Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older
CompletedPhase 2Results postedLast updated 4 April 2022
What this trial tests
Phase 2 trial testing Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate Vaccine in Meningitis in 301 participants. Completed in 17 January 2013.
56 and older, any sex, with Meningitis or Meningococcal Meningitis. 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.
Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® VaccinePrimary· Day 0 (pre-vaccination)
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Serogroup A: ≥1:4
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
95.9
92.1 – 98.2
Group 2: Menomune® A/C/Y/W 135 Vaccine
96.8
91.0 – 99.3
Serogroup A: ≥1:8
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
76.4
69.8 – 82.2
Group 2: Menomune® A/C/Y/W 135 Vaccine
79.8
70.2 – 87.4
Serogroup C: ≥1:4
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
27.7
21.5 – 34.5
Group 2: Menomune® A/C/Y/W 135 Vaccine
30.9
21.7 – 41.2
Serogroup C: ≥1:8
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
17.4
12.4 – 23.5
Group 2: Menomune® A/C/Y/W 135 Vaccine
10.6
5.2 – 18.7
Serogroup Y: ≥1:4
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
22.1
16.4 – 28.5
Group 2: Menomune® A/C/Y/W 135 Vaccine
26.6
18.0 – 36.7
Serogroup Y: ≥1:8
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
13.3
8.9 – 18.9
Group 2: Menomune® A/C/Y/W 135 Vaccine
24.5
16.2 – 34.4
Serogroup W 135: ≥1:4
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
26.2
20.1 – 32.9
Group 2: Menomune® A/C/Y/W 135 Vaccine
26.6
18.0 – 36.7
Serogroup W 135: ≥1:8
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
13.3
8.9 – 18.9
Group 2: Menomune® A/C/Y/W 135 Vaccine
8.5
3.7 – 16.1
Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® VaccinePrimary· Day 30 (post-vaccination)
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Serogroup A: ≥1:4
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
97.4
94.1 – 99.2
Group 2: Menomune® A/C/Y/W 135 Vaccine
93.6
86.6 – 97.6
Serogroup A: ≥1:8
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
93.8
89.5 – 96.8
Group 2: Menomune® A/C/Y/W 135 Vaccine
85.1
76.3 – 91.6
Serogroup C: ≥1:4
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
85.6
79.9 – 90.2
Group 2: Menomune® A/C/Y/W 135 Vaccine
79.8
70.2 – 87.4
Serogroup C: ≥1:8
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
74.9
68.2 – 80.8
Group 2: Menomune® A/C/Y/W 135 Vaccine
62.8
52.2 – 72.5
Serogroup Y: ≥1:4
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
87.2
81.7 – 91.5
Group 2: Menomune® A/C/Y/W 135 Vaccine
73.4
63.3 – 82.0
Serogroup Y: ≥1:8
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
80.5
74.2 – 85.8
Group 2: Menomune® A/C/Y/W 135 Vaccine
59.6
49.0 – 69.6
Serogroup W 135: ≥1:4
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
88.7
83.4 – 92.8
Group 2: Menomune® A/C/Y/W 135 Vaccine
77.7
67.9 – 85.6
Serogroup W 135: ≥1:8
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
79.5
73.1 – 84.9
Group 2: Menomune® A/C/Y/W 135 Vaccine
60.6
50.0 – 70.6
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® VaccinePrimary· Day 30 (post-vaccination)
Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by hSBA assay method. Seroresponse was defined as post-vaccination hSBA titers ≥1:8 for participants with pre-vaccination hSBA titers less than (\<) 1:8, or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers ≥1:8.
Serogroup A
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
65.1
58.0 – 71.8
Group 2: Menomune® A/C/Y/W 135 Vaccine
46.8
36.4 – 57.4
Serogroup C
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
70.8
63.8 – 77.0
Group 2: Menomune® A/C/Y/W 135 Vaccine
59.6
49.0 – 69.6
Serogroup Y
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
75.4
68.7 – 81.3
Group 2: Menomune® A/C/Y/W 135 Vaccine
48.9
38.5 – 59.5
Serogroup W 135
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
74.4
67.6 – 80.3
Group 2: Menomune® A/C/Y/W 135 Vaccine
55.3
44.7 – 65.6
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® VaccinePrimary· Day 0 (pre-vaccination)
GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Serogroup A
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
9.73
8.65 – 10.9
Group 2: Menomune® A/C/Y/W 135 Vaccine
10.4
8.58 – 12.5
Serogroup C
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
3.32
2.87 – 3.85
Group 2: Menomune® A/C/Y/W 135 Vaccine
2.87
2.49 – 3.31
Serogroup Y
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
3.02
2.63 – 3.47
Group 2: Menomune® A/C/Y/W 135 Vaccine
3.53
2.84 – 4.38
Serogroup W 135
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
2.83
2.56 – 3.14
Group 2: Menomune® A/C/Y/W 135 Vaccine
2.83
2.40 – 3.33
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® VaccinePrimary· Day 30 (post-vaccination)
GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Serogroup A
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
51.0
40.7 – 63.9
Group 2: Menomune® A/C/Y/W 135 Vaccine
31.8
22.5 – 44.9
Serogroup C
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
48.3
34.8 – 67.1
Group 2: Menomune® A/C/Y/W 135 Vaccine
18.5
12.1 – 28.3
Serogroup Y
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
41.9
31.8 – 55.3
Group 2: Menomune® A/C/Y/W 135 Vaccine
16.6
11.3 – 24.5
Serogroup W 135
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
29.0
22.5 – 37.3
Group 2: Menomune® A/C/Y/W 135 Vaccine
17.1
11.6 – 25.2
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune®Primary· Day 0 (pre-vaccination)
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.
Serogroup A: ≥1:8
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
28.2
22.0 – 35.1
Group 2: Menomune® A/C/Y/W 135 Vaccine
26.9
18.2 – 37.1
Serogroup A: ≥1:128
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
22.1
16.4 – 28.5
Group 2: Menomune® A/C/Y/W 135 Vaccine
22.6
14.6 – 32.4
Serogroup C: ≥1:8
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
12.3
8.0 – 17.8
Group 2: Menomune® A/C/Y/W 135 Vaccine
9.6
4.5 – 17.4
Serogroup C: ≥1:128
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
8.2
4.8 – 13.0
Group 2: Menomune® A/C/Y/W 135 Vaccine
4.3
1.2 – 10.5
Serogroup Y: ≥1:8
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
50.3
43.0 – 57.5
Group 2: Menomune® A/C/Y/W 135 Vaccine
50.0
39.5 – 60.5
Serogroup Y: ≥1:128
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
27.7
21.5 – 34.5
Group 2: Menomune® A/C/Y/W 135 Vaccine
20.2
12.6 – 29.8
Serogroup W 135: ≥1:8
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
20.0
14.6 – 26.3
Group 2: Menomune® A/C/Y/W 135 Vaccine
27.7
18.9 – 37.8
Serogroup W 135: ≥1:128
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
12.8
8.5 – 18.3
Group 2: Menomune® A/C/Y/W 135 Vaccine
14.9
8.4 – 23.7
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune®Primary· Day 30 (post-vaccination)
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.
Serogroup A: ≥1:8
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
95.9
92.0 – 98.2
Group 2: Menomune® A/C/Y/W 135 Vaccine
94.7
88.0 – 98.3
Serogroup A: ≥1:128
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
94.3
90.0 – 97.1
Group 2: Menomune® A/C/Y/W 135 Vaccine
89.4
81.3 – 94.8
Serogroup C: ≥1:8
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
95.9
92.0 – 98.2
Group 2: Menomune® A/C/Y/W 135 Vaccine
87.2
78.8 – 93.2
Serogroup C: ≥1:128
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
93.3
88.8 – 96.4
Group 2: Menomune® A/C/Y/W 135 Vaccine
77.7
67.9 – 85.6
Serogroup Y: ≥1:8
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
97.4
94.1 – 99.2
Group 2: Menomune® A/C/Y/W 135 Vaccine
94.7
88.0 – 98.3
Serogroup Y: ≥1:128
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
88.1
82.7 – 92.3
Group 2: Menomune® A/C/Y/W 135 Vaccine
73.4
63.3 – 82.0
Serogroup W 135: ≥1:8
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
98.4
95.5 – 99.7
Group 2: Menomune® A/C/Y/W 135 Vaccine
94.7
88.0 – 98.3
Serogroup W 135: ≥1:128
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
94.3
90.0 – 97.1
Group 2: Menomune® A/C/Y/W 135 Vaccine
79.8
70.2 – 87.4
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® VaccinePrimary· Day 30 (post-vaccination)
Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by rSBA assay method. Seroresponse was defined as post-vaccination rSBA titers ≥1:8 for participants with pre-vaccination rSBA titers \<1:8, or at least a 4-fold increase in rSBA titers from pre- to post-vaccination for participants with pre-vaccination rSBA titers ≥1:8.
Serogroup A
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
90.2
85.1 – 94.0
Group 2: Menomune® A/C/Y/W 135 Vaccine
89.2
81.1 – 94.7
Serogroup C
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
94.8
90.7 – 97.5
Group 2: Menomune® A/C/Y/W 135 Vaccine
86.2
77.5 – 92.4
Serogroup Y
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
86.5
80.9 – 91.0
Group 2: Menomune® A/C/Y/W 135 Vaccine
75.5
65.6 – 83.8
Serogroup W 135
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
95.3
91.3 – 97.8
Group 2: Menomune® A/C/Y/W 135 Vaccine
90.4
82.6 – 95.5
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® VaccinePrimary· Day 0 (pre-vaccination)
GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.
Serogroup A
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
7.75
5.65 – 10.6
Group 2: Menomune® A/C/Y/W 135 Vaccine
7.32
4.62 – 11.6
Serogroup C
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
3.40
2.76 – 4.18
Group 2: Menomune® A/C/Y/W 135 Vaccine
2.93
2.28 – 3.77
Serogroup Y
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
15.3
11.4 – 20.7
Group 2: Menomune® A/C/Y/W 135 Vaccine
13.1
8.63 – 19.9
Serogroup W 135
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
4.74
3.68 – 6.12
Group 2: Menomune® A/C/Y/W 135 Vaccine
6.05
4.11 – 8.89
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® VaccinePrimary· Day 30 (post-vaccination)
GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.
Serogroup A
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
1054
825 – 1346
Group 2: Menomune® A/C/Y/W 135 Vaccine
746
501 – 1109
Serogroup C
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
1559
1140 – 2131
Group 2: Menomune® A/C/Y/W 135 Vaccine
445
255 – 776
Serogroup Y
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
591
464 – 753
Group 2: Menomune® A/C/Y/W 135 Vaccine
260
177 – 382
Serogroup W 135
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
910
728 – 1136
Group 2: Menomune® A/C/Y/W 135 Vaccine
493
316 – 772
Number of Participants With Immediate Unsolicited Adverse Events (AEs) After VaccinationPrimary· Within 30 minutes after vaccination
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. All participants were obse
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
0
Group 2: Menomune® A/C/Y/W 135 Vaccine
0
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After VaccinationPrimary· Within 7 days after vaccination
A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (symptom and onset) prelisted in the CRF. Solicited injection site reactions included: pain, erythema, and swelling. Solicited systemic reactions included: fever, headache, malaise and, myalgia.
Pain
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
61
Group 2: Menomune® A/C/Y/W 135 Vaccine
32
Erythema
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
23
Group 2: Menomune® A/C/Y/W 135 Vaccine
5
Swelling
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
15
Group 2: Menomune® A/C/Y/W 135 Vaccine
2
Fever
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
3
Group 2: Menomune® A/C/Y/W 135 Vaccine
1
Headache
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
47
Group 2: Menomune® A/C/Y/W 135 Vaccine
28
Malaise
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
44
Group 2: Menomune® A/C/Y/W 135 Vaccine
15
Myalgia
Group
Value
95% CI
Group 1: MenACYW Conjugate Vaccine
70
Group 2: Menomune® A/C/Y/W 135 Vaccine
26
Adverse events — posted to ClinicalTrials.gov
Time frame: Unsolicited AE data were collected from Day 0 up to Day 30 post-vaccination. The SRs were collected within 7 days post-vaccination. SAE information was collected throughout the trial (up to 30 days post-vaccination)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Primary objectives:
* To describe the antibody responses to meningococcal serogroups A, C, Y, and W 135, measured by serum bactericidal assay using human complement (hSBA) and baby rabbit complement (rSBA), induced by a single dose of Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein (MenACYW) Conjugate vaccine or Menomune® - A/C/Y/W 135.
* To describe the safety profile of a single dose of MenACYW Conjugate vaccine or Menomune® - A/C/Y/W 135.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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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 Sanofi Pasteur, a Sanofi Company
Last refreshed: 4 April 2022
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/NCT01732627.