Trial to Describe the Safety, Tolerability, and Immunogen... | NCT04893811

ID	Type	Description	Link
2018-002588-24	EudraCT Number

Label	Type	Description	Intervention Names
Single Arm	Experimental	Bivalent recombinant lipoprotein 2086 vaccine	Biological: Trumenba

Name	Type	Description	Arm Group Labels	Other Names
Trumenba	Biological	Bivalent recombinant lipoprotein 2086 vaccine	Single Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	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.	Baseline (Before Vaccination 1 on Day 1/Month 0)
Percentage of Participants With hSBA Titer => LLOQ for Each of the 4 Primary MnB Test Strains at 1 Month After Vaccination 2	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.	1 Month after Vaccination 2 (Vaccination 2 at Month 6)
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).	Within 7 Days after Vaccination 1 (Vaccination 1 on Day 1/Month 0)

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Fakultni Nemocnice Brno - Detska Nemocnice - Klinika Detskych Infekcnich Nemoci Center 3		Brno		613 00	Czechia

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Trumenba (B1971060)	Eligible participants were enrolled and received Trumenba 0.5 milliliter (mL), intramuscularly (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).

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 22, 2021	Jul 15, 2024

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

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.

B1971060: EIP was analyzed. 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. "Number Analyzed" signifies number of participants evaluable for specified rows.

Posted

Number

95% Confidence Interval

Percentage of participants

Baseline (Before Vaccination 1 on Day 1/Month 0)

ID	Title	Description
OG000	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).
OG001	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.

Units	Counts
Participants	OG00043 OG00144

Title

Denominators

Categories

PMB80 (A22)

- ParticipantsOG00043
- ParticipantsOG00142

Title	Measurements
	OG00032.6(19.1 to 48.5)

Primary

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

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.

B1971060: EIP was analyzed. 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 Analyzed" signifies number of participants evaluable for specified rows.

Posted

Number

95% Confidence Interval

Percentage of participants

1 Month after Vaccination 2 (Vaccination 2 at Month 6)

ID	Title	Description
OG000	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).
OG001	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.

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).

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.

Posted

Number

95% Confidence Interval

Percentage of participants

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

ID	Title	Description
OG000	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).
OG001

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).

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. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

Posted

Number

95% Confidence Interval

Percentage of participants

Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)

ID	Title	Description
OG000	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).

Primary

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

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).

Posted

Number

95% Confidence Interval

Percentage of participants

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

ID	Title	Description
OG000	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).

Primary

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

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).

Posted

Number

95% Confidence Interval

Percentage of participants

Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)

ID	Title	Description
OG000	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).

Primary

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

Posted

Number

95% Confidence Interval

Percentage of participants

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

ID	Title	Description
OG000	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).
OG001	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.

Primary

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

Posted

Number

95% Confidence Interval

Percentage of participants

Within 7 Days after Vaccination 2 (Vaccination 2 at Month 6)

ID	Title	Description
OG000	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).
OG001	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.

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.

Posted

Number

95% Confidence Interval

Percentage of participants

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

ID	Title	Description
OG000	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).
OG001	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.

Primary

Percentage of Participants Reporting AEs During 30 Days After Vaccination 2

Posted

Number

95% Confidence Interval

Percentage of participants

30 Days after Vaccination 2 (Vaccination 2 at Month 6)

ID	Title	Description
OG000	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).
OG001	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.

Primary

Percentage of Participants Reporting AEs During 30 Days After Any Vaccination

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.

Posted

Number

95% Confidence Interval

Percentage of participants

30 Days after any Vaccination

ID	Title	Description
OG000	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).
OG001	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.

Primary

Percentage of Participants Reporting AEs During the Vaccination Phase

Posted

Number

95% Confidence Interval

Percentage of participants

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

ID	Title	Description
OG000	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).
OG001	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.

Primary

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

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.

Posted

Number

95% Confidence Interval

Percentage of participants

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

ID	Title	Description
OG000	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).

Primary

Percentage of Participants Reporting SAEs During 30 Days After Vaccination 2

Posted

Number

95% Confidence Interval

Percentage of participants

30 Days after Vaccination 2 (Vaccination 2 at Month 6)

ID	Title	Description
OG000	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).

Primary

Percentage of Participants Reporting SAEs During 30 Days After Any Vaccination

Posted

Number

95% Confidence Interval

Percentage of participants

30 Days after any Vaccination

ID	Title	Description
OG000	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).
OG001

Primary

Percentage of Participants Reporting SAEs During the Vaccination Phase

Posted

Number

95% Confidence Interval

Percentage of participants

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

ID	Title	Description
OG000	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).

Primary

Percentage of Participants Reporting SAEs During the Follow-up Phase

B1971060: Follow-up safety set included all participants who received at least 1 dose of study intervention and for whom safety information was available from after Visit 4 up to and including Visit 5. B1971057: Historical data of the age- and sex-matched healthy participants (selected randomly) as reference for current study, relevant for this outcome measure.

Posted

Number

95% Confidence Interval

Percentage of participants

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

ID	Title	Description
OG000	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).

Primary

Percentage of Participants Reporting SAEs During the Entire Study

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.

Posted

Number

95% Confidence Interval

Percentage of participants

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

ID	Title	Description
OG000	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).

Primary

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

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

Posted

Number

95% Confidence Interval

Percentage of participants

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

ID	Title	Description
OG000	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).
OG001	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.

Primary

Percentage of Participants Reporting MAEs During 30 Days After Vaccination 2

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

Posted

Number

95% Confidence Interval

Percentage of participants

30 Days after Vaccination 2 (Vaccination 2 at Month 6)

ID	Title	Description
OG000	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).
OG001	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.

Primary

Percentage of Participants Reporting MAEs During 30 Days After Any Vaccination

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

Posted

Number

95% Confidence Interval

Percentage of participants

30 Days after any Vaccination

ID	Title	Description
OG000	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).
OG001	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.

Primary

Percentage of Participants Reporting MAEs During the Vaccination Phase

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

Posted

Number

95% Confidence Interval

Percentage of participants

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

ID	Title	Description
OG000	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).
OG001	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.

Primary

Percentage of Participants Reporting MAEs During the Follow-up Phase

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

Posted

Number

95% Confidence Interval

Percentage of participants

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

ID	Title	Description
OG000	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).
OG001	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.

Primary

Percentage of Participants Reporting MAEs During the Entire Study

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

Posted

Number

95% Confidence Interval

Percentage of participants

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

ID	Title	Description
OG000	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).
OG001	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.

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.

Posted

Number

95% Confidence Interval

Percentage of participants

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

ID	Title	Description
OG000	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).
OG001	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.

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.

Posted

Number

95% Confidence Interval

Percentage of participants

30 Minutes post Vaccination 2 (Vaccination 2 at Month 6)

ID	Title	Description
OG000	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).
OG001	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.

Primary

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

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.

Posted

Number

95% Confidence Interval

Percentage of participants

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

ID	Title	Description
OG000	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).
OG001	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.

Primary

Percentage of Participants With NDCMC During the Follow-up Phase

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.

Posted

Number

95% Confidence Interval

Percentage of participants

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

ID	Title	Description
OG000	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).
OG001	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.

Primary

Percentage of Participants With NDCMC During the Entire Study

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.

Posted

Number

95% Confidence Interval

Percentage of participants

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

ID	Title	Description
OG000	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).
OG001	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.

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.

Posted

Mean

Standard Deviation

Days

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

ID	Title	Description
OG000	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).
OG001	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.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Alanine aminotransferase increased	Investigations	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 26.0	Non-systematic Assessment	EG0002 events1 affected53 at risk EG0010 events0 affected51 at risk
SARS-CoV-2 test positive	Investigations	MedDRA 26.0	Non-systematic Assessment	EG0002 events2 affected53 at risk EG0010 events0 affected51 at risk
Sickle cell anaemia with crisis	Blood and lymphatic system disorders	MedDRA 26.0	Non-systematic Assessment	EG0002 events1 affected53 at risk EG0010 events0 affected51 at risk
Dizziness	Nervous system disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Headache	Nervous system disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0013 events2 affected51 at risk
Headache (HEADACHE)	Nervous system disorders	MedDRA 26.0	Systematic Assessment	EG00038 events25 affected53 at risk EG00128 events21 affected51 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Syncope	Nervous system disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Conjunctivitis allergic	Eye disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Eye haemorrhage	Eye disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Periorbital swelling	Eye disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Vocal cord polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0012 events2 affected51 at risk
Diarrhoea (DIARRHEA)	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0009 events8 affected53 at risk EG0018 events7 affected51 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Vomiting (VOMITING)	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment	EG0002 events2 affected53 at risk EG0011 events1 affected51 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0011 events1 affected51 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Erythema (REDNESS)	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment	EG00019 events14 affected53 at risk EG0019 events6 affected51 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Arthralgia (JOINT PAIN)	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00021 events14 affected53 at risk EG00117 events13 affected51 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Non-systematic Assessment	EG0003 events3 affected53 at risk EG0010 events0 affected51 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Myalgia (MUSCLE PAIN)	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment	EG00020 events16 affected53 at risk EG00117 events14 affected51 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0011 events1 affected51 at risk
Soft tissue swelling	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Bronchitis	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0012 events2 affected51 at risk
COVID-19	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0005 events5 affected53 at risk EG0010 events0 affected51 at risk
Chronic sinusitis	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Conjunctivitis	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Furuncle	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Hordeolum	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Influenza	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0005 events5 affected53 at risk EG0010 events0 affected51 at risk
Nasopharyngitis	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0011 events1 affected51 at risk
Oral herpes	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Otitis media	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Otitis media bacterial	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Pharyngitis	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Respiratory tract infection	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Sinusitis	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0014 events4 affected51 at risk
Tonsillitis	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0004 events4 affected53 at risk EG0010 events0 affected51 at risk
Tonsillitis streptococcal	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Tracheitis	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0002 events2 affected53 at risk EG0015 events4 affected51 at risk
Urethritis	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Urethritis mycoplasmal	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0011 events1 affected51 at risk
Viral pharyngitis	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0002 events2 affected53 at risk EG0010 events0 affected51 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Secondary hypertension	Vascular disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Chills (CHILLS)	General disorders	MedDRA 26.0	Systematic Assessment	EG00012 events11 affected53 at risk EG00116 events11 affected51 at risk
Fatigue	General disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0012 events2 affected51 at risk
Fatigue (FATIGUE)	General disorders	MedDRA 26.0	Systematic Assessment	EG00053 events31 affected53 at risk EG00144 events27 affected51 at risk
Injection site pain	General disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0012 events2 affected51 at risk
Injection site pain (PAIN AT INJECTION SITE)	General disorders	MedDRA 26.0	Systematic Assessment	EG00088 events48 affected53 at risk EG00167 events45 affected51 at risk
Oedema peripheral	General disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Pyrexia (FEVER)	General disorders	MedDRA 26.0	Systematic Assessment	EG0003 events2 affected53 at risk EG0012 events2 affected51 at risk
Swelling (SWELLING)	General disorders	MedDRA 26.0	Systematic Assessment	EG00024 events17 affected53 at risk EG0018 events7 affected51 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk

ID	Term
D000755	Anemia, Sickle Cell
D000081208	Hereditary Complement Deficiency Diseases

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D006453	Hemoglobinopathies
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D000081207	Primary Immunodeficiency Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Title	Description
BG000	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).
BG001	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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).	1	53	10	53	51	53
EG001	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.	0	51	1	51	49	51

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Cardiac arrest	Cardiac disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Sickle cell anaemia with crisis	Blood and lymphatic system disorders	MedDRA 26.0	Non-systematic Assessment	EG0008 events4 affected53 at risk EG0010 events0 affected51 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
COVID-19	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0002 events2 affected53 at risk EG0010 events0 affected51 at risk
Pneumonia	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0000 events0 affected53 at risk EG0011 events1 affected51 at risk
Urinary tract infection	Infections and infestations	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Non-systematic Assessment	EG0001 events1 affected53 at risk EG0010 events0 affected51 at risk