Trial Outcomes & Findings for Study to Assess the Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's (GSK) Meningococcal MenACWY-CRM Vaccine (Menveo), Administered to Subjects 15 Through 55 Years of Age, Approximately 4-6 Years After Primary ACWY Vaccination (NCT NCT02986854)

Last Updated: 2019-11-25

Results Overview

Seroresponse was defined as follows:for subjects with pre-vaccination hSBA titers\< 4,postvaccination hSBA titers≥16;for subjects with pre-vaccination hSBA titers≥4,post vaccination hSBA titers of atleast 4 times the pre-vaccination titers.Criteria to demonstrate primary objectives:Immune response sufficiency was tested sequentially;first in the group of subjects who received primary vaccination with Menveo \&,if met,also in group of subjects who received primary vaccination with Menactra.Immune response is considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of subjects with hSBA seroresponse against serogroups A, C, W \& Y is greater than 75%.Study is considered successful if immune response sufficiency is demonstrated atleast in group of subjects who received primary vaccination with Menveo.This outcome measure was assessed only on subjects from Menveo-Menveo \& Menactra-Menveo groups.Data from pooled and Naive groups are presented as part of secondary objectives

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

704 participants

Primary outcome timeframe

At Day 29

Results posted on

2019-11-25

Participant Flow

Subjects were recruited from 1 center in Puerto Rico and 37 centers in Unites States.

704 subjects were enrolled in this study. Out of the 704 enrolled, 701 received the study vaccine

Participant milestones

Participant milestones
Measure	Menveo-Menveo Group Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Menactra-Menveo Group Healthy subjects,15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Naive Group Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
Overall Study STARTED	301	300	100
Overall Study COMPLETED	298	288	97
Overall Study NOT COMPLETED	3	12	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Menveo-Menveo Group Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Menactra-Menveo Group Healthy subjects,15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Naive Group Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
Overall Study Withdrawal by Subject	0	1	1
Overall Study Lost to Follow-up	3	11	2

Baseline Characteristics

Study to Assess the Safety and Immunogenicity of a Single Dose of GlaxoSmithKline's (GSK) Meningococcal MenACWY-CRM Vaccine (Menveo), Administered to Subjects 15 Through 55 Years of Age, Approximately 4-6 Years After Primary ACWY Vaccination

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Menveo-Menveo Group n=301 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Menactra-Menveo Group n=300 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Naive Group n=100 Participants Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.	Total n=701 Participants Total of all reporting groups
Age, Continuous	17.1 Years STANDARD_DEVIATION 3.66 • n=5 Participants	17.9 Years STANDARD_DEVIATION 4.54 • n=7 Participants	38.8 Years STANDARD_DEVIATION 10.47 • n=5 Participants	20.5 Years STANDARD_DEVIATION 9.25 • n=4 Participants
Sex: Female, Male Female	144 Participants n=5 Participants	156 Participants n=7 Participants	68 Participants n=5 Participants	368 Participants n=4 Participants
Sex: Female, Male Male	157 Participants n=5 Participants	144 Participants n=7 Participants	32 Participants n=5 Participants	333 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	14 Participants n=7 Participants	3 Participants n=5 Participants	21 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	24 Participants n=5 Participants	23 Participants n=7 Participants	12 Participants n=5 Participants	59 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Unspecified	17 Participants n=5 Participants	23 Participants n=7 Participants	5 Participants n=5 Participants	45 Participants n=4 Participants
Race/Ethnicity, Customized White	251 Participants n=5 Participants	233 Participants n=7 Participants	79 Participants n=5 Participants	563 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Day 29

Population: Analysis was performed on the per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis who received the study vaccination \& provided evaluable serum samples at Day 29 with results available for atleast one serogroup

Outcome measures

Outcome measures
Measure	Menveo-Menveo Group n=290 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Menactra-Menveo Group n=282 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Pooled Group (Menveo-Menveo and Menactra-Menveo) n=571 Participants Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups	Naive Group n=93 Participants Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. hSBA-Men A, Total seroresponse	96.54 Percentage of subjects Interval 93.73 to 98.33	96.45 Percentage of subjects Interval 93.58 to 98.29	96.50 Percentage of subjects Interval 94.64 to 97.85	65.59 Percentage of subjects Interval 55.02 to 75.14
Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. hSBA-Men C, Pre < 4	100 Percentage of subjects Interval 95.75 to 100.0	100 Percentage of subjects Interval 96.48 to 100.0	100 Percentage of subjects Interval 98.06 to 100.0	55.81 Percentage of subjects Interval 39.88 to 70.92
Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. hSBA-Men C, Pre ≥ 4	93.6 Percentage of subjects Interval 89.3 to 96.55	93.79 Percentage of subjects Interval 89.15 to 96.86	93.68 Percentage of subjects Interval 90.75 to 95.91	58.00 Percentage of subjects Interval 43.21 to 71.81
Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. hSBA-Men C, Total seroresponse	95.49 Percentage of subjects Interval 92.4 to 97.57	96.07 Percentage of subjects Interval 93.08 to 98.02	95.77 Percentage of subjects Interval 93.78 to 97.27	56.99 Percentage of subjects Interval 46.31 to 67.22
Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. hSBA-Men W, Pre < 4	100 Percentage of subjects Interval 93.15 to 100.0	100 Percentage of subjects Interval 93.84 to 100.0	100 Percentage of subjects Interval 96.7 to 100.0	54.55 Percentage of subjects Interval 36.35 to 71.89
Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. hSBA-Men W, Pre ≥ 4	94.94 Percentage of subjects Interval 91.32 to 97.36	91.48 Percentage of subjects Interval 87.01 to 94.79	93.26 Percentage of subjects Interval 90.57 to 95.38	25.42 Percentage of subjects Interval 14.98 to 38.44
Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. hSBA-Men W, Total seroresponse	95.85 Percentage of subjects Interval 92.86 to 97.84	93.24 Percentage of subjects Interval 89.64 to 95.88	94.56 Percentage of subjects Interval 92.37 to 96.28	35.87 Percentage of subjects Interval 26.13 to 46.54
Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. hSBA-Men Y, Pre < 4	100 Percentage of subjects Interval 96.84 to 100.0	97.56 Percentage of subjects Interval 93.04 to 99.49	98.74 Percentage of subjects Interval 96.36 to 99.74	55.56 Percentage of subjects Interval 41.4 to 69.08
Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. hSBA-Men Y, Pre ≥ 4	94.77 Percentage of subjects Interval 90.3 to 97.58	91.72 Percentage of subjects Interval 86.26 to 95.52	93.31 Percentage of subjects Interval 90.05 to 95.76	46.15 Percentage of subjects Interval 30.09 to 62.82
Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. hSBA-Men Y, Total seroresponse	96.86 Percentage of subjects Interval 94.13 to 98.56	94.29 Percentage of subjects Interval 90.89 to 96.7	95.59 Percentage of subjects Interval 93.56 to 97.13	51.61 Percentage of subjects Interval 41.01 to 62.11
Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. hSBA-Men A, Pre < 4	97.97 Percentage of subjects Interval 95.32 to 99.34	97.01 Percentage of subjects Interval 93.93 to 98.79	97.50 Percentage of subjects Interval 95.67 to 98.7	64.71 Percentage of subjects Interval 53.59 to 74.77
Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y. hSBA-Men A, Pre ≥ 4	88.37 Percentage of subjects Interval 74.92 to 96.11	93.75 Percentage of subjects Interval 82.8 to 98.69	91.21 Percentage of subjects Interval 83.41 to 96.13	75.00 Percentage of subjects Interval 34.91 to 96.81

SECONDARY outcome

Timeframe: Within 30 minutes after vaccination

Population: Analysis was performed on the unsolicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the study, received a subject ID and reported any unsolicited adverse event.

An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event is an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.

Outcome measures

Outcome measures
Measure	Menveo-Menveo Group n=301 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Menactra-Menveo Group n=300 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Pooled Group (Menveo-Menveo and Menactra-Menveo) n=601 Participants Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups	Naive Group n=100 Participants Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)	0 Participants	8 Participants	8 Participants	1 Participants

SECONDARY outcome

Timeframe: From Day 1 (6 hours) through Day 7 after vaccination

Population: Analysis was performed on the solicited safety set which included all subjects who provided informed consent and demographic and/or baseline screening assessments, regardless of the subject's randomization and treatment status in the study, received a subject ID and reported any solicited adverse event.

Assessed solicited local symptoms were injection site pain, erythema, induration. Assessed solicited systemic symptoms were fatigue, headache, myalgia, arthralgia, loss of appetite, nausea, chills and fever \[defined and measured by a body temperature ≥37.5 degrees Celsius (ºC)\]. Threshold for Erythema and Induration: Grade 0 (\<25 mm), Any (\>= 25 mm)

Outcome measures

Outcome measures
Measure	Menveo-Menveo Group n=296 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Menactra-Menveo Group n=296 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Pooled Group (Menveo-Menveo and Menactra-Menveo) n=592 Participants Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups	Naive Group n=97 Participants Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
Number of Subjects Reporting Solicited Local and Systemic AEs Any Local symptom	119 Participants	97 Participants	216 Participants	41 Participants
Number of Subjects Reporting Solicited Local and Systemic AEs Any Systemic symptom	162 Participants	148 Participants	310 Participants	35 Participants
Number of Subjects Reporting Solicited Local and Systemic AEs Any Induration	15 Participants	9 Participants	24 Participants	8 Participants
Number of Subjects Reporting Solicited Local and Systemic AEs Any Erythema	12 Participants	8 Participants	20 Participants	10 Participants
Number of Subjects Reporting Solicited Local and Systemic AEs Any Pain	114 Participants	96 Participants	210 Participants	40 Participants
Number of Subjects Reporting Solicited Local and Systemic AEs Any Nausea	48 Participants	44 Participants	92 Participants	13 Participants
Number of Subjects Reporting Solicited Local and Systemic AEs Any Fatigue	113 Participants	110 Participants	223 Participants	19 Participants
Number of Subjects Reporting Solicited Local and Systemic AEs Any Myalgia	55 Participants	54 Participants	109 Participants	15 Participants
Number of Subjects Reporting Solicited Local and Systemic AEs Any Arthralgia	44 Participants	38 Participants	82 Participants	13 Participants
Number of Subjects Reporting Solicited Local and Systemic AEs Any Headache	100 Participants	82 Participants	182 Participants	21 Participants
Number of Subjects Reporting Solicited Local and Systemic AEs Any loss of apetite	37 Participants	46 Participants	83 Participants	6 Participants
Number of Subjects Reporting Solicited Local and Systemic AEs Any chills	34 Participants	35 Participants	69 Participants	10 Participants
Number of Subjects Reporting Solicited Local and Systemic AEs Fever	2 Participants	5 Participants	7 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 (6 hours) through Day 7 after vaccination

Assessed indicators of reactogenicity were use of analgesics/antipyretics for prophylaxis, use of analgesics/antipyretics for treatment, body temperature (described as 0.5 °C increments from ≥ 36.0ºC)

Outcome measures

Outcome measures
Measure	Menveo-Menveo Group n=296 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Menactra-Menveo Group n=296 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Pooled Group (Menveo-Menveo and Menactra-Menveo) n=592 Participants Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups	Naive Group n=97 Participants Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
Number of Subjects Reporting Other Indicators of Reactogenicity Body temperature (39.5 - 39.9 ºC)	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Other Indicators of Reactogenicity Analgesics/antipyretics for prophylaxis	13 Participants	15 Participants	28 Participants	5 Participants
Number of Subjects Reporting Other Indicators of Reactogenicity Analgesics/antipyretics for treatment	18 Participants	24 Participants	42 Participants	10 Participants
Number of Subjects Reporting Other Indicators of Reactogenicity Body temperature (36.0 - 36.4 ºC)	68 Participants	57 Participants	125 Participants	16 Participants
Number of Subjects Reporting Other Indicators of Reactogenicity Body temperature (36.5 - 36.9 ºC)	135 Participants	141 Participants	276 Participants	45 Participants
Number of Subjects Reporting Other Indicators of Reactogenicity Body temperature (37.0 - 37.4 ºC)	83 Participants	77 Participants	160 Participants	33 Participants
Number of Subjects Reporting Other Indicators of Reactogenicity Body temperature (37.5 - 37.9 ºC)	6 Participants	9 Participants	15 Participants	3 Participants
Number of Subjects Reporting Other Indicators of Reactogenicity Body temperature (38.0 - 38.4 ºC)	1 Participants	2 Participants	3 Participants	0 Participants
Number of Subjects Reporting Other Indicators of Reactogenicity Body temperature (38.5 - 38.9 ºC)	1 Participants	3 Participants	4 Participants	0 Participants
Number of Subjects Reporting Other Indicators of Reactogenicity Body temperature (39.0 - 39.4 ºC)	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Other Indicators of Reactogenicity Body temperature (>=40ºC)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Day 1 through Day 29 after vaccination

An AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom , or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. An unsolicited adverse event was an adverse event that was not solicited using a subject diary and that was spontaneously communicated by a subject and/or parent(s)/legal guardian(s) who has signed the informed consent.

Outcome measures

Outcome measures
Measure	Menveo-Menveo Group n=301 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Menactra-Menveo Group n=300 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Pooled Group (Menveo-Menveo and Menactra-Menveo) n=601 Participants Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups	Naive Group n=100 Participants Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
Number of Subjects Reporting All Unsolicited AEs	74 Participants	78 Participants	152 Participants	22 Participants

SECONDARY outcome

Timeframe: From Day 1 through Day 181 (entire study period)

Medically attended AEs were defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. SAE was defined as any untoward medical occurrence that at any dose resulted in: death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, an important and significant medical event that might not have been immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, might jeopardized the subject or might required intervention to prevent one of the other outcomes listed.

Outcome measures

Outcome measures
Measure	Menveo-Menveo Group n=301 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Menactra-Menveo Group n=300 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Pooled Group (Menveo-Menveo and Menactra-Menveo) n=601 Participants Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups	Naive Group n=100 Participants Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs) Any MAAEs	102 Participants	79 Participants	181 Participants	19 Participants
Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs) Any AEs leading to withdrawal	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs) Any SAEs	3 Participants	2 Participants	5 Participants	3 Participants

SECONDARY outcome

Timeframe: At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29

Population: Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.

Outcome measures

Outcome measures
Measure	Menveo-Menveo Group n=290 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Menactra-Menveo Group n=282 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Pooled Group (Menveo-Menveo and Menactra-Menveo) n=572 Participants Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups	Naive Group n=93 Participants Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A hSBA-Men A ≥ 8, Day 1	12.46 Percentages of subjects Interval 8.88 to 16.83	14.89 Percentages of subjects Interval 10.95 to 19.59	13.66 Percentages of subjects Interval 10.95 to 16.75	4.3 Percentages of subjects Interval 1.18 to 10.65
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A hSBA-Men A ≥ 8, Day 4	11.11 Percentages of subjects Interval 6.49 to 17.42	13.04 Percentages of subjects Interval 7.92 to 19.83	12.06 Percentages of subjects Interval 8.5 to 16.44	4.17 Percentages of subjects Interval 0.51 to 14.25
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A hSBA-Men A ≥ 8, Day 6	53.42 Percentages of subjects Interval 44.99 to 61.71	47.14 Percentages of subjects Interval 38.66 to 55.75	50.35 Percentages of subjects Interval 44.4 to 56.29	9.09 Percentages of subjects Interval 2.53 to 21.67
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup A hSBA-Men A ≥ 8, Day 29	98.62 Percentages of subjects Interval 96.51 to 99.62	98.94 Percentages of subjects Interval 96.92 to 99.78	98.78 Percentages of subjects Interval 97.49 to 99.51	70.97 Percentages of subjects Interval 60.64 to 79.92

SECONDARY outcome

Timeframe: At day 1(pre-vaccination) , day 4, day 6 and day 29

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.

Outcome measures

Outcome measures
Measure	Menveo-Menveo Group n=290 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Menactra-Menveo Group n=281 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Pooled Group (Menveo-Menveo and Menactra-Menveo) n=571 Participants Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups	Naive Group n=93 Participants Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C hSBA-Men C ≥ 8, Day 1	61.11 Percentage of subjects Interval 55.22 to 66.77	53.74 Percentage of subjects Interval 47.72 to 59.68	57.47 Percentage of subjects Interval 53.29 to 61.57	33.33 Percentage of subjects Interval 23.89 to 43.87
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C hSBA-Men C ≥ 8, Day 4	70.83 Percentage of subjects Interval 62.68 to 78.1	60.14 Percentage of subjects Interval 51.47 to 68.38	65.6 Percentage of subjects Interval 59.74 to 71.13	43.75 Percentage of subjects Interval 29.48 to 58.82
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C hSBA-Men C ≥ 8, Day 6	87.59 Percentage of subjects Interval 81.09 to 92.47	92.09 Percentage of subjects Interval 86.28 to 95.98	89.79 Percentage of subjects Interval 85.66 to 93.05	43.18 Percentage of subjects Interval 28.35 to 58.97
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup C hSBA-Men C ≥ 8, Day 29	100 Percentage of subjects Interval 98.74 to 100.0	99.64 Percentage of subjects Interval 98.03 to 99.99	99.82 Percentage of subjects Interval 99.03 to 100.0	87.1 Percentage of subjects Interval 78.55 to 93.15

SECONDARY outcome

Timeframe: At day 1(pre-vaccination), day 4, day 6 and day 29

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.

Outcome measures

Outcome measures
Measure	Menveo-Menveo Group n=290 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Menactra-Menveo Group n=282 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Pooled Group (Menveo-Menveo and Menactra-Menveo) n=571 Participants Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups	Naive Group n=93 Participants Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W hSBA-Men W ≥ 8, Day 1	75.43 Percentage of subjects Interval 70.05 to 80.29	76.95 Percentage of subjects Interval 71.59 to 81.74	76.18 Percentage of subjects Interval 72.47 to 79.62	61.29 Percentage of subjects Interval 50.62 to 71.22
Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W hSBA-Men W ≥ 8, Day 4	81.94 Percentage of subjects Interval 74.67 to 87.85	82.61 Percentage of subjects Interval 75.24 to 88.53	82.27 Percentage of subjects Interval 77.3 to 86.54	62.5 Percentage of subjects Interval 47.35 to 76.05
Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W hSBA-Men W ≥ 8, Day 6	93.84 Percentage of subjects Interval 88.62 to 97.14	97.86 Percentage of subjects Interval 93.87 to 99.56	95.8 Percentage of subjects Interval 92.79 to 97.81	63.64 Percentage of subjects Interval 47.77 to 77.59
Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup W hSBA-Men W ≥ 8, Day 29	100 Percentage of subjects Interval 98.74 to 100.0	100 Percentage of subjects Interval 98.7 to 100.0	100 Percentage of subjects Interval 99.36 to 100.0	84.78 Percentage of subjects Interval 75.79 to 91.42

SECONDARY outcome

Timeframe: At day 1(pre-vaccination), day 4, day 6 and day 29

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥8 and associated two-sided 95%CIs were calculated.

Outcome measures

Outcome measures
Measure	Menveo-Menveo Group n=290 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Menactra-Menveo Group n=281 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Pooled Group (Menveo-Menveo and Menactra-Menveo) n=571 Participants Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups	Naive Group n=93 Participants Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y hSBA-Men Y ≥ 8, Day 1	54.01 Percentage of subjects Interval 48.05 to 59.88	46.98 Percentage of subjects Interval 41.02 to 52.99	50.53 Percentage of subjects Interval 46.33 to 54.72	32.26 Percentage of subjects Interval 22.93 to 42.75
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y hSBA-Men Y ≥ 8, Day 4	55.24 Percentage of subjects Interval 46.71 to 63.56	55.8 Percentage of subjects Interval 47.1 to 64.24	55.52 Percentage of subjects Interval 49.5 to 61.42	33.33 Percentage of subjects Interval 20.4 to 48.41
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y hSBA-Men Y ≥ 8, Day 6	85.52 Percentage of subjects Interval 78.72 to 90.81	87.86 Percentage of subjects Interval 81.27 to 92.76	86.67 Percentage of subjects Interval 82.16 to 90.39	45.45 Percentage of subjects Interval 30.39 to 61.15
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup Y hSBA-Men Y ≥ 8, Day 29	100 Percentage of subjects Interval 98.74 to 100.0	99.64 Percentage of subjects Interval 98.03 to 99.99	99.82 Percentage of subjects Interval 99.03 to 100.0	77.42 Percentage of subjects Interval 67.58 to 85.45

SECONDARY outcome

Timeframe: At day 1(pre-vaccination), day 4, day 6 and day 29

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.

Outcome measures

Outcome measures
Measure	Menveo-Menveo Group n=290 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Menactra-Menveo Group n=282 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Pooled Group (Menveo-Menveo and Menactra-Menveo) n=572 Participants Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups	Naive Group n=93 Participants Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A hSBA-Men A ≥ 16, Day 1	8.3 Percentage of subjects Interval 5.39 to 12.1	9.57 Percentage of subjects Interval 6.4 to 13.62	8.93 Percentage of subjects Interval 6.72 to 11.58	1.08 Percentage of subjects Interval 0.03 to 5.85
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A hSBA-Men A ≥ 16, Day 4	8.33 Percentage of subjects Interval 4.38 to 14.1	8.7 Percentage of subjects Interval 4.57 to 14.7	8.51 Percentage of subjects Interval 5.53 to 12.4	2.08 Percentage of subjects Interval 0.05 to 11.07
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A hSBA-Men A ≥ 16, Day 6	45.89 Percentage of subjects Interval 37.62 to 54.33	41.43 Percentage of subjects Interval 33.17 to 50.05	43.71 Percentage of subjects Interval 37.87 to 49.67	4.55 Percentage of subjects Interval 0.56 to 15.47
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup A hSBA-Men A ≥ 16, Day 29	98.28 Percentage of subjects Interval 96.02 to 99.44	97.52 Percentage of subjects Interval 94.95 to 99.0	97.9 Percentage of subjects Interval 96.36 to 98.91	66.67 Percentage of subjects Interval 56.13 to 76.11

SECONDARY outcome

Timeframe: At day 1(pre-vaccination) , day 4, day 6 and day 29

Analysis was performed on per protocol set for immunogenicity, which included all randomized subjects who had no protocol deviations and were not excluded due to other reasons defined prior to unblinding/analysis, who received study vaccination and provided evaluable serum samples at each time point, with result available for at least 1 serogroup

Outcome measures

Outcome measures
Measure	Menveo-Menveo Group n=290 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Menactra-Menveo Group n=281 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Pooled Group (Menveo-Menveo and Menactra-Menveo) n=571 Participants Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups	Naive Group n=93 Participants Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C hSBA-Men C ≥ 16, Day 29	99.66 Percentage of subjects Interval 98.09 to 99.99	99.64 Percentage of subjects Interval 98.03 to 99.99	99.65 Percentage of subjects Interval 98.74 to 99.96	69.89 Percentage of subjects Interval 59.5 to 78.97
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C hSBA-Men C ≥ 16, Day 1	47.22 Percentage of subjects Interval 41.34 to 53.16	38.08 Percentage of subjects Interval 32.38 to 44.04	42.71 Percentage of subjects Interval 38.6 to 46.89	17.2 Percentage of subjects Interval 10.17 to 26.43
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C hSBA-Men C ≥ 16, Day 4	54.17 Percentage of subjects Interval 45.67 to 62.49	44.93 Percentage of subjects Interval 36.46 to 53.62	49.65 Percentage of subjects Interval 43.66 to 55.64	29.17 Percentage of subjects Interval 16.95 to 44.06
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup C hSBA-Men C ≥ 16, Day 6	82.07 Percentage of subjects Interval 74.84 to 87.94	81.29 Percentage of subjects Interval 73.81 to 87.4	81.69 Percentage of subjects Interval 76.69 to 86.01	31.82 Percentage of subjects Interval 18.61 to 47.58

SECONDARY outcome

Timeframe: At day 1(pre-vaccination), day 4, day 6 and day 29

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.

Outcome measures

Outcome measures
Measure	Menveo-Menveo Group n=290 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Menactra-Menveo Group n=282 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Pooled Group (Menveo-Menveo and Menactra-Menveo) n=571 Participants Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups	Naive Group n=93 Participants Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W hSBA-Men W ≥ 16, Day 1	65.74 Percentage of subjects Interval 59.96 to 71.2	66.31 Percentage of subjects Interval 60.47 to 71.81	66.02 Percentage of subjects Interval 61.98 to 69.91	48.39 Percentage of subjects Interval 37.89 to 58.99
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W hSBA-Men W ≥ 16, Day 4	68.75 Percentage of subjects Interval 60.5 to 76.21	76.81 Percentage of subjects Interval 68.87 to 83.57	72.7 Percentage of subjects Interval 67.1 to 77.81	54.17 Percentage of subjects Interval 39.17 to 68.63
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W hSBA-Men W ≥ 16, Day 6	89.04 Percentage of subjects Interval 82.81 to 93.6	92.14 Percentage of subjects Interval 86.38 to 96.01	90.56 Percentage of subjects Interval 86.56 to 93.69	50 Percentage of subjects Interval 34.56 to 65.44
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup W hSBA-Men W ≥ 16, Day 29	100 Percentage of subjects Interval 98.74 to 100.0	100 Percentage of subjects Interval 98.7 to 100.0	100 Percentage of subjects Interval 99.36 to 100.0	80.43 Percentage of subjects Interval 70.85 to 87.97

SECONDARY outcome

Timeframe: At day 1(pre-vaccination) , day 4, day 6 and day 29

For each study group and in the pooled group, percentages of subjects with hSBA titer ≥16 and associated two-sided 95%CIs were calculated.

Outcome measures

Outcome measures
Measure	Menveo-Menveo Group n=290 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Menactra-Menveo Group n=281 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Pooled Group (Menveo-Menveo and Menactra-Menveo) n=571 Participants Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups	Naive Group n=93 Participants Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y hSBA-Men Y ≥ 16, Day 1	39.02 Percentage of subjects Interval 33.35 to 44.93	34.88 Percentage of subjects Interval 29.31 to 40.76	36.97 Percentage of subjects Interval 32.99 to 41.09	17.2 Percentage of subjects Interval 10.17 to 26.43
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y hSBA-Men Y ≥ 16, Day 4	39.16 Percentage of subjects Interval 31.11 to 47.67	39.13 Percentage of subjects Interval 30.94 to 47.8	39.15 Percentage of subjects Interval 33.4 to 45.12	20.83 Percentage of subjects Interval 10.47 to 34.99
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y hSBA-Men Y ≥ 16, Day 6	80.69 Percentage of subjects Interval 73.31 to 86.77	80 Percentage of subjects Interval 72.41 to 86.28	80.35 Percentage of subjects Interval 75.26 to 84.8	31.82 Percentage of subjects Interval 18.61 to 47.58
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup Y hSBA-Men Y ≥ 16, Day 29	100 Percentage of subjects Interval 98.74 to 100.0	98.58 Percentage of subjects Interval 96.4 to 99.61	99.3 Percentage of subjects Interval 98.22 to 99.81	64.52 Percentage of subjects Interval 53.91 to 74.17

SECONDARY outcome

Timeframe: At Day 4 and Day 6

Seroresponse is defined for this study as follows: For subjects with pre-vaccination titers \<4, postvaccination titers ≥ 16; for subjects with pre-vaccination titers ≥4, post vaccination titers at least 4 times the pre-vaccination titers.

Outcome measures

Outcome measures
Measure	Menveo-Menveo Group n=289 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Menactra-Menveo Group n=282 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Pooled Group (Menveo-Menveo and Menactra-Menveo) n=571 Participants Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups	Naive Group n=93 Participants Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men A, Pre < 4, Day 4	0.81 Percentages of subjects Interval 0.02 to 4.45	2.56 Percentages of subjects Interval 0.53 to 7.31	1.67 Percentages of subjects Interval 0.46 to 4.21	0 Percentages of subjects Interval 0.0 to 7.87
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men A, Pre ≥ 4, Day 4	4.76 Percentages of subjects Interval 0.12 to 23.82	0 Percentages of subjects Interval 0.0 to 16.11	2.38 Percentages of subjects Interval 0.06 to 12.57	0 Percentages of subjects Interval 0.0 to 70.76
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men A, Total seroresponse, Day 4	1.39 Percentages of subjects Interval 0.17 to 4.93	2.17 Percentages of subjects Interval 0.45 to 6.22	1.77 Percentages of subjects Interval 0.58 to 4.09	0 Percentages of subjects Interval 0.0 to 7.4
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men A, Pre < 4, Day 6	39.84 Percentages of subjects Interval 31.12 to 49.05	33.63 Percentages of subjects Interval 25.01 to 43.12	36.86 Percentages of subjects Interval 30.7 to 43.37	2.56 Percentages of subjects Interval 0.06 to 13.48
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men A, Pre ≥ 4, Day 6	36.36 Percentages of subjects Interval 17.2 to 59.34	22.22 Percentages of subjects Interval 8.62 to 42.26	28.57 Percentages of subjects Interval 16.58 to 43.26	20 Percentages of subjects Interval 0.51 to 71.64
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men A, Total seroresponse, Day 6	39.31 Percentages of subjects Interval 31.31 to 47.76	31.43 Percentages of subjects Interval 23.85 to 39.81	35.44 Percentages of subjects Interval 29.89 to 41.3	4.55 Percentages of subjects Interval 0.56 to 15.47
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men C, Pre < 4, Day 4	0 Percentages of subjects Interval 0.0 to 9.74	9.8 Percentages of subjects Interval 3.26 to 21.41	5.75 Percentages of subjects Interval 1.89 to 12.9	5 Percentages of subjects Interval 0.13 to 24.87
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men C, Pre ≥ 4, Day 4	3.74 Percentages of subjects Interval 1.03 to 9.3	8.14 Percentages of subjects Interval 3.34 to 16.05	5.7 Percentages of subjects Interval 2.88 to 9.97	7.14 Percentages of subjects Interval 0.88 to 23.5
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men C, Total seroresponse, Day 4	2.8 Percentages of subjects Interval 0.77 to 7.01	8.76 Percentages of subjects Interval 4.61 to 14.8	5.71 Percentages of subjects Interval 3.3 to 9.11	6.25 Percentages of subjects Interval 1.31 to 17.2
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men C, Pre < 4, Day 6	65.31 Percentages of subjects Interval 50.36 to 78.33	64.71 Percentages of subjects Interval 50.07 to 77.57	65 Percentages of subjects Interval 54.82 to 74.27	13.04 Percentages of subjects Interval 2.78 to 33.59
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men C, Pre ≥ 4, Day 6	44.21 Percentages of subjects Interval 34.02 to 54.77	38.64 Percentages of subjects Interval 28.44 to 49.62	41.53 Percentages of subjects Interval 34.31 to 49.03	9.52 Percentages of subjects Interval 1.17 to 30.38
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men C, Total seroresponse, Day 6	51.39 Percentages of subjects Interval 42.92 to 59.8	48.2 Percentages of subjects Interval 39.65 to 56.83	49.82 Percentages of subjects Interval 43.85 to 55.8	11.36 Percentages of subjects Interval 3.79 to 24.56
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men W, Pre < 4, Day 4	9.52 Percentages of subjects Interval 1.17 to 30.38	30 Percentages of subjects Interval 14.73 to 49.4	21.57 Percentages of subjects Interval 11.29 to 35.32	11.76 Percentages of subjects Interval 1.46 to 36.44
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men W, Pre ≥ 4, Day 4	1.63 Percentages of subjects Interval 0.2 to 5.75	4.63 Percentages of subjects Interval 1.52 to 10.47	3.03 Percentages of subjects Interval 1.23 to 6.14	3.23 Percentages of subjects Interval 0.08 to 16.7
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men W, Total seroresponse, Day 4	2.78 Percentages of subjects Interval 0.76 to 6.96	10.14 Percentages of subjects Interval 5.66 to 16.44	6.38 Percentages of subjects Interval 3.83 to 9.9	6.25 Percentages of subjects Interval 1.31 to 17.2
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men W, Pre < 4, Day 6	64.52 Percentages of subjects Interval 45.37 to 80.77	75 Percentages of subjects Interval 55.13 to 89.31	69.49 Percentages of subjects Interval 56.13 to 80.81	25 Percentages of subjects Interval 7.27 to 52.38
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men W, Pre ≥ 4, Day 6	46.49 Percentages of subjects Interval 37.1 to 56.07	42.86 Percentages of subjects Interval 33.55 to 52.55	44.69 Percentages of subjects Interval 38.09 to 51.43	3.57 Percentages of subjects Interval 0.09 to 18.35
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men W, Total seroresponse, Day 6	50.34 Percentages of subjects Interval 41.93 to 58.75	49.29 Percentages of subjects Interval 40.74 to 57.86	49.82 Percentages of subjects Interval 43.87 to 55.78	11.36 Percentages of subjects Interval 3.79 to 24.56
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men Y, Pre < 4, Day 4	8.06 Percentages of subjects Interval 2.67 to 17.83	6.67 Percentages of subjects Interval 1.85 to 16.2	7.38 Percentages of subjects Interval 3.43 to 13.54	0 Percentages of subjects Interval 0.0 to 12.77
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men Y, Pre ≥ 4, Day 4	7.5 Percentages of subjects Interval 2.8 to 15.61	2.6 Percentages of subjects Interval 0.32 to 9.07	5.1 Percentages of subjects Interval 2.23 to 9.79	0 Percentages of subjects Interval 0.0 to 16.11
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men Y, Total seroresponse, Day 4	7.75 Percentages of subjects Interval 3.93 to 13.44	4.38 Percentages of subjects Interval 1.62 to 9.29	6.09 Percentages of subjects Interval 3.59 to 9.58	0 Percentages of subjects Interval 0.0 to 7.4
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men Y, Pre < 4, Day 6	63.46 Percentages of subjects Interval 48.96 to 76.38	75.81 Percentages of subjects Interval 63.26 to 85.78	70.18 Percentages of subjects Interval 60.89 to 78.38	11.11 Percentages of subjects Interval 2.35 to 29.16
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men Y, Pre ≥ 4, Day 6	40.66 Percentages of subjects Interval 30.48 to 51.47	42.31 Percentages of subjects Interval 31.19 to 54.02	41.42 Percentages of subjects Interval 33.91 to 49.24	5.88 Percentages of subjects Interval 0.15 to 28.69
Percentages of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y hSBA-Men Y, Total seroresponse, Day 6	48.95 Percentages of subjects Interval 40.51 to 57.44	57.14 Percentages of subjects Interval 48.51 to 65.47	53 Percentages of subjects Interval 47.01 to 58.94	9.09 Percentages of subjects Interval 2.53 to 21.67

SECONDARY outcome

Timeframe: At Day 1 (pre-vaccination), Day 4, Day 6 and Day 29

For each N. meningitidis serogroup A, C, W and Y, unadjusted GMTs were calculated, with their associated two-sided 95% Confidence Interval.

Outcome measures

Outcome measures
Measure	Menveo-Menveo Group n=290 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Menactra-Menveo Group n=282 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Pooled Group (Menveo-Menveo and Menactra-Menveo) n=572 Participants Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups	Naive Group n=93 Participants Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. hSBA-Men A, Day 1	2.81 Titers Interval 2.54 to 3.11	2.95 Titers Interval 2.67 to 3.27	2.88 Titers Interval 2.68 to 3.09	2.27 Titers Interval 1.9 to 2.71
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. hSBA-Men A, Day 4	2.83 Titers Interval 2.43 to 3.29	3 Titers Interval 2.57 to 3.51	2.91 Titers Interval 2.61 to 3.25	2.25 Titers Interval 1.73 to 2.93
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. hSBA-Men A, Day 6	12.87 Titers Interval 9.63 to 17.19	10.17 Titers Interval 7.57 to 13.66	11.47 Titers Interval 9.32 to 14.1	2.48 Titers Interval 1.46 to 4.2
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. hSBA-Men A, Day 29	210.1 Titers Interval 181.07 to 243.78	236.69 Titers Interval 203.56 to 275.2	222.81 Titers Interval 200.43 to 247.7	32.11 Titers Interval 24.7 to 41.76
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. hSBA-Men C, Day 1	16.11 Titers Interval 13.28 to 19.54	10.72 Titers Interval 8.82 to 13.03	13.17 Titers Interval 11.48 to 15.12	5.06 Titers Interval 3.6 to 7.1
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. hSBA-Men C, Day 4	22.96 Titers Interval 17.31 to 30.45	14.29 Titers Interval 10.71 to 19.07	18.21 Titers Interval 14.86 to 22.31	6.69 Titers Interval 4.1 to 10.9
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. hSBA-Men C, Day 6	92.27 Titers Interval 68.91 to 123.56	90.06 Titers Interval 66.84 to 121.35	91.18 Titers Interval 74.04 to 112.3	6.71 Titers Interval 3.95 to 11.4
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. hSBA-Men C, Day 29	1159.93 Titers Interval 977.33 to 1376.63	1057.66 Titers Interval 888.74 to 1258.68	1108.42 Titers Interval 981.09 to 1252.27	59.7 Titers Interval 44.12 to 80.78
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. hSBA-Men W, Day 1	22.07 Titers Interval 18.54 to 26.29	23.46 Titers Interval 19.66 to 28.0	22.75 Titers Interval 20.09 to 25.76	12.21 Titers Interval 8.98 to 16.62
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. hSBA-Men W, Day 4	25.9 Titers Interval 20.13 to 33.32	33.87 Titers Interval 26.18 to 43.82	29.53 Titers Interval 24.66 to 35.37	13.8 Titers Interval 8.92 to 21.35
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. hSBA-Men W, Day 6	112.49 Titers Interval 86.26 to 146.71	143.75 Titers Interval 109.61 to 188.54	126.84 Titers Interval 104.9 to 153.37	15.98 Titers Interval 9.85 to 25.93
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. hSBA-Men W, Day 29	1394.65 Titers Interval 1176.59 to 1653.11	1883.96 Titers Interval 1585.12 to 2239.15	1617.11 Titers Interval 1431.93 to 1826.23	55.31 Titers Interval 40.9 to 74.8
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. hSBA-Men Y, Day 1	9.24 Titers Interval 7.81 to 10.94	8.22 Titers Interval 6.93 to 9.75	8.72 Titers Interval 7.74 to 9.83	4.56 Titers Interval 3.39 to 6.13
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. hSBA-Men Y, Day 4	10.87 Titers Interval 8.26 to 14.32	12.12 Titers Interval 9.16 to 16.04	11.47 Titers Interval 9.43 to 13.95	4.63 Titers Interval 2.88 to 7.44
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. hSBA-Men Y, Day 6	63.3 Titers Interval 47.73 to 83.95	61.56 Titers Interval 46.18 to 82.05	62.44 Titers Interval 51.06 to 76.34	6.44 Titers Interval 3.86 to 10.76
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A, C, W and Y. hSBA-Men Y, Day 29	1066.66 Titers Interval 900.67 to 1263.25	1007.62 Titers Interval 848.53 to 1196.54	1037.19 Titers Interval 919.46 to 1169.98	37.4 Titers Interval 27.75 to 50.42

SECONDARY outcome

Timeframe: At Day 4, Day 6, Day 29 compared to Day 1

Within each study group and for each serogroup, GMRs were calculated,at: Visit Day 4 versus at Visit Day 1; Visit Day 6 versus at Visit Day 1; and Visit Day 29 versus at Visit Day 1. The unadjusted GMRs and 95% CIs are constructed by exponentiating the mean within-group differences in log-transformed titers and the corresponding 95% CIs.

Outcome measures

Outcome measures
Measure	Menveo-Menveo Group n=289 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Menactra-Menveo Group n=282 Participants Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Pooled Group (Menveo-Menveo and Menactra-Menveo) n=571 Participants Pooled subjects from both Menveo-Menveo and Menactra-Menveo Groups	Naive Group n=93 Participants Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
Within Group hSBA Geometric Mean Ratios (GMRs) hSBA-Men A, Day 29/Day 1	75.02 Ratios Interval 63.87 to 88.12	80.13 Ratios Interval 68.09 to 94.3	77.5 Ratios Interval 69.12 to 86.9	14.14 Ratios Interval 10.65 to 18.77
Within Group hSBA Geometric Mean Ratios (GMRs) hSBA-Men C, Day 4/Day 1	1.12 Ratios Interval 0.99 to 1.28	1.35 Ratios Interval 1.19 to 1.54	1.23 Ratios Interval 1.12 to 1.35	1.21 Ratios Interval 0.97 to 1.51
Within Group hSBA Geometric Mean Ratios (GMRs) hSBA-Men C, Day 6/Day 1	7.25 Ratios Interval 5.39 to 9.75	7.94 Ratios Interval 5.87 to 10.73	7.58 Ratios Interval 6.14 to 9.36	1.45 Ratios Interval 0.85 to 2.48
Within Group hSBA Geometric Mean Ratios (GMRs) hSBA-Men Y, Day 29/Day 1	116.58 Ratios Interval 94.42 to 143.95	123.41 Ratios Interval 99.69 to 152.78	119.91 Ratios Interval 103.21 to 139.3	8.21 Ratios Interval 5.67 to 11.89
Within Group hSBA Geometric Mean Ratios (GMRs) hSBA-Men C, Day 29/Day 1	71.72 Ratios Interval 58.88 to 87.37	97.13 Ratios Interval 79.51 to 118.65	83.29 Ratios Interval 72.34 to 95.89	11.81 Ratios Interval 8.34 to 16.71
Within Group hSBA Geometric Mean Ratios (GMRs) hSBA-Men W, Day 4/Day 1	1.05 Ratios Interval 0.91 to 1.23	1.4 Ratios Interval 1.2 to 1.63	1.21 Ratios Interval 1.09 to 1.35	1.14 Ratios Interval 0.88 to 1.48
Within Group hSBA Geometric Mean Ratios (GMRs) hSBA-Men W, Day 6/Day 1	5.71 Ratios Interval 4.37 to 7.45	6.27 Ratios Interval 4.78 to 8.23	5.98 Ratios Interval 4.95 to 7.23	1.32 Ratios Interval 0.81 to 2.15
Within Group hSBA Geometric Mean Ratios (GMRs) hSBA-Men W, Day 29/Day 1	63.63 Ratios Interval 51.37 to 78.81	80.61 Ratios Interval 64.88 to 100.14	71.5 Ratios Interval 61.38 to 83.27	4.57 Ratios Interval 3.13 to 6.68
Within Group hSBA Geometric Mean Ratios (GMRs) hSBA-Men Y, Day 4/Day 1	1.35 Ratios Interval 1.15 to 1.59	1.31 Ratios Interval 1.11 to 1.54	1.33 Ratios Interval 1.19 to 1.49	0.99 Ratios Interval 0.75 to 1.31
Within Group hSBA Geometric Mean Ratios (GMRs) hSBA-Men Y, Day 6/Day 1	6.09 Ratios Interval 4.53 to 8.19	8.59 Ratios Interval 6.37 to 11.59	7.22 Ratios Interval 5.85 to 8.92	1.48 Ratios Interval 0.87 to 2.52
Within Group hSBA Geometric Mean Ratios (GMRs) hSBA-Men A, Day 4/Day 1	1.02 Ratios Interval 0.93 to 1.12	1.07 Ratios Interval 0.97 to 1.17	1.04 Ratios Interval 0.98 to 1.11	0.99 Ratios Interval 0.84 to 1.16
Within Group hSBA Geometric Mean Ratios (GMRs) hSBA-Men A, Day 6/Day 1	4.58 Ratios Interval 3.49 to 6.0	3.25 Ratios Interval 2.46 to 4.28	3.87 Ratios Interval 3.19 to 4.7	1.09 Ratios Interval 0.66 to 1.78

Adverse Events

Menveo-Menveo Group

Serious events: 3 serious events

Other events: 243 other events

Deaths: 0 deaths

Menactra-Menveo Group

Serious events: 2 serious events

Other events: 211 other events

Deaths: 0 deaths

Naive Group

Serious events: 3 serious events

Other events: 60 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Menveo-Menveo Group n=301 participants at risk Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menveo (MenACWY-CRM) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Menactra-Menveo Group n=300 participants at risk Healthy subjects, 15 through 55 years of age were vaccinated with a single dose of Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine, MenACWY-D) 4 to 6 years before and received one dose of MenACWY-CRM at Day 1.	Naive Group n=100 participants at risk Healthy subjects,15 through 55 years of age, who have not received any meningococcal vaccination, received one dose of MenACWY-CRM at Day 1.
Gastrointestinal disorders Abdominal pain	0.33% 1/301 • Number of events 1 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).	0.00% 0/300 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).	0.00% 0/100 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).
Infections and infestations Diverticulitis	0.00% 0/301 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).	0.00% 0/300 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).	1.0% 1/100 • Number of events 1 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).
Infections and infestations Septic shock	0.33% 1/301 • Number of events 1 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).	0.00% 0/300 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).	0.00% 0/100 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).
Infections and infestations Tonsillitis	0.33% 1/301 • Number of events 1 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).	0.00% 0/300 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).	0.00% 0/100 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).
Injury, poisoning and procedural complications Intentional overdose	0.33% 1/301 • Number of events 1 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).	0.00% 0/300 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).	0.00% 0/100 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).
Nervous system disorders Diabetic ketoacidotic hyperglycaemic coma	0.00% 0/301 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).	0.00% 0/300 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).	1.0% 1/100 • Number of events 1 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/301 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).	0.00% 0/300 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).	1.0% 1/100 • Number of events 1 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).
Psychiatric disorders Suicide attempt	0.66% 2/301 • Number of events 2 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).	0.33% 1/300 • Number of events 1 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).	0.00% 0/100 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).
Psychiatric disorders Major depression	0.33% 1/301 • Number of events 1 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).	0.00% 0/300 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).	0.00% 0/100 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).
Psychiatric disorders Suicidal ideation	0.00% 0/301 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).	0.33% 1/300 • Number of events 1 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).	0.00% 0/100 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.33% 1/301 • Number of events 1 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).	0.00% 0/300 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).	0.00% 0/100 • Solicited AEs were assessed between 6 hours through Day 7. Unsolicited AEs were assessed between Day 1 trough Day 29. SAEs were assessed during the entire study period (from Day 1 to Day 181).

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