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.

Study Overview
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Brief Summary
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This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a 0-,6- month schedule. This trial is also studying safety and immunogenicity of a meningococcal pentavalent vaccine.

Official Title
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A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED STUDY TO ASSESS THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF BIVALENT RLP2086 WHEN ADMINISTERED AS A 2-DOSE REGIMEN AND A FIRST-IN-HUMAN STUDY TO DESCRIBE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A BIVALENT RLP2086-CONTAINING PENTAVALENT VACCINE (MENABCWY) IN HEALTHY SUBJECTS>=10 TO <26 YEARS OF AGE

Conditions
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Meningococcal Vaccine

Intervention / Treatment
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* Biological: MenABCWY
* Biological: Saline
* Biological: rLP2086
* Biological: MenACWY-CRM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subject aged >=10 and <26 years at the time of enrollment. Healthy subject as determined by medical history, physical examination, and judgment of the investigator. Negative urine pregnancy test for all female subjects. Subjects who have not received, or who have received no more than 1 prior dose within the past 4 years, of a vaccine containing 1 or more ACWY serogroup Exclusion Criteria: Previous vaccination with any meningococcal serogroup B or purely polysaccharide (nonconjugate) meningococcal vaccine. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses. A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study. Significant neurological disorder or history of seizure (excluding simple febrile seizure). Current chronic use of systemic antibiotics. Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (ACWY Naive subjects, MenABCWY/Saline)<br>ACWY Naive subjects, MenABCWY/Saline | Biological: MenABCWY<br>* N meningitidis group A, B, C, W, and Y vaccine<br>Biological: Saline<br>* Placebo<br>|
| Experimental: Group 2 (ACWY Naive subjects, rLP2086/MenACWY-CRM)<br>ACWY Naive subjects, rLP2086/MenACWY-CRM | Biological: rLP2086<br>* Bivalent recombinant lipoprotein 2086 vaccine<br>Biological: MenACWY-CRM<br>* meningococcal group A, C, W-135, and Y conjugate vaccine<br>|
| Experimental: Group 3 (ACWY Experienced subjects, MenABCWY/Saline)<br>ACWY Experienced subjects, MenABCWY/Saline | Biological: MenABCWY<br>* N meningitidis group A, B, C, W, and Y vaccine<br>Biological: Saline<br>* Placebo<br>|
| Experimental: Group 4 (ACWY Experienced subjects, rLP2086/MenACWY-CRM)<br>ACWY Experienced subjects, rLP2086/MenACWY-CRM | Biological: rLP2086<br>* Bivalent recombinant lipoprotein 2086 vaccine<br>Biological: MenACWY-CRM<br>* meningococcal group A, C, W-135, and Y conjugate vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | 1 month after Vaccination 2 | 
| 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) | 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. | From Baseline (blood draw prior to Vaccination 1) to 1 month after Vaccination 2 | 
| Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) | 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). | 7 days after Vaccination 1 | 
| Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) | 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). | 7 days after Vaccination 2 | 
| Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) | 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). | 7 days after Vaccination 1 | 
| Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) | 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). | 7 days after Vaccination 2 | 
| Stage1: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Vaccination 1 (Group 2 and 4 Combined) |  | 7 days after Vaccination 1 | 
| Stage1: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Vaccination 2 (Group 2 and 4 Combined) |  | 7 days after Vaccination 2 | 
| Stage1: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 1 (Group 2 and 4 Combined) | 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. | 30 days after Vaccination 1 | 
| Stage1: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 2 (Group 2 and 4 Combined) | 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. | 30 days after Vaccination 2 | 
| Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Any Vaccination (Group 2 and 4 Combined) | 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. | 30 days after any vaccination | 
| Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined) | 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. | Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months) | 
| Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Follow-up Phase (Group 2 and 4 Combined) | 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. | Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months) | 
| Stage1: Percentage of Participants With at Least 1 SAE Throughout the Stage 1 (Group 2 and 4 Combined) | 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. | Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months) | 
| Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 1 (Group 2 and 4 Combined) | Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. | 30 days after Vaccination 1 | 
| Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 2 (Group 2 and 4 Combined) | Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. | 30 days after Vaccination 2 | 
| Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination (Group 2 and 4 Combined) | Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. | 30 days after any vaccination | 
| Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined) | Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. | Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months) | 
| Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Follow-up Phase (Group 2 and 4 Combined) | Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. | Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months) | 
| Stage1: Percentage of Participants With at Least 1 Medically Attended AE Throughout the Stage 1 (Group 2 and 4 Combined) | Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. | Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months) | 
| 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) | 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. | 30 days after Vaccination 1 | 
| 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) | 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. | 30 days after Vaccination 2 | 
| 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) | 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. | 30 days after any Vaccination | 
| 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) | 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. | Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months) | 
| 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) | 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. | Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months) | 
| Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Throughout the Stage 1 (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. | Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months) | 
| Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 1 (Group 2 and 4 Combined) | 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. | 30 days after Vaccination 1 | 
| Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 2 (Group 2 and 4 Combined) | 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. | 30 days after Vaccination 2 | 
| Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Any Vaccination (Group 2 and 4 Combined) | 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. | 30 days after any vaccination | 
| Stage1: Percentage of Participants With at Least 1 AE During Vaccination Phase (Group 2 and 4 Combined) | 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. | Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months) | 
| Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 1 (Group 2 and 4 Combined) | Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration. | 30 minutes after Vaccination 1 | 
| Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 2 (Group 2 and 4 Combined) | Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration. | 30 minutes after Vaccination 2 | 
| Stage1: Number of Participants Who Missed School/Work Due to AE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined) |  | Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months) | 
| Stage2: Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 1 Through Group 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). | 7 days after booster vaccination | 
| Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4 | 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). | 7 days after booster vaccination | 
| Stage2: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Booster Vaccination: Group 1 Through Group 4 |  | 7 days after booster vaccination | 
| Stage2: Percentage of Participants With at Least 1 SAE During Booster Vaccination Phase: Group 1 Through Group 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. SAE of pregnancy for one participant during the booster vaccination phase was recorded erroneously and hence it was included in results of Group 4. | Booster vaccination phase: From booster vaccination through 1 month after booster vaccination | 
| Stage2: Percentage of Participants With at Least 1 SAE During the Booster Follow-up Phase: Group 1 Through Group 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. | Booster follow-up phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months) | 
| Stage2: Percentage of Participants With at Least 1 SAE Throughout Booster Phase: Group 1 Through Group 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. 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. | Throughout Booster phase: From booster vaccination through 6 months after booster vaccination | 
| Stage2: Percentage of Participants With at Least 1 Medically Attended AE During Booster Vaccination Phase: Group 1 Through Group 4 | Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. | Booster vaccination phase: From booster vaccination through 1 month after booster vaccination | 
| Stage2: Percentage of Participants With at Least 1 Medically Attended AE During the Booster Follow-up Phase: Group 1 Through Group 4 | Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. | Booster Follow-up Phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months) | 
| Stage2: Percentage of Participants With at Least 1 Medically Attended AE Throughout Booster Phase: Group 1 Through Group 4 | Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. | Throughout Booster Phase: From booster vaccination through 6 months after booster vaccination | 
| Stage2: Percentage of Participants With at Least 1 NDCMC During Booster Vaccination Phase: Group 1 Through Group 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. | Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination | 
| Stage2: Percentage of Participants With at Least 1 NDCMC During the Booster Follow-up Phase: Group 1 Through Group 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. | Booster Follow-up Phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months) | 
| Stage2: Percentage of Participants With at Least 1 NDCMC Throughout Booster Phase: Group 1 Through Group 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. | Throughout Booster Phase: From booster vaccination through 6 months after booster vaccination | 
| Stage2: Percentage of Participants With at Least 1 AE During Booster Vaccination Phase: Group 1 Through Group 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. | Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination | 
| Stage2: Percentage of Participants With at Least 1 Immediate AE After Booster Vaccination: Group 1 Through Group 4 | Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration. | 30 minutes after booster vaccination | 
| Stage2: Number of Participants Who Missed School/Work Due to AE After Booster Vaccination: Group 1 Through Group 4 |  | Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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). | 1 month after Vaccination 2 | 
| 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) | 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). | 1 month after Vaccination 2 (Vacc 2) | 
| Stage1: hSBA Geometric Mean Titers (GMTs) for All 4 Primary MenB Test Strains Combined 1 Month After Vaccination 2 (Group 2 and 4 Combined) | 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). | 1 month after Vaccination 2 (Vacc 2) | 
| 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) | 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. | 1 month after Vaccination 2 (Vacc 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) | 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). | 1 month after Vaccination 2 (Vacc 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) | 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. | 1 month after Vaccination 2 (Vacc 2) | 
| 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 | 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. | 1 month after Vaccination 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 | 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. | 1 month after Vaccination 1 | 
| Stage1: hSBA Geometric Mean Titers (GMTs) for ACWY Test Strains 1 Month After Vaccination 1: Groups 1, 2, 3 and 4 | 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. | 1 month after Vaccination 1 | 
| 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 | 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. | For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2 | 
| 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 | 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. | For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2 | 
| 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 | 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. | For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2 | 
| 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) | 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. | 1 month after Vaccination 2 (Vacc 2) | 
| 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) | 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. | Baseline to 1 month after Vaccination 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 From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined) | 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. | 1 month after Vaccination 2 | 
| 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) | 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. | 1 month after Vaccination 2 | 
| 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 | 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. | Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 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 Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 | 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. | Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1] | 
| Stage1: hSBA GMTs for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4 | 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. | Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 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) | 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. | Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 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) | 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. | Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 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) | 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. | Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 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 | 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. | 12, 24, 36 and 48 months after Vaccination 2 (Vacc 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) | 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. | 12, 24, 36 and 48 months after Vaccination 2 (Vacc 2) | 
| 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) | 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. | 1 month after booster vaccination | 
| 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) | 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. | 1 month after booster vaccination | 
| Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: Group 1 and Group 3 | 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). | 7 days after Vaccination 1 (Vacc 1) | 
| Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: Group 1 and Group 3 | 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). | 7 days after Vaccination 2 (Vacc 2) | 
| Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3 | 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). | 7 days after Vaccination 1 (Vacc 1) | 
| Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3 | 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). | 7 days after Vaccination 2 (Vacc 2) | 
| Stage1: Percentage of Participants With Antipyretic Medication Use 30 Days After Vaccination 1: Group 1 and Group 3 |  | 30 days after Vaccination 1 | 
| Stage1: Percentage of Participants With Antipyretic Medication Use 30 Days After Vaccination 2: Group 1 and Group 3 |  | 30 days after Vaccination 2 | 
| Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Vaccination 1: Group 1 and Group 3 | 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. | 30 days after Vaccination 1 | 
| Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Vaccination 2: Group 1 and Group 3 | 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. | 30 days after Vaccination 2 | 
| Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Any Vaccination: Group 1 and Group 3 | 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. | 30 days after any vaccination | 
| Stage1: Percentage of Participants With at Least 1 SAE During the Vaccination Phase: Group 1 and Group 3 | 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. | Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months) | 
| Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Follow-up Phase: Group 1 and Group 3 | 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. | Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months) | 
| Stage1: Percentage of Participants With at Least 1 SAE Throughout the Stage 1: Group 1 and Group 3 | 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. | Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months) | 
| Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 1: Group 1 and Group 3 | Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. | 30 days after vaccination 1 | 
| Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 2: Group 1 and Group 3 | Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. | 30 days after vaccination 2 | 
| Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination: Group 1 and Group 3 | Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. | 30 days after any vaccination | 
| Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Vaccination Phase: Group 1 and Group 3 | Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. | Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months) | 
| Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Follow-up Phase: Group 1 and Group 3 | Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. | Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months) | 
| Stage1: Percentage of Participants With at Least 1 Medically Attended AE Throughout the Stage 1: Group 1 and Group 3 | Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility. | Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months) | 
| Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Vaccination 1: Group 1 and Group 3 | 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. | 30 days after vaccination 1 | 
| Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Vaccination 2: Group 1 and Group 3 | 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. | 30 days after vaccination 2 | 
| Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Any Vaccination: Group 1 and Group 3 | 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. | 30 days after any vaccination | 
| Stage1: Percentage of Participants With at Least 1 NDCMC During the Stage 1 Vaccination Phase: Group 1 and Group 3 | 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. | Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months) | 
| Stage1: Percentage of Participants With at Least 1 NDCMC During the Stage 1 Follow-up Phase: Group 1 and Group 3 | 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. | Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months) | 
| Stage1: Percentage of Participants With at Least 1 NDCMC Throughout the Stage 1: Group 1 and Group 3 | 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. | Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months) | 
| Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 1: Group 1 and Group 3 | 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. | 30 days after vaccination 1 | 
| Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 2: Group 1 and Group 3 | 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. | 30 days after vaccination 2 | 
| Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination Any Vaccination: Group 1 and Group 3 | 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. | 30 days after any vaccination | 
| Stage1: Percentage of Participants With at Least 1 AE During the Stage 1 Vaccination Phase: Group 1 and Group 3 | 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. | Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months) | 
| Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 1: Group 1 and Group 3 | Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration. | 30 minutes after Vaccination 1 | 
| Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 2: Group 1 and Group 3 | Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration. | 30 minutes after Vaccination 2 | 
| Stage1: Number of Participants Who Missed School/Work Due to AE During the Stage 1 Vaccination Phase: Group 1 and Group 3 |  | Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months) |