Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immunocompromised Participants ≥10 Years of Age

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04893811

Enrollment

Registered

2021-05-20

Start date

2021-08-18

Completion date

2023-09-06

Last updated

2024-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningococcal Vaccine

Keywords

Meningococcal Vaccine, Meningitis Vaccine, Asplenia, Sickle cell anemia, Complement deficiencies

Brief summary

The aim of this study is to evaluate the safety, tolerability, and immunogenicity of 2 doses of Trumenba® (on a 0- and 6-month schedule) in immunocompromised participants by functionally assessing antibody production in asplenic and complement-deficient individuals ≥10 years of age.

Interventions

BIOLOGICALTrumenba

Bivalent recombinant lipoprotein 2086 vaccine

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Male or female participants ≥10 years of age at the time of consent. * Participants with an increased risk for meningococcal disease due to anatomic asplenia or functional asplenia (eg, sickle cell anemia) or complement deficiencies. * Negative urine pregnancy test for all female participants.

Exclusion criteria

* Previous vaccination with any meningococcal serogroup B vaccine. * Participants who are receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses. * History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae. * Significant neurological disorder or history of seizure (excluding simple febrile seizure). * Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis. * Any confirmed or suspected human immunodeficiency virus infection. * Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * Receipt of immunoglobulin infusion or injection during the 42 days preceding enrollment. * Current chronic use of systemic antibiotics. * Previous receipt or current use of complement inhibitors (eg, eculizumab, ravulizumab). * Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation.

Design outcomes

Primary

Measure	Time frame	Description
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	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	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	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	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	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	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	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	Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)	—
Percentage of Participants Reporting Adverse Events (AEs) During 30 Days After Vaccination 1	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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.

Countries

Czechia, Poland, Turkey (Türkiye)

Participant flow

Recruitment details

A total of 53 immunocompromised participants greater than or equal to (\>=) 10 years of age with asplenia (anatomic or functional) or complement deficiency were enrolled and received Trumenba on a 2-dose, 0- and 6-month schedule in the Study B1971060 \[NCT04893811\].

Pre-assignment details

Historical data from age- and sex-matched healthy participants (randomly selected) from previously completed Phase 3 Study B1971057 (Stage 1) \[NCT03135834\] was used as a reference for safety and immunogenicity analysis of Trumenba administered in the current Study B1971060 \[NCT04893811\]. Participants whose historical data was used for reference/control, were not included in enrolment number of the current study.

Participants by arm

Arm	Count
Trumenba (B1971060) Eligible participants were enrolled and received Trumenba 0.5 mL, IM on Day 1 of Visit 1 (Month 0, Vaccination 1) and Visit 3 (Month 6, Vaccination 2) in the study B1971060. Vaccination phase was from the date of the first vaccination (Visit 1) through 1 month after the second vaccination (Visit 4) and Follow-up phase was defined as the time from 1 month after the second vaccination (Visit 4) through 6 months after the second vaccination (Visit 5).	53
Trumenba (B1971057, Historical Age- and Sex-Matched Control) Age- and sex-matched healthy participants from group 2 or 4 (Trumenba groups) from study B1971057 Stage 1 \[NCT03135834\] were randomly selected and included in this group. Participants included in this arm were not enrolled in the study, only their historical data was used as a reference. This arm served as a control arm for the study.	51
Total	104

Withdrawals & dropouts

Period	Reason	FG000	FG001
Follow-up Phase	Lost to Follow-up	0	1
Vaccination Phase	Death	1	0
Vaccination Phase	Lost to Follow-up	1	1
Vaccination Phase	No longer met eligibility criteria	0	1
Vaccination Phase	Other	0	1
Vaccination Phase	Protocol Violation	2	0
Vaccination Phase	Withdrawal by Subject	2	1

Baseline characteristics

Characteristic	Trumenba (B1971060)	Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Total
Age, Customized 12-17 years	8 Participants	6 Participants	14 Participants
Age, Customized 18-64 years	40 Participants	43 Participants	83 Participants
Age, Customized 2-11 years	2 Participants	2 Participants	4 Participants
Age, Customized 65-84 years	3 Participants	0 Participants	3 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	7 Participants	7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants	44 Participants	97 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	2 Participants	2 Participants
Race (NIH/OMB) Black or African American	0 Participants	3 Participants	3 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	53 Participants	46 Participants	99 Participants
Sex: Female, Male Female	23 Participants	21 Participants	44 Participants
Sex: Female, Male Male	30 Participants	30 Participants	60 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	1 / 53	0 / 51
other Total, other adverse events	51 / 53	49 / 51
serious Total, serious adverse events	10 / 53	1 / 51

Outcome results

Primary

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

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.

Time frame: Vaccination Phase: From Vaccination 1 through 1 Month after Vaccination 2 (approximately 7 Months)

Population: B1971060: Safety set included all enrolled participants who received at least 1 dose of the study intervention and have safety data reported after vaccination. B1971057: Historical data of the age- and sex-matched healthy participants (selected randomly) as reference for current study, relevant for this outcome measure. Here, Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
Trumenba (B1971060)	Mean Number of Days Participants Missed School or Work Because of AEs During the Vaccination Phase	12.7 Days	Standard Deviation 7.6
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Mean Number of Days Participants Missed School or Work Because of AEs During the Vaccination Phase	2.5 Days	Standard Deviation 2.3

Primary

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

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.

Time frame: 30 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)

Population: B1971060: Vaccination 1 safety set included all participants who received the first dose of study intervention at Visit 1 and for whom safety information was available from Visit 1 to prior to Visit 3. B1971057: Historical data of the age- and sex-matched healthy participants (selected randomly) as reference for current study, relevant for this outcome measure.

Arm	Measure	Value (NUMBER)
Trumenba (B1971060)	Percentage of Participants Reporting Adverse Events (AEs) During 30 Days After Vaccination 1	26.4 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Adverse Events (AEs) During 30 Days After Vaccination 1	9.8 Percentage of participants

Primary

Percentage of Participants Reporting AEs During 30 Days After Any Vaccination

Time frame: 30 Days after any Vaccination

Arm	Measure	Value (NUMBER)
Trumenba (B1971060)	Percentage of Participants Reporting AEs During 30 Days After Any Vaccination	34.0 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting AEs During 30 Days After Any Vaccination	17.6 Percentage of participants

Primary

Percentage of Participants Reporting AEs During 30 Days After Vaccination 2

Time frame: 30 Days after Vaccination 2 (Vaccination 2 at Month 6)

Population: B1971060: Vaccination 2 safety set included all participants who received the second dose of study intervention at Visit 3 and for whom safety information was available from Visit 3 up to and including Visit 4. B1971057: Historical data of the age- and sex-matched healthy participants (selected randomly) as reference for current study, relevant for this outcome measure.

Arm	Measure	Value (NUMBER)
Trumenba (B1971060)	Percentage of Participants Reporting AEs During 30 Days After Vaccination 2	12.8 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting AEs During 30 Days After Vaccination 2	12.8 Percentage of participants

Primary

Percentage of Participants Reporting AEs During the Vaccination Phase

Time frame: Vaccination Phase: From Vaccination 1 through one Month after Vaccination 2 (approximately 7 Months)

Arm	Measure	Value (NUMBER)
Trumenba (B1971060)	Percentage of Participants Reporting AEs During the Vaccination Phase	60.4 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting AEs During the Vaccination Phase	41.2 Percentage of participants

Primary

Percentage of Participants Reporting Immediate AEs After Vaccination 1

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

Time frame: 30 Minutes post Vaccination 1 (Vaccination 1 on Day 1/Month 0)

Arm	Measure	Value (NUMBER)
Trumenba (B1971060)	Percentage of Participants Reporting Immediate AEs After Vaccination 1	0 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Immediate AEs After Vaccination 1	2.0 Percentage of participants

Primary

Percentage of Participants Reporting Immediate AEs After Vaccination 2

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

Time frame: 30 Minutes post Vaccination 2 (Vaccination 2 at Month 6)

Arm	Measure	Value (NUMBER)
Trumenba (B1971060)	Percentage of Participants Reporting Immediate AEs After Vaccination 2	0 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Immediate AEs After Vaccination 2	0 Percentage of participants

Primary

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

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).

Time frame: Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)

Arm	Measure	Group	Value (NUMBER)
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Swelling: Moderate	15.1 Percentage of participants
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Swelling: Mild	7.5 Percentage of participants
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Swelling: Severe	0 Percentage of participants
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Redness: Moderate	9.4 Percentage of participants
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Pain at injection site: Any	86.8 Percentage of participants
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Redness: Any	18.9 Percentage of participants
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Pain at injection site: Mild	41.5 Percentage of participants
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Swelling: Any	22.6 Percentage of participants
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Pain at injection site: Moderate	32.1 Percentage of participants
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Redness: Severe	3.8 Percentage of participants
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Pain at injection site: Severe	13.2 Percentage of participants
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Redness: Mild	5.7 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Pain at injection site: Severe	0 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Redness: Any	11.8 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Redness: Mild	5.9 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Redness: Severe	2.0 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Swelling: Any	11.8 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Swelling: Mild	7.8 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Swelling: Moderate	3.9 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Swelling: Severe	0 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Pain at injection site: Any	80.4 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Pain at injection site: Mild	47.1 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Pain at injection site: Moderate	33.3 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1	Redness: Moderate	3.9 Percentage of participants

Primary

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

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).

Time frame: Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)

Arm	Measure	Group	Value (NUMBER)
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Swelling: Moderate	13.3 Percentage of participants
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Redness: Mild	6.7 Percentage of participants
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Swelling: Severe	0 Percentage of participants
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Redness: Severe	2.2 Percentage of participants
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Pain at injection site: Any	93.3 Percentage of participants
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Redness: Any	20.0 Percentage of participants
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Pain at injection site: Mild	44.4 Percentage of participants
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Swelling: Any	26.7 Percentage of participants
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Pain at injection site: Moderate	35.6 Percentage of participants
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Redness: Moderate	11.1 Percentage of participants
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Pain at injection site: Severe	13.3 Percentage of participants
Trumenba (B1971060)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Swelling: Mild	13.3 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Pain at injection site: Severe	2.3 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Redness: Any	7.0 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Redness: Mild	2.3 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Redness: Moderate	4.7 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Redness: Severe	0 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Swelling: Any	4.7 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Swelling: Moderate	4.7 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Swelling: Severe	0 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Pain at injection site: Any	60.5 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Pain at injection site: Mild	30.2 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Pain at injection site: Moderate	27.9 Percentage of participants
Trumenba (B1971057, Historical Age- and Sex-Matched Control)	Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2	Swelling: Mild	0 Percentage of participants

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