase but was not included in the follow-up safety population for Stage 1 (but in the safety population for Stage 1). Therefore, the SAE was not included in the follow-up table but in the broadly defined throughout Stage 1 table.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=950 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Follow-up Phase (Group 2 and 4 Combined)	0.5 Percentage of participants Interval 0.2 to 1.2	—	—	—

PRIMARY outcome

Timeframe: Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)

Population: Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4. Here overall number of participants analysed included those participants who met criteria for Stage 1 safety population.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. There was one participant who did not meet criteria for Stage 1 follow-up safety population. The subject's SAE happened in the follow-up phase but was not included in the follow-up safety population for Stage 1 (but in the safety population for Stage 1). Therefore, the SAE was not included in the follow-up table but in the broadly defined throughout Stage 1 table.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=1057 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 SAE Throughout the Stage 1 (Group 2 and 4 Combined)	1.3 Percentage of participants Interval 0.7 to 2.2	—	—	—

PRIMARY outcome

Timeframe: 30 days after Vaccination 1

Population: Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for combined Group 2 and 4.

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=1057 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)	6.3 Percentage of participants Interval 4.9 to 8.0	—	—	—

PRIMARY outcome

Timeframe: 30 days after Vaccination 2

Population: Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Analysis was planned for combined Group 2 and 4.

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=946 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)	8.8 Percentage of participants Interval 7.0 to 10.8	—	—	—

PRIMARY outcome

Timeframe: 30 days after any vaccination

Population: Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=1057 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination (Group 2 and 4 Combined)	13.3 Percentage of participants Interval 11.3 to 15.5	—	—	—

PRIMARY outcome

Timeframe: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

Population: Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=1057 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)	26.7 Percentage of participants Interval 24.0 to 29.5	—	—	—

PRIMARY outcome

Timeframe: Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)

Population: Stage 1 Follow-up Safety population: participants who received at least 1 dose of investigational product and for whom safety information was available from after Visit 4 (Month 7) up to and including Visit 5 (Month 12). Analysis was planned for combined Group 2 and 4.

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=950 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Follow-up Phase (Group 2 and 4 Combined)	16.6 Percentage of participants Interval 14.3 to 19.2	—	—	—

PRIMARY outcome

Timeframe: Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)

Population: Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=1057 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Medically Attended AE Throughout the Stage 1 (Group 2 and 4 Combined)	33.7 Percentage of participants Interval 30.8 to 36.6	—	—	—

PRIMARY outcome

Timeframe: 30 days after Vaccination 1

Population: Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for combined Group 2 and 4.

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=1057 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)	0.3 Percentage of participants Interval 0.1 to 0.8	—	—	—

PRIMARY outcome

Timeframe: 30 days after Vaccination 2

Population: Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Analysis was planned for combined Group 2 and 4.

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=946 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)	0.2 Percentage of participants Interval 0.0 to 0.8	—	—	—

PRIMARY outcome

Timeframe: 30 days after any Vaccination

Population: Safety population for Stage 1 included participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=1057 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Any Vaccination (Group 2 and 4 Combined)	0.5 Percentage of participants Interval 0.2 to 1.1	—	—	—

PRIMARY outcome

Timeframe: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

Population: Safety population for Stage 1 included participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=1057 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)	0.8 Percentage of participants Interval 0.3 to 1.5	—	—	—

PRIMARY outcome

Timeframe: Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)

Population: Stage 1 Follow-up Safety population: participants who received at least 1 dose of investigational product and for whom safety information was available from after Visit 4 (Month 7) up to and including Visit 5 (Month 12). Analysis was planned for combined Group 2 and 4.

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=950 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) During the Stage 1 Follow-up Phase (Group 2 and 4 Combined)	0.3 Percentage of participants Interval 0.1 to 0.9	—	—	—

PRIMARY outcome

Timeframe: Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)

Population: Safety population for Stage 1 included participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=1057 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Throughout the Stage 1 (Group 2 and 4)	0.9 Percentage of participants Interval 0.5 to 1.7	—	—	—

PRIMARY outcome

Timeframe: 30 days after Vaccination 1

Population: Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for combined Group 2 and 4.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=1057 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)	13.8 Percentage of participants Interval 11.8 to 16.0	—	—	—

PRIMARY outcome

Timeframe: 30 days after Vaccination 2

Population: Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Analysis was planned for combined Group 2 and 4.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=946 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)	14.7 Percentage of participants Interval 12.5 to 17.1	—	—	—

PRIMARY outcome

Timeframe: 30 days after any vaccination

Population: Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=1057 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Any Vaccination (Group 2 and 4 Combined)	24.1 Percentage of participants Interval 21.6 to 26.8	—	—	—

PRIMARY outcome

Timeframe: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

Population: Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=1057 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 AE During Vaccination Phase (Group 2 and 4 Combined)	40.7 Percentage of participants Interval 37.7 to 43.7	—	—	—

PRIMARY outcome

Timeframe: 30 minutes after Vaccination 1

Population: Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for combined Group 2 and 4.

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

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=1057 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 1 (Group 2 and 4 Combined)	0.9 Percentage of participants Interval 0.4 to 1.6	—	—	—

PRIMARY outcome

Timeframe: 30 minutes after Vaccination 2

Population: Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (Month 7) was available. Analysis was planned for combined Group 2 and 4.

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

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=946 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 2 (Group 2 and 4 Combined)	0.3 Percentage of participants Interval 0.1 to 0.9	—	—	—

PRIMARY outcome

Timeframe: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

Population: Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=1057 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Number of Participants Who Missed School/Work Due to AE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)	171 Participants	—	—	—

PRIMARY outcome

Timeframe: 7 days after booster vaccination

Population: Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available. Here, 'Overall Number of Participants Analyzed' signifies number of participants with known values.

Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm) and severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=59 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=35 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=74 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=55 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage2: Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Redness: Any	13.6 Percentage of participants Interval 6.0 to 25.0	28.6 Percentage of participants Interval 14.6 to 46.3	21.6 Percentage of participants Interval 12.9 to 32.7	25.5 Percentage of participants Interval 14.7 to 39.0
Stage2: Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Redness: Mild	5.1 Percentage of participants Interval 1.1 to 14.1	11.4 Percentage of participants Interval 3.2 to 26.7	9.5 Percentage of participants Interval 3.9 to 18.5	14.5 Percentage of participants Interval 6.5 to 26.7
Stage2: Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Redness: Moderate	3.4 Percentage of participants Interval 0.4 to 11.7	11.4 Percentage of participants Interval 3.2 to 26.7	8.1 Percentage of participants Interval 3.0 to 16.8	9.1 Percentage of participants Interval 3.0 to 20.0
Stage2: Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Redness: Severe	5.1 Percentage of participants Interval 1.1 to 14.1	5.7 Percentage of participants Interval 0.7 to 19.2	4.1 Percentage of participants Interval 0.8 to 11.4	1.8 Percentage of participants Interval 0.0 to 9.7
Stage2: Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Swelling: Any	18.6 Percentage of participants Interval 9.7 to 30.9	25.7 Percentage of participants Interval 12.5 to 43.3	18.9 Percentage of participants Interval 10.7 to 29.7	18.2 Percentage of participants Interval 9.1 to 30.9
Stage2: Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Swelling: Mild	10.2 Percentage of participants Interval 3.8 to 20.8	11.4 Percentage of participants Interval 3.2 to 26.7	6.8 Percentage of participants Interval 2.2 to 15.1	9.1 Percentage of participants Interval 3.0 to 20.0
Stage2: Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Swelling: Moderate	8.5 Percentage of participants Interval 2.8 to 18.7	11.4 Percentage of participants Interval 3.2 to 26.7	12.2 Percentage of participants Interval 5.7 to 21.8	7.3 Percentage of participants Interval 2.0 to 17.6
Stage2: Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Swelling: Severe	0.0 Percentage of participants Interval 0.0 to 6.1	2.9 Percentage of participants Interval 0.1 to 14.9	0.0 Percentage of participants Interval 0.0 to 4.9	1.8 Percentage of participants Interval 0.0 to 9.7
Stage2: Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Pain at injection site: Any	79.3 Percentage of participants Interval 66.6 to 88.8	85.7 Percentage of participants Interval 69.7 to 95.2	85.1 Percentage of participants Interval 75.0 to 92.3	85.5 Percentage of participants Interval 73.3 to 93.5
Stage2: Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Pain at injection site: Mild	41.4 Percentage of participants Interval 28.6 to 55.1	25.7 Percentage of participants Interval 12.5 to 43.3	36.5 Percentage of participants Interval 25.6 to 48.5	47.3 Percentage of participants Interval 33.7 to 61.2
Stage2: Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Pain at injection site: Moderate	36.2 Percentage of participants Interval 24.0 to 49.9	45.7 Percentage of participants Interval 28.8 to 63.4	47.3 Percentage of participants Interval 35.6 to 59.3	38.2 Percentage of participants Interval 25.4 to 52.3
Stage2: Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Pain at injection site: Severe	1.7 Percentage of participants Interval 0.0 to 9.2	14.3 Percentage of participants Interval 4.8 to 30.3	1.4 Percentage of participants Interval 0.0 to 7.3	0.0 Percentage of participants Interval 0.0 to 6.5

PRIMARY outcome

Timeframe: 7 days after booster vaccination

Population: Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available. Here, 'Overall Number of Participants Analyzed' signifies number of participants with known values.

Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain and joint pain were recorded in an e-diary. Fever was defined as >=38.0 degree Celsius (C) and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 in 24 hours).

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=60 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=39 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=76 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=56 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Vomiting: Mild	1.7 Percentage of participants Interval 0.0 to 8.9	0.0 Percentage of participants Interval 0.0 to 9.0	1.3 Percentage of participants Interval 0.0 to 7.1	1.8 Percentage of participants Interval 0.0 to 9.6
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Vomiting: Moderate	1.7 Percentage of participants Interval 0.0 to 8.9	0.0 Percentage of participants Interval 0.0 to 9.0	1.3 Percentage of participants Interval 0.0 to 7.1	0.0 Percentage of participants Interval 0.0 to 6.4
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Fever: >= 38.0 degree C	5.0 Percentage of participants Interval 1.0 to 13.9	2.6 Percentage of participants Interval 0.1 to 13.5	0.0 Percentage of participants Interval 0.0 to 4.7	1.8 Percentage of participants Interval 0.0 to 9.6
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Fever: 38.0 to 38.4 degree C	1.7 Percentage of participants Interval 0.0 to 8.9	0.0 Percentage of participants Interval 0.0 to 9.0	0.0 Percentage of participants Interval 0.0 to 4.7	1.8 Percentage of participants Interval 0.0 to 9.6
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Fever: 38.4 to 38.9 degree C	0.0 Percentage of participants Interval 0.0 to 6.0	2.6 Percentage of participants Interval 0.1 to 13.5	0.0 Percentage of participants Interval 0.0 to 4.7	0.0 Percentage of participants Interval 0.0 to 6.4
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Fever: 38.9 to 40.0 degree C	3.3 Percentage of participants Interval 0.4 to 11.5	0.0 Percentage of participants Interval 0.0 to 9.0	0.0 Percentage of participants Interval 0.0 to 4.7	0.0 Percentage of participants Interval 0.0 to 6.4
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Fever: > 40.0 degree C	0.0 Percentage of participants Interval 0.0 to 6.0	0.0 Percentage of participants Interval 0.0 to 9.0	0.0 Percentage of participants Interval 0.0 to 4.7	0.0 Percentage of participants Interval 0.0 to 6.4
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Fatigue: Any	46.7 Percentage of participants Interval 33.7 to 60.0	61.5 Percentage of participants Interval 44.6 to 76.6	61.8 Percentage of participants Interval 50.0 to 72.8	66.1 Percentage of participants Interval 52.2 to 78.2
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Fatigue: Mild	25.0 Percentage of participants Interval 14.7 to 37.9	25.6 Percentage of participants Interval 13.0 to 42.1	50.0 Percentage of participants Interval 38.3 to 61.7	37.5 Percentage of participants Interval 24.9 to 51.5
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Fatigue: Moderate	21.7 Percentage of participants Interval 12.1 to 34.2	30.8 Percentage of participants Interval 17.0 to 47.6	10.5 Percentage of participants Interval 4.7 to 19.7	23.2 Percentage of participants Interval 13.0 to 36.4
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Fatigue: Severe	0.0 Percentage of participants Interval 0.0 to 6.0	5.1 Percentage of participants Interval 0.6 to 17.3	1.3 Percentage of participants Interval 0.0 to 7.1	5.4 Percentage of participants Interval 1.1 to 14.9
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Headache: Any	36.7 Percentage of participants Interval 24.6 to 50.1	53.8 Percentage of participants Interval 37.2 to 69.9	46.1 Percentage of participants Interval 34.5 to 57.9	55.4 Percentage of participants Interval 41.5 to 68.7
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Headache: Mild	25.0 Percentage of participants Interval 14.7 to 37.9	20.5 Percentage of participants Interval 9.3 to 36.5	34.2 Percentage of participants Interval 23.7 to 46.0	39.3 Percentage of participants Interval 26.5 to 53.2
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Headache: Moderate	8.3 Percentage of participants Interval 2.8 to 18.4	28.2 Percentage of participants Interval 15.0 to 44.9	10.5 Percentage of participants Interval 4.7 to 19.7	14.3 Percentage of participants Interval 6.4 to 26.2
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Headache: Severe	3.3 Percentage of participants Interval 0.4 to 11.5	5.1 Percentage of participants Interval 0.6 to 17.3	1.3 Percentage of participants Interval 0.0 to 7.1	1.8 Percentage of participants Interval 0.0 to 9.6
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Chills: Any	10.0 Percentage of participants Interval 3.8 to 20.5	17.9 Percentage of participants Interval 7.5 to 33.5	18.4 Percentage of participants Interval 10.5 to 29.0	14.3 Percentage of participants Interval 6.4 to 26.2
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Chills: Mild	10.0 Percentage of participants Interval 3.8 to 20.5	12.8 Percentage of participants Interval 4.3 to 27.4	15.8 Percentage of participants Interval 8.4 to 26.0	12.5 Percentage of participants Interval 5.2 to 24.1
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Chills: Moderate	0.0 Percentage of participants Interval 0.0 to 6.0	5.1 Percentage of participants Interval 0.6 to 17.3	2.6 Percentage of participants Interval 0.3 to 9.2	0.0 Percentage of participants Interval 0.0 to 6.4
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Chills: Severe	0.0 Percentage of participants Interval 0.0 to 6.0	0.0 Percentage of participants Interval 0.0 to 9.0	0.0 Percentage of participants Interval 0.0 to 4.7	1.8 Percentage of participants Interval 0.0 to 9.6
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Vomiting: Any	3.3 Percentage of participants Interval 0.4 to 11.5	0.0 Percentage of participants Interval 0.0 to 9.0	2.6 Percentage of participants Interval 0.3 to 9.2	1.8 Percentage of participants Interval 0.0 to 9.6
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Vomiting: severe	0.0 Percentage of participants Interval 0.0 to 6.0	0.0 Percentage of participants Interval 0.0 to 9.0	0.0 Percentage of participants Interval 0.0 to 4.7	0.0 Percentage of participants Interval 0.0 to 6.4
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Diarrhea: Any	5.0 Percentage of participants Interval 1.0 to 13.9	10.3 Percentage of participants Interval 2.9 to 24.2	9.2 Percentage of participants Interval 3.8 to 18.1	12.5 Percentage of participants Interval 5.2 to 24.1
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Diarrhea: Mild	5.0 Percentage of participants Interval 1.0 to 13.9	7.7 Percentage of participants Interval 1.6 to 20.9	7.9 Percentage of participants Interval 3.0 to 16.4	7.1 Percentage of participants Interval 2.0 to 17.3
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Diarrhea: Moderate	0.0 Percentage of participants Interval 0.0 to 6.0	2.6 Percentage of participants Interval 0.1 to 13.5	1.3 Percentage of participants Interval 0.0 to 7.1	5.4 Percentage of participants Interval 1.1 to 14.9
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Diarrhea: Severe	0.0 Percentage of participants Interval 0.0 to 6.0	0.0 Percentage of participants Interval 0.0 to 9.0	0.0 Percentage of participants Interval 0.0 to 4.7	0.0 Percentage of participants Interval 0.0 to 6.4
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Muscle Pain: Any	18.3 Percentage of participants Interval 9.5 to 30.4	30.8 Percentage of participants Interval 17.0 to 47.6	31.6 Percentage of participants Interval 21.4 to 43.3	23.2 Percentage of participants Interval 13.0 to 36.4
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Muscle pain: Mild	13.3 Percentage of participants Interval 5.9 to 24.6	10.3 Percentage of participants Interval 2.9 to 24.2	22.4 Percentage of participants Interval 13.6 to 33.4	19.6 Percentage of participants Interval 10.2 to 32.4
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Muscle pain: Moderate	5.0 Percentage of participants Interval 1.0 to 13.9	12.8 Percentage of participants Interval 4.3 to 27.4	7.9 Percentage of participants Interval 3.0 to 16.4	3.6 Percentage of participants Interval 0.4 to 12.3
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Muscle pain: Severe	0.0 Percentage of participants Interval 0.0 to 6.0	7.7 Percentage of participants Interval 1.6 to 20.9	1.3 Percentage of participants Interval 0.0 to 7.1	0.0 Percentage of participants Interval 0.0 to 6.4
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Joint Pain: Any	18.3 Percentage of participants Interval 9.5 to 30.4	25.6 Percentage of participants Interval 13.0 to 42.1	21.1 Percentage of participants Interval 12.5 to 31.9	16.1 Percentage of participants Interval 7.6 to 28.3
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Joint pain: Mild	15.0 Percentage of participants Interval 7.1 to 26.6	12.8 Percentage of participants Interval 4.3 to 27.4	11.8 Percentage of participants Interval 5.6 to 21.3	12.5 Percentage of participants Interval 5.2 to 24.1
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Joint pain: Moderate	3.3 Percentage of participants Interval 0.4 to 11.5	10.3 Percentage of participants Interval 2.9 to 24.2	9.2 Percentage of participants Interval 3.8 to 18.1	3.6 Percentage of participants Interval 0.4 to 12.3
Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 Joint pain: Severe	0.0 Percentage of participants Interval 0.0 to 6.0	2.6 Percentage of participants Interval 0.1 to 13.5	0.0 Percentage of participants Interval 0.0 to 4.7	0.0 Percentage of participants Interval 0.0 to 6.4

PRIMARY outcome

Timeframe: 7 days after booster vaccination

Population: Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available. Here, 'Overall Number of Participants Analyzed' signifies number of participants with known values.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=60 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=39 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=76 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=56 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage2: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Booster Vaccination: Group 1 Through Group 4	16.7 Percentage of participants Interval 8.3 to 28.5	20.5 Percentage of participants Interval 9.3 to 36.5	13.2 Percentage of participants Interval 6.5 to 22.9	10.7 Percentage of participants Interval 4.0 to 21.9

PRIMARY outcome

Timeframe: Booster vaccination phase: From booster vaccination through 1 month after booster vaccination

Population: Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. SAE of "pregnancy" for one participant during the booster vaccination phase was recorded erroneously and hence it was included in results of Group 4.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=67 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=40 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=77 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=56 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage2: Percentage of Participants With at Least 1 SAE During Booster Vaccination Phase: Group 1 Through Group 4	0.0 Percentage of participants Interval 0.0 to 5.4	0.0 Percentage of participants Interval 0.0 to 8.8	0.0 Percentage of participants Interval 0.0 to 4.7	1.8 Percentage of participants Interval 0.0 to 9.6

PRIMARY outcome

Timeframe: Booster follow-up phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months)

Population: Booster Follow-up safety population for Stage 2 included participants who received the booster dose of investigational product and for whom safety information was available from after Visit 11 (Month 55) up to and including Visit 12 (Month 60).

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=67 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=38 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=77 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=56 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage2: Percentage of Participants With at Least 1 SAE During the Booster Follow-up Phase: Group 1 Through Group 4	0.0 Percentage of participants Interval 0.0 to 5.4	0.0 Percentage of participants Interval 0.0 to 9.3	2.6 Percentage of participants Interval 0.3 to 9.1	0.0 Percentage of participants Interval 0.0 to 6.4

PRIMARY outcome

Timeframe: Throughout Booster phase: From booster vaccination through 6 months after booster vaccination

Population: Booster safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 12 (Month 60) was available.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. SAE of "pregnancy" for one participant during the booster vaccination phase was recorded erroneously and hence it was reported in result of outcome measure 37 for Group 4. Subsequently correction was made by the trial site and not included in subsequent phase/results. Hence, that 1 participant is not included in results of Group 4 here.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=67 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=40 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=77 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=56 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage2: Percentage of Participants With at Least 1 SAE Throughout Booster Phase: Group 1 Through Group 4	0.0 Percentage of participants Interval 0.0 to 5.4	0.0 Percentage of participants Interval 0.0 to 8.8	2.6 Percentage of participants Interval 0.3 to 9.1	0.0 Percentage of participants Interval 0.0 to 6.4

PRIMARY outcome

Timeframe: Booster vaccination phase: From booster vaccination through 1 month after booster vaccination

Population: Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available.

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=67 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=40 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=77 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=56 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage2: Percentage of Participants With at Least 1 Medically Attended AE During Booster Vaccination Phase: Group 1 Through Group 4	9.0 Percentage of participants Interval 3.4 to 18.5	5.0 Percentage of participants Interval 0.6 to 16.9	2.6 Percentage of participants Interval 0.3 to 9.1	7.1 Percentage of participants Interval 2.0 to 17.3

PRIMARY outcome

Timeframe: Booster Follow-up Phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months)

Population: Booster Follow-up safety population for Stage 2 included participants who received the booster dose of investigational product and for whom safety information was available from after Visit 11 (Month 55) up to and including Visit 12 (Month 60).

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=67 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=38 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=77 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=56 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage2: Percentage of Participants With at Least 1 Medically Attended AE During the Booster Follow-up Phase: Group 1 Through Group 4	3.0 Percentage of participants Interval 0.4 to 10.4	13.2 Percentage of participants Interval 4.4 to 28.1	6.5 Percentage of participants Interval 2.1 to 14.5	7.1 Percentage of participants Interval 2.0 to 17.3

PRIMARY outcome

Timeframe: Throughout Booster Phase: From booster vaccination through 6 months after booster vaccination

Population: Booster safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 12 (Month 60) was available.

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=67 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=40 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=77 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=56 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage2: Percentage of Participants With at Least 1 Medically Attended AE Throughout Booster Phase: Group 1 Through Group 4	10.4 Percentage of participants Interval 4.3 to 20.3	15.0 Percentage of participants Interval 5.7 to 29.8	7.8 Percentage of participants Interval 2.9 to 16.2	14.3 Percentage of participants Interval 6.4 to 26.2

PRIMARY outcome

Timeframe: Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination

Population: Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available.

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=67 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=40 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=77 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=56 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage2: Percentage of Participants With at Least 1 NDCMC During Booster Vaccination Phase: Group 1 Through Group 4	0.0 Percentage of participants Interval 0.0 to 5.4	0.0 Percentage of participants Interval 0.0 to 8.8	0.0 Percentage of participants Interval 0.0 to 4.7	0.0 Percentage of participants Interval 0.0 to 6.4

PRIMARY outcome

Timeframe: Booster Follow-up Phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months)

Population: Booster Follow-up safety population for Stage 2 included participants who received the booster dose of investigational product and for whom safety information was available from after Visit 11 (Month 55) up to and including Visit 12 (Month 60).

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=67 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=38 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=77 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=56 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage2: Percentage of Participants With at Least 1 NDCMC During the Booster Follow-up Phase: Group 1 Through Group 4	0.0 Percentage of participants Interval 0.0 to 5.4	0.0 Percentage of participants Interval 0.0 to 9.3	2.6 Percentage of participants Interval 0.3 to 9.1	0.0 Percentage of participants Interval 0.0 to 6.4

PRIMARY outcome

Timeframe: Throughout Booster Phase: From booster vaccination through 6 months after booster vaccination

Population: Booster safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 12 (Month 60) was available.

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=67 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=40 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=77 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=56 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage2: Percentage of Participants With at Least 1 NDCMC Throughout Booster Phase: Group 1 Through Group 4	0.0 Percentage of participants Interval 0.0 to 5.4	0.0 Percentage of participants Interval 0.0 to 8.8	2.6 Percentage of participants Interval 0.3 to 9.1	0.0 Percentage of participants Interval 0.0 to 6.4

PRIMARY outcome

Timeframe: Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination

Population: Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=67 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=40 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=77 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=56 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage2: Percentage of Participants With at Least 1 AE During Booster Vaccination Phase: Group 1 Through Group 4	13.4 Percentage of participants Interval 6.3 to 24.0	10.0 Percentage of participants Interval 2.8 to 23.7	10.4 Percentage of participants Interval 4.6 to 19.4	17.9 Percentage of participants Interval 8.9 to 30.4

PRIMARY outcome

Timeframe: 30 minutes after booster vaccination

Population: Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available.

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

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=67 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=40 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=77 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=56 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage2: Percentage of Participants With at Least 1 Immediate AE After Booster Vaccination: Group 1 Through Group 4	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: Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination

Population: Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=67 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=40 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=77 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=56 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage2: Number of Participants Who Missed School/Work Due to AE After Booster Vaccination: Group 1 Through Group 4	3 Participants	0 Participants	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 1 month after Vaccination 2

Population: Stage 1 EIP analyzed. Here "Overall Number of Participants analyzed" included all participants who were measured and analyzed. Here, 'Number Analyzed' signifies number of participants with valid and determinate hSBA results on all 4 strains at given time point. Analysis was planned combined for Group 2 and 4.

Percentage of participants who achieved an hSBA titer >= LLOQ for all 4 primary MenB test strains combined (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure. Four primary MenB test strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=864 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB80 (A22) 1 month after Vaccination 2	91.0 Percentage of participants Interval 88.8 to 92.8	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2001 (A56) 1 month after Vaccination 2	99.4 Percentage of participants Interval 98.6 to 99.8	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2948 (B24) 1 month after Vaccination 2	79.3 Percentage of participants Interval 76.4 to 82.0	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2707 (B44) 1 month after Vaccination 2	94.5 Percentage of participants Interval 92.7 to 95.9	—	—	—

SECONDARY outcome

Timeframe: 1 month after Vaccination 2 (Vacc 2)

Population: Stage 1 EIP analyzed. Here "Overall Number of Participants analyzed" included all participants who were measured and analyzed. Here, 'Number Analyzed' signifies number of participants with valid and determinate hSBA results on all 4 strains at given time point. Analysis was planned for combined Group 2 and 4.

Percentage of participants who achieved an hSBA titer >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for all 4 primary MenB test strains was reported in this outcome measure. Four primary MenB test strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=864 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB80 (A22) 1 Month after Vacc 2 >=1:4	91.7 Percentage of participants Interval 89.6 to 93.4	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB80 (A22) 1 Month after Vacc 2 >=1:8	91.5 Percentage of participants Interval 89.5 to 93.3	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB80 (A22) 1 Month after Vacc 2 >=1:16	91.0 Percentage of participants Interval 88.8 to 92.8	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB80 (A22) 1 Month after Vacc 2 >=1:32	80.2 Percentage of participants Interval 77.3 to 82.8	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB80 (A22) 1 Month after Vacc 2 >=1:64	54.9 Percentage of participants Interval 51.5 to 58.3	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB80 (A22) 1 Month after Vacc 2 >=1:128	27.3 Percentage of participants Interval 24.4 to 30.5	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2001 (A56) 1 Month after Vacc 2 >=1:4	99.5 Percentage of participants Interval 98.8 to 99.9	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2001 (A56) 1 Month after Vacc 2 >=1:8	99.4 Percentage of participants Interval 98.6 to 99.8	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2001 (A56) 1 Month after Vacc 2 >=1:16	99.1 Percentage of participants Interval 98.2 to 99.6	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2001 (A56) 1 Month after Vacc 2 >=1:32	97.0 Percentage of participants Interval 95.6 to 98.0	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2001 (A56) 1 Month after Vacc 2 >=1:64	87.7 Percentage of participants Interval 85.3 to 89.8	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2001 (A56) 1 Month after Vacc 2 >=1:128	69.2 Percentage of participants Interval 66.0 to 72.3	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2948 (B24) 1 Month after Vacc 2 >=1:4	81.2 Percentage of participants Interval 78.4 to 83.8	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2948 (B24) 1 Month after Vacc 2 >=1:8	79.3 Percentage of participants Interval 76.4 to 82.0	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2948 (B24) 1 Month after Vacc 2 >=1:16	74.0 Percentage of participants Interval 70.9 to 76.9	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2948 (B24) 1 Month after Vacc 2 >=1:32	47.9 Percentage of participants Interval 44.4 to 51.3	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2948 (B24) 1 Month after Vacc 2 >=1:64	24.9 Percentage of participants Interval 22.1 to 28.0	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2948 (B24) 1 Month after Vacc 2 >=1:128	9.6 Percentage of participants Interval 7.7 to 11.8	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2707 (B44) 1 Month after Vacc 2 >=1:4	96.2 Percentage of participants Interval 94.7 to 97.4	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2707 (B44) 1 Month after Vacc 2 >=1:8	94.5 Percentage of participants Interval 92.7 to 95.9	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2707 (B44) 1 Month after Vacc 2 >=1:16	89.0 Percentage of participants Interval 86.7 to 91.0	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2707 (B44) 1 Month after Vacc 2 >=1:32	68.6 Percentage of participants Interval 65.3 to 71.7	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2707 (B44) 1 Month after Vacc 2 >=1:64	41.0 Percentage of participants Interval 37.7 to 44.4	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2707 (B44) 1 Month after Vacc 2 >=1:128	19.2 Percentage of participants Interval 16.6 to 22.0	—	—	—

SECONDARY outcome

Timeframe: 1 month after Vaccination 2 (Vacc 2)

Population: Stage 1 EIP analyzed. Here "Overall Number of Participants analyzed" included all participants who were measured and analyzed. Here, 'Number Analyzed' signifies number of participants with valid and determinate hSBA results on all 4 strains at given time point. Analysis was planned for combined Group 2 and 4.

GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:16 for A22; 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5 * LLOQ for analysis. Four primary MenB test strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=864 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: hSBA Geometric Mean Titers (GMTs) for All 4 Primary MenB Test Strains Combined 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB80 (A22) 1 month after Vacc 2	49.3 Titers Interval 46.2 to 52.6	—	—	—
Stage1: hSBA Geometric Mean Titers (GMTs) for All 4 Primary MenB Test Strains Combined 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2001 (A56) 1 month after Vacc 2	139.5 Titers Interval 130.6 to 149.1	—	—	—
Stage1: hSBA Geometric Mean Titers (GMTs) for All 4 Primary MenB Test Strains Combined 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2948 (B24) 1 month after Vacc 2	21.2 Titers Interval 19.6 to 22.9	—	—	—
Stage1: hSBA Geometric Mean Titers (GMTs) for All 4 Primary MenB Test Strains Combined 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB2707 (B44) 1 month after Vacc 2	37.8 Titers Interval 35.1 to 40.8	—	—	—

SECONDARY outcome

Timeframe: 1 month after Vaccination 2 (Vacc 2)

Population: Stage 1 EIP analyzed. Here "Overall Number of Participants analyzed" included all participants who were measured and analyzed. Here, 'Number Analyzed' signifies number of participants with valid and determinate hSBA results on all 10 strains at given time point. Analysis was planned for combined Group 2 and 4.

Percentage of participants who achieved an hSBA titer greater than or equal to LLOQ for 10 Secondary MenB test strains combined (LLOQ = 1:16 for A06, A12, and A19; 1:8 for A07, A15, A29, B03, B09, B15, and B16) was reported in this outcome measure.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=180 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3175 (A29) 1 month after Vacc 2	95.2 Percentage of participants Interval 90.7 to 97.9	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3010 (A06) 1 month after Vacc 2	89.3 Percentage of participants Interval 83.4 to 93.6	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB824 (A12) 1 month after Vacc 2	83.4 Percentage of participants Interval 76.7 to 88.9	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3040 (A07) 1 month after Vacc 2	96.8 Percentage of participants Interval 92.7 to 99.0	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1672 (A15) 1 month after Vacc 2	89.1 Percentage of participants Interval 83.3 to 93.4	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1989 (A19) 1 month after Vacc 2	90.4 Percentage of participants Interval 84.9 to 94.4	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB648 (B16) 1 month after Vacc 2	77.4 Percentage of participants Interval 70.3 to 83.6	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB866 (B09) 1 month after Vacc 2	71.1 Percentage of participants Interval 63.6 to 77.8	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1256 (B03) 1 month after Vacc 2	74.4 Percentage of participants Interval 67.0 to 80.9	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB431 (B15) 1 month after Vacc 2	85.0 Percentage of participants Interval 78.7 to 90.1	—	—	—

SECONDARY outcome

Timeframe: 1 month after Vaccination 2 (Vacc 2)

Population: Stage 1 EIP analyzed. Here "Overall Number of Participants analyzed" included all participants who were measured and analyzed. Here, 'Number Analyzed' signifies number of participants with valid and determinate hSBA results on all 10 strains at given time point. Analysis was planned for combined Group 2 and 4.

Percentage of participants who achieved an hSBA titer >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for each of the 10 secondary MenB test strains was reported in this outcome measure. 10 secondary MenB test strains were PMB3175 (A29), PMB3010 (A06), PMB824 (A12), PMB3040 (A07), PMB1672 (A15), PMB1989 (A19), PMB648 (B16), PMB866 (B09), PMB1256 (B03) and PMB431 (B15).

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=180 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3175 (A29) 1 Month after Vacc 2 >=1:4	95.8 Percentage of participants Interval 91.5 to 98.3	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3175 (A29) 1 Month after Vacc 2 >=1:8	95.2 Percentage of participants Interval 90.7 to 97.9	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3175 (A29) 1 Month after Vacc 2 >=1:16	92.2 Percentage of participants Interval 87.0 to 95.8	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3175 (A29) 1 Month after Vacc 2 >=1:32	71.7 Percentage of participants Interval 64.2 to 78.4	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3175 (A29) 1 Month after Vacc 2 >=1:64	38.0 Percentage of participants Interval 30.5 to 45.8	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3175 (A29) 1 Month after Vacc 2 >=1:128	13.9 Percentage of participants Interval 9.0 to 20.1	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3010 (A06) 1 Month after Vacc 2 >=1:4	89.9 Percentage of participants Interval 84.2 to 94.1	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3010 (A06) 1 Month after Vacc 2 >=1:8	89.3 Percentage of participants Interval 83.4 to 93.6	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3010 (A06) 1 Month after Vacc 2 >=1:16	89.3 Percentage of participants Interval 83.4 to 93.6	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3010 (A06) 1 Month after Vacc 2 >=1:32	79.9 Percentage of participants Interval 72.8 to 85.8	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3010 (A06) 1 Month after Vacc 2 >=1:64	54.7 Percentage of participants Interval 46.6 to 62.6	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3010 (A06) 1 Month after Vacc 2 >=1:128	22.0 Percentage of participants Interval 15.8 to 29.3	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB824 (A12) 1 Month after Vacc 2 >=1:4	89.2 Percentage of participants Interval 83.2 to 93.6	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB824 (A12) 1 Month after Vacc 2 >=1:8	87.9 Percentage of participants Interval 81.7 to 92.6	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB824 (A12) 1 Month after Vacc 2 >=1:16	83.4 Percentage of participants Interval 76.7 to 88.9	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB824 (A12) 1 Month after Vacc 2 >=1:32	52.9 Percentage of participants Interval 44.8 to 60.9	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB824 (A12) 1 Month after Vacc 2 >=1:64	18.5 Percentage of participants Interval 12.7 to 25.4	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB824 (A12) 1 Month after Vacc 2 >=1:128	1.3 Percentage of participants Interval 0.2 to 4.5	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3040 (A07) 1 Month after Vacc 2 >=1:4	96.8 Percentage of participants Interval 92.7 to 99.0	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3040 (A07) 1 Month after Vacc 2 >=1:8	96.8 Percentage of participants Interval 92.7 to 99.0	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3040 (A07) 1 Month after Vacc 2 >=1:16	96.8 Percentage of participants Interval 92.7 to 99.0	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3040 (A07) 1 Month after Vacc 2 >=1:32	94.3 Percentage of participants Interval 89.4 to 97.3	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3040 (A07) 1 Month after Vacc 2 >=1:64	68.8 Percentage of participants Interval 60.9 to 75.9	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3040 (A07) 1 Month after Vacc 2 >=1:128	31.2 Percentage of participants Interval 24.1 to 39.1	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1672 (A15) 1 Month after Vacc 2 >=1:4	89.1 Percentage of participants Interval 83.3 to 93.4	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1672 (A15) 1 Month after Vacc 2 >=1:8	89.1 Percentage of participants Interval 83.3 to 93.4	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1672 (A15) 1 Month after Vacc 2 >=1:16	87.3 Percentage of participants Interval 81.2 to 91.9	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1672 (A15) (n=165) 1 Month after Vacc 2 >=1:32	69.7 Percentage of participants Interval 62.1 to 76.6	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1672 (A15) 1 Month after Vacc 2 >=1:64	30.3 Percentage of participants Interval 23.4 to 37.9	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1672 (A15) 1 Month after Vacc 2 >=1:128	5.5 Percentage of participants Interval 2.5 to 10.1	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1989 (A19) 1 Month after Vacc 2 >=1:4	92.2 Percentage of participants Interval 87.1 to 95.8	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1989 (A19) 1 Month after Vacc 2 >=1:8	92.2 Percentage of participants Interval 87.1 to 95.8	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1989 (A19) 1 Month after Vacc 2 >=1:16	90.4 Percentage of participants Interval 84.9 to 94.4	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1989 (A19) 1 Month after Vacc 2 >=1:32	84.4 Percentage of participants Interval 78.0 to 89.6	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1989 (A19) 1 Month after Vacc 2 >=1:64	61.1 Percentage of participants Interval 53.2 to 68.5	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1989 (A19) 1 Month after Vacc 2 >=1:128	28.7 Percentage of participants Interval 22.0 to 36.2	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB648 (B16) 1 Month after Vacc 2 >=1:4	79.3 Percentage of participants Interval 72.3 to 85.2	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB648 (B16) 1 Month after Vacc 2 >=1:8	77.4 Percentage of participants Interval 70.3 to 83.6	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB648 (B16) 1 Month after Vacc 2 >=1:16	73.8 Percentage of participants Interval 66.4 to 80.3	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB648 (B16) 1 Month after Vacc 2 >=1:32	51.2 Percentage of participants Interval 43.3 to 59.1	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB648 (B16) 1 Month after Vacc 2 >=1:64	28.7 Percentage of participants Interval 21.9 to 36.2	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB648 (B16) 1 Month after Vacc 2 >=1:128	6.1 Percentage of participants Interval 3.0 to 10.9	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB866 (B09) 1 Month after Vacc 2 >=1:4	74.7 Percentage of participants Interval 67.4 to 81.1	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB866 (B09) 1 Month after Vacc 2 >=1:8	71.1 Percentage of participants Interval 63.6 to 77.8	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB866 (B09) 1 Month after Vacc 2 >=1:16	63.3 Percentage of participants Interval 55.4 to 70.6	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB866 (B09) 1 Month after Vacc 2 >=1:32	34.3 Percentage of participants Interval 27.2 to 42.1	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB866 (B09) 1 Month after Vacc 2 >=1:64	8.4 Percentage of participants Interval 4.7 to 13.7	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB866 (B09) 1 Month after Vacc 2 >=1:128	2.4 Percentage of participants Interval 0.7 to 6.1	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1256 (B03) 1 Month after Vacc 2 >=1:4	77.4 Percentage of participants Interval 70.3 to 83.6	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1256 (B03) 1 Month after Vacc 2 >=1:8	74.4 Percentage of participants Interval 67.0 to 80.9	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1256 (B03) 1 Month after Vacc 2 >=1:16	64.0 Percentage of participants Interval 56.2 to 71.4	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1256 (B03) 1 Month after Vacc 2 >=1:32	42.1 Percentage of participants Interval 34.4 to 50.0	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1256 (B03) 1 Month after Vacc 2 >=1:64	23.2 Percentage of participants Interval 16.9 to 30.4	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1256 (B03) 1 Month after Vacc 2 >=1:128	7.3 Percentage of participants Interval 3.8 to 12.4	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB431 (B15) 1 Month after Vacc 2 >=1:4	87.4 Percentage of participants Interval 81.4 to 92.0	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB431 (B15) 1 Month after Vacc 2 >=1:8	85.0 Percentage of participants Interval 78.7 to 90.1	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB431 (B15) 1 Month after Vacc 2 >=1:16	72.5 Percentage of participants Interval 65.0 to 79.1	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB431 (B15) 1 Month after Vacc 2 >=1:32	36.5 Percentage of participants Interval 29.2 to 44.3	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB431 (B15) 1 Month after Vacc 2 >=1:64	15.0 Percentage of participants Interval 9.9 to 21.3	—	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB431 (B15) 1 Month after Vacc 2 >=1:128	2.4 Percentage of participants Interval 0.7 to 6.0	—	—	—

SECONDARY outcome

Timeframe: 1 month after Vaccination 2 (Vacc 2)

Population: Stage 1 EIP analyzed. Here "Overall Number of Participants analyzed" included all participants who were measured and analyzed. Here, 'Number Analyzed' signifies number of participants with valid and determinate hSBA results on all 10 strains at given time point. Analysis was planned for combined Group 2 and 4.

GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:16 for A06, A12, and A19; 1:8 for A07, A15, A29, B03, B09, B15, and B16. Titers below the LLOQ were set to 0.5*LLOQ for analysis.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=180 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3175 (A29) 1 month after Vacc 2	35.7 Titers Interval 30.9 to 41.2	—	—	—
Stage1: hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3010 (A06) 1 month after Vacc 2	46.0 Titers Interval 39.7 to 53.1	—	—	—
Stage1: hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB824 (A12) 1 month after Vacc 2	23.7 Titers Interval 21.2 to 26.5	—	—	—
Stage1: hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB3040 (A07) 1 month after Vacc 2	60.7 Titers Interval 53.6 to 68.8	—	—	—
Stage1: hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1672 (A15) 1 month after Vacc 2	28.4 Titers Interval 24.7 to 32.7	—	—	—
Stage1: hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1989 (A19) 1 month after Vacc 2	53.5 Titers Interval 46.3 to 61.9	—	—	—
Stage1: hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB648 (B16) 1 month after Vacc 2	20.8 Titers Interval 17.5 to 24.6	—	—	—
Stage1: hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB866 (B09) 1 month after Vacc 2	13.9 Titers Interval 12.0 to 16.2	—	—	—
Stage1: hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB1256 (B03) 1 month after Vacc 2	17.7 Titers Interval 14.8 to 21.3	—	—	—
Stage1: hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined) PMB431 (B15) 1 month after Vacc 2	17.3 Titers Interval 15.1 to 19.8	—	—	—

SECONDARY outcome

Timeframe: 1 month after Vaccination 1

Population: Stage 1 modified intent-to-treat (mITT) population: all randomized participants who had received at least 1 study vaccination, who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from Month 0 to 7. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure. 'Number Analyzed': participants with valid and determinate hSBA results for ACWY test strains at the given time point.

Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=272 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=534 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=271 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=523 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=LLOQ for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenA	99.2 Percentage of participants Interval 97.3 to 99.9	98.4 Percentage of participants Interval 96.9 to 99.3	100.0 Percentage of participants Interval 98.3 to 100.0	99.3 Percentage of participants Interval 97.9 to 99.8
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=LLOQ for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenC	92.4 Percentage of participants Interval 88.5 to 95.3	88.6 Percentage of participants Interval 85.5 to 91.2	100.0 Percentage of participants Interval 98.6 to 100.0	99.4 Percentage of participants Interval 98.3 to 99.9
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=LLOQ for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenW	98.5 Percentage of participants Interval 96.2 to 99.6	95.5 Percentage of participants Interval 93.3 to 97.1	99.5 Percentage of participants Interval 97.5 to 100.0	99.5 Percentage of participants Interval 98.3 to 99.9
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=LLOQ for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenY	99.6 Percentage of participants Interval 97.9 to 100.0	96.9 Percentage of participants Interval 95.0 to 98.2	99.5 Percentage of participants Interval 97.5 to 100.0	99.8 Percentage of participants Interval 98.7 to 100.0

SECONDARY outcome

Timeframe: 1 month after Vaccination 1

Population: Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and 'Number Analyzed' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.

Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for ACWY test strains was reported in this outcome measure.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=272 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=534 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=271 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=523 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenA >=1:4	99.6 Percentage of participants Interval 97.9 to 100.0	98.4 Percentage of participants Interval 96.9 to 99.3	100.0 Percentage of participants Interval 98.3 to 100.0	99.3 Percentage of participants Interval 97.9 to 99.8
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenA >=1:8	99.2 Percentage of participants Interval 97.3 to 99.9	98.4 Percentage of participants Interval 96.9 to 99.3	100.0 Percentage of participants Interval 98.3 to 100.0	99.3 Percentage of participants Interval 97.9 to 99.8
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenA >=1:16	98.5 Percentage of participants Interval 96.2 to 99.6	98.0 Percentage of participants Interval 96.4 to 99.1	100.0 Percentage of participants Interval 98.3 to 100.0	99.3 Percentage of participants Interval 97.9 to 99.8
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenA >=1:32	97.7 Percentage of participants Interval 95.1 to 99.2	93.9 Percentage of participants Interval 91.5 to 95.8	99.5 Percentage of participants Interval 97.5 to 100.0	99.0 Percentage of participants Interval 97.5 to 99.7
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenA >=1:64	90.9 Percentage of participants Interval 86.8 to 94.1	86.3 Percentage of participants Interval 83.0 to 89.1	99.1 Percentage of participants Interval 96.7 to 99.9	98.3 Percentage of participants Interval 96.5 to 99.3
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenA >= 1:128	75.0 Percentage of participants Interval 69.3 to 80.1	71.2 Percentage of participants Interval 67.0 to 75.1	95.4 Percentage of participants Interval 91.7 to 97.8	96.4 Percentage of participants Interval 94.1 to 97.9
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenC >=1:4	95.4 Percentage of participants Interval 92.1 to 97.6	93.3 Percentage of participants Interval 90.8 to 95.3	100.0 Percentage of participants Interval 98.6 to 100.0	99.4 Percentage of participants Interval 98.3 to 99.9
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenC >=1:8	92.4 Percentage of participants Interval 88.5 to 95.3	88.6 Percentage of participants Interval 85.5 to 91.2	100.0 Percentage of participants Interval 98.6 to 100.0	99.4 Percentage of participants Interval 98.3 to 99.9
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenC >=1:16	88.2 Percentage of participants Interval 83.6 to 91.8	80.9 Percentage of participants Interval 77.3 to 84.3	100.0 Percentage of participants Interval 98.6 to 100.0	99.2 Percentage of participants Interval 98.0 to 99.8
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenC >=1:32	76.3 Percentage of participants Interval 70.7 to 81.3	67.8 Percentage of participants Interval 63.5 to 71.8	98.9 Percentage of participants Interval 96.7 to 99.8	98.2 Percentage of participants Interval 96.7 to 99.2
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenC >=1:64	61.8 Percentage of participants Interval 55.7 to 67.7	55.0 Percentage of participants Interval 50.6 to 59.4	97.3 Percentage of participants Interval 94.6 to 98.9	97.2 Percentage of participants Interval 95.4 to 98.5
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenC >=1:128	50.8 Percentage of participants Interval 44.5 to 57.0	45.6 Percentage of participants Interval 41.2 to 50.0	95.5 Percentage of participants Interval 92.2 to 97.6	94.1 Percentage of participants Interval 91.6 to 96.0
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenW >=1:4	99.6 Percentage of participants Interval 97.9 to 100.0	97.7 Percentage of participants Interval 95.9 to 98.8	100.0 Percentage of participants Interval 98.3 to 100.0	99.5 Percentage of participants Interval 98.3 to 99.9
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenW >=1:8	98.5 Percentage of participants Interval 96.2 to 99.6	95.5 Percentage of participants Interval 93.3 to 97.1	99.5 Percentage of participants Interval 97.5 to 100.0	99.5 Percentage of participants Interval 98.3 to 99.9
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenW >=1:16	96.2 Percentage of participants Interval 93.1 to 98.2	89.3 Percentage of participants Interval 86.2 to 91.8	99.5 Percentage of participants Interval 97.5 to 100.0	99.3 Percentage of participants Interval 97.9 to 99.9
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenW >=1:32	82.2 Percentage of participants Interval 77.0 to 86.6	75.0 Percentage of participants Interval 71.0 to 78.7	99.5 Percentage of participants Interval 97.5 to 100.0	98.1 Percentage of participants Interval 96.2 to 99.2
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenW >=1:64	65.9 Percentage of participants Interval 59.8 to 71.6	56.1 Percentage of participants Interval 51.6 to 60.4	99.1 Percentage of participants Interval 96.7 to 99.9	96.6 Percentage of participants Interval 94.4 to 98.1
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenW >=1:128	43.9 Percentage of participants Interval 37.9 to 50.2	38.1 Percentage of participants Interval 33.9 to 42.4	98.6 Percentage of participants Interval 96.0 to 99.7	94.0 Percentage of participants Interval 91.2 to 96.1
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenY >=1:4	100.0 Percentage of participants Interval 98.6 to 100.0	99.2 Percentage of participants Interval 98.0 to 99.8	99.5 Percentage of participants Interval 97.5 to 100.0	100.0 Percentage of participants Interval 99.1 to 100.0
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenY >=1:8	99.6 Percentage of participants Interval 97.9 to 100.0	96.9 Percentage of participants Interval 95.0 to 98.2	99.5 Percentage of participants Interval 97.5 to 100.0	99.8 Percentage of participants Interval 98.7 to 100.0
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenY >=1:16	98.9 Percentage of participants Interval 96.7 to 99.8	92.9 Percentage of participants Interval 90.4 to 95.0	99.5 Percentage of participants Interval 97.5 to 100.0	99.3 Percentage of participants Interval 97.9 to 99.8
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenY >=1:32	92.4 Percentage of participants Interval 88.5 to 95.3	82.4 Percentage of participants Interval 78.8 to 85.6	99.1 Percentage of participants Interval 96.7 to 99.9	99.0 Percentage of participants Interval 97.5 to 99.7
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenY >=1:64	78.3 Percentage of participants Interval 72.9 to 83.2	66.9 Percentage of participants Interval 62.6 to 70.9	99.1 Percentage of participants Interval 96.7 to 99.9	97.1 Percentage of participants Interval 95.0 to 98.5
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4 MenY >=1:128	62.0 Percentage of participants Interval 55.8 to 67.9	48.6 Percentage of participants Interval 44.2 to 53.1	98.6 Percentage of participants Interval 96.0 to 99.7	94.9 Percentage of participants Interval 92.3 to 96.8

SECONDARY outcome

Timeframe: 1 month after Vaccination 1

Population: Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and 'Number Analyzed' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.

GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:8 for all MenA, MenC, MenW, and MenY. Titers below the LLOQ were set to 0.5*LLOQ for analysis.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=272 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=534 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=271 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=523 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: hSBA Geometric Mean Titers (GMTs) for ACWY Test Strains 1 Month After Vaccination 1: Groups 1, 2, 3 and 4 MenY	141.9 Titers Interval 118.8 to 169.4	96.6 Titers Interval 83.9 to 111.2	1174.0 Titers Interval 990.3 to 1391.9	1000.2 Titers Interval 872.1 to 1147.1
Stage1: hSBA Geometric Mean Titers (GMTs) for ACWY Test Strains 1 Month After Vaccination 1: Groups 1, 2, 3 and 4 MenA	215.8 Titers Interval 184.6 to 252.4	203.2 Titers Interval 178.7 to 231.0	568.6 Titers Interval 492.9 to 656.0	916.1 Titers Interval 809.1 to 1037.3
Stage1: hSBA Geometric Mean Titers (GMTs) for ACWY Test Strains 1 Month After Vaccination 1: Groups 1, 2, 3 and 4 MenC	111.5 Titers Interval 87.2 to 142.6	81.4 Titers Interval 68.1 to 97.4	814.9 Titers Interval 689.4 to 963.2	827.0 Titers Interval 722.5 to 946.6
Stage1: hSBA Geometric Mean Titers (GMTs) for ACWY Test Strains 1 Month After Vaccination 1: Groups 1, 2, 3 and 4 MenW	98.4 Titers Interval 80.7 to 120.0	71.2 Titers Interval 61.5 to 82.4	1214.9 Titers Interval 1032.0 to 1430.1	1176.7 Titers Interval 1017.9 to 1360.2

SECONDARY outcome

Timeframe: For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2

Population: Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and 'Number Analyzed' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.

Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >= LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=534 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=523 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=242 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=244 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ, Whichever is Higher) for ACWY Test Strains 1 Month After the Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenA	98.4 Percentage of participants Interval 96.9 to 99.3	99.3 Percentage of participants Interval 97.9 to 99.8	100.0 Percentage of participants Interval 98.4 to 100.0	99.5 Percentage of participants Interval 97.1 to 100.0
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ, Whichever is Higher) for ACWY Test Strains 1 Month After the Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenC	88.6 Percentage of participants Interval 85.5 to 91.2	99.4 Percentage of participants Interval 98.3 to 99.9	100.0 Percentage of participants Interval 98.4 to 100.0	99.6 Percentage of participants Interval 97.7 to 100.0
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ, Whichever is Higher) for ACWY Test Strains 1 Month After the Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenW	95.5 Percentage of participants Interval 93.3 to 97.1	99.5 Percentage of participants Interval 98.3 to 99.9	100.0 Percentage of participants Interval 98.4 to 100.0	99.5 Percentage of participants Interval 97.1 to 100.0
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ, Whichever is Higher) for ACWY Test Strains 1 Month After the Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenY	96.9 Percentage of participants Interval 95.0 to 98.2	99.8 Percentage of participants Interval 98.7 to 100.0	100.0 Percentage of participants Interval 98.4 to 100.0	99.5 Percentage of participants Interval 97.1 to 100.0

SECONDARY outcome

Timeframe: For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2

Population: Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and 'Number Analyzed' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.

Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for ACWY test strains was reported in this outcome measure.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=534 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=523 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=242 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=244 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenA >=1:4	98.4 Percentage of participants Interval 96.9 to 99.3	99.3 Percentage of participants Interval 97.9 to 99.8	100.0 Percentage of participants Interval 98.4 to 100.0	99.5 Percentage of participants Interval 97.1 to 100.0
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenA >=1:8	98.4 Percentage of participants Interval 96.9 to 99.3	99.3 Percentage of participants Interval 97.9 to 99.8	100.0 Percentage of participants Interval 98.4 to 100.0	99.5 Percentage of participants Interval 97.1 to 100.0
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenA >=1:16	98.0 Percentage of participants Interval 96.4 to 99.1	99.3 Percentage of participants Interval 97.9 to 99.8	100.0 Percentage of participants Interval 98.4 to 100.0	99.5 Percentage of participants Interval 97.1 to 100.0
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenA >=1:32	93.9 Percentage of participants Interval 91.5 to 95.8	99.0 Percentage of participants Interval 97.5 to 99.7	97.8 Percentage of participants Interval 95.0 to 99.3	99.5 Percentage of participants Interval 97.1 to 100.0
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenA >=1:64	86.3 Percentage of participants Interval 83.0 to 89.1	98.3 Percentage of participants Interval 96.5 to 99.3	92.2 Percentage of participants Interval 88.0 to 95.3	97.4 Percentage of participants Interval 94.0 to 99.1
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenA >=1:128	71.2 Percentage of participants Interval 67.0 to 75.1	96.4 Percentage of participants Interval 94.1 to 97.9	69.4 Percentage of participants Interval 63.0 to 75.3	92.7 Percentage of participants Interval 88.0 to 95.9
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenC >=1:4	93.3 Percentage of participants Interval 90.8 to 95.3	99.4 Percentage of participants Interval 98.3 to 99.9	100.0 Percentage of participants Interval 98.4 to 100.0	99.6 Percentage of participants Interval 97.7 to 100.0
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenC >=1:8	88.6 Percentage of participants Interval 85.5 to 91.2	99.4 Percentage of participants Interval 98.3 to 99.9	100.0 Percentage of participants Interval 98.4 to 100.0	99.6 Percentage of participants Interval 97.7 to 100.0
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenC >=1:16	80.9 Percentage of participants Interval 77.3 to 84.3	99.2 Percentage of participants Interval 98.0 to 99.8	99.6 Percentage of participants Interval 97.6 to 100.0	99.6 Percentage of participants Interval 97.7 to 100.0
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenC >=1:32	67.8 Percentage of participants Interval 63.5 to 71.8	98.2 Percentage of participants Interval 96.7 to 99.2	97.4 Percentage of participants Interval 94.4 to 99.0	99.6 Percentage of participants Interval 97.7 to 100.0
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenC >=1:64	55.0 Percentage of participants Interval 50.6 to 59.4	97.2 Percentage of participants Interval 95.4 to 98.5	90.9 Percentage of participants Interval 86.4 to 94.3	98.3 Percentage of participants Interval 95.7 to 99.5
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenC >=1:128	45.6 Percentage of participants Interval 41.2 to 50.0	94.1 Percentage of participants Interval 91.6 to 96.0	78.8 Percentage of participants Interval 72.9 to 83.9	92.8 Percentage of participants Interval 88.8 to 95.8
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenW >=1:4	97.7 Percentage of participants Interval 95.9 to 98.8	99.5 Percentage of participants Interval 98.3 to 99.9	100.0 Percentage of participants Interval 98.4 to 100.0	100.0 Percentage of participants Interval 98.1 to 100.0
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenW >=1:8	95.5 Percentage of participants Interval 93.3 to 97.1	99.5 Percentage of participants Interval 98.3 to 99.9	100.0 Percentage of participants Interval 98.4 to 100.0	99.5 Percentage of participants Interval 97.1 to 100.0
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenW >=1:16	89.3 Percentage of participants Interval 86.2 to 91.8	99.3 Percentage of participants Interval 97.9 to 99.9	100.0 Percentage of participants Interval 98.4 to 100.0	99.5 Percentage of participants Interval 97.1 to 100.0
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenW >=1:32	75.0 Percentage of participants Interval 71.0 to 78.7	98.1 Percentage of participants Interval 96.2 to 99.2	99.6 Percentage of participants Interval 97.6 to 100.0	99.5 Percentage of participants Interval 97.1 to 100.0
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenW >=1:64	56.1 Percentage of participants Interval 51.6 to 60.4	96.6 Percentage of participants Interval 94.4 to 98.1	97.0 Percentage of participants Interval 93.9 to 98.8	99.0 Percentage of participants Interval 96.3 to 99.9
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenW >=1:128	38.1 Percentage of participants Interval 33.9 to 42.4	94.0 Percentage of participants Interval 91.2 to 96.1	89.7 Percentage of participants Interval 85.1 to 93.3	97.9 Percentage of participants Interval 94.7 to 99.4
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenY >=1:4	99.2 Percentage of participants Interval 98.0 to 99.8	100.0 Percentage of participants Interval 99.1 to 100.0	100.0 Percentage of participants Interval 98.4 to 100.0	99.5 Percentage of participants Interval 97.1 to 100.0
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenY >=1:8	96.9 Percentage of participants Interval 95.0 to 98.2	99.8 Percentage of participants Interval 98.7 to 100.0	100.0 Percentage of participants Interval 98.4 to 100.0	99.5 Percentage of participants Interval 97.1 to 100.0
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenY >=1:16	92.9 Percentage of participants Interval 90.4 to 95.0	99.3 Percentage of participants Interval 97.9 to 99.8	100.0 Percentage of participants Interval 98.4 to 100.0	99.5 Percentage of participants Interval 97.1 to 100.0
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenY >=1:32	82.4 Percentage of participants Interval 78.8 to 85.6	99.0 Percentage of participants Interval 97.5 to 99.7	100.0 Percentage of participants Interval 98.4 to 100.0	99.5 Percentage of participants Interval 97.1 to 100.0
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenY >=1:64	66.9 Percentage of participants Interval 62.6 to 70.9	97.1 Percentage of participants Interval 95.0 to 98.5	97.4 Percentage of participants Interval 94.5 to 99.0	99.5 Percentage of participants Interval 97.1 to 100.0
Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3 MenY >=1:128	48.6 Percentage of participants Interval 44.2 to 53.1	94.9 Percentage of participants Interval 92.3 to 96.8	89.7 Percentage of participants Interval 85.1 to 93.3	95.3 Percentage of participants Interval 91.2 to 97.8

SECONDARY outcome

Timeframe: For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2

Population: Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and 'Number Analyzed' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.

GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:8 for all MenA, MenC, MenW, and MenY. Titers below the LLOQ were set to 0.5*LLOQ for analysis.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=534 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=523 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=242 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=244 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: hSBA GMTs for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4 and 1 Month After Vaccination 2 in Groups 1 and 3 MenY	96.6 Titers Interval 83.9 to 111.2	1000.2 Titers Interval 872.1 to 1147.1	301.5 Titers Interval 266.6 to 341.0	558.6 Titers Interval 470.0 to 663.9
Stage1: hSBA GMTs for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4 and 1 Month After Vaccination 2 in Groups 1 and 3 MenA	203.2 Titers Interval 178.7 to 231.0	916.1 Titers Interval 809.1 to 1037.3	151.3 Titers Interval 134.1 to 170.7	337.3 Titers Interval 291.7 to 390.0
Stage1: hSBA GMTs for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4 and 1 Month After Vaccination 2 in Groups 1 and 3 MenC	81.4 Titers Interval 68.1 to 97.4	827.0 Titers Interval 722.5 to 946.6	229.1 Titers Interval 194.7 to 269.5	498.7 Titers Interval 429.1 to 579.6
Stage1: hSBA GMTs for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4 and 1 Month After Vaccination 2 in Groups 1 and 3 MenW	71.2 Titers Interval 61.5 to 82.4	1176.7 Titers Interval 1017.9 to 1360.2	274.1 Titers Interval 242.7 to 309.7	570.9 Titers Interval 484.3 to 673.0

SECONDARY outcome

Timeframe: 1 month after Vaccination 2 (Vacc 2)

Population: Stage 1 EIP analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants measured and analyzed for this outcome measure. "Number Analyzed" signifies number of participants with valid and determinate hSBA results for each strains at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.

Percentage of participants who achieved an hSBA titer >=LLOQ for all 4 primary MenB test strains (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=438 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=864 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) 1 month after Vacc 2	91.0 Percentage of participants Interval 87.9 to 93.5	91.0 Percentage of participants Interval 88.8 to 92.8	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) 1 month after Vacc 2	98.6 Percentage of participants Interval 97.0 to 99.5	99.4 Percentage of participants Interval 98.6 to 99.8	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) 1 month after Vacc 2	84.3 Percentage of participants Interval 80.5 to 87.6	79.3 Percentage of participants Interval 76.4 to 82.0	—	—
Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) 1 month after Vacc 2	95.4 Percentage of participants Interval 93.0 to 97.2	94.5 Percentage of participants Interval 92.7 to 95.9	—	—

SECONDARY outcome

Timeframe: Baseline to 1 month after Vaccination 2

Population: Stage 1 EIP analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants measure and analyzed for this outcome measure. "Number Analyzed" signifies number of participants with valid and determinate hSBA results on all 4 strains at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.

Percentage of participants who achieved an hSBA titer greater than or equal to LLOQ for all 4 primary MenB test strains combined (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=438 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=864 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With >=4 Fold Rise in hSBA for 4 Primary MenB Strains and Composite Response (hSBA >=LLOQ for All 4 Primary MenB Strains Combined) From Baseline-1 Month After Vaccination 2 (Group 1 and 3 Combined;Group 2 and 4 Combined) PMB80 (A22)	75.8 Percentage of participants Interval 71.5 to 79.8	73.8 Percentage of participants Interval 70.6 to 76.7	—	—
Stage1: Percentage of Participants With >=4 Fold Rise in hSBA for 4 Primary MenB Strains and Composite Response (hSBA >=LLOQ for All 4 Primary MenB Strains Combined) From Baseline-1 Month After Vaccination 2 (Group 1 and 3 Combined;Group 2 and 4 Combined) PMB2001 (A56)	94.7 Percentage of participants Interval 92.1 to 96.7	95.0 Percentage of participants Interval 93.3 to 96.4	—	—
Stage1: Percentage of Participants With >=4 Fold Rise in hSBA for 4 Primary MenB Strains and Composite Response (hSBA >=LLOQ for All 4 Primary MenB Strains Combined) From Baseline-1 Month After Vaccination 2 (Group 1 and 3 Combined;Group 2 and 4 Combined) PMB2948 (B24)	76.1 Percentage of participants Interval 71.7 to 80.1	67.4 Percentage of participants Interval 64.1 to 70.6	—	—
Stage1: Percentage of Participants With >=4 Fold Rise in hSBA for 4 Primary MenB Strains and Composite Response (hSBA >=LLOQ for All 4 Primary MenB Strains Combined) From Baseline-1 Month After Vaccination 2 (Group 1 and 3 Combined;Group 2 and 4 Combined) PMB2707 (B44)	91.7 Percentage of participants Interval 88.6 to 94.1	86.4 Percentage of participants Interval 83.9 to 88.6	—	—
Stage1: Percentage of Participants With >=4 Fold Rise in hSBA for 4 Primary MenB Strains and Composite Response (hSBA >=LLOQ for All 4 Primary MenB Strains Combined) From Baseline-1 Month After Vaccination 2 (Group 1 and 3 Combined;Group 2 and 4 Combined) Composite hSBA response	79.9 Percentage of participants Interval 75.7 to 83.6	74.3 Percentage of participants Interval 71.2 to 77.3	—	—

SECONDARY outcome

Timeframe: 1 month after Vaccination 2

Population: Stage 1 EIP analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants measure and analyzed for this outcome measure. "Number Analyzed" signifies number of participants with valid and determinate hSBA results on all 4 strains at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.

Percentage of participants who achieved an hSBA titer >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for all 4 primary MenB test strains was reported in this outcome measure.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=438 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=864 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) >=1:4	91.9 Percentage of participants Interval 88.9 to 94.3	91.7 Percentage of participants Interval 89.6 to 93.4	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) >=1:8	91.7 Percentage of participants Interval 88.7 to 94.1	91.5 Percentage of participants Interval 89.5 to 93.3	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) >=1:16	91.0 Percentage of participants Interval 87.9 to 93.5	91.0 Percentage of participants Interval 88.8 to 92.8	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) >=1:32	82.4 Percentage of participants Interval 78.5 to 85.9	80.2 Percentage of participants Interval 77.3 to 82.8	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) >=1:64	58.0 Percentage of participants Interval 53.2 to 62.7	54.9 Percentage of participants Interval 51.5 to 58.3	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) >=1:128	27.9 Percentage of participants Interval 23.8 to 32.4	27.3 Percentage of participants Interval 24.4 to 30.5	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) >=1:4	98.9 Percentage of participants Interval 97.3 to 99.6	99.5 Percentage of participants Interval 98.8 to 99.9	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) >=1:8	98.6 Percentage of participants Interval 97.0 to 99.5	99.4 Percentage of participants Interval 98.6 to 99.8	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) >=1:32	72.9 Percentage of participants Interval 68.5 to 77.1	68.6 Percentage of participants Interval 65.3 to 71.7	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) >=1:16	98.6 Percentage of participants Interval 97.0 to 99.5	99.1 Percentage of participants Interval 98.2 to 99.6	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) >=1:64	48.9 Percentage of participants Interval 44.1 to 53.7	41.0 Percentage of participants Interval 37.7 to 44.4	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) >=1:32	96.8 Percentage of participants Interval 94.7 to 98.2	97.0 Percentage of participants Interval 95.6 to 98.0	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) >=1:64	90.1 Percentage of participants Interval 86.9 to 92.8	87.7 Percentage of participants Interval 85.3 to 89.8	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) >=1:128	74.0 Percentage of participants Interval 69.6 to 78.1	69.2 Percentage of participants Interval 66.0 to 72.3	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) >=1:4	86.9 Percentage of participants Interval 83.3 to 89.9	81.2 Percentage of participants Interval 78.4 to 83.8	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) >=1:8	84.3 Percentage of participants Interval 80.5 to 87.6	79.3 Percentage of participants Interval 76.4 to 82.0	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) >=1:16	80.8 Percentage of participants Interval 76.7 to 84.4	74.0 Percentage of participants Interval 70.9 to 76.9	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) >=1:32	58.5 Percentage of participants Interval 53.6 to 63.2	47.9 Percentage of participants Interval 44.4 to 51.3	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) >=1:64	31.0 Percentage of participants Interval 26.6 to 35.6	24.9 Percentage of participants Interval 22.1 to 28.0	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) >=1:128	13.4 Percentage of participants Interval 10.3 to 17.0	9.6 Percentage of participants Interval 7.7 to 11.8	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) >=1:4	97.2 Percentage of participants Interval 95.2 to 98.6	96.2 Percentage of participants Interval 94.7 to 97.4	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) >=1:8	95.4 Percentage of participants Interval 93.0 to 97.2	94.5 Percentage of participants Interval 92.7 to 95.9	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) >=1:16	92.4 Percentage of participants Interval 89.5 to 94.7	89.0 Percentage of participants Interval 86.7 to 91.0	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) >=1:128	22.0 Percentage of participants Interval 18.2 to 26.2	19.2 Percentage of participants Interval 16.6 to 22.0	—	—

SECONDARY outcome

Timeframe: 1 month after Vaccination 2

Population: Stage 1 EIP analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants measure and analyzed for this outcome measure. "Number Analyzed" signifies number of participants with valid and determinate hSBA results on all 4 strains at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.

GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ =1:16 for A22; 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5*LLOQ for analysis.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=438 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=864 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22)	51.0 Titers Interval 46.7 to 55.7	49.3 Titers Interval 46.2 to 52.6	—	—
Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56)	152.3 Titers Interval 138.5 to 167.5	139.5 Titers Interval 130.6 to 149.1	—	—
Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24)	26.6 Titers Interval 23.9 to 29.7	21.2 Titers Interval 19.6 to 22.9	—	—
Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44)	43.3 Titers Interval 39.1 to 47.9	37.8 Titers Interval 35.1 to 40.8	—	—

SECONDARY outcome

Timeframe: Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]

Population: Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and 'Number Analyzed' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.

Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=272 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=534 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=271 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=523 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW and hSBA-MenY Titers >=1:8 (or LLOQ) for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenA Before Vacc 1	15.9 Percentage of participants Interval 11.8 to 20.8	22.9 Percentage of participants Interval 19.4 to 26.7	53.9 Percentage of participants Interval 47.0 to 60.6	52.6 Percentage of participants Interval 47.7 to 57.5
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW and hSBA-MenY Titers >=1:8 (or LLOQ) for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenA Before Vacc 2	91.6 Percentage of participants Interval 87.3 to 94.8	86.2 Percentage of participants Interval 82.7 to 89.2	99.0 Percentage of participants Interval 96.4 to 99.9	98.4 Percentage of participants Interval 96.6 to 99.4
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW and hSBA-MenY Titers >=1:8 (or LLOQ) for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenC Before Vacc 1	38.6 Percentage of participants Interval 32.7 to 44.7	39.0 Percentage of participants Interval 34.8 to 43.3	59.5 Percentage of participants Interval 53.3 to 65.4	61.1 Percentage of participants Interval 56.7 to 65.3
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW and hSBA-MenY Titers >=1:8 (or LLOQ) for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenC Before Vacc 2	92.9 Percentage of participants Interval 88.9 to 95.8	76.5 Percentage of participants Interval 72.4 to 80.3	98.4 Percentage of participants Interval 95.8 to 99.5	98.3 Percentage of participants Interval 96.7 to 99.3
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW and hSBA-MenY Titers >=1:8 (or LLOQ) for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenW Before Vacc 1	32.1 Percentage of participants Interval 26.5 to 38.0	34.5 Percentage of participants Interval 30.5 to 38.8	61.9 Percentage of participants Interval 55.1 to 68.4	60.8 Percentage of participants Interval 55.9 to 65.5
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW and hSBA-MenY Titers >=1:8 (or LLOQ) for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenW Before Vacc 2	99.2 Percentage of participants Interval 97.0 to 99.9	91.0 Percentage of participants Interval 88.0 to 93.4	100.0 Percentage of participants Interval 98.2 to 100.0	99.0 Percentage of participants Interval 97.4 to 99.7
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW and hSBA-MenY Titers >=1:8 (or LLOQ) for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenY Before Vacc 1	54.0 Percentage of participants Interval 47.8 to 60.1	58.1 Percentage of participants Interval 53.8 to 62.4	79.9 Percentage of participants Interval 74.0 to 85.0	77.9 Percentage of participants Interval 73.6 to 81.8
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW and hSBA-MenY Titers >=1:8 (or LLOQ) for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenY Before Vacc 2	100.0 Percentage of participants Interval 98.5 to 100.0	97.2 Percentage of participants Interval 95.2 to 98.5	100.0 Percentage of participants Interval 98.2 to 100.0	99.5 Percentage of participants Interval 98.1 to 99.9

SECONDARY outcome

Timeframe: Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]

Population: Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and 'Number Analyzed' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.

Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=1:4, >= :8, >=1:16, >=1:32, >=1:64, >=1:128 for ACWY test strains was reported in this outcome measure.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=272 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=534 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=271 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=523 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenW Before Vacc 2 >=1:32	78.5 Percentage of participants Interval 72.8 to 83.5	64.2 Percentage of participants Interval 59.7 to 68.6	98.5 Percentage of participants Interval 95.7 to 99.7	95.8 Percentage of participants Interval 93.3 to 97.6
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenW Before Vacc 1 >=1:64	7.5 Percentage of participants Interval 4.6 to 11.3	6.3 Percentage of participants Interval 4.3 to 8.7	9.2 Percentage of participants Interval 5.7 to 13.8	11.2 Percentage of participants Interval 8.4 to 14.7
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenW Before Vacc 1 >=1:128	4.5 Percentage of participants Interval 2.3 to 7.7	1.5 Percentage of participants Interval 0.7 to 3.0	5.5 Percentage of participants Interval 2.9 to 9.4	6.2 Percentage of participants Interval 4.1 to 9.0
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenW Before Vacc 2 >=1:4	99.2 Percentage of participants Interval 97.0 to 99.9	96.6 Percentage of participants Interval 94.5 to 98.0	100.0 Percentage of participants Interval 98.2 to 100.0	99.0 Percentage of participants Interval 97.4 to 99.7
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenW Before Vacc 2 >=1:64	56.6 Percentage of participants Interval 50.1 to 62.9	41.1 Percentage of participants Interval 36.6 to 45.7	95.5 Percentage of participants Interval 91.6 to 97.9	89.1 Percentage of participants Interval 85.5 to 92.0
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenW Before Vacc 2 >=1:8	99.2 Percentage of participants Interval 97.0 to 99.9	91.0 Percentage of participants Interval 88.0 to 93.4	100.0 Percentage of participants Interval 98.2 to 100.0	99.0 Percentage of participants Interval 97.4 to 99.7
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenW Before Vacc 2 >=1:16	95.5 Percentage of participants Interval 92.0 to 97.7	82.7 Percentage of participants Interval 78.9 to 86.0	99.5 Percentage of participants Interval 97.2 to 100.0	97.7 Percentage of participants Interval 95.6 to 98.9
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenW Before Vacc 2 >=1:128	34.3 Percentage of participants Interval 28.3 to 40.6	24.2 Percentage of participants Interval 20.4 to 28.3	84.4 Percentage of participants Interval 78.6 to 89.2	79.0 Percentage of participants Interval 74.5 to 82.9
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenY Before Vacc 2 >=1:64	69.9 Percentage of participants Interval 63.6 to 75.6	56.2 Percentage of participants Interval 51.5 to 60.7	94.9 Percentage of participants Interval 90.9 to 97.6	88.5 Percentage of participants Interval 84.8 to 91.5
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenY Before Vacc 2 >=1:128	41.0 Percentage of participants Interval 34.7 to 47.5	31.1 Percentage of participants Interval 26.9 to 35.5	86.4 Percentage of participants Interval 80.8 to 90.8	80.6 Percentage of participants Interval 76.3 to 84.5
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenA Before Vacc 1 >=1:4	26.3 Percentage of participants Interval 21.1 to 32.0	33.3 Percentage of participants Interval 29.3 to 37.5	64.4 Percentage of participants Interval 57.7 to 70.7	65.8 Percentage of participants Interval 61.0 to 70.3
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenA Before Vacc 1 >=1:8	15.9 Percentage of participants Interval 11.8 to 20.8	22.9 Percentage of participants Interval 19.4 to 26.7	53.9 Percentage of participants Interval 47.0 to 60.6	52.6 Percentage of participants Interval 47.7 to 57.5
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenA Before Vacc 1 >=1:16	14.4 Percentage of participants Interval 10.5 to 19.2	18.0 Percentage of participants Interval 14.8 to 21.5	40.2 Percentage of participants Interval 33.6 to 47.0	41.6 Percentage of participants Interval 36.9 to 46.5
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenA Before Vacc 1 >=1:32	8.5 Percentage of participants Interval 5.5 to 12.5	10.6 Percentage of participants Interval 8.1 to 13.6	24.2 Percentage of participants Interval 18.7 to 30.4	22.0 Percentage of participants Interval 18.1 to 26.3
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenA Before Vacc 1 >=1:64	5.2 Percentage of participants Interval 2.9 to 8.5	5.5 Percentage of participants Interval 3.7 to 7.8	12.8 Percentage of participants Interval 8.7 to 17.9	15.1 Percentage of participants Interval 11.8 to 18.9
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenA Before Vacc 1 >=1:128	3.0 Percentage of participants Interval 1.3 to 5.8	4.0 Percentage of participants Interval 2.5 to 6.0	7.8 Percentage of participants Interval 4.6 to 12.1	6.2 Percentage of participants Interval 4.1 to 9.0
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenA Before Vacc 2 >=1:4	93.3 Percentage of participants Interval 89.3 to 96.1	88.3 Percentage of participants Interval 85.1 to 91.1	99.0 Percentage of participants Interval 96.4 to 99.9	98.4 Percentage of participants Interval 96.6 to 99.4
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenA Before Vacc 2 >=1:8	91.6 Percentage of participants Interval 87.3 to 94.8	86.2 Percentage of participants Interval 82.7 to 89.2	99.0 Percentage of participants Interval 96.4 to 99.9	98.4 Percentage of participants Interval 96.6 to 99.4
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenA Before Vacc 2 >=1:16	87.4 Percentage of participants Interval 82.5 to 91.3	81.9 Percentage of participants Interval 78.0 to 85.3	98.0 Percentage of participants Interval 95.0 to 99.5	98.4 Percentage of participants Interval 96.6 to 99.4
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenA Before Vacc 2 >=1:32	72.3 Percentage of participants Interval 66.1 to 77.9	66.3 Percentage of participants Interval 61.8 to 70.6	95.5 Percentage of participants Interval 91.6 to 97.9	96.1 Percentage of participants Interval 93.7 to 97.8
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenA Before Vacc 2 >=1:64	44.5 Percentage of participants Interval 38.1 to 51.1	50.5 Percentage of participants Interval 45.9 to 55.2	85.0 Percentage of participants Interval 79.3 to 89.6	88.8 Percentage of participants Interval 85.3 to 91.8
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenA Before Vacc 2 >=1:128	25.2 Percentage of participants Interval 19.8 to 31.2	33.5 Percentage of participants Interval 29.2 to 38.0	64.0 Percentage of participants Interval 56.9 to 70.6	75.3 Percentage of participants Interval 70.7 to 79.6
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenC Before Vacc 1 >=1:4	63.7 Percentage of participants Interval 57.6 to 69.4	59.7 Percentage of participants Interval 55.4 to 63.9	76.1 Percentage of participants Interval 70.5 to 81.1	78.3 Percentage of participants Interval 74.4 to 81.8
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenC Before Vacc 1 >=1:8	38.6 Percentage of participants Interval 32.7 to 44.7	39.0 Percentage of participants Interval 34.8 to 43.3	59.5 Percentage of participants Interval 53.3 to 65.4	61.1 Percentage of participants Interval 56.7 to 65.3
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenC Before Vacc 1 >=1:16	24.3 Percentage of participants Interval 19.3 to 29.9	24.5 Percentage of participants Interval 20.9 to 28.4	42.0 Percentage of participants Interval 36.0 to 48.3	44.4 Percentage of participants Interval 40.1 to 48.9
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenC Before Vacc 1 >=1:32	12.0 Percentage of participants Interval 8.3 to 16.5	12.5 Percentage of participants Interval 9.8 to 15.7	26.9 Percentage of participants Interval 21.6 to 32.7	29.7 Percentage of participants Interval 25.8 to 33.9
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenY Before Vacc 1 >=1:64	10.9 Percentage of participants Interval 7.5 to 15.3	11.2 Percentage of participants Interval 8.6 to 14.2	21.9 Percentage of participants Interval 16.6 to 28.0	20.2 Percentage of participants Interval 16.5 to 24.3
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenC Before Vacc 1 >=1:64	5.2 Percentage of participants Interval 2.9 to 8.6	6.8 Percentage of participants Interval 4.8 to 9.3	15.9 Percentage of participants Interval 11.7 to 20.9	18.2 Percentage of participants Interval 14.9 to 21.8
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenC Before Vacc 1 >=1:128	4.5 Percentage of participants Interval 2.3 to 7.7	4.0 Percentage of participants Interval 2.5 to 6.0	6.8 Percentage of participants Interval 4.1 to 10.6	9.2 Percentage of participants Interval 6.8 to 12.0
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenC Before Vacc 2 >=1:4	95.0 Percentage of participants Interval 91.4 to 97.4	85.9 Percentage of participants Interval 82.3 to 88.9	99.6 Percentage of participants Interval 97.7 to 100.0	99.4 Percentage of participants Interval 98.2 to 99.9
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenC Before Vacc 2 >=1:8	92.9 Percentage of participants Interval 88.9 to 95.8	76.5 Percentage of participants Interval 72.4 to 80.3	98.4 Percentage of participants Interval 95.8 to 99.5	98.3 Percentage of participants Interval 96.7 to 99.3
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenC Before Vacc 2 >=1:16	84.9 Percentage of participants Interval 79.8 to 89.2	68.3 Percentage of participants Interval 63.8 to 72.5	98.4 Percentage of participants Interval 95.8 to 99.5	97.3 Percentage of participants Interval 95.4 to 98.5
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenC Before Vacc 2 >=1:32	68.2 Percentage of participants Interval 61.9 to 74.1	52.4 Percentage of participants Interval 47.7 to 57.0	95.9 Percentage of participants Interval 92.6 to 98.0	91.6 Percentage of participants Interval 88.7 to 93.9
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenC Before Vacc 2 >=1:64	53.1 Percentage of participants Interval 46.6 to 59.6	39.3 Percentage of participants Interval 34.9 to 44.0	92.6 Percentage of participants Interval 88.5 to 95.6	81.2 Percentage of participants Interval 77.4 to 84.6
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenC Before Vacc 2 >=1:128	36.8 Percentage of participants Interval 30.7 to 43.3	27.8 Percentage of participants Interval 23.8 to 32.2	78.2 Percentage of participants Interval 72.5 to 83.2	66.2 Percentage of participants Interval 61.8 to 70.5
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenW Before Vacc 1 >=1:4	47.8 Percentage of participants Interval 41.6 to 53.9	50.5 Percentage of participants Interval 46.1 to 54.8	83.0 Percentage of participants Interval 77.4 to 87.8	76.3 Percentage of participants Interval 71.9 to 80.3
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenW Before Vacc 1 >=1:8	32.1 Percentage of participants Interval 26.5 to 38.0	34.5 Percentage of participants Interval 30.5 to 38.8	61.9 Percentage of participants Interval 55.1 to 68.4	60.8 Percentage of participants Interval 55.9 to 65.5
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenW Before Vacc 1 >=1:16	23.9 Percentage of participants Interval 18.9 to 29.4	22.8 Percentage of participants Interval 19.3 to 26.6	37.6 Percentage of participants Interval 31.2 to 44.4	39.7 Percentage of participants Interval 35.0 to 44.6
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenW Before Vacc 1 >=1:32	10.8 Percentage of participants Interval 7.4 to 15.2	13.7 Percentage of participants Interval 10.8 to 16.9	20.2 Percentage of participants Interval 15.1 to 26.1	21.8 Percentage of participants Interval 17.9 to 26.0
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenY Before Vacc 2 >=1:4	100.0 Percentage of participants Interval 98.5 to 100.0	98.9 Percentage of participants Interval 97.5 to 99.6	100.0 Percentage of participants Interval 98.2 to 100.0	99.5 Percentage of participants Interval 98.1 to 99.9
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenY Before Vacc 1 >=1:4	67.2 Percentage of participants Interval 61.2 to 72.8	70.3 Percentage of participants Interval 66.2 to 74.1	87.7 Percentage of participants Interval 82.6 to 91.7	89.5 Percentage of participants Interval 86.2 to 92.3
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenY Before Vacc 1 >=1:8	54.0 Percentage of participants Interval 47.8 to 60.1	58.1 Percentage of participants Interval 53.8 to 62.4	79.9 Percentage of participants Interval 74.0 to 85.0	77.9 Percentage of participants Interval 73.6 to 81.8
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenY Before Vacc 2 >=1:8	100.0 Percentage of participants Interval 98.5 to 100.0	97.2 Percentage of participants Interval 95.2 to 98.5	100.0 Percentage of participants Interval 98.2 to 100.0	99.5 Percentage of participants Interval 98.1 to 99.9
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenY Before Vacc 1 >=1:16	44.2 Percentage of participants Interval 38.1 to 50.4	46.6 Percentage of participants Interval 42.3 to 50.9	67.1 Percentage of participants Interval 60.5 to 73.3	65.8 Percentage of participants Interval 61.0 to 70.3
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenY Before Vacc 1 >=1:32	21.1 Percentage of participants Interval 16.4 to 26.5	26.7 Percentage of participants Interval 23.0 to 30.7	38.4 Percentage of participants Interval 31.9 to 45.1	40.9 Percentage of participants Interval 36.1 to 45.7
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenY Before Vacc 2 >=1:16	98.3 Percentage of participants Interval 95.8 to 99.5	92.9 Percentage of participants Interval 90.1 to 95.0	100.0 Percentage of participants Interval 98.2 to 100.0	99.2 Percentage of participants Interval 97.7 to 99.8
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenY Before Vacc 2 >=1:32	87.0 Percentage of participants Interval 82.1 to 91.0	77.1 Percentage of participants Interval 73.0 to 80.9	99.0 Percentage of participants Interval 96.4 to 99.9	95.8 Percentage of participants Interval 93.3 to 97.6
Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenY Before Vacc 1 >=1:128	4.9 Percentage of participants Interval 2.6 to 8.2	6.3 Percentage of participants Interval 4.3 to 8.7	10.0 Percentage of participants Interval 6.4 to 14.8	10.5 Percentage of participants Interval 7.7 to 13.8

SECONDARY outcome

Timeframe: Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]

Population: Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and 'Number Analyzed' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.

GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains. Titers below the LLOQ were set to 0.5*LLOQ for analysis. Confidence intervals were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations, or the mean of the ratio.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=272 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=534 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=271 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=523 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: hSBA GMTs for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenA Before Vacc 1	5.7 Titers Interval 5.1 to 6.3	6.3 Titers Interval 5.7 to 6.8	11.0 Titers Interval 9.3 to 13.0	10.7 Titers Interval 9.6 to 12.0
Stage1: hSBA GMTs for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenA Before Vacc 2	42.7 Titers Interval 36.1 to 50.4	47.2 Titers Interval 40.8 to 54.5	158.7 Titers Interval 132.6 to 189.8	214.6 Titers Interval 187.7 to 245.3
Stage1: hSBA GMTs for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenC Before Vacc 1	7.5 Titers Interval 6.6 to 8.5	7.5 Titers Interval 6.8 to 8.2	11.9 Titers Interval 10.2 to 13.8	13.4 Titers Interval 11.9 to 15.1
Stage1: hSBA GMTs for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenC Before Vacc 2	61.5 Titers Interval 49.5 to 76.3	32.7 Titers Interval 27.8 to 38.5	253.1 Titers Interval 213.0 to 300.8	186.7 Titers Interval 161.9 to 215.2
Stage1: hSBA GMTs for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenW Before Vacc 1	7.0 Titers Interval 6.2 to 7.9	7.0 Titers Interval 6.4 to 7.5	10.5 Titers Interval 9.1 to 12.2	11.0 Titers Interval 9.8 to 12.3
Stage1: hSBA GMTs for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenW Before Vacc 2	62.6 Titers Interval 53.5 to 73.1	39.1 Titers Interval 34.4 to 44.5	376.8 Titers Interval 311.4 to 456.0	255.5 Titers Interval 221.4 to 295.0
Stage1: hSBA GMTs for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenY Before Vacc 1	10.5 Titers Interval 9.1 to 12.1	11.5 Titers Interval 10.4 to 12.7	19.2 Titers Interval 16.3 to 22.5	19.0 Titers Interval 16.8 to 21.4
Stage1: hSBA GMTs for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 MenY Before Vacc 2	83.6 Titers Interval 71.4 to 97.8	58.6 Titers Interval 52.0 to 66.0	395.2 Titers Interval 327.8 to 476.3	264.0 Titers Interval 228.5 to 305.0

SECONDARY outcome

Timeframe: Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]

Population: Stage 1 EIP analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants measured and analyzed for this outcome measure. "Number Analyzed" signifies number of participants with valid and determinate hSBA results for each strains at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.

Percentage of participants who achieved an hSBA titer >=LLOQ for all 4 primary MenB test strains (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=438 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=864 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) Before Vacc 1	25.3 Percentage of participants Interval 21.2 to 29.7	25.1 Percentage of participants Interval 22.2 to 28.2	—	—
Stage1: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) Before Vacc 2	41.6 Percentage of participants Interval 36.9 to 46.5	41.9 Percentage of participants Interval 38.6 to 45.3	—	—
Stage1: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) Before Vacc 1	13.8 Percentage of participants Interval 10.6 to 17.4	12.8 Percentage of participants Interval 10.6 to 15.3	—	—
Stage1: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) Before Vacc 2	52.2 Percentage of participants Interval 47.2 to 57.1	45.7 Percentage of participants Interval 42.3 to 49.2	—	—
Stage1: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) Before Vacc 1	10.4 Percentage of participants Interval 7.7 to 13.6	11.9 Percentage of participants Interval 9.8 to 14.3	—	—
Stage1: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) Before Vacc 2	26.5 Percentage of participants Interval 22.4 to 31.0	24.2 Percentage of participants Interval 21.3 to 27.2	—	—
Stage1: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) Before Vacc 1	3.7 Percentage of participants Interval 2.1 to 5.9	4.5 Percentage of participants Interval 3.2 to 6.1	—	—
Stage1: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) Before Vacc 2	18.8 Percentage of participants Interval 15.1 to 22.8	16.5 Percentage of participants Interval 14.0 to 19.2	—	—

SECONDARY outcome

Timeframe: Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]

Population: Stage 1 EIP analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants measured and analyzed for this outcome measure. "Number Analyzed" signifies number of participants with valid and determinate hSBA results for each strain at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.

Percentage of participants who achieved an hSBA titer >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for each of the 4 primary MenB test strains was reported in this outcome measure.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=438 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=864 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) Before Vacc 1 >=1:4	34.7 Percentage of participants Interval 30.1 to 39.4	36.6 Percentage of participants Interval 33.3 to 40.0	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) Before Vacc 1 >=1:8	31.9 Percentage of participants Interval 27.5 to 36.5	31.8 Percentage of participants Interval 28.7 to 35.1	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) Before Vacc 1 >=1:16	25.3 Percentage of participants Interval 21.2 to 29.7	25.1 Percentage of participants Interval 22.2 to 28.2	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) Before Vacc 1 >=1:32	11.0 Percentage of participants Interval 8.2 to 14.4	11.4 Percentage of participants Interval 9.4 to 13.8	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) Before Vacc 1 >=1:64	4.7 Percentage of participants Interval 2.9 to 7.1	4.4 Percentage of participants Interval 3.1 to 6.0	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) Before Vacc 1 >=1:128	1.4 Percentage of participants Interval 0.5 to 3.0	0.8 Percentage of participants Interval 0.3 to 1.7	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) Before Vacc 2 >=1:4	48.2 Percentage of participants Interval 43.4 to 53.1	49.8 Percentage of participants Interval 46.3 to 53.2	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) Before Vacc 2 >=1:8	44.5 Percentage of participants Interval 39.7 to 49.3	46.6 Percentage of participants Interval 43.1 to 50.0	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) Before Vacc 2 >=1:16	41.6 Percentage of participants Interval 36.9 to 46.5	41.9 Percentage of participants Interval 38.6 to 45.3	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) Before Vacc 2 >=1:32	23.5 Percentage of participants Interval 19.6 to 27.9	23.5 Percentage of participants Interval 20.7 to 26.5	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) Before Vacc 2 >=1:64	9.9 Percentage of participants Interval 7.2 to 13.1	9.0 Percentage of participants Interval 7.2 to 11.2	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) Before Vacc 2 >=1:128	2.6 Percentage of participants Interval 1.3 to 4.6	3.2 Percentage of participants Interval 2.1 to 4.6	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) Before Vacc 1 >=1:4	19.5 Percentage of participants Interval 15.8 to 23.6	17.5 Percentage of participants Interval 15.0 to 20.3	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) Before Vacc 1 >=1:8	13.8 Percentage of participants Interval 10.6 to 17.4	12.8 Percentage of participants Interval 10.6 to 15.3	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) Before Vacc 1 >=1:16	10.7 Percentage of participants Interval 7.9 to 14.0	11.0 Percentage of participants Interval 9.0 to 13.4	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) Before Vacc 1 >=1:32	6.7 Percentage of participants Interval 4.5 to 9.5	7.6 Percentage of participants Interval 5.9 to 9.6	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) Before Vacc 1 >=1:64	3.8 Percentage of participants Interval 2.2 to 6.1	4.3 Percentage of participants Interval 3.0 to 5.9	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) Before Vacc 1 >=1:128	2.9 Percentage of participants Interval 1.5 to 4.9	2.4 Percentage of participants Interval 1.5 to 3.7	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) Before Vacc 2 >=1:4	56.6 Percentage of participants Interval 51.6 to 61.4	50.6 Percentage of participants Interval 47.1 to 54.1	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) Before Vacc 2 >=1:8	52.2 Percentage of participants Interval 47.2 to 57.1	45.7 Percentage of participants Interval 42.3 to 49.2	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) Before Vacc 2 >=1:16	47.1 Percentage of participants Interval 42.2 to 52.0	41.2 Percentage of participants Interval 37.8 to 44.7	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) Before Vacc 2 >=1:32	35.2 Percentage of participants Interval 30.6 to 40.0	30.9 Percentage of participants Interval 27.8 to 34.3	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) Before Vacc 2 >=1:64	21.4 Percentage of participants Interval 17.5 to 25.6	19.0 Percentage of participants Interval 16.3 to 21.9	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) Before Vacc 2 >=1:128	10.0 Percentage of participants Interval 7.2 to 13.3	9.5 Percentage of participants Interval 7.6 to 11.7	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) Before Vacc 1 >=1:4	14.1 Percentage of participants Interval 10.9 to 17.7	14.6 Percentage of participants Interval 12.3 to 17.2	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) Before Vacc 1 >=1:8	10.4 Percentage of participants Interval 7.7 to 13.6	11.9 Percentage of participants Interval 9.8 to 14.3	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) Before Vacc 1 >=1:16	6.2 Percentage of participants Interval 4.1 to 8.9	8.2 Percentage of participants Interval 6.4 to 10.2	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) Before Vacc 1 >=1:32	3.7 Percentage of participants Interval 2.1 to 5.9	4.2 Percentage of participants Interval 3.0 to 5.8	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) Before Vacc 1 >=1:64	0.9 Percentage of participants Interval 0.3 to 2.3	2.3 Percentage of participants Interval 1.4 to 3.6	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) Before Vacc 1 >=1:128	0.2 Percentage of participants Interval 0.0 to 1.3	1.1 Percentage of participants Interval 0.5 to 2.0	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) Before Vacc 2 >=1:4	30.5 Percentage of participants Interval 26.1 to 35.1	28.0 Percentage of participants Interval 25.0 to 31.2	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) Before Vacc 2 >=1:8	26.5 Percentage of participants Interval 22.4 to 31.0	24.2 Percentage of participants Interval 21.3 to 27.2	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) Before Vacc 2 >=1:16	21.4 Percentage of participants Interval 17.6 to 25.6	20.2 Percentage of participants Interval 17.5 to 23.0	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) Before Vacc 2 >=1:32	11.2 Percentage of participants Interval 8.3 to 14.5	11.0 Percentage of participants Interval 9.0 to 13.3	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) Before Vacc 2 >=1:64	5.1 Percentage of participants Interval 3.2 to 7.6	5.7 Percentage of participants Interval 4.2 to 7.5	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) Before Vacc 2 >=1:128	2.3 Percentage of participants Interval 1.1 to 4.2	2.3 Percentage of participants Interval 1.4 to 3.5	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) Before Vacc 1 >=1:4	7.1 Percentage of participants Interval 4.9 to 10.0	7.2 Percentage of participants Interval 5.6 to 9.1	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) Before Vacc 1 >=1:8	3.7 Percentage of participants Interval 2.1 to 5.9	4.5 Percentage of participants Interval 3.2 to 6.1	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) Before Vacc 1 >=1:16	2.1 Percentage of participants Interval 1.0 to 3.9	3.3 Percentage of participants Interval 2.2 to 4.7	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) Before Vacc 1 >=1:32	0.9 Percentage of participants Interval 0.3 to 2.3	2.1 Percentage of participants Interval 1.2 to 3.3	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) Before Vacc 1 >=1:64	0.7 Percentage of participants Interval 0.1 to 2.0	1.2 Percentage of participants Interval 0.6 to 2.1	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) Before Vacc 1 >=1:128	0.5 Percentage of participants Interval 0.1 to 1.7	0.3 Percentage of participants Interval 0.1 to 1.0	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) Before Vacc 2 >=1:4	29.2 Percentage of participants Interval 24.9 to 33.8	25.7 Percentage of participants Interval 22.8 to 28.8	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) Before Vacc 2 >=1:8	18.8 Percentage of participants Interval 15.1 to 22.8	16.5 Percentage of participants Interval 14.0 to 19.2	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) Before Vacc 2 >=1:16	13.5 Percentage of participants Interval 10.4 to 17.2	11.7 Percentage of participants Interval 9.6 to 14.1	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) Before Vacc 2 >=1:32	7.6 Percentage of participants Interval 5.3 to 10.6	5.8 Percentage of participants Interval 4.3 to 7.6	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) Before Vacc 2 >=1:64	3.3 Percentage of participants Interval 1.8 to 5.5	2.8 Percentage of participants Interval 1.8 to 4.2	—	—
Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) Before Vacc 2 >=1:128	0.7 Percentage of participants Interval 0.1 to 2.1	1.4 Percentage of participants Interval 0.7 to 2.5	—	—

SECONDARY outcome

Timeframe: Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]

Population: Stage 1 EIP analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants measured and analyzed for this outcome measure. "Number Analyzed" signifies number of participants with valid and determinate hSBA results for each of the 4 strains at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.

GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ =1:16 for A22; 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5*LLOQ for analysis. CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the hSBA titers.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=438 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=864 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22), Before vacc 1	10.8 Titers Interval 10.2 to 11.5	10.7 Titers Interval 10.3 to 11.1	—	—
Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22), Before vacc 2	13.7 Titers Interval 12.8 to 14.8	13.8 Titers Interval 13.1 to 14.5	—	—
Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56), Before vacc 1	5.2 Titers Interval 4.9 to 5.7	5.3 Titers Interval 5.0 to 5.6	—	—
Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56), Before vacc 2	13.0 Titers Interval 11.4 to 14.8	11.4 Titers Interval 10.4 to 12.5	—	—
Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24), Before vacc 1	4.6 Titers Interval 4.4 to 4.9	4.9 Titers Interval 4.7 to 5.1	—	—
Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24), Before vacc 2	6.3 Titers Interval 5.8 to 6.9	6.2 Titers Interval 5.9 to 6.6	—	—
Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44), Before vacc 1	4.2 Titers Interval 4.1 to 4.4	4.3 Titers Interval 4.2 to 4.5	—	—
Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44), Before vacc 2	5.4 Titers Interval 5.1 to 5.8	5.3 Titers Interval 5.0 to 5.5	—	—

SECONDARY outcome

Timeframe: 12, 24, 36 and 48 months after Vaccination 2 (Vacc 2)

Population: Stage 2 mITT population included all participants who signed the ICD at Month 18 and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available in Stage 2. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and 'Number Analyzed' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.

Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=LLOQ for ACWY Test Strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=112 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=64 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) n=101 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=73 Participants Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4 MenA 12 Months after Vacc 2	91.1 Percentage of participants Interval 84.2 to 95.6	71.2 Percentage of participants Interval 57.9 to 82.2	97.9 Percentage of participants Interval 88.9 to 99.9	100.0 Percentage of participants Interval 84.6 to 100.0
Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4 MenA 24 Months after Vacc 2	88.1 Percentage of participants Interval 80.2 to 93.7	70.0 Percentage of participants Interval 56.8 to 81.2	100.0 Percentage of participants Interval 94.1 to 100.0	100.0 Percentage of participants Interval 90.5 to 100.0
Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4 MenA 36 Months after Vacc 2	88.4 Percentage of participants Interval 80.2 to 94.1	72.2 Percentage of participants Interval 58.4 to 83.5	100.0 Percentage of participants Interval 93.7 to 100.0	97.0 Percentage of participants Interval 84.2 to 99.9
Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4 MenA 48 Months after Vacc 2	81.7 Percentage of participants Interval 70.7 to 89.9	63.4 Percentage of participants Interval 46.9 to 77.9	100.0 Percentage of participants Interval 91.2 to 100.0	100.0 Percentage of participants Interval 85.2 to 100.0
Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4 MenC 12 Months after Vacc 2	76.8 Percentage of participants Interval 67.9 to 84.2	51.6 Percentage of participants Interval 38.6 to 64.5	96.3 Percentage of participants Interval 87.3 to 99.5	91.3 Percentage of participants Interval 72.0 to 98.9
Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4 MenC 24 Months after Vacc 2	75.2 Percentage of participants Interval 65.7 to 83.3	47.5 Percentage of participants Interval 34.6 to 60.7	96.9 Percentage of participants Interval 91.2 to 99.4	94.4 Percentage of participants Interval 86.2 to 98.4
Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4 MenC 36 Months after Vacc 2	67.4 Percentage of participants Interval 57.0 to 76.6	44.4 Percentage of participants Interval 30.9 to 58.6	96.9 Percentage of participants Interval 91.1 to 99.4	95.5 Percentage of participants Interval 87.5 to 99.1
Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4 MenC 48 Months after Vacc 2	62.0 Percentage of participants Interval 49.7 to 73.2	38.1 Percentage of participants Interval 23.6 to 54.4	98.7 Percentage of participants Interval 92.9 to 100.0	89.7 Percentage of participants Interval 78.8 to 96.1
Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4 MenW 12 Months after Vacc 2	99.1 Percentage of participants Interval 95.1 to 100.0	83.9 Percentage of participants Interval 72.3 to 92.0	100.0 Percentage of participants Interval 92.6 to 100.0	95.5 Percentage of participants Interval 77.2 to 99.9
Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4 MenW 24 Months after Vacc 2	99.0 Percentage of participants Interval 94.7 to 100.0	78.7 Percentage of participants Interval 66.3 to 88.1	100.0 Percentage of participants Interval 94.1 to 100.0	94.6 Percentage of participants Interval 81.8 to 99.3
Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4 MenW 36 Months after Vacc 2	94.8 Percentage of participants Interval 88.4 to 98.3	77.8 Percentage of participants Interval 64.4 to 88.0	100.0 Percentage of participants Interval 93.7 to 100.0	97.0 Percentage of participants Interval 84.2 to 99.9
Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4 MenW 48 Months after Vacc 2	91.4 Percentage of participants Interval 82.3 to 96.8	70.7 Percentage of participants Interval 54.5 to 83.9	100.0 Percentage of participants Interval 91.2 to 100.0	91.3 Percentage of participants Interval 72.0 to 98.9
Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4 MenY 12 Months after Vacc 2	100.0 Percentage of participants Interval 96.8 to 100.0	98.4 Percentage of participants Interval 91.3 to 100.0	100.0 Percentage of participants Interval 92.6 to 100.0	100.0 Percentage of participants Interval 84.6 to 100.0
Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4 MenY 24 Months after Vacc 2	100.0 Percentage of participants Interval 96.4 to 100.0	93.4 Percentage of participants Interval 84.1 to 98.2	100.0 Percentage of participants Interval 94.1 to 100.0	100.0 Percentage of participants Interval 90.5 to 100.0
Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4 MenY 36 Months after Vacc 2	100.0 Percentage of participants Interval 96.3 to 100.0	90.7 Percentage of participants Interval 79.7 to 96.9	100.0 Percentage of participants Interval 93.7 to 100.0	100.0 Percentage of participants Interval 84.2 to 100.0
Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4 MenY 48 Months after Vacc 2	100.0 Percentage of participants Interval 94.9 to 100.0	95.2 Percentage of participants Interval 83.8 to 99.4	100.0 Percentage of participants Interval 91.2 to 100.0	100.0 Percentage of participants Interval 84.6 to 100.0

SECONDARY outcome

Timeframe: 12, 24, 36 and 48 months after Vaccination 2 (Vacc 2)

Population: Stage 2 mITT population analyzed. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and 'Number Analyzed' signifies number of participants with valid and determinate hSBA results on all 4 strains at the given time point. Analysis planned for combined Group 1 and 3, and Group 1 and 4.

Percentage of participants who achieved an hSBA titer >=LLOQ for all 4 primary MenB test strains (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=213 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=137 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) 12 months after Vacc 2	32.7 Percentage of participants Interval 25.6 to 40.5	26.5 Percentage of participants Interval 17.4 to 37.3	—	—
Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) 24 months after Vacc 2	36.7 Percentage of participants Interval 30.0 to 43.9	28.9 Percentage of participants Interval 21.2 to 37.6	—	—
Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) 36 months after Vacc 2	29.2 Percentage of participants Interval 22.8 to 36.3	25.9 Percentage of participants Interval 18.2 to 34.8	—	—
Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22) 48 months after Vacc 2	28.1 Percentage of participants Interval 20.8 to 36.3	31.9 Percentage of participants Interval 22.7 to 42.3	—	—
Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) 12 months after Vacc 2	33.3 Percentage of participants Interval 26.1 to 41.2	32.1 Percentage of participants Interval 22.4 to 43.2	—	—
Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) 24 months after Vacc 2	34.7 Percentage of participants Interval 28.1 to 41.8	33.6 Percentage of participants Interval 25.6 to 42.4	—	—
Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) 36 months after Vacc 2	29.0 Percentage of participants Interval 22.6 to 36.1	33.9 Percentage of participants Interval 25.4 to 43.2	—	—
Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56) 48 months after Vacc 2	34.5 Percentage of participants Interval 26.8 to 42.8	29.6 Percentage of participants Interval 20.8 to 39.7	—	—
Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) 12 months after Vacc 2	30.9 Percentage of participants Interval 24.0 to 38.6	28.2 Percentage of participants Interval 19.0 to 39.0	—	—
Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) 24 months after Vacc 2	33.2 Percentage of participants Interval 26.6 to 40.2	27.5 Percentage of participants Interval 20.0 to 36.0	—	—
Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) 36 months after Vacc 2	35.4 Percentage of participants Interval 28.7 to 42.6	28.3 Percentage of participants Interval 20.5 to 37.3	—	—
Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24) 48 months after Vacc 2	36.6 Percentage of participants Interval 28.7 to 44.9	26.5 Percentage of participants Interval 18.1 to 36.4	—	—
Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) 12 months after Vacc 2	18.7 Percentage of participants Interval 13.1 to 25.4	15.3 Percentage of participants Interval 8.4 to 24.7	—	—
Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) 24 months after Vacc 2	18.0 Percentage of participants Interval 12.9 to 24.0	18.2 Percentage of participants Interval 12.0 to 25.8	—	—
Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) 36 months after Vacc 2	20.2 Percentage of participants Interval 14.8 to 26.6	19.8 Percentage of participants Interval 13.1 to 28.1	—	—
Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44) 48 months after Vacc 2	18.2 Percentage of participants Interval 12.4 to 25.4	16.2 Percentage of participants Interval 9.5 to 24.9	—	—

SECONDARY outcome

Timeframe: 1 month after booster vaccination

Population: Booster EIP=participants who were eligible(met Stage \[S\] 1 eligibility criteria, continually met S 2 eligibility criteria), received booster dose (BD) as intended (same vaccine as received in S 1), had blood drawn for assay testing in required time frame at Month 55, had valid and determinate (VAD) MenB or MenA/C/W/Y assay result after BD, no major protocol violations determined by medical monitor. 'Number Analyzed': participants with VAD hSBA results for ACWY test strains at given time point.

Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer >=LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure. Analysis was planned for Group 1 and 3 separately.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=60 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=70 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or >=LLOQ if Higher) for ACWY Test Strains 1 Month After Booster Vaccination: Groups 1 and 3 (Separately) MenA	100.0 Percentage of participants Interval 94.0 to 100.0	100.0 Percentage of participants Interval 89.4 to 100.0	—	—
Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or >=LLOQ if Higher) for ACWY Test Strains 1 Month After Booster Vaccination: Groups 1 and 3 (Separately) MenC	100.0 Percentage of participants Interval 94.0 to 100.0	100.0 Percentage of participants Interval 94.9 to 100.0	—	—
Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or >=LLOQ if Higher) for ACWY Test Strains 1 Month After Booster Vaccination: Groups 1 and 3 (Separately) MenW	100.0 Percentage of participants Interval 94.0 to 100.0	100.0 Percentage of participants Interval 89.4 to 100.0	—	—
Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or >=LLOQ if Higher) for ACWY Test Strains 1 Month After Booster Vaccination: Groups 1 and 3 (Separately) MenY	100.0 Percentage of participants Interval 94.0 to 100.0	100.0 Percentage of participants Interval 89.4 to 100.0	—	—

SECONDARY outcome

Timeframe: 1 month after booster vaccination

Population: Booster EIP analyzed. Here, "Overall Number of Participants analyzed" signifies number of participants who were measured and analyzed for this outcome measure. 'Number Analyzed'=number of participants with VAD hSBA results for ACWY test strains at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.

Percentage of participants who achieved an hSBA titer >=LLOQ for all 4 primary MenB test strains (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=130 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=88 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains 1 Month After Booster Vaccination (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB80 (A22)	95.1 Percentage of participants Interval 89.6 to 98.2	93.8 Percentage of participants Interval 86.2 to 98.0	—	—
Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains 1 Month After Booster Vaccination (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2001 (A56)	100.0 Percentage of participants Interval 97.1 to 100.0	98.8 Percentage of participants Interval 93.7 to 100.0	—	—
Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains 1 Month After Booster Vaccination (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2948 (B24)	95.1 Percentage of participants Interval 89.7 to 98.2	95.2 Percentage of participants Interval 88.3 to 98.7	—	—
Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains 1 Month After Booster Vaccination (Group 1 and 3 Combined; Group 2 and 4 Combined) PMB2707 (B44)	99.2 Percentage of participants Interval 95.7 to 100.0	98.8 Percentage of participants Interval 93.7 to 100.0	—	—

SECONDARY outcome

Timeframe: 7 days after Vaccination 1 (Vacc 1)

Population: Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Here, 'Number of Participants Analyzed' signifies number of participants measured and analyzed for this outcome measure. Analysis was planned for Group 1 and 3 separately.

Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm) and severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=269 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=269 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: Group 1 and Group 3 Redness: Any	19.7 Percentage of participants Interval 15.1 to 25.0	14.9 Percentage of participants Interval 10.8 to 19.7	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: Group 1 and Group 3 Redness: Mild	7.4 Percentage of participants Interval 4.6 to 11.2	5.6 Percentage of participants Interval 3.2 to 9.0	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: Group 1 and Group 3 Redness: Moderate	10.0 Percentage of participants Interval 6.7 to 14.3	7.4 Percentage of participants Interval 4.6 to 11.2	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: Group 1 and Group 3 Redness: Severe	2.2 Percentage of participants Interval 0.8 to 4.8	1.9 Percentage of participants Interval 0.6 to 4.3	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: Group 1 and Group 3 Swelling: Any	20.8 Percentage of participants Interval 16.1 to 26.2	17.5 Percentage of participants Interval 13.1 to 22.5	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: Group 1 and Group 3 Swelling: Mild	9.3 Percentage of participants Interval 6.1 to 13.4	8.6 Percentage of participants Interval 5.5 to 12.6	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: Group 1 and Group 3 Swelling: Moderate	10.4 Percentage of participants Interval 7.0 to 14.7	8.6 Percentage of participants Interval 5.5 to 12.6	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: Group 1 and Group 3 Swelling: Severe	1.1 Percentage of participants Interval 0.2 to 3.2	0.4 Percentage of participants Interval 0.0 to 2.1	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: Group 1 and Group 3 Pain at injection site: Any	89.2 Percentage of participants Interval 84.9 to 92.7	90.3 Percentage of participants Interval 86.2 to 93.6	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: Group 1 and Group 3 Pain at injection site: Mild	37.2 Percentage of participants Interval 31.4 to 43.3	45.4 Percentage of participants Interval 39.3 to 51.5	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: Group 1 and Group 3 Pain at injection site: Moderate	45.7 Percentage of participants Interval 39.7 to 51.9	40.1 Percentage of participants Interval 34.2 to 46.3	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: Group 1 and Group 3 Pain at injection site: Severe	6.3 Percentage of participants Interval 3.7 to 9.9	4.8 Percentage of participants Interval 2.6 to 8.1	—	—

SECONDARY outcome

Timeframe: 7 days after Vaccination 2 (Vacc 2)

Population: Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Here, 'Number of Participants Analyzed' signifies number of participants measured and analyzed for this outcome measure. Analysis was planned for Group 1 and 3 separately.

Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm) and severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=230 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=233 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: Group 1 and Group 3 Redness: Any	23.0 Percentage of participants Interval 17.8 to 29.0	19.3 Percentage of participants Interval 14.4 to 25.0	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: Group 1 and Group 3 Redness: Mild	7.0 Percentage of participants Interval 4.0 to 11.1	6.9 Percentage of participants Interval 4.0 to 10.9	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: Group 1 and Group 3 Redness: Moderate	11.7 Percentage of participants Interval 7.9 to 16.6	9.0 Percentage of participants Interval 5.7 to 13.4	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: Group 1 and Group 3 Redness: Severe	4.3 Percentage of participants Interval 2.1 to 7.9	3.4 Percentage of participants Interval 1.5 to 6.7	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: Group 1 and Group 3 Swelling: Any	19.1 Percentage of participants Interval 14.3 to 24.8	18.0 Percentage of participants Interval 13.3 to 23.6	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: Group 1 and Group 3 Swelling: Mild	8.7 Percentage of participants Interval 5.4 to 13.1	5.6 Percentage of participants Interval 3.0 to 9.4	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: Group 1 and Group 3 Swelling: Moderate	10.0 Percentage of participants Interval 6.4 to 14.6	11.2 Percentage of participants Interval 7.4 to 15.9	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: Group 1 and Group 3 Swelling: Severe	0.4 Percentage of participants Interval 0.0 to 2.4	1.3 Percentage of participants Interval 0.3 to 3.7	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: Group 1 and Group 3 Pain at injection site: Any	85.2 Percentage of participants Interval 80.0 to 89.5	83.7 Percentage of participants Interval 78.3 to 88.2	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: Group 1 and Group 3 Pain at injection site: Mild	34.3 Percentage of participants Interval 28.2 to 40.9	37.8 Percentage of participants Interval 31.5 to 44.3	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: Group 1 and Group 3 Pain at injection site: Moderate	47.0 Percentage of participants Interval 40.4 to 53.6	38.2 Percentage of participants Interval 31.9 to 44.8	—	—
Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: Group 1 and Group 3 Pain at injection site: Severe	3.9 Percentage of participants Interval 1.8 to 7.3	7.7 Percentage of participants Interval 4.6 to 11.9	—	—

SECONDARY outcome

Timeframe: 7 days after Vaccination 1 (Vacc 1)

Population: Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Here, 'Number of Participants Analyzed' signifies number of participants measured and analyzed for this outcome measure. Analysis was planned for Group 1 and 3 separately.

Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain and joint pain were recorded in an e-diary. Fever was defined as >=38.0 degree C and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 in 24 hours).

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=269 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=269 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Fever: >= 38.0 degree C	7.4 Percentage of participants Interval 4.6 to 11.2	5.2 Percentage of participants Interval 2.9 to 8.6	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Fever: 38.0 to 38.4 degree C	4.1 Percentage of participants Interval 2.1 to 7.2	4.1 Percentage of participants Interval 2.1 to 7.2	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Fever: 38.4 to 38.9 degree C	2.2 Percentage of participants Interval 0.8 to 4.8	0.7 Percentage of participants Interval 0.1 to 2.7	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Fever: 38.9 to 40.0 degree C	1.1 Percentage of participants Interval 0.2 to 3.2	0.4 Percentage of participants Interval 0.0 to 2.1	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Fever: > 40.0 degree C	0.0 Percentage of participants Interval 0.0 to 1.4	0.0 Percentage of participants Interval 0.0 to 1.4	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Fatigue: Any	56.5 Percentage of participants Interval 50.4 to 62.5	49.1 Percentage of participants Interval 42.9 to 55.2	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Fatigue: Mild	26.8 Percentage of participants Interval 21.6 to 32.5	27.9 Percentage of participants Interval 22.6 to 33.6	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Fatigue: Moderate	25.3 Percentage of participants Interval 20.2 to 30.9	17.5 Percentage of participants Interval 13.1 to 22.5	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Fatigue: Severe	4.5 Percentage of participants Interval 2.3 to 7.7	3.7 Percentage of participants Interval 1.8 to 6.7	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Headache: Any	48.3 Percentage of participants Interval 42.2 to 54.5	45.0 Percentage of participants Interval 38.9 to 51.1	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Headache: Mild	27.1 Percentage of participants Interval 21.9 to 32.9	29.4 Percentage of participants Interval 24.0 to 35.2	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Headache: Moderate	19.3 Percentage of participants Interval 14.8 to 24.6	14.1 Percentage of participants Interval 10.2 to 18.9	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Headache: Severe	1.9 Percentage of participants Interval 0.6 to 4.3	1.5 Percentage of participants Interval 0.4 to 3.8	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Chills: Any	20.1 Percentage of participants Interval 15.5 to 25.4	14.9 Percentage of participants Interval 10.8 to 19.7	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Chills: Mild	14.5 Percentage of participants Interval 10.5 to 19.3	9.3 Percentage of participants Interval 6.1 to 13.4	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Chills: Moderate	4.5 Percentage of participants Interval 2.3 to 7.7	4.8 Percentage of participants Interval 2.6 to 8.1	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Chills: Severe	1.1 Percentage of participants Interval 0.2 to 3.2	0.7 Percentage of participants Interval 0.1 to 2.7	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Vomiting: Any	2.6 Percentage of participants Interval 1.1 to 5.3	1.9 Percentage of participants Interval 0.6 to 4.3	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Vomiting: Mild	2.2 Percentage of participants Interval 0.8 to 4.8	1.9 Percentage of participants Interval 0.6 to 4.3	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Vomiting: Moderate	0.4 Percentage of participants Interval 0.0 to 2.1	0.0 Percentage of participants Interval 0.0 to 1.4	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Vomiting: severe	0.0 Percentage of participants Interval 0.0 to 1.4	0.0 Percentage of participants Interval 0.0 to 1.4	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Diarrhea: Any	12.3 Percentage of participants Interval 8.6 to 16.8	15.2 Percentage of participants Interval 11.2 to 20.1	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Diarrhea: Mild	10.0 Percentage of participants Interval 6.7 to 14.3	10.8 Percentage of participants Interval 7.3 to 15.1	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Diarrhea: Moderate	2.2 Percentage of participants Interval 0.8 to 4.8	4.5 Percentage of participants Interval 2.3 to 7.7	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Diarrhea: Severe	0.0 Percentage of participants Interval 0.0 to 1.4	0.0 Percentage of participants Interval 0.0 to 1.4	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Muscle pain: Any	29.0 Percentage of participants Interval 23.6 to 34.8	22.7 Percentage of participants Interval 17.8 to 28.2	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Muscle pain: Mild	17.1 Percentage of participants Interval 12.8 to 22.1	14.5 Percentage of participants Interval 10.5 to 19.3	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Muscle pain: Moderate	10.4 Percentage of participants Interval 7.0 to 14.7	7.1 Percentage of participants Interval 4.3 to 10.8	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Muscle pain: Severe	1.5 Percentage of participants Interval 0.4 to 3.8	1.1 Percentage of participants Interval 0.2 to 3.2	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Joint pain: Any	20.8 Percentage of participants Interval 16.1 to 26.2	18.2 Percentage of participants Interval 13.8 to 23.4	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Joint pain: Mild	13.0 Percentage of participants Interval 9.2 to 17.6	10.8 Percentage of participants Interval 7.3 to 15.1	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Joint pain: Moderate	7.8 Percentage of participants Interval 4.9 to 11.7	6.7 Percentage of participants Interval 4.0 to 10.4	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 Joint pain: Severe	0.0 Percentage of participants Interval 0.0 to 1.4	0.7 Percentage of participants Interval 0.1 to 2.7	—	—

SECONDARY outcome

Timeframe: 7 days after Vaccination 2 (Vacc 2)

Population: Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Here, 'Number of Participants Analyzed' signifies number of participants measured and analyzed for this outcome measure. Analysis was planned for Group 1 and 3 separately.

Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain and joint pain were recorded in an e-diary. Fever was defined as >=38.0 degree C and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 in 24 hours).

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=230 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=233 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Fever: >= 38.0 degree C	3.5 Percentage of participants Interval 1.5 to 6.7	1.7 Percentage of participants Interval 0.5 to 4.3	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Fever: 38.0 to 38.4°C	2.2 Percentage of participants Interval 0.7 to 5.0	0.9 Percentage of participants Interval 0.1 to 3.1	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Fever: 38.5 to 38.9°C	1.3 Percentage of participants Interval 0.3 to 3.8	0.9 Percentage of participants Interval 0.1 to 3.1	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Fever: 39.0 to 40.0°C	0.0 Percentage of participants Interval 0.0 to 1.6	0.0 Percentage of participants Interval 0.0 to 1.6	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Fever: > 40.0°C	0.0 Percentage of participants Interval 0.0 to 1.6	0.0 Percentage of participants Interval 0.0 to 1.6	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Fatigue: Any	49.6 Percentage of participants Interval 42.9 to 56.2	47.6 Percentage of participants Interval 41.1 to 54.3	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Fatigue: Mild	20.9 Percentage of participants Interval 15.8 to 26.7	26.2 Percentage of participants Interval 20.7 to 32.3	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Fatigue: Moderate	26.1 Percentage of participants Interval 20.5 to 32.3	18.9 Percentage of participants Interval 14.1 to 24.5	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Fatigue: Severe	2.6 Percentage of participants Interval 1.0 to 5.6	2.6 Percentage of participants Interval 1.0 to 5.5	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Headache: Any	41.7 Percentage of participants Interval 35.3 to 48.4	43.8 Percentage of participants Interval 37.3 to 50.4	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Headache: Mild	22.6 Percentage of participants Interval 17.4 to 28.6	26.6 Percentage of participants Interval 21.1 to 32.8	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Headache: Moderate	17.8 Percentage of participants Interval 13.1 to 23.4	13.3 Percentage of participants Interval 9.2 to 18.4	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Headache: Severe	1.3 Percentage of participants Interval 0.3 to 3.8	3.9 Percentage of participants Interval 1.8 to 7.2	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Chills: Any	20.9 Percentage of participants Interval 15.8 to 26.7	19.3 Percentage of participants Interval 14.4 to 25.0	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Chills: Mild	16.1 Percentage of participants Interval 11.6 to 21.5	11.6 Percentage of participants Interval 7.8 to 16.4	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Chills: Moderate	3.9 Percentage of participants Interval 1.8 to 7.3	5.2 Percentage of participants Interval 2.7 to 8.8	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Chills: Severe	0.9 Percentage of participants Interval 0.1 to 3.1	2.6 Percentage of participants Interval 1.0 to 5.5	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Vomiting: Any	1.7 Percentage of participants Interval 0.5 to 4.4	3.9 Percentage of participants Interval 1.8 to 7.2	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Vomiting: Mild	1.7 Percentage of participants Interval 0.5 to 4.4	3.4 Percentage of participants Interval 1.5 to 6.7	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Vomiting: Moderate	0.0 Percentage of participants Interval 0.0 to 1.6	0.4 Percentage of participants Interval 0.0 to 2.4	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Vomiting: Severe	0.0 Percentage of participants Interval 0.0 to 1.6	0.0 Percentage of participants Interval 0.0 to 1.6	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Diarrhea: Any	13.5 Percentage of participants Interval 9.3 to 18.6	8.2 Percentage of participants Interval 5.0 to 12.4	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Diarrhea: Mild	9.6 Percentage of participants Interval 6.1 to 14.1	5.2 Percentage of participants Interval 2.7 to 8.8	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Diarrhea: Moderate	3.9 Percentage of participants Interval 1.8 to 7.3	2.6 Percentage of participants Interval 1.0 to 5.5	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Diarrhea: Severe	0.0 Percentage of participants Interval 0.0 to 1.6	0.4 Percentage of participants Interval 0.0 to 2.4	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Muscle pain: Any	24.8 Percentage of participants Interval 19.3 to 30.9	19.3 Percentage of participants Interval 14.4 to 25.0	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Muscle pain: Mild	13.0 Percentage of participants Interval 9.0 to 18.1	8.6 Percentage of participants Interval 5.3 to 12.9	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Muscle pain: Moderate	10.9 Percentage of participants Interval 7.2 to 15.6	9.9 Percentage of participants Interval 6.4 to 14.4	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Muscle pain: Severe	0.9 Percentage of participants Interval 0.1 to 3.1	0.9 Percentage of participants Interval 0.1 to 3.1	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Joint pain: Any	18.7 Percentage of participants Interval 13.9 to 24.3	18.0 Percentage of participants Interval 13.3 to 23.6	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Joint pain: Mild	9.1 Percentage of participants Interval 5.7 to 13.6	10.7 Percentage of participants Interval 7.1 to 15.4	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Joint pain: Moderate	9.1 Percentage of participants Interval 5.7 to 13.6	6.4 Percentage of participants Interval 3.6 to 10.4	—	—
Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 Joint pain: Severe	0.4 Percentage of participants Interval 0.0 to 2.4	0.9 Percentage of participants Interval 0.1 to 3.1	—	—

SECONDARY outcome

Timeframe: 30 days after Vaccination 1

Population: Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Here, 'Number of Participants Analyzed' signifies number of participants measured and analyzed for this outcome measure. Analysis was planned for Group 1 and Group 3 separately.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=269 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=269 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With Antipyretic Medication Use 30 Days After Vaccination 1: Group 1 and Group 3	20.8 Percentage of participants Interval 16.1 to 26.2	13.8 Percentage of participants Interval 9.9 to 18.5	—	—

SECONDARY outcome

Timeframe: 30 days after Vaccination 2

Population: Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Here, 'Number of Participants Analyzed' signifies number of participants measured and analyzed for this outcome measure. Analysis was planned for Group 1 and Group 3 separately.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=230 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=233 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With Antipyretic Medication Use 30 Days After Vaccination 2: Group 1 and Group 3	17.8 Percentage of participants Interval 13.1 to 23.4	13.3 Percentage of participants Interval 9.2 to 18.4	—	—

SECONDARY outcome

Timeframe: 30 days after Vaccination 1

Population: Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for Group 1 and Group 3 separately.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=272 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=271 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Vaccination 1: Group 1 and Group 3	0.0 Percentage of participants Interval 0.0 to 1.3	0.7 Percentage of participants Interval 0.1 to 2.6	—	—

SECONDARY outcome

Timeframe: 30 days after Vaccination 2

Population: Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Analysis was planned for Group 1 and Group 3 separately.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=242 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=244 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Vaccination 2: Group 1 and Group 3	0.4 Percentage of participants Interval 0.0 to 2.3	0.0 Percentage of participants Interval 0.0 to 1.5	—	—

SECONDARY outcome

Timeframe: 30 days after any vaccination

Population: The safety population for Stage 1 included participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3 separately.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=272 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=271 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Any Vaccination: Group 1 and Group 3	0.4 Percentage of participants Interval 0.0 to 2.0	0.7 Percentage of participants Interval 0.1 to 2.6	—	—

SECONDARY outcome

Timeframe: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

Population: Stage 1 safety population: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and 3 separately.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=272 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=271 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 SAE During the Vaccination Phase: Group 1 and Group 3	0.4 Percentage of participants Interval 0.0 to 2.0	1.8 Percentage of participants Interval 0.6 to 4.3	—	—

SECONDARY outcome

Timeframe: Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)

Population: Stage 1 Follow-up Safety population: participants who received at least 1 dose of investigational product and for whom safety information was available from after Visit 4 (Month 7) up to and including Visit 5 (Month 12). Analysis was planned for Group 1 and 3 separately. Overall number of participants analysed included only those participants who met criteria for Stage 1 follow-up safety population.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. There was one participant who did not meet criteria for Stage 1 follow-up safety population. The subject's SAE happened in the follow-up phase but was not included in the follow-up safety population for Stage 1 (but in the safety population for Stage 1). Therefore, the SAE was not included in the follow-up table but in the broadly defined throughout Stage 1 table.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=239 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=239 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Follow-up Phase: Group 1 and Group 3	0.8 Percentage of participants Interval 0.1 to 3.0	0.4 Percentage of participants Interval 0.0 to 2.3	—	—

SECONDARY outcome

Timeframe: Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)

Population: Stage 1 safety population: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and 3 separately. Here overall number of participants analysed included those participants who met criteria for Stage 1 safety population.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. There was one participant who did not meet criteria for Stage 1 follow-up safety population. The subject's SAE happened in the follow-up phase but was not included in the follow-up safety population for Stage 1 (but in the safety population for Stage 1). Therefore, the SAE was not included in the follow-up table but in the broadly defined throughout Stage 1 table.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=272 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=271 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 SAE Throughout the Stage 1: Group 1 and Group 3	1.5 Percentage of participants Interval 0.4 to 3.7	2.2 Percentage of participants Interval 0.8 to 4.8	—	—

SECONDARY outcome

Timeframe: 30 days after vaccination 1

Population: Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for Group 1 and Group 3 separately.

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=272 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=271 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 1: Group 1 and Group 3	4.8 Percentage of participants Interval 2.6 to 8.0	5.9 Percentage of participants Interval 3.4 to 9.4	—	—

SECONDARY outcome

Timeframe: 30 days after vaccination 2

Population: Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Analysis was planned for Group 1 and Group 3 separately.

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=242 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=244 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 2: Group 1 and Group 3	5.8 Percentage of participants Interval 3.2 to 9.5	9.0 Percentage of participants Interval 5.7 to 13.3	—	—

SECONDARY outcome

Timeframe: 30 days after any vaccination

Population: Stage 1 safety population: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3 separately.

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=272 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=271 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination: Group 1 and Group 3	9.6 Percentage of participants Interval 6.3 to 13.7	13.3 Percentage of participants Interval 9.5 to 17.9	—	—

SECONDARY outcome

Timeframe: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

Population: Stage 1 safety population: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and 3 separately.

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=272 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=271 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Vaccination Phase: Group 1 and Group 3	23.9 Percentage of participants Interval 19.0 to 29.4	28.4 Percentage of participants Interval 23.1 to 34.2	—	—

SECONDARY outcome

Timeframe: Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)

Population: Stage 1 Follow-up Safety population: participants who received at least 1 dose of investigational product and for whom safety information was available from after Visit 4 (Month 7) up to and including Visit 5 (Month 12). Analysis was planned for Group 1 and 3 separately.

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=239 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=239 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Follow-up Phase: Group 1 and Group 3	13.8 Percentage of participants Interval 9.7 to 18.8	18.8 Percentage of participants Interval 14.1 to 24.4	—	—

SECONDARY outcome

Timeframe: Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)

Population: Stage 1 safety population: Participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and 3 separately.

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=272 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=271 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Medically Attended AE Throughout the Stage 1: Group 1 and Group 3	30.9 Percentage of participants Interval 25.4 to 36.7	35.1 Percentage of participants Interval 29.4 to 41.1	—	—

SECONDARY outcome

Timeframe: 30 days after vaccination 1

Population: Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for Group 1 and Group 3 separately.

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=272 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=271 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Vaccination 1: Group 1 and Group 3	0.0 Percentage of participants Interval 0.0 to 1.3	0.0 Percentage of participants Interval 0.0 to 1.4	—	—

SECONDARY outcome

Timeframe: 30 days after vaccination 2

Population: Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Analysis was planned for Group 1 and Group 3 separately.

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=242 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=244 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Vaccination 2: Group 1 and Group 3	0.0 Percentage of participants Interval 0.0 to 1.5	0.0 Percentage of participants Interval 0.0 to 1.5	—	—

SECONDARY outcome

Timeframe: 30 days after any vaccination

Population: Stage 1 safety population: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3 separately.

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=272 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=271 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Any Vaccination: Group 1 and Group 3	0.0 Percentage of participants Interval 0.0 to 1.3	0.0 Percentage of participants Interval 0.0 to 1.4	—	—

SECONDARY outcome

Timeframe: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

Population: Stage 1 safety population: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3 separately.

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=272 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=271 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 NDCMC During the Stage 1 Vaccination Phase: Group 1 and Group 3	0.7 Percentage of participants Interval 0.1 to 2.6	0.0 Percentage of participants Interval 0.0 to 1.4	—	—

SECONDARY outcome

Timeframe: Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)

Population: Stage 1 Follow-up Safety population: participants who received at least 1 dose of investigational product and for whom safety information was available from after Visit 4 (Month 7) up to and including Visit 5 (Month 12). Analysis was planned for Group 1 and Group 3 separately.

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=239 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=239 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 NDCMC During the Stage 1 Follow-up Phase: Group 1 and Group 3	0.4 Percentage of participants Interval 0.0 to 2.3	0.0 Percentage of participants Interval 0.0 to 1.5	—	—

SECONDARY outcome

Timeframe: Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)

Population: Stage 1 safety population: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3 separately.

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=272 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=271 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 NDCMC Throughout the Stage 1: Group 1 and Group 3	1.1 Percentage of participants Interval 0.2 to 3.2	0.0 Percentage of participants Interval 0.0 to 1.4	—	—

SECONDARY outcome

Timeframe: 30 days after vaccination 1

Population: Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for Group 1 and Group 3 separately.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=272 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=271 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 1: Group 1 and Group 3	15.1 Percentage of participants Interval 11.0 to 19.9	11.1 Percentage of participants Interval 7.6 to 15.4	—	—

SECONDARY outcome

Timeframe: 30 days after vaccination 2

Population: Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Analysis was planned for Group 1 and Group 3 separately.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=242 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=244 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 2: Group 1 and Group 3	16.1 Percentage of participants Interval 11.7 to 21.4	12.3 Percentage of participants Interval 8.5 to 17.1	—	—

SECONDARY outcome

Timeframe: 30 days after any vaccination

Population: Stage 1 safety population: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3 separately.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=272 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=271 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination Any Vaccination: Group 1 and Group 3	25.7 Percentage of participants Interval 20.6 to 31.4	19.9 Percentage of participants Interval 15.3 to 25.2	—	—

SECONDARY outcome

Timeframe: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

Population: Stage 1 safety population: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3 separately.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=272 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=271 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 AE During the Stage 1 Vaccination Phase: Group 1 and Group 3	41.5 Percentage of participants Interval 35.6 to 47.6	36.9 Percentage of participants Interval 31.1 to 42.9	—	—

SECONDARY outcome

Timeframe: 30 minutes after Vaccination 1

Population: Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for Group 1 and 3 separately.

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

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=272 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=271 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 1: Group 1 and Group 3	0.0 Percentage of participants Interval 0.0 to 1.3	0.0 Percentage of participants Interval 0.0 to 1.4	—	—

SECONDARY outcome

Timeframe: 30 minutes after Vaccination 2

Population: Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Analysis was planned for Group 1 and 3 separately.

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

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=242 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=244 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 2: Group 1 and Group 3	0.0 Percentage of participants Interval 0.0 to 1.5	0.0 Percentage of participants Interval 0.0 to 1.5	—	—

SECONDARY outcome

Timeframe: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

Population: Safety population for Stage 1 included participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3 separately.

Outcome measures

Measure	Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM) n=272 Participants Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.	Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=271 Participants Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Group 3: MenABCWY + Saline (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Stage1: Number of Participants Who Missed School/Work Due to AE During the Stage 1 Vaccination Phase: Group 1 and Group 3	38 Participants	46 Participants	—	—

Adverse Events

Stage 1: Group 1: MenABCWY + Saline (ACWY-Naive)

Serious events: 5 serious events

Other events: 267 other events

Deaths: 1 deaths

Stage 1: Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)

Serious events: 6 serious events

Other events: 508 other events

Deaths: 0 deaths

Stage 1: Group 3: MenABCWY + Saline (ACWY-Experienced)

Serious events: 6 serious events

Other events: 259 other events

Deaths: 0 deaths

Stage 1: Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)

Serious events: 9 serious events

Other events: 502 other events

Deaths: 0 deaths

Stage 2: Group 1: MenABCWY + Saline (ACWY-Naive)

Serious events: 1 serious events

Other events: 54 other events

Deaths: 0 deaths

Stage 2: Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

Stage 2: Group 3: MenABCWY + Saline (ACWY-Experienced)

Serious events: 3 serious events

Other events: 72 other events

Deaths: 0 deaths

Stage 2: Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)

Serious events: 2 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Measure	Stage 1: Group 1: MenABCWY + Saline (ACWY-Naive) n=272 participants at risk Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Stage 1: Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=534 participants at risk Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Stage 1: Group 3: MenABCWY + Saline (ACWY-Experienced) n=271 participants at risk Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Stage 1: Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=523 participants at risk Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Stage 2: Group 1: MenABCWY + Saline (ACWY-Naive) n=114 participants at risk Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Stage 2: Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=65 participants at risk Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Stage 2: Group 3: MenABCWY + Saline (ACWY-Experienced) n=101 participants at risk Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Stage 2: Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=73 participants at risk Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Cardiac disorders Cardiac failure chronic	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Cardiac disorders Cardiopulmonary failure	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Cardiac disorders Myocarditis	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Gastrointestinal disorders Faecaloma	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
General disorders Cyst	0.37% 1/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Hepatobiliary disorders Cholelithiasis	0.37% 1/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations Meningitis viral	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations Pharyngitis	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations Pneumonia	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Injury, poisoning and procedural complications Overdose	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 1/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Injury, poisoning and procedural complications Road traffic accident	0.37% 1/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 1/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioma	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Nervous system disorders Dyskinesia	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 1/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Nervous system disorders Epilepsy	0.37% 1/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Nervous system disorders Migraine with aura	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 1/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.37% 1/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.88% 1/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.99% 1/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.4% 1/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Psychiatric disorders Aggression	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 1/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Psychiatric disorders Conversion disorder	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 1/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Psychiatric disorders Depression	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Psychiatric disorders Depression suicidal	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Psychiatric disorders Major depression	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.5% 1/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Psychiatric disorders Oppositional defiant disorder	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Psychiatric disorders Suicidal ideation	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.74% 2/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Psychiatric disorders Suicide attempt	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 1/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.99% 1/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	2.0% 2/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Psychiatric disorders Psychotic disorder	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.4% 1/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.

Other adverse events

Measure	Stage 1: Group 1: MenABCWY + Saline (ACWY-Naive) n=272 participants at risk Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Stage 1: Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=534 participants at risk Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Stage 1: Group 3: MenABCWY + Saline (ACWY-Experienced) n=271 participants at risk Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Stage 1: Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=523 participants at risk Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Stage 2: Group 1: MenABCWY + Saline (ACWY-Naive) n=114 participants at risk Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Stage 2: Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive) n=65 participants at risk Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.	Stage 2: Group 3: MenABCWY + Saline (ACWY-Experienced) n=101 participants at risk Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.	Stage 2: Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced) n=73 participants at risk Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.
Cardiac disorders Tachycardia	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.5% 1/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Congenital, familial and genetic disorders Pectus excavatum	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.5% 1/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Gastrointestinal disorders Abdominal pain	1.8% 5/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 1/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.38% 2/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.4% 1/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Gastrointestinal disorders Constipation	1.5% 4/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 2/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.38% 2/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Gastrointestinal disorders Diarrhoea	0.37% 1/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.1% 3/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.76% 4/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.37% 1/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.3% 7/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Gastrointestinal disorders Nausea	1.5% 4/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.7% 9/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 1/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.96% 5/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.88% 1/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	2.0% 2/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Gastrointestinal disorders Vomiting	4.8% 13/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	5.8% 31/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	4.8% 13/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	6.3% 33/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.8% 2/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	2.0% 2/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.4% 1/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
General disorders Influenza like illness	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 2/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.5% 4/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	2.1% 11/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
General disorders Pain	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.4% 1/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Immune system disorders Seasonal allergy	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.56% 3/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.1% 3/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.38% 2/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations Acute sinusitis	2.2% 6/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.94% 5/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.74% 2/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	2.5% 13/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations Bacterial vaginosis	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.1% 3/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations Bronchitis	1.1% 3/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.1% 6/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.74% 2/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	2.5% 13/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.8% 2/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations COVID-19	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	2.6% 3/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	6.2% 4/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	4.0% 4/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	2.7% 2/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations Ear infection	1.1% 3/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.1% 6/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations Gastroenteritis	2.2% 6/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	2.6% 14/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.5% 4/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.7% 9/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations Gastroenteritis viral	2.9% 8/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	2.2% 12/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.5% 4/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.1% 6/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.88% 1/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations Impetigo	0.37% 1/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.1% 3/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.88% 1/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations Influenza	3.3% 9/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	2.6% 14/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.5% 4/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	3.4% 18/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.8% 2/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations Nasopharyngitis	4.0% 11/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	3.6% 19/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	5.9% 16/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	4.0% 21/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.99% 1/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations Otitis externa	1.1% 3/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 2/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.74% 2/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.96% 5/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations Otitis media	0.37% 1/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	2.1% 11/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	2.2% 6/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.76% 4/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations Otitis media acute	1.1% 3/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.94% 5/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 1/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.38% 2/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations Pharyngitis	1.1% 3/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.7% 9/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	3.0% 8/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	2.9% 15/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations Pharyngitis streptococcal	2.2% 6/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.7% 9/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	3.3% 9/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	2.5% 13/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations Sinusitis	1.8% 5/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.7% 9/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	3.3% 9/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	2.7% 14/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations Tonsillitis	0.74% 2/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 2/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	2.6% 7/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.1% 6/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations Upper respiratory tract infection	5.1% 14/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	6.0% 32/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	4.1% 11/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	5.4% 28/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.4% 1/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations Urinary tract infection	1.8% 5/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	2.1% 11/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.8% 5/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.9% 10/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.88% 1/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.4% 1/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations Viral pharyngitis	1.1% 3/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.56% 3/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 1/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.7% 9/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Infections and infestations Viral upper respiratory tract infection	1.1% 3/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	2.1% 11/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 1/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.5% 8/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Injury, poisoning and procedural complications Contusion	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.8% 5/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.1% 6/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Injury, poisoning and procedural complications Eye injury	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.4% 1/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Injury, poisoning and procedural complications Ligament sprain	1.8% 5/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.3% 7/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	3.0% 8/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.3% 7/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.88% 1/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.99% 1/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Injury, poisoning and procedural complications Muscle strain	0.37% 1/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 2/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.74% 2/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.3% 7/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Injury, poisoning and procedural complications Skin laceration	1.5% 4/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.56% 3/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 1/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.1% 6/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.88% 1/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.5% 1/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.4% 1/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Investigations SARS-CoV-2 test positive	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.88% 1/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	2.0% 2/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	4.1% 3/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.1% 3/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.57% 3/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Musculoskeletal and connective tissue disorders Arthralgia	1.1% 3/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.56% 3/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.1% 3/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.76% 4/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.5% 1/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.99% 1/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Musculoskeletal and connective tissue disorders Back pain	0.37% 1/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.94% 5/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.1% 3/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.96% 5/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Musculoskeletal and connective tissue disorders Pain in extremity	0.37% 1/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.56% 3/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.1% 3/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Musculoskeletal and connective tissue disorders Scoliosis	0.37% 1/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.4% 1/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Nervous system disorders Dizziness	0.37% 1/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.3% 7/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.74% 2/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.38% 2/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.88% 1/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Nervous system disorders Headache	59.9% 163/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	58.4% 312/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	58.7% 159/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	59.7% 312/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	20.2% 23/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	32.3% 21/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	34.7% 35/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	42.5% 31/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Nervous system disorders Migraine	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.94% 5/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.1% 3/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.99% 1/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Nervous system disorders Syncope	0.74% 2/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.3% 7/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.1% 3/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.38% 2/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.88% 1/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Psychiatric disorders Anxiety	1.1% 3/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.1% 6/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.96% 5/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.99% 1/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Psychiatric disorders Depression	1.5% 4/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.75% 4/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 1/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.76% 4/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.4% 1/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Psychiatric disorders Insomnia	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 1/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.5% 1/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Psychiatric disorders Psychophysiologic insomnia	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.4% 1/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Reproductive system and breast disorders Dysmenorrhoea	0.74% 2/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 2/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.74% 2/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.38% 2/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.4% 1/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Respiratory, thoracic and mediastinal disorders Cough	0.37% 1/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 2/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 1/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.1% 6/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	4.6% 3/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.1% 3/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.56% 3/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 1/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.76% 4/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.4% 1/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.74% 2/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.5% 4/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.57% 3/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.5% 1/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Skin and subcutaneous tissue disorders Dermatitis contact	1.5% 4/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.5% 4/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.76% 4/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Skin and subcutaneous tissue disorders Eczema	1.1% 3/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.74% 2/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.57% 3/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.88% 1/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Skin and subcutaneous tissue disorders Urticaria	1.1% 3/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.37% 1/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.1% 6/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Vascular disorders Haematoma	0.00% 0/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.19% 1/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.4% 1/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Gastrointestinal disorders Diarrhoea (DIARRHEA)	20.2% 55/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	19.5% 104/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	19.9% 54/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	20.1% 105/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	2.6% 3/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	6.2% 4/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	6.9% 7/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	9.6% 7/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
General disorders Chills	30.1% 82/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	28.5% 152/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	24.7% 67/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	27.0% 141/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	5.3% 6/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	10.8% 7/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	13.9% 14/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	11.0% 8/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
General disorders Fatigue	66.2% 180/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	59.0% 315/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	60.1% 163/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	65.8% 344/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	24.6% 28/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	36.9% 24/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	46.5% 47/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	50.7% 37/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
General disorders Injection site pain (PAIN AT INJECTION SITE)	94.1% 256/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	89.7% 479/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	92.6% 251/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	91.8% 480/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	42.1% 48/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	52.3% 34/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	64.4% 65/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	68.5% 50/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
General disorders Pyrexia (FEVER)	10.7% 29/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	10.5% 56/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	6.3% 17/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	7.1% 37/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	2.6% 3/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.5% 1/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	0.00% 0/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	1.4% 1/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
General disorders Swelling	28.3% 77/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	23.0% 123/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	24.7% 67/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	21.8% 114/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	9.6% 11/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	13.8% 9/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	13.9% 14/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	13.7% 10/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Musculoskeletal and connective tissue disorders Arthralgia (JOINT PAIN)	29.0% 79/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	28.7% 153/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	28.8% 78/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	28.3% 148/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	10.5% 12/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	15.4% 10/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	15.8% 16/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	12.3% 9/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Musculoskeletal and connective tissue disorders Myalgia (MUSCLE PAIN)	38.2% 104/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	38.2% 204/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	32.1% 87/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	35.6% 186/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	9.6% 11/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	18.5% 12/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	23.8% 24/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	17.8% 13/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.
Skin and subcutaneous tissue disorders Erythema (REDNESS)	26.8% 73/272 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	24.3% 130/534 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	22.5% 61/271 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	18.2% 95/523 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	7.0% 8/114 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	16.9% 11/65 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	15.8% 16/101 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.	19.2% 14/73 • Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from the 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