A PHASE 4, OPEN-LABEL, SINGLE-ARM TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF TRUMENBA(REGISTERED) WHEN ADMINISTERED TO IMMUNOCOMPROMISED PARTICIPANTS ≥10 YEARS OF AGE

Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer => Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains at Baseline

时间窗: Baseline (Before Vaccination 1 on Day 1/Month 0)

Four primary MnB strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). The percentage of participants who achieved an hSBA titer PMB80 (A22) more than or equal to (=\>)1:16, and hSBA titer PMB2001 (A56), PMB2001 (B24), and PMB2707 (B44) =\>1:8 are reported. Evaluable immunogenicity population (EIP) included all participants who were eligible through 1 month after Vaccination 2, received the study vaccination at Visit 1 and Visit 3 as planned, had blood drawn for assay testing within the required time frames at Visit 1 (before Vaccination 1) and 1 month after Vaccination 2 (28-42 days after Visit 3), had at least 1 valid and determinate assay result 1 month after Vaccination 2, received no prohibited vaccines or medications through Visit 4, and had no major protocol deviations through Visit 4.

Percentage of Participants With hSBA Titer => LLOQ for Each of the 4 Primary MnB Test Strains at 1 Month After Vaccination 2

时间窗: 1 Month after Vaccination 2 (Vaccination 2 at Month 6)

Four primary MnB strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). The percentage of participants who achieved an hSBA titer PMB80 (A22) =\>1:16, and hSBA titer PMB2001 (A56), PMB2001 (B24), and PMB2707 (B44) =\>1:8 were reported.

Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1

时间窗: Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)

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

Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2

时间窗: Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)

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

Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1

时间窗: Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)

Systemic events included: fever, fatigue, headache, chills, muscle pain, joint pain, vomiting, and diarrhea. Fever classified as =\>38.0 degree Celsius (C), 38.0-38.4, \>38.4-38.9, \>38.9 40.0 and \>40.0-degree C. Fatigue, headache, chills, muscle pain and joint pain graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting graded as mild (1-2 times in 24 hours \[hrs\]), moderate (\>2 times in 24 hrs) and severe (required intravenous \[IV\] hydration). Diarrhea graded as mild (2-3 loose stools in 24 hrs), moderate (4-5 loose stools in 24 hrs) and severe (=\>6 in 24 hrs).

Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2

时间窗: Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)

Systemic events included: fever, fatigue, headache, chills, muscle pain, joint pain, vomiting, and diarrhea. Fever classified as =\>38.0 degree C, 38.0-38.4, \>38.4-38.9, \>38.9 40.0 and \>40.0-degree C. Fatigue, headache, chills, muscle pain and joint pain graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting graded as mild (1-2 times in 24 hrs), moderate (\>2 times in 24 hrs) and severe (required IV hydration). Diarrhea graded as mild (2-3 loose stools in 24 hrs), moderate (4-5 loose stools in 24 hrs) and severe (=\>6 in 24 hrs).

Percentage of Participants Reporting Use of Antipyretic Medication Within 7 Days After Vaccination 1

时间窗: Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)

Percentage of Participants Reporting Use of Antipyretic Medication Within 7 Days After Vaccination 2

时间窗: Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)

Percentage of Participants Reporting Adverse Events (AEs) During 30 Days After Vaccination 1

时间窗: 30 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events.

Percentage of Participants Reporting AEs During 30 Days After Vaccination 2

时间窗: 30 Days after Vaccination 2 (Vaccination 2 at Month 6)

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events.

Percentage of Participants Reporting AEs During 30 Days After Any Vaccination

时间窗: 30 Days after any Vaccination

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events.

Percentage of Participants Reporting AEs During the Vaccination Phase

时间窗: Vaccination Phase: From Vaccination 1 through one Month after Vaccination 2 (approximately 7 Months)

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs excluded local reactions and systematic events.

Percentage of Participants Reporting Serious Adverse Events (SAEs) During 30 Days After Vaccination 1

时间窗: 30 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)

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.

Percentage of Participants Reporting SAEs During 30 Days After Vaccination 2

时间窗: 30 Days after Vaccination 2 (Vaccination 2 at Month 6)

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.

Percentage of Participants Reporting SAEs During 30 Days After Any Vaccination

时间窗: 30 Days after any Vaccination

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.

Percentage of Participants Reporting SAEs During the Vaccination Phase

时间窗: Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)

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.

Percentage of Participants Reporting SAEs During the Follow-up Phase

时间窗: Follow-up Phase: From 1 Month after Vaccination 2 through 6 Months after Vaccination 2 (approximately 5 Months)

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.

Percentage of Participants Reporting SAEs During the Entire Study

时间窗: Entire Study: From Vaccination 1 through 6 Months after Vaccination 2 (approximately 12 Months)

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.

Percentage of Participants Reporting Medically Attended Adverse Event (MAEs) During 30 Days After Vaccination 1

时间窗: 30 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)

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

Percentage of Participants Reporting MAEs During 30 Days After Vaccination 2

时间窗: 30 Days after Vaccination 2 (Vaccination 2 at Month 6)

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

Percentage of Participants Reporting MAEs During 30 Days After Any Vaccination

时间窗: 30 Days after any Vaccination

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

Percentage of Participants Reporting MAEs During the Vaccination Phase

时间窗: Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)

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

Percentage of Participants Reporting MAEs During the Follow-up Phase

时间窗: Follow-up Phase: From 1 Month after Vaccination 2 through 6 Months after Vaccination 2 (approximately 5 Months)

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

Percentage of Participants Reporting MAEs During the Entire Study

时间窗: Entire Study: From Vaccination 1 through 6 Months after Vaccination 2 (approximately 12 Months)

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

Percentage of Participants Reporting Immediate AEs After Vaccination 1

时间窗: 30 Minutes post Vaccination 1 (Vaccination 1 on Day 1/Month 0)

Immediate AE was defined as AE occurring within the first 30 minutes after study intervention administration.

Percentage of Participants Reporting Immediate AEs After Vaccination 2

时间窗: 30 Minutes post Vaccination 2 (Vaccination 2 at Month 6)

Immediate AE was defined as AE occurring within the first 30 minutes after study intervention administration.

Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase

时间窗: Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)

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.

Percentage of Participants With NDCMC During the Follow-up Phase

时间窗: Follow-up Phase: From 1 Month after Vaccination 2 through 6 Months after Vaccination 2 (approximately 5 Months)

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.

Percentage of Participants With NDCMC During the Entire Study

时间窗: Entire Study: From Vaccination 1 through 6 Months after Vaccination 2 (approximately 12 Months)

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.

Mean Number of Days Participants Missed School or Work Because of AEs During the Vaccination Phase

时间窗: Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)

An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.