Trial Outcomes & Findings for Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immunocompromised Participants ≥10 Years of Age (NCT NCT04893811)

Last Updated: 2024-10-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

53 participants

Primary outcome timeframe

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

Results posted on

2024-10-16

Participant Flow

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 \[NCT04893811\].

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.

Participant milestones

Participant milestones
Measure	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).	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.
Vaccination Phase STARTED	53	51
Vaccination Phase Vaccination 1	53	51
Vaccination Phase Vaccination 2	47	47
Vaccination Phase COMPLETED	47	47
Vaccination Phase NOT COMPLETED	6	4
Follow-up Phase STARTED	47	47
Follow-up Phase Follow-up Safety Set	44	48
Follow-up Phase COMPLETED	47	46
Follow-up Phase NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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).	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.
Vaccination Phase Death	1	0
Vaccination Phase Lost to Follow-up	1	1
Vaccination Phase Protocol Violation	2	0
Vaccination Phase Withdrawal by Subject	2	1
Vaccination Phase Other	0	1
Vaccination Phase No longer met eligibility criteria	0	1
Follow-up Phase Lost to Follow-up	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trumenba (B1971060) n=53 Participants 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).	Trumenba (B1971057, Historical Age- and Sex-Matched Control) n=51 Participants 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.	Total n=104 Participants Total of all reporting groups
Age, Customized 2-11 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Customized 12-17 years	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Age, Customized 18-64 years	40 Participants n=5 Participants	43 Participants n=7 Participants	83 Participants n=5 Participants
Age, Customized 65-84 years	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	21 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=5 Participants	44 Participants n=7 Participants	97 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	53 Participants n=5 Participants	46 Participants n=7 Participants	99 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

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

Population: 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.

Outcome measures

Outcome measures
Measure	Trumenba (B1971060) n=43 Participants 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).	Trumenba (B1971057, Historical Age- and Sex-Matched Control) n=44 Participants 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.
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 PMB80 (A22)	32.6 Percentage of participants Interval 19.1 to 48.5	31.0 Percentage of participants Interval 17.6 to 47.1
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 PMB2001 (A56)	25.6 Percentage of participants Interval 13.5 to 41.2	23.3 Percentage of participants Interval 11.8 to 38.6
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 PMB2948 (B24)	2.4 Percentage of participants Interval 0.1 to 12.6	23.3 Percentage of participants Interval 11.8 to 38.6
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 PMB2707 (B44)	9.3 Percentage of participants Interval 2.6 to 22.1	11.4 Percentage of participants Interval 3.8 to 24.6

PRIMARY outcome

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

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Trumenba (B1971060) n=44 Participants 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).	Trumenba (B1971057, Historical Age- and Sex-Matched Control) n=44 Participants 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.
Percentage of Participants With hSBA Titer => LLOQ for Each of the 4 Primary MnB Test Strains at 1 Month After Vaccination 2 PMB80 (A22)	75.0 Percentage of participants Interval 59.7 to 86.8	95.3 Percentage of participants Interval 84.2 to 99.4
Percentage of Participants With hSBA Titer => LLOQ for Each of the 4 Primary MnB Test Strains at 1 Month After Vaccination 2 PMB2001 (A56)	90.9 Percentage of participants Interval 78.3 to 97.5	100.0 Percentage of participants Interval 92.0 to 100.0
Percentage of Participants With hSBA Titer => LLOQ for Each of the 4 Primary MnB Test Strains at 1 Month After Vaccination 2 PMB2948 (B24)	70.5 Percentage of participants Interval 54.8 to 83.2	81.8 Percentage of participants Interval 67.3 to 91.8
Percentage of Participants With hSBA Titer => LLOQ for Each of the 4 Primary MnB Test Strains at 1 Month After Vaccination 2 PMB2707 (B44)	79.1 Percentage of participants Interval 64.0 to 90.0	92.9 Percentage of participants Interval 80.5 to 98.5

PRIMARY outcome

Timeframe: Within 7 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.

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).

Outcome measures

Outcome measures
Measure	Trumenba (B1971060) n=53 Participants 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).	Trumenba (B1971057, Historical Age- and Sex-Matched Control) n=51 Participants 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.
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1 Pain at injection site: Mild	41.5 Percentage of participants Interval 28.1 to 55.9	47.1 Percentage of participants Interval 32.9 to 61.5
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1 Pain at injection site: Moderate	32.1 Percentage of participants Interval 19.9 to 46.3	33.3 Percentage of participants Interval 20.8 to 47.9
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1 Pain at injection site: Severe	13.2 Percentage of participants Interval 5.5 to 25.3	0 Percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1 Redness: Any	18.9 Percentage of participants Interval 9.4 to 32.0	11.8 Percentage of participants Interval 4.4 to 23.9
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1 Redness: Mild	5.7 Percentage of participants Interval 1.2 to 15.7	5.9 Percentage of participants Interval 1.2 to 16.2
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1 Redness: Moderate	9.4 Percentage of participants Interval 3.1 to 20.7	3.9 Percentage of participants Interval 0.5 to 13.5
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1 Redness: Severe	3.8 Percentage of participants Interval 0.5 to 13.0	2.0 Percentage of participants Interval 0.0 to 10.4
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1 Swelling: Any	22.6 Percentage of participants Interval 12.3 to 36.2	11.8 Percentage of participants Interval 4.4 to 23.9
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1 Swelling: Mild	7.5 Percentage of participants Interval 2.1 to 18.2	7.8 Percentage of participants Interval 2.2 to 18.9
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1 Swelling: Moderate	15.1 Percentage of participants Interval 6.7 to 27.6	3.9 Percentage of participants Interval 0.5 to 13.5
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1 Swelling: Severe	0 Percentage of participants Interval 0.0 to 6.7	0 Percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 1 Pain at injection site: Any	86.8 Percentage of participants Interval 74.7 to 94.5	80.4 Percentage of participants Interval 66.9 to 90.2

PRIMARY outcome

Timeframe: Within 7 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. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure.

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).

Outcome measures

Outcome measures
Measure	Trumenba (B1971060) n=45 Participants 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).	Trumenba (B1971057, Historical Age- and Sex-Matched Control) n=43 Participants 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.
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2 Redness: Mild	6.7 Percentage of participants Interval 1.4 to 18.3	2.3 Percentage of participants Interval 0.1 to 12.3
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2 Redness: Moderate	11.1 Percentage of participants Interval 3.7 to 24.1	4.7 Percentage of participants Interval 0.6 to 15.8
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2 Redness: Any	20.0 Percentage of participants Interval 9.6 to 34.6	7.0 Percentage of participants Interval 1.5 to 19.1
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2 Redness: Severe	2.2 Percentage of participants Interval 0.1 to 11.8	0 Percentage of participants Interval 0.0 to 8.2
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2 Swelling: Any	26.7 Percentage of participants Interval 14.6 to 41.9	4.7 Percentage of participants Interval 0.6 to 15.8
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2 Swelling: Mild	13.3 Percentage of participants Interval 5.1 to 26.8	0 Percentage of participants Interval 0.0 to 8.2
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2 Swelling: Moderate	13.3 Percentage of participants Interval 5.1 to 26.8	4.7 Percentage of participants Interval 0.6 to 15.8
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2 Swelling: Severe	0 Percentage of participants Interval 0.0 to 7.9	0 Percentage of participants Interval 0.0 to 8.2
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2 Pain at injection site: Any	93.3 Percentage of participants Interval 81.7 to 98.6	60.5 Percentage of participants Interval 44.4 to 75.0
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2 Pain at injection site: Mild	44.4 Percentage of participants Interval 29.6 to 60.0	30.2 Percentage of participants Interval 17.2 to 46.1
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2 Pain at injection site: Moderate	35.6 Percentage of participants Interval 21.9 to 51.2	27.9 Percentage of participants Interval 15.3 to 43.7
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination 2 Pain at injection site: Severe	13.3 Percentage of participants Interval 5.1 to 26.8	2.3 Percentage of participants Interval 0.1 to 12.3

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Trumenba (B1971060) n=53 Participants 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).	Trumenba (B1971057, Historical Age- and Sex-Matched Control) n=51 Participants 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.
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Fever: =>38.0 degree C	3.8 Percentage of participants Interval 0.5 to 13.0	2.0 Percentage of participants Interval 0.0 to 10.4
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Fever: 38.0 to 38.4 degree C	1.9 Percentage of participants Interval 0.0 to 10.1	0 Percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Fever: >38.4 to 38.9 degree C	0 Percentage of participants Interval 0.0 to 6.7	2.0 Percentage of participants Interval 0.0 to 10.4
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Fever: >38.9 to 40.0 degree C	1.9 Percentage of participants Interval 0.0 to 10.1	0 Percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Fever: >40.0 degree C	0 Percentage of participants Interval 0.0 to 6.7	0 Percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Fatigue: Any	54.7 Percentage of participants Interval 40.4 to 68.4	51.0 Percentage of participants Interval 36.6 to 65.2
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Fatigue: Mild	26.4 Percentage of participants Interval 15.3 to 40.3	39.2 Percentage of participants Interval 25.8 to 53.9
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Fatigue: Moderate	22.6 Percentage of participants Interval 12.3 to 36.2	11.8 Percentage of participants Interval 4.4 to 23.9
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Fatigue: Severe	5.7 Percentage of participants Interval 1.2 to 15.7	0 Percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Headache: Any	41.5 Percentage of participants Interval 28.1 to 55.9	29.4 Percentage of participants Interval 17.5 to 43.8
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Headache: Mild	18.9 Percentage of participants Interval 9.4 to 32.0	25.5 Percentage of participants Interval 14.3 to 39.6
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Headache: Moderate	18.9 Percentage of participants Interval 9.4 to 32.0	2.0 Percentage of participants Interval 0.0 to 10.4
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Headache: Severe	3.8 Percentage of participants Interval 0.5 to 13.0	2.0 Percentage of participants Interval 0.0 to 10.4
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Chills: Any	15.1 Percentage of participants Interval 6.7 to 27.6	19.6 Percentage of participants Interval 9.8 to 33.1
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Chills: Mild	11.3 Percentage of participants Interval 4.3 to 23.0	17.6 Percentage of participants Interval 8.4 to 30.9
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Chills: Moderate	1.9 Percentage of participants Interval 0.0 to 10.1	2.0 Percentage of participants Interval 0.0 to 10.4
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Chills: Severe	1.9 Percentage of participants Interval 0.0 to 10.1	0 Percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Muscle Pain: Any	26.4 Percentage of participants Interval 15.3 to 40.3	23.5 Percentage of participants Interval 12.8 to 37.5
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Muscle Pain: Mild	15.1 Percentage of participants Interval 6.7 to 27.6	11.8 Percentage of participants Interval 4.4 to 23.9
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Muscle Pain: Moderate	9.4 Percentage of participants Interval 3.1 to 20.7	9.8 Percentage of participants Interval 3.3 to 21.4
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Muscle Pain: Severe	1.9 Percentage of participants Interval 0.0 to 10.1	2.0 Percentage of participants Interval 0.0 to 10.4
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Joint Pain: Any	22.6 Percentage of participants Interval 12.3 to 36.2	19.6 Percentage of participants Interval 9.8 to 33.1
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Joint Pain: Mild	9.4 Percentage of participants Interval 3.1 to 20.7	11.8 Percentage of participants Interval 4.4 to 23.9
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Joint Pain: Moderate	9.4 Percentage of participants Interval 3.1 to 20.7	5.9 Percentage of participants Interval 1.2 to 16.2
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Joint Pain: Severe	3.8 Percentage of participants Interval 0.5 to 13.0	2.0 Percentage of participants Interval 0.0 to 10.4
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Vomiting: Any	1.9 Percentage of participants Interval 0.0 to 10.1	2.0 Percentage of participants Interval 0.0 to 10.4
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Vomiting: Mild	1.9 Percentage of participants Interval 0.0 to 10.1	2.0 Percentage of participants Interval 0.0 to 10.4
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Vomiting: Moderate	0 Percentage of participants Interval 0.0 to 6.7	0 Percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Vomiting: Severe	0 Percentage of participants Interval 0.0 to 6.7	0 Percentage of participants Interval 0.0 to 7.0
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Diarrhea: Any	9.4 Percentage of participants Interval 3.1 to 20.7	11.8 Percentage of participants Interval 4.4 to 23.9
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Diarrhea: Mild	9.4 Percentage of participants Interval 3.1 to 20.7	5.9 Percentage of participants Interval 1.2 to 16.2
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Diarrhea: Moderate	0 Percentage of participants Interval 0.0 to 6.7	5.9 Percentage of participants Interval 1.2 to 16.2
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 1 Diarrhea: Severe	0 Percentage of participants Interval 0.0 to 6.7	0 Percentage of participants Interval 0.0 to 7.0

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Trumenba (B1971060) n=45 Participants 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).	Trumenba (B1971057, Historical Age- and Sex-Matched Control) n=43 Participants 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.
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Fever: >38.9 to 40.0 degree C	0 Percentage of participants Interval 0.0 to 7.9	0 Percentage of participants Interval 0.0 to 8.2
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Chills: Mild	4.4 Percentage of participants Interval 0.5 to 15.1	11.6 Percentage of participants Interval 3.9 to 25.1
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Fever: =>38.0 degree C	2.2 Percentage of participants Interval 0.1 to 11.8	2.3 Percentage of participants Interval 0.1 to 12.3
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Fever: 38.0 to 38.4 degree C	2.2 Percentage of participants Interval 0.1 to 11.8	0 Percentage of participants Interval 0.0 to 8.2
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Fever: >38.4 to 38.9 degree C	0 Percentage of participants Interval 0.0 to 7.9	2.3 Percentage of participants Interval 0.1 to 12.3
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Fever: >40.0 degree C	0 Percentage of participants Interval 0.0 to 7.9	0 Percentage of participants Interval 0.0 to 8.2
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Fatigue: Any	53.3 Percentage of participants Interval 37.9 to 68.3	41.9 Percentage of participants Interval 27.0 to 57.9
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Fatigue: Mild	24.4 Percentage of participants Interval 12.9 to 39.5	23.3 Percentage of participants Interval 11.8 to 38.6
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Fatigue: Moderate	24.4 Percentage of participants Interval 12.9 to 39.5	14.0 Percentage of participants Interval 5.3 to 27.9
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Fatigue: Severe	4.4 Percentage of participants Interval 0.5 to 15.1	4.7 Percentage of participants Interval 0.6 to 15.8
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Headache: Any	35.6 Percentage of participants Interval 21.9 to 51.2	30.2 Percentage of participants Interval 17.2 to 46.1
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Headache: Mild	6.7 Percentage of participants Interval 1.4 to 18.3	23.3 Percentage of participants Interval 11.8 to 38.6
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Headache: Moderate	22.2 Percentage of participants Interval 11.2 to 37.1	7.0 Percentage of participants Interval 1.5 to 19.1
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Headache: Severe	6.7 Percentage of participants Interval 1.4 to 18.3	0 Percentage of participants Interval 0.0 to 8.2
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Chills: Any	8.9 Percentage of participants Interval 2.5 to 21.2	14.0 Percentage of participants Interval 5.3 to 27.9
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Chills: Moderate	2.2 Percentage of participants Interval 0.1 to 11.8	2.3 Percentage of participants Interval 0.1 to 12.3
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Chills: Severe	2.2 Percentage of participants Interval 0.1 to 11.8	0 Percentage of participants Interval 0.0 to 8.2
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Muscle Pain: Any	13.3 Percentage of participants Interval 5.1 to 26.8	11.6 Percentage of participants Interval 3.9 to 25.1
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Muscle Pain: Mild	4.4 Percentage of participants Interval 0.5 to 15.1	7.0 Percentage of participants Interval 1.5 to 19.1
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Muscle Pain: Moderate	8.9 Percentage of participants Interval 2.5 to 21.2	2.3 Percentage of participants Interval 0.1 to 12.3
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Muscle Pain: Severe	0 Percentage of participants Interval 0.0 to 7.9	2.3 Percentage of participants Interval 0.1 to 12.3
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Joint Pain: Any	20.0 Percentage of participants Interval 9.6 to 34.6	16.3 Percentage of participants Interval 6.8 to 30.7
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Joint Pain: Mild	6.7 Percentage of participants Interval 1.4 to 18.3	14.0 Percentage of participants Interval 5.3 to 27.9
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Joint Pain: Moderate	11.1 Percentage of participants Interval 3.7 to 24.1	0 Percentage of participants Interval 0.0 to 8.2
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Joint Pain: Severe	2.2 Percentage of participants Interval 0.1 to 11.8	2.3 Percentage of participants Interval 0.1 to 12.3
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Vomiting: Any	2.2 Percentage of participants Interval 0.1 to 11.8	0 Percentage of participants Interval 0.0 to 8.2
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Vomiting: Mild	2.2 Percentage of participants Interval 0.1 to 11.8	0 Percentage of participants Interval 0.0 to 8.2
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Vomiting: Moderate	0 Percentage of participants Interval 0.0 to 7.9	0 Percentage of participants Interval 0.0 to 8.2
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Vomiting: Severe	0 Percentage of participants Interval 0.0 to 7.9	0 Percentage of participants Interval 0.0 to 8.2
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Diarrhea: Any	8.9 Percentage of participants Interval 2.5 to 21.2	4.7 Percentage of participants Interval 0.6 to 15.8
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Diarrhea: Mild	6.7 Percentage of participants Interval 1.4 to 18.3	4.7 Percentage of participants Interval 0.6 to 15.8
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Diarrhea: Moderate	2.2 Percentage of participants Interval 0.1 to 11.8	0 Percentage of participants Interval 0.0 to 8.2
Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination 2 Diarrhea: Severe	0 Percentage of participants Interval 0.0 to 7.9	0 Percentage of participants Interval 0.0 to 8.2

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Trumenba (B1971060) n=53 Participants 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).	Trumenba (B1971057, Historical Age- and Sex-Matched Control) n=51 Participants 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.
Percentage of Participants Reporting Use of Antipyretic Medication Within 7 Days After Vaccination 1	34.0 Percentage of participants Interval 21.5 to 48.3	9.8 Percentage of participants Interval 3.3 to 21.4

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Trumenba (B1971060) n=45 Participants 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).	Trumenba (B1971057, Historical Age- and Sex-Matched Control) n=43 Participants 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.
Percentage of Participants Reporting Use of Antipyretic Medication Within 7 Days After Vaccination 2	28.9 Percentage of participants Interval 16.4 to 44.3	7.0 Percentage of participants Interval 1.5 to 19.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Trumenba (B1971060) n=53 Participants 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).	Trumenba (B1971057, Historical Age- and Sex-Matched Control) n=51 Participants 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.
Percentage of Participants Reporting Adverse Events (AEs) During 30 Days After Vaccination 1	26.4 Percentage of participants Interval 15.3 to 40.3	9.8 Percentage of participants Interval 3.3 to 21.4

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Trumenba (B1971060) n=47 Participants 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).	Trumenba (B1971057, Historical Age- and Sex-Matched Control) n=47 Participants 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.
Percentage of Participants Reporting AEs During 30 Days After Vaccination 2	12.8 Percentage of participants Interval 4.8 to 25.7	12.8 Percentage of participants Interval 4.8 to 25.7

PRIMARY outcome

Timeframe: 30 Days after any Vaccination

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.

Outcome measures

Outcome measures
Measure	Trumenba (B1971060) n=53 Participants 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).	Trumenba (B1971057, Historical Age- and Sex-Matched Control) n=51 Participants 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.
Percentage of Participants Reporting AEs During 30 Days After Any Vaccination	34.0 Percentage of participants Interval 21.5 to 48.3	17.6 Percentage of participants Interval 8.4 to 30.9

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Trumenba (B1971060) n=53 Participants 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).	Trumenba (B1971057, Historical Age- and Sex-Matched Control) n=51 Participants 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.
Percentage of Participants Reporting AEs During the Vaccination Phase	60.4 Percentage of participants Interval 46.0 to 73.5	41.2 Percentage of participants Interval 27.6 to 55.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Trumenba (B1971060) n=53 Participants 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).	Trumenba (B1971057, Historical Age- and Sex-Matched Control) n=51 Participants 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.
Percentage of Participants Reporting Serious Adverse Events (SAEs) During 30 Days After Vaccination 1	9.4 Percentage of participants Interval 3.1 to 20.7	0 Percentage of participants Interval 0.0 to 7.0

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Trumenba (B1971060) n=47 Participants 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).	Trumenba (B1971057, Historical Age- and Sex-Matched Control) n=47 Participants 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.
Percentage of Participants Reporting SAEs During 30 Days After Vaccination 2	0 Percentage of participants Interval 0.0 to 7.5	0 Percentage of participants Interval 0.0 to 7.5

PRIMARY outcome

Timeframe: 30 Days after any Vaccination

Outcome measures

Outcome measures
Measure	Trumenba (B1971060) n=53 Participants 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).	Trumenba (B1971057, Historical Age- and Sex-Matched Control) n=51 Participants 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.
Percentage of Participants Reporting SAEs During 30 Days After Any Vaccination	9.4 Percentage of participants Interval 3.1 to 20.7	0 Percentage of participants Interval 0.0 to 7.0

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Trumenba (B1971060) n=53 Participants 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).	Trumenba (B1971057, Historical Age- and Sex-Matched Control) n=51 Participants 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.
Percentage of Participants Reporting SAEs During the Vaccination Phase	17.0 Percentage of participants Interval 8.1 to 29.8	0 Percentage of participants Interval 0.0 to 7.0

PRIMARY outcome

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

Population: 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.

Outcome measures

Outcome measures
Measure	Trumenba (B1971060) n=44 Participants 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).	Trumenba (B1971057, Historical Age- and Sex-Matched Control) n=48 Participants 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.
Percentage of Participants Reporting SAEs During the Follow-up Phase	4.5 Percentage of participants Interval 0.6 to 15.5	2.1 Percentage of participants Interval 0.1 to 11.1

PRIMARY outcome

Timeframe: 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.