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
CompletedPhase 3Results postedLast updated 25 November 2019
What this trial tests
Phase 3 trial testing Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo) in Infections, Meningococcal in 704 participants. Completed in 7 December 2017.
Adults 15 to 55, any sex, with Infections, Meningococcal. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentages of Subjects With Human Serum Bactericidal Antibody (hSBA) Seroresponse Against Neisseria Meningitidis Serogroups A, C, W and Y.Primary· At Day 29
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
hSBA-Men A, Pre < 4
Group
Value
95% CI
Menveo-Menveo Group
97.97
95.32 – 99.34
Menactra-Menveo Group
97.01
93.93 – 98.79
Pooled Group (Menveo-Menveo and Menactra-Menveo)
97.50
95.67 – 98.70
Naive Group
64.71
53.59 – 74.77
hSBA-Men A, Pre ≥ 4
Group
Value
95% CI
Menveo-Menveo Group
88.37
74.92 – 96.11
Menactra-Menveo Group
93.75
82.8 – 98.69
Pooled Group (Menveo-Menveo and Menactra-Menveo)
91.21
83.41 – 96.13
Naive Group
75.00
34.91 – 96.81
hSBA-Men A, Total seroresponse
Group
Value
95% CI
Menveo-Menveo Group
96.54
93.73 – 98.33
Menactra-Menveo Group
96.45
93.58 – 98.29
Pooled Group (Menveo-Menveo and Menactra-Menveo)
96.50
94.64 – 97.85
Naive Group
65.59
55.02 – 75.14
hSBA-Men C, Pre < 4
Group
Value
95% CI
Menveo-Menveo Group
100
95.75 – 100
Menactra-Menveo Group
100
96.48 – 100
Pooled Group (Menveo-Menveo and Menactra-Menveo)
100
98.06 – 100
Naive Group
55.81
39.88 – 70.92
hSBA-Men C, Pre ≥ 4
Group
Value
95% CI
Menveo-Menveo Group
93.6
89.3 – 96.55
Menactra-Menveo Group
93.79
89.15 – 96.86
Pooled Group (Menveo-Menveo and Menactra-Menveo)
93.68
90.75 – 95.91
Naive Group
58.00
43.21 – 71.81
hSBA-Men C, Total seroresponse
Group
Value
95% CI
Menveo-Menveo Group
95.49
92.4 – 97.57
Menactra-Menveo Group
96.07
93.08 – 98.02
Pooled Group (Menveo-Menveo and Menactra-Menveo)
95.77
93.78 – 97.27
Naive Group
56.99
46.31 – 67.22
hSBA-Men W, Pre < 4
Group
Value
95% CI
Menveo-Menveo Group
100
93.15 – 100
Menactra-Menveo Group
100
93.84 – 100
Pooled Group (Menveo-Menveo and Menactra-Menveo)
100
96.70 – 100
Naive Group
54.55
36.35 – 71.89
hSBA-Men W, Pre ≥ 4
Group
Value
95% CI
Menveo-Menveo Group
94.94
91.32 – 97.36
Menactra-Menveo Group
91.48
87.01 – 94.79
Pooled Group (Menveo-Menveo and Menactra-Menveo)
93.26
90.57 – 95.38
Naive Group
25.42
14.98 – 38.44
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)Secondary· Within 30 minutes 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 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.
Group
Value
95% CI
Menveo-Menveo Group
0
Menactra-Menveo Group
8
Pooled Group (Menveo-Menveo and Menactra-Menveo)
8
Naive Group
1
Number of Subjects Reporting Solicited Local and Systemic AEsSecondary· From Day 1 (6 hours) through Day 7 after vaccination
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)
Any Local symptom
Group
Value
95% CI
Menveo-Menveo Group
119
Menactra-Menveo Group
97
Pooled Group (Menveo-Menveo and Menactra-Menveo)
216
Naive Group
41
Any Systemic symptom
Group
Value
95% CI
Menveo-Menveo Group
162
Menactra-Menveo Group
148
Pooled Group (Menveo-Menveo and Menactra-Menveo)
310
Naive Group
35
Any Induration
Group
Value
95% CI
Menveo-Menveo Group
15
Menactra-Menveo Group
9
Pooled Group (Menveo-Menveo and Menactra-Menveo)
24
Naive Group
8
Any Erythema
Group
Value
95% CI
Menveo-Menveo Group
12
Menactra-Menveo Group
8
Pooled Group (Menveo-Menveo and Menactra-Menveo)
20
Naive Group
10
Any Pain
Group
Value
95% CI
Menveo-Menveo Group
114
Menactra-Menveo Group
96
Pooled Group (Menveo-Menveo and Menactra-Menveo)
210
Naive Group
40
Any Nausea
Group
Value
95% CI
Menveo-Menveo Group
48
Menactra-Menveo Group
44
Pooled Group (Menveo-Menveo and Menactra-Menveo)
92
Naive Group
13
Any Fatigue
Group
Value
95% CI
Menveo-Menveo Group
113
Menactra-Menveo Group
110
Pooled Group (Menveo-Menveo and Menactra-Menveo)
223
Naive Group
19
Any Myalgia
Group
Value
95% CI
Menveo-Menveo Group
55
Menactra-Menveo Group
54
Pooled Group (Menveo-Menveo and Menactra-Menveo)
109
Naive Group
15
Number of Subjects Reporting Other Indicators of ReactogenicitySecondary· 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)
Analgesics/antipyretics for prophylaxis
Group
Value
95% CI
Menveo-Menveo Group
13
Menactra-Menveo Group
15
Pooled Group (Menveo-Menveo and Menactra-Menveo)
28
Naive Group
5
Analgesics/antipyretics for treatment
Group
Value
95% CI
Menveo-Menveo Group
18
Menactra-Menveo Group
24
Pooled Group (Menveo-Menveo and Menactra-Menveo)
42
Naive Group
10
Body temperature (36.0 - 36.4 ºC)
Group
Value
95% CI
Menveo-Menveo Group
68
Menactra-Menveo Group
57
Pooled Group (Menveo-Menveo and Menactra-Menveo)
125
Naive Group
16
Body temperature (36.5 - 36.9 ºC)
Group
Value
95% CI
Menveo-Menveo Group
135
Menactra-Menveo Group
141
Pooled Group (Menveo-Menveo and Menactra-Menveo)
276
Naive Group
45
Body temperature (37.0 - 37.4 ºC)
Group
Value
95% CI
Menveo-Menveo Group
83
Menactra-Menveo Group
77
Pooled Group (Menveo-Menveo and Menactra-Menveo)
160
Naive Group
33
Body temperature (37.5 - 37.9 ºC)
Group
Value
95% CI
Menveo-Menveo Group
6
Menactra-Menveo Group
9
Pooled Group (Menveo-Menveo and Menactra-Menveo)
15
Naive Group
3
Body temperature (38.0 - 38.4 ºC)
Group
Value
95% CI
Menveo-Menveo Group
1
Menactra-Menveo Group
2
Pooled Group (Menveo-Menveo and Menactra-Menveo)
3
Naive Group
0
Body temperature (38.5 - 38.9 ºC)
Group
Value
95% CI
Menveo-Menveo Group
1
Menactra-Menveo Group
3
Pooled Group (Menveo-Menveo and Menactra-Menveo)
4
Naive Group
0
Number of Subjects Reporting All Unsolicited AEsSecondary· 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.
Group
Value
95% CI
Menveo-Menveo Group
74
Menactra-Menveo Group
78
Pooled Group (Menveo-Menveo and Menactra-Menveo)
152
Naive Group
22
Number of Subjects Reporting Medically-attended AEs (MAAEs), AEs Leading to Withdrawal and Serious AEs (SAEs)Secondary· 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
Any MAAEs
Group
Value
95% CI
Menveo-Menveo Group
102
Menactra-Menveo Group
79
Pooled Group (Menveo-Menveo and Menactra-Menveo)
181
Naive Group
19
Any AEs leading to withdrawal
Group
Value
95% CI
Menveo-Menveo Group
0
Menactra-Menveo Group
0
Pooled Group (Menveo-Menveo and Menactra-Menveo)
0
Naive Group
0
Any SAEs
Group
Value
95% CI
Menveo-Menveo Group
3
Menactra-Menveo Group
2
Pooled Group (Menveo-Menveo and Menactra-Menveo)
5
Naive Group
3
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup ASecondary· 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.
hSBA-Men A ≥ 8, Day 1
Group
Value
95% CI
Menveo-Menveo Group
12.46
8.88 – 16.83
Menactra-Menveo Group
14.89
10.95 – 19.59
Pooled Group (Menveo-Menveo and Menactra-Menveo)
13.66
10.95 – 16.75
Naive Group
4.3
1.18 – 10.65
hSBA-Men A ≥ 8, Day 4
Group
Value
95% CI
Menveo-Menveo Group
11.11
6.49 – 17.42
Menactra-Menveo Group
13.04
7.92 – 19.83
Pooled Group (Menveo-Menveo and Menactra-Menveo)
12.06
8.5 – 16.44
Naive Group
4.17
0.51 – 14.25
hSBA-Men A ≥ 8, Day 6
Group
Value
95% CI
Menveo-Menveo Group
53.42
44.99 – 61.71
Menactra-Menveo Group
47.14
38.66 – 55.75
Pooled Group (Menveo-Menveo and Menactra-Menveo)
50.35
44.4 – 56.29
Naive Group
9.09
2.53 – 21.67
hSBA-Men A ≥ 8, Day 29
Group
Value
95% CI
Menveo-Menveo Group
98.62
96.51 – 99.62
Menactra-Menveo Group
98.94
96.92 – 99.78
Pooled Group (Menveo-Menveo and Menactra-Menveo)
98.78
97.49 – 99.51
Naive Group
70.97
60.64 – 79.92
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup CSecondary· 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.
hSBA-Men C ≥ 8, Day 1
Group
Value
95% CI
Menveo-Menveo Group
61.11
55.22 – 66.77
Menactra-Menveo Group
53.74
47.72 – 59.68
Pooled Group (Menveo-Menveo and Menactra-Menveo)
57.47
53.29 – 61.57
Naive Group
33.33
23.89 – 43.87
hSBA-Men C ≥ 8, Day 4
Group
Value
95% CI
Menveo-Menveo Group
70.83
62.68 – 78.1
Menactra-Menveo Group
60.14
51.47 – 68.38
Pooled Group (Menveo-Menveo and Menactra-Menveo)
65.6
59.74 – 71.13
Naive Group
43.75
29.48 – 58.82
hSBA-Men C ≥ 8, Day 6
Group
Value
95% CI
Menveo-Menveo Group
87.59
81.09 – 92.47
Menactra-Menveo Group
92.09
86.28 – 95.98
Pooled Group (Menveo-Menveo and Menactra-Menveo)
89.79
85.66 – 93.05
Naive Group
43.18
28.35 – 58.97
hSBA-Men C ≥ 8, Day 29
Group
Value
95% CI
Menveo-Menveo Group
100
98.74 – 100
Menactra-Menveo Group
99.64
98.03 – 99.99
Pooled Group (Menveo-Menveo and Menactra-Menveo)
99.82
99.03 – 100
Naive Group
87.1
78.55 – 93.15
Percentage of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup WSecondary· 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.
hSBA-Men W ≥ 8, Day 1
Group
Value
95% CI
Menveo-Menveo Group
75.43
70.05 – 80.29
Menactra-Menveo Group
76.95
71.59 – 81.74
Pooled Group (Menveo-Menveo and Menactra-Menveo)
76.18
72.47 – 79.62
Naive Group
61.29
50.62 – 71.22
hSBA-Men W ≥ 8, Day 4
Group
Value
95% CI
Menveo-Menveo Group
81.94
74.67 – 87.85
Menactra-Menveo Group
82.61
75.24 – 88.53
Pooled Group (Menveo-Menveo and Menactra-Menveo)
82.27
77.3 – 86.54
Naive Group
62.5
47.35 – 76.05
hSBA-Men W ≥ 8, Day 6
Group
Value
95% CI
Menveo-Menveo Group
93.84
88.62 – 97.14
Menactra-Menveo Group
97.86
93.87 – 99.56
Pooled Group (Menveo-Menveo and Menactra-Menveo)
95.8
92.79 – 97.81
Naive Group
63.64
47.77 – 77.59
hSBA-Men W ≥ 8, Day 29
Group
Value
95% CI
Menveo-Menveo Group
100
98.74 – 100
Menactra-Menveo Group
100
98.7 – 100
Pooled Group (Menveo-Menveo and Menactra-Menveo)
100
99.36 – 100
Naive Group
84.78
75.79 – 91.42
Percentages of Subjects With hSBA Titer ≥8 Against N. Meningitidis Serogroup YSecondary· 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.
hSBA-Men Y ≥ 8, Day 1
Group
Value
95% CI
Menveo-Menveo Group
54.01
48.05 – 59.88
Menactra-Menveo Group
46.98
41.02 – 52.99
Pooled Group (Menveo-Menveo and Menactra-Menveo)
50.53
46.33 – 54.72
Naive Group
32.26
22.93 – 42.75
hSBA-Men Y ≥ 8, Day 4
Group
Value
95% CI
Menveo-Menveo Group
55.24
46.71 – 63.56
Menactra-Menveo Group
55.8
47.1 – 64.24
Pooled Group (Menveo-Menveo and Menactra-Menveo)
55.52
49.5 – 61.42
Naive Group
33.33
20.4 – 48.41
hSBA-Men Y ≥ 8, Day 6
Group
Value
95% CI
Menveo-Menveo Group
85.52
78.72 – 90.81
Menactra-Menveo Group
87.86
81.27 – 92.76
Pooled Group (Menveo-Menveo and Menactra-Menveo)
86.67
82.16 – 90.39
Naive Group
45.45
30.39 – 61.15
hSBA-Men Y ≥ 8, Day 29
Group
Value
95% CI
Menveo-Menveo Group
100
98.74 – 100
Menactra-Menveo Group
99.64
98.03 – 99.99
Pooled Group (Menveo-Menveo and Menactra-Menveo)
99.82
99.03 – 100
Naive Group
77.42
67.58 – 85.45
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup ASecondary· 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.
hSBA-Men A ≥ 16, Day 1
Group
Value
95% CI
Menveo-Menveo Group
8.3
5.39 – 12.1
Menactra-Menveo Group
9.57
6.4 – 13.62
Pooled Group (Menveo-Menveo and Menactra-Menveo)
8.93
6.72 – 11.58
Naive Group
1.08
0.03 – 5.85
hSBA-Men A ≥ 16, Day 4
Group
Value
95% CI
Menveo-Menveo Group
8.33
4.38 – 14.1
Menactra-Menveo Group
8.7
4.57 – 14.7
Pooled Group (Menveo-Menveo and Menactra-Menveo)
8.51
5.53 – 12.4
Naive Group
2.08
0.05 – 11.07
hSBA-Men A ≥ 16, Day 6
Group
Value
95% CI
Menveo-Menveo Group
45.89
37.62 – 54.33
Menactra-Menveo Group
41.43
33.17 – 50.05
Pooled Group (Menveo-Menveo and Menactra-Menveo)
43.71
37.87 – 49.67
Naive Group
4.55
0.56 – 15.47
hSBA-Men A ≥ 16, Day 29
Group
Value
95% CI
Menveo-Menveo Group
98.28
96.02 – 99.44
Menactra-Menveo Group
97.52
94.95 – 99
Pooled Group (Menveo-Menveo and Menactra-Menveo)
97.9
96.36 – 98.91
Naive Group
66.67
56.13 – 76.11
Percentages of Subjects With hSBA Titer ≥16 Against N. Meningitidis Serogroup CSecondary· 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
hSBA-Men C ≥ 16, Day 1
Group
Value
95% CI
Menveo-Menveo Group
47.22
41.34 – 53.16
Menactra-Menveo Group
38.08
32.38 – 44.04
Pooled Group (Menveo-Menveo and Menactra-Menveo)
42.71
38.6 – 46.89
Naive Group
17.2
10.17 – 26.43
hSBA-Men C ≥ 16, Day 4
Group
Value
95% CI
Menveo-Menveo Group
54.17
45.67 – 62.49
Menactra-Menveo Group
44.93
36.46 – 53.62
Pooled Group (Menveo-Menveo and Menactra-Menveo)
49.65
43.66 – 55.64
Naive Group
29.17
16.95 – 44.06
hSBA-Men C ≥ 16, Day 6
Group
Value
95% CI
Menveo-Menveo Group
82.07
74.84 – 87.94
Menactra-Menveo Group
81.29
73.81 – 87.4
Pooled Group (Menveo-Menveo and Menactra-Menveo)
81.69
76.69 – 86.01
Naive Group
31.82
18.61 – 47.58
hSBA-Men C ≥ 16, Day 29
Group
Value
95% CI
Menveo-Menveo Group
99.66
98.09 – 99.99
Menactra-Menveo Group
99.64
98.03 – 99.99
Pooled Group (Menveo-Menveo and Menactra-Menveo)
99.65
98.74 – 99.96
Naive Group
69.89
59.5 – 78.97
Adverse events — posted to ClinicalTrials.gov
Time frame: 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)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Menveo-Menveo Group
Serious: 3/301 (1%)
Deaths: 0/301
Menactra-Menveo Group
Serious: 2/300 (1%)
Deaths: 0/300
Naive Group
Serious: 3/100 (3%)
Deaths: 0/100
Serious adverse events (11 terms)
Reaction
System
Menveo-Menveo Group
Menactra-Menveo Group
Naive Group
Suicide attempt
Psychiatric disorders
—
—
—
Abdominal pain
Gastrointestinal disorders
—
—
—
Diverticulitis
Infections and infestations
—
—
—
Septic shock
Infections and infestations
—
—
—
Tonsillitis
Infections and infestations
—
—
—
Intentional overdose
Injury, poisoning and procedural complications
—
—
—
Diabetic ketoacidotic hyperglycaemic coma
Nervous system disorders
—
—
—
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
—
—
—
Major depression
Psychiatric disorders
—
—
—
Suicidal ideation
Psychiatric disorders
—
—
—
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
—
—
—
Other adverse events (188 terms — click to expand)
The purpose/aim of this study is to assess the safety and antibody response to vaccination with a booster dose of Menveo given 4-6 years after primary MenACWY vaccination and to assess the safety and antibody response to a single dose of Menveo given to vaccine-naïve subjects
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E
· Phase 3
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NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months
· Phase 1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 25 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02986854.