Trial Outcomes & Findings for Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine (NCT NCT04707391)

Last Updated: 2024-07-03

Results Overview

Four-fold rise is defined as: - a post-vaccination hSBA titer equal to or higher than (\>=) 16 for participants with a pre-vaccination hSBA titer \<4; - a post-vaccination hSBA titer \>= 4 times the LLOQ for participants with a pre vaccination hSBA titer \>= limit of detection (LOD) but \< LLOQ; and - a post-vaccination hSBA titer \>= 4 times the pre-vaccination titer for participants with a pre-vaccination hSBA titer \>= LLOQ.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1250 participants

Primary outcome timeframe

At 1 month after vaccination schedule (i.e., Day 211 for ABCWY group and Day 31 for ACWY group) compared to Day 1 (Baseline)

Results posted on

2024-07-03

Participant Flow

Out of 1250 participants enrolled,3 participants did not receive vaccination as they did not meet the eligibility criteria, therefore only 1247 participants were included in the Exposed Set and started the study.

Participant milestones

Participant milestones
Measure	ABCWY Group Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.	ACWY Group Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
Overall Study STARTED	626	621
Overall Study COMPLETED	541	542
Overall Study NOT COMPLETED	85	79

Reasons for withdrawal

Reasons for withdrawal
Measure	ABCWY Group Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.	ACWY Group Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
Overall Study Adverse Event	5	8
Overall Study Lost to Follow-up	44	31
Overall Study Protocol Violation	1	5
Overall Study Withdrawal by Subject	27	25
Overall Study MIGRATED / MOVED FROM THE STUDY AREA	8	8
Overall Study Other	0	2

Baseline Characteristics

Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ABCWY Group n=626 Participants Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.	ACWY Group n=621 Participants Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.	Total n=1247 Participants Total of all reporting groups
Age, Continuous	17.2 YEARS STANDARD_DEVIATION 2.53 • n=5 Participants	17.2 YEARS STANDARD_DEVIATION 2.63 • n=7 Participants	17.2 YEARS STANDARD_DEVIATION 2.58 • n=5 Participants
Sex: Female, Male Female	343 Participants n=5 Participants	324 Participants n=7 Participants	667 Participants n=5 Participants
Sex: Female, Male Male	283 Participants n=5 Participants	297 Participants n=7 Participants	580 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	94 Participants n=5 Participants	86 Participants n=7 Participants	180 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	22 Participants n=5 Participants	33 Participants n=7 Participants	55 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized White	474 Participants n=5 Participants	464 Participants n=7 Participants	938 Participants n=5 Participants
Race/Ethnicity, Customized Other UNSPECIFIED	33 Participants n=5 Participants	31 Participants n=7 Participants	64 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 1 month after vaccination schedule (i.e., Day 211 for ABCWY group and Day 31 for ACWY group) compared to Day 1 (Baseline)

Population: Analysis was performed on Per Protocol Set (PPS), which included participants who received at least 1 dose of the study intervention to which they were randomized and had post-vaccination data available at the specified timepoint minus participants with protocol deviations that led to exclusion from the PPS.

Outcome measures

Outcome measures
Measure	ABCWY Group n=181 Participants Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.	ACWY Group n=546 Participants Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
Percentages of Participants With a 4-fold Rise in Human Serum Bactericidal Assay (hSBA) Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline Meningitis A	95.3 Percentage of Participants Interval 90.89 to 97.93	95.0 Percentage of Participants Interval 92.78 to 96.77
Percentages of Participants With a 4-fold Rise in Human Serum Bactericidal Assay (hSBA) Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline Meningitis C	94.5 Percentage of Participants Interval 90.07 to 97.32	94.0 Percentage of Participants Interval 91.62 to 95.8
Percentages of Participants With a 4-fold Rise in Human Serum Bactericidal Assay (hSBA) Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline Meningitis W	95.6 Percentage of Participants Interval 91.48 to 98.07	93.9 Percentage of Participants Interval 91.59 to 95.79
Percentages of Participants With a 4-fold Rise in Human Serum Bactericidal Assay (hSBA) Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline Meningitis Y	95.0 Percentage of Participants Interval 90.72 to 97.69	94.4 Percentage of Participants Interval 92.12 to 96.2

PRIMARY outcome

Timeframe: At 1 month after the first vaccination (i.e., Day 31) compared to Day 1 (Baseline)

Outcome measures

Outcome measures
Measure	ABCWY Group n=570 Participants Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.	ACWY Group n=546 Participants Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
Percentages of Participants With a 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline Meningitis A	92.5 Percentage of Participants Interval 89.9 to 94.66	95.0 Percentage of Participants Interval 92.78 to 96.77
Percentages of Participants With a 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline Meningitis C	94.0 Percentage of Participants Interval 91.76 to 95.83	94.0 Percentage of Participants Interval 91.62 to 95.8
Percentages of Participants With a 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline Meningitis W	94.3 Percentage of Participants Interval 92.1 to 96.09	93.9 Percentage of Participants Interval 91.59 to 95.79
Percentages of Participants With a 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline Meningitis Y	93.7 Percentage of Participants Interval 91.32 to 95.51	94.4 Percentage of Participants Interval 92.12 to 96.2

PRIMARY outcome

Timeframe: During the 7 days (including day of vaccination) following vaccination at day 1 for ABCWY group and ACWY group

Population: Analysis was performed on Solicited Safety Set (SSS),which included participants who received at least 1 dose of the study intervention and had solicited administration data available during the specified period.

Assessed solicited administration site events include injection site pain, erythema, swelling, induration. Any pain = occurrence of the symptom regardless of intensity grade and any erythema, swelling and induration are defined as a symptom with a surface diameter equal to or greater than 25 millimeters.

Outcome measures

Outcome measures
Measure	ABCWY Group n=608 Participants Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.	ACWY Group n=601 Participants Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
Number of Participants With Solicited Administration Site Events Following Vaccination at Day 1 for ABCWY Group and ACWY Group Injection site pain	486 Participants	191 Participants
Number of Participants With Solicited Administration Site Events Following Vaccination at Day 1 for ABCWY Group and ACWY Group Erythema	29 Participants	9 Participants
Number of Participants With Solicited Administration Site Events Following Vaccination at Day 1 for ABCWY Group and ACWY Group Swelling	26 Participants	13 Participants
Number of Participants With Solicited Administration Site Events Following Vaccination at Day 1 for ABCWY Group and ACWY Group Induration	24 Participants	14 Participants

PRIMARY outcome

Timeframe: During the 7 days (including day of vaccination) following vaccination at Day 181 for ABCWY group

Population: Analysis was performed on Solicited Safety Set (SSS), which included participants who received at least 2 dose of the study intervention and had solicited data available during the specified period.

Outcome measures

Outcome measures
Measure	ABCWY Group n=507 Participants Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.	ACWY Group Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
Number of Participants With Solicited Administration Site Events Following Vaccination at Day 181 for ABCWY Group Injection site pain	377 Participants	—
Number of Participants With Solicited Administration Site Events Following Vaccination at Day 181 for ABCWY Group Erythema	31 Participants	—
Number of Participants With Solicited Administration Site Events Following Vaccination at Day 181 for ABCWY Group Swelling	30 Participants	—
Number of Participants With Solicited Administration Site Events Following Vaccination at Day 181 for ABCWY Group Induration	22 Participants	—

PRIMARY outcome

Timeframe: During the 7 days (including day of vaccination) following vaccination at day 1 for the ABCWY group and ACWY group

Population: Analysis was performed on Solicited Safety Set (SSS), which included participants who received at least 1 dose of the study intervention and had solicited systemic data available during the specified period.

Assessed solicited systemic events include fever \[body temperature \>= 38.0°C (celsius) /100.4°F (Fahrenheit)\], nausea, fatigue, myalgia, arthralgia, headache.

Outcome measures

Outcome measures
Measure	ABCWY Group n=608 Participants Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.	ACWY Group n=601 Participants Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group Headache	249 Participants	208 Participants
Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group Fever	12 Participants	7 Participants
Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group Nausea	88 Participants	75 Participants
Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group Fatigue	244 Participants	222 Participants
Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group Myalgia	90 Participants	66 Participants
Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group Arthralgia	45 Participants	49 Participants

PRIMARY outcome

Timeframe: During the 7 days (including day of vaccination) following vaccination at day 181 for the ABCWY group

Population: Analysis was performed on Solicited Safety Set (SSS),which included participants who received at least 2 dose of the study intervention and had solicited systemic data available during the specified period.

Assessed solicited systemic events include fever \[body temperature \>= 38.0°C/100.4°F\], nausea, fatigue, myalgia, arthralgia, headache.

Outcome measures

Outcome measures
Measure	ABCWY Group n=505 Participants Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.	ACWY Group Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
Number of Participants With Solicited Systemic Events Following Vaccination at Day 181 for the ABCWY Group Arthralgia	30 Participants	—
Number of Participants With Solicited Systemic Events Following Vaccination at Day 181 for the ABCWY Group Headache	167 Participants	—
Number of Participants With Solicited Systemic Events Following Vaccination at Day 181 for the ABCWY Group Fever	9 Participants	—
Number of Participants With Solicited Systemic Events Following Vaccination at Day 181 for the ABCWY Group Nausea	58 Participants	—
Number of Participants With Solicited Systemic Events Following Vaccination at Day 181 for the ABCWY Group Fatigue	167 Participants	—
Number of Participants With Solicited Systemic Events Following Vaccination at Day 181 for the ABCWY Group Myalgia	67 Participants	—

PRIMARY outcome

Timeframe: During the 30 days (including day of vaccination) following vaccination at day 1 for ABCWY group and ACWY group

Population: Analysis was performed on the Unsolicited Safety Set (USS), which included participants who received at least 1 dose of the study intervention and had unsolicited AEs during the specific period.

Unsolicited AE-AE not solicited using an eDiary and spontaneously communicated by a participant/participant's parent(s)/Legally acceptable representative(s) who has signed informed consent. SAEs-events that result in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect in the offspring of a study participant/results in abnormal pregnancy outcomes. AESIs-predefined AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it. An MAE is defined as an unsolicited AE for which the participant received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider.

Outcome measures

Outcome measures
Measure	ABCWY Group n=626 Participants Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.	ACWY Group n=621 Participants Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
Number of Participants With Any Unsolicited Adverse Events (AEs) (Including All Serious Adverse Events [SAEs], AEs Leading to Withdrawal, AEs of Special Interest [AESIs] and Medically Attended AEs)	96 Participants	93 Participants

PRIMARY outcome

Timeframe: During the 30 days (including day of vaccination) following vaccination at day 181 for ABCWY group

Any AE-untoward medical occurrence in a patient/clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AE-AE not solicited using an eDiary and spontaneously communicated by a participant/participant's parent(s)/Legally acceptable representative(s) who has signed informed consent. SAEs-events that result in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect in the offspring of a study participant/results in abnormal pregnancy outcomes. AESIs-predefined AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.

Outcome measures

Outcome measures
Measure	ABCWY Group n=626 Participants Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.	ACWY Group Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
Number of Participants With Any Unsolicited Adverse Events (AEs) (Including All Serious Adverse Events [SAEs], AEs Leading to Withdrawal, AEs of Special Interest [AESIs] and Medically Attended AEs) Following Vaccination at Day 181 for ABCWY Group	72 Participants	—

PRIMARY outcome

Timeframe: From Day 1 to Day 361 (throughout the study period)

SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were assessed throughout the study period are reported in this outcome measure.

Outcome measures

Outcome measures
Measure	ABCWY Group n=626 Participants Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.	ACWY Group n=621 Participants Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs SAEs	18 Participants	7 Participants
Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs Medically Attended AEs	223 Participants	206 Participants
Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs AEs leading to withdrawal	4 Participants	6 Participants
Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs AESIs	0 Participants	4 Participants

SECONDARY outcome

Timeframe: At Day 1 (pre-vaccination) and 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group)

Population: Analysis was performed on the Full Analysis Set (FAS), which included participants who received at least 1 dose of the study intervention and had post-vaccination immunogenicity data for the specified analysis at the specified time points.

The immune response to MenABCWY vaccine after the first dose and single dose of MenACWY vaccine was evaluated by measuring the percentage of participants with hSBA titers \>= LLOQ against each of the serogroups A, C, W and Y.

Outcome measures

Outcome measures
Measure	ABCWY Group n=609 Participants Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.	ACWY Group n=593 Participants Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination Meningitis A, Day 1	27.7 Percentage of Participants Interval 23.94 to 31.61	28.8 Percentage of Participants Interval 25.02 to 32.77
Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination Meningitis A, Day 31	98.3 Percentage of Participants Interval 96.98 to 99.2	98.1 Percentage of Participants Interval 96.66 to 99.06
Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination Meningitis C, Day 1	57.7 Percentage of Participants Interval 53.67 to 61.72	56.2 Percentage of Participants Interval 52.03 to 60.23
Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination Meningitis C, Day 31	98.9 Percentage of Participants Interval 97.65 to 99.54	99.0 Percentage of Participants Interval 97.81 to 99.63
Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination Meningitis W, Day 1	36.3 Percentage of Participants Interval 32.48 to 40.35	33.4 Percentage of Participants Interval 29.62 to 37.44
Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination Meningitis Y, Day 1	37.5 Percentage of Participants Interval 33.61 to 41.51	34.9 Percentage of Participants Interval 31.0 to 38.94
Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination Meningitis W, Day 31	98.4 Percentage of Participants Interval 96.99 to 99.21	96.8 Percentage of Participants Interval 95.03 to 98.06
Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination Meningitis Y, Day 31	97.9 Percentage of Participants Interval 96.36 to 98.85	97.6 Percentage of Participants Interval 96.06 to 98.7

SECONDARY outcome

Timeframe: 1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose])

The immune response to MenABCWY vaccine after the second dose was evaluated by measuring the percentage of participants with hSBA titers \>= LLOQ against each of the serogroups A, C, W and Y.

Outcome measures

Outcome measures
Measure	ABCWY Group n=609 Participants Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.	ACWY Group Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination Meningitis C, Day 211	100.0 Percentage of Participants Interval 98.27 to 100.0	—
Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination Meningitis W, Day 211	100.0 Percentage of Participants Interval 98.28 to 100.0	—
Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination Meningitis A, Day 211	99.5 Percentage of Participants Interval 97.41 to 99.99	—
Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination Meningitis Y, Day 211	100.0 Percentage of Participants Interval 98.26 to 100.0	—

SECONDARY outcome

Timeframe: At Day 1 and 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group)

The immune response to MenABCWY after first dose and single dose of MenACWY vaccine was evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y in terms of GMTs. For each serogroup, the GMTs with their associated 2-sided 95% confidence intervals were calculated.

Outcome measures

Outcome measures
Measure	ABCWY Group n=609 Participants Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.	ACWY Group n=593 Participants Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination Meningitis A, Day 31	670.78 Titers Interval 594.71 to 756.58	1282.56 Titers Interval 1135.84 to 1448.23
hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination Meningitis C, Day 31	2945.68 Titers Interval 2471.13 to 3511.36	2552.27 Titers Interval 2138.66 to 3045.87
hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination Meningitis Y, Day 1	12.84 Titers Interval 11.16 to 14.76	11.86 Titers Interval 10.29 to 13.66
hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination Meningitis Y, Day 31	1590.71 Titers Interval 1380.78 to 1832.55	1578.42 Titers Interval 1369.0 to 1819.88
hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination Meningitis A, Day 1	15.30 Titers Interval 13.07 to 17.92	16.34 Titers Interval 13.96 to 19.14
hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination Meningitis C, Day 1	31.90 Titers Interval 26.63 to 38.23	29.76 Titers Interval 24.81 to 35.71
hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination Meningitis W, Day 1	12.08 Titers Interval 10.31 to 14.15	11.08 Titers Interval 9.45 to 12.99
hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination Meningitis W, Day 31	1899.60 Titers Interval 1638.73 to 2202.0	1665.64 Titers Interval 1435.57 to 1932.58

SECONDARY outcome

Timeframe: 1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose])

The immune response to MenABCWY after second dose was evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y in terms of GMTs. For each serogroup, the GMTs with their associated 2-sided 95% confidence intervals were calculated.

Outcome measures

Outcome measures
Measure	ABCWY Group n=609 Participants Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.	ACWY Group Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination Meningitis C, Day 211	2350.14 Titers Interval 1809.69 to 3052.0	—
hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination Meningitis A, Day 211	645.24 Titers Interval 544.11 to 765.16	—
hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination Meningitis W, Day 211	1173.61 Titers Interval 940.25 to 1464.89	—
hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination Meningitis Y, Day 211	1130.54 Titers Interval 916.85 to 1394.04	—

SECONDARY outcome

Timeframe: At 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group) compared to baseline (Day 1)

The immune response to MenABCWY vaccine after first and single dose of MenACWY vaccine are evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y, compared to baseline (Day 1) and expressed as GMRs. Within group GMRs was calculated as ratio of GMTs in the post-vaccination timepoint to the pre-vaccination timepoint.

Outcome measures

Outcome measures
Measure	ABCWY Group n=597 Participants Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.	ACWY Group n=583 Participants Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination Meningitis A, Day 31	43.98 Ratio Interval 36.92 to 52.4	76.91 Ratio Interval 64.53 to 91.66
Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination Meningitis C, Day 31	92.87 Ratio Interval 77.13 to 111.83	86.36 Ratio Interval 71.63 to 104.12
Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination Meningitis W, Day 31	154.09 Ratio Interval 125.8 to 188.73	150.83 Ratio Interval 123.0 to 184.96
Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination Meningitis Y, Day 31	124.11 Ratio Interval 103.23 to 149.23	134.66 Ratio Interval 111.75 to 162.26

SECONDARY outcome

Timeframe: At 1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose]) compared to baseline (Day 1)

The immune response to MenABCWY vaccine after second dose are evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y, compared to baseline (Day 1) and expressed as GMRs. Within group GMRs was calculated as ratio of GMTs in the post-vaccination timepoint to the pre-vaccination timepoint.

Outcome measures

Outcome measures
Measure	ABCWY Group n=597 Participants Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.	ACWY Group Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After Second MenABCWY Vaccination Meningitis A, Day 211	44.74 Ratio Interval 34.67 to 57.74	—
Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After Second MenABCWY Vaccination Meningitis C, Day 211	68.33 Ratio Interval 52.19 to 89.46	—
Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After Second MenABCWY Vaccination Meningitis W, Day 211	97.66 Ratio Interval 72.52 to 131.52	—
Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After Second MenABCWY Vaccination Meningitis Y, Day 211	82.45 Ratio Interval 62.8 to 108.24	—

SECONDARY outcome

Timeframe: At Day 1 and at Day 211

Population: Analysis was performed on the Full Analysis Set (FAS), which included participants from only ABCWY Group who received at least 1 dose of the MenABCWY vaccine and had post vaccination immunogenicity data for the specified analysis at the specified time points.

The immune response to MenABCWY vaccine after second dose was evaluated by measuring bactericidal activity against each (individual response) and all (composite response) N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively).

Outcome measures

Outcome measures
Measure	ABCWY Group n=184 Participants Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.	ACWY Group Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination fHbp (M14459) Ab, Day 1	8.7 Percentage of Participants Interval 5.05 to 13.74	—
Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination NadA (96217) Ab, Day 1	7.7 Percentage of Participants Interval 4.25 to 12.5	—
Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination NadA (96217) Ab, Day 211	95.8 Percentage of Participants Interval 91.45 to 98.28	—
Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination NHBA (M13520) Ab, Day 1	20.2 Percentage of Participants Interval 14.65 to 26.77	—
Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination PorAP1.4 (NZ98/254) Ab, Day 211	75.6 Percentage of Participants Interval 68.3 to 81.97	—
Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination Composite Response, Day 1	1.1 Percentage of Participants Interval 0.13 to 3.93	—
Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination Composite Response, Day 211	72.0 Percentage of Participants Interval 64.41 to 78.68	—
Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination fHbp (M14459) Ab, Day 211	88.5 Percentage of Participants Interval 82.6 to 92.92	—
Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination NHBA (M13520) Ab, Day 211	96.3 Percentage of Participants Interval 92.21 to 98.65	—
Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination PorAP1.4 (NZ98/254) Ab, Day 1	2.7 Percentage of Participants Interval 0.89 to 6.23	—

SECONDARY outcome

Timeframe: At Day 211 compared to baseline (Day 1)

The immune response to MenABCWY after second dose is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively). compared to baseline (day 1) in terms of 4-fold rise in hSBA titers. For each of the serogroup B indicator strains, the 4-fold rise is defined as: a post-vaccination hSBA titer \>=16 for participants with a pre-vaccination hSBA titer \<4; . a post-vaccination hSBA titer \>= 4 times the LLOQ for participants with a prevaccination hSBA titer \>= limit of detection (LOD) but \< LLOQ; and, a post-vaccination hSBA titer \>= 4 times the pre-vaccination titer for participants with a pre-vaccination hSBA titer \>= LLOQ.

Outcome measures

Outcome measures
Measure	ABCWY Group n=163 Participants Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.	ACWY Group Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
Percentages of Participants With 4-fold Rise in hSBA Titers Against Each N. Meningitidis Serogroup B Indicator Strains at 1 Month After the Second MenABCWY Vaccination fHbp (M14459) Ab	68.1 Percentage of Participants Interval 60.35 to 75.17	—
Percentages of Participants With 4-fold Rise in hSBA Titers Against Each N. Meningitidis Serogroup B Indicator Strains at 1 Month After the Second MenABCWY Vaccination PorAP1.4 (NZ98/254) Ab	45.7 Percentage of Participants Interval 37.84 to 53.68	—
Percentages of Participants With 4-fold Rise in hSBA Titers Against Each N. Meningitidis Serogroup B Indicator Strains at 1 Month After the Second MenABCWY Vaccination NadA (96217) Ab	90.1 Percentage of Participants Interval 84.46 to 94.25	—
Percentages of Participants With 4-fold Rise in hSBA Titers Against Each N. Meningitidis Serogroup B Indicator Strains at 1 Month After the Second MenABCWY Vaccination NHBA (M13520) Ab	64.6 Percentage of Participants Interval 56.68 to 71.96	—

SECONDARY outcome

Timeframe: At Day 1 and at Day 211

The immune response to MenABCWY vaccine after the second dose was evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively) in terms of GMTs at baseline (Day 1) and 1 month after second MenABCWY vaccination.

Outcome measures

Outcome measures
Measure	ABCWY Group n=184 Participants Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.	ACWY Group Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination NadA (96217) Ab, Day 211	143.61 Titers Interval 106.71 to 193.26	—
GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination NHBA (M13520) Ab, Day 211	24.82 Titers Interval 19.19 to 32.11	—
GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination PorAP1.4 (NZ98/254) Ab, Day 211	11.44 Titers Interval 8.61 to 15.19	—
GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination fHbp (M14459) Ab, Day 1	2.84 Titers Interval 2.53 to 3.19	—
GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination fHbp (M14459) Ab, Day 211	17.56 Titers Interval 13.52 to 22.8	—
GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination NadA (96217) Ab, Day 1	8.62 Titers Interval 7.39 to 10.06	—
GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination NHBA (M13520) Ab, Day 1	3.28 Titers Interval 2.59 to 4.15	—
GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination PorAP1.4 (NZ98/254) Ab, Day 1	3.13 Titers Interval 2.86 to 3.43	—

SECONDARY outcome

Timeframe: At Day 211 compared to baseline (Day 1)

The immune response to MenABCWY vaccine after second dose was evaluated by measuring the human serum bactericidal activity against each of the N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively) compared to baseline (Day 1) and expressed as GMRs. Within group GMRs was calculated as ratio of GMTs in the post-vaccination timepoint to the pre-vaccination timepoint.

Outcome measures

Outcome measures
Measure	ABCWY Group n=163 Participants Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.	ACWY Group Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
GMRs Against Each Serogroup B Indicator Strains at 1 Month After Second Dose of MenABCWY Vaccination fHbp (M14459) Ab	6.29 Ratio Interval 4.84 to 8.18	—
GMRs Against Each Serogroup B Indicator Strains at 1 Month After Second Dose of MenABCWY Vaccination NadA (96217) Ab	16.67 Ratio Interval 12.25 to 22.7	—
GMRs Against Each Serogroup B Indicator Strains at 1 Month After Second Dose of MenABCWY Vaccination NHBA (M13520) Ab	7.69 Ratio Interval 6.08 to 9.72	—
GMRs Against Each Serogroup B Indicator Strains at 1 Month After Second Dose of MenABCWY Vaccination PorAP1.4 (NZ98/254) Ab	3.65 Ratio Interval 2.76 to 4.83	—

Adverse Events

ABCWY Group

Serious events: 18 serious events

Other events: 583 other events

Deaths: 1 deaths

ACWY Group

Serious events: 7 serious events

Other events: 552 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	ABCWY Group n=626 participants at risk Participants received 2 doses of the MenABCWY vaccine on Day 1 and Day 181 (0,6-month schedule) and 1 dose of placebo on Day 211.	ACWY Group n=621 participants at risk Participants received 1 dose of MenACWY vaccine on Day 1 and 2 doses of MenB vaccine on Day 181 and Day 211.
Infections and infestations Appendicitis	0.32% 2/626 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/621 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Norovirus infection	0.16% 1/626 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/621 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Parotitis	0.16% 1/626 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/621 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Pilonidal disease	0.16% 1/626 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.32% 2/621 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Pyelonephritis acute	0.16% 1/626 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/621 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Infections and infestations Tonsillitis	0.16% 1/626 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/621 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Bipolar disorder	0.00% 0/626 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.16% 1/621 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Completed suicide	0.16% 1/626 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.16% 1/621 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Depression	0.00% 0/626 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.16% 1/621 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Intentional self-injury	0.00% 0/626 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.16% 1/621 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Major depression	0.16% 1/626 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/621 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Psychiatric disorders Suicidal ideation	0.32% 2/626 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/621 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Headache	0.16% 1/626 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/621 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Seizure	0.16% 1/626 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/621 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Nervous system disorders Syncope	0.16% 1/626 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/621 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Impaired gastric emptying	0.16% 1/626 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/621 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Gastrointestinal disorders Vomiting	0.16% 1/626 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/621 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.16% 1/626 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/621 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Congenital, familial and genetic disorders Gastroschisis	0.00% 0/626 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.16% 1/621 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Congenital, familial and genetic disorders Wolff-Parkinson-White syndrome congenital	0.16% 1/626 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/621 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Gun shot wound	0.16% 1/626 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/621 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Intentional overdose	0.16% 1/626 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/621 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Joint injury	0.00% 0/626 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.16% 1/621 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])
Injury, poisoning and procedural complications Pneumothorax traumatic	0.16% 1/626 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])	0.00% 0/621 • Solicited AEs were collected during the 7-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected through the entire period of the study (from Day 1 up to study end [Day 361])