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Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01732627
Recruitment Status : Completed
First Posted : November 26, 2012
Results First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Meningitis
Meningococcal Meningitis
Meningococcal Infections
Invasive Meningococcal Disease
Interventions Biological: Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate Vaccine
Biological: Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W 135 Combined
Enrollment 301
Recruitment Details Study was conducted from 12-November-2012 to 17-January-2013 at 12 sites in the United States.
Pre-assignment Details A total of 301 participants were enrolled and vaccinated in the study.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® A/C/Y/W 135 Vaccine
Hide Arm/Group Description Adult participants aged greater than or equal to (≥) 56 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W 135) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0. Adult participants aged ≥56 years received a single dose of Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W 135 Combined (Menomune®) vaccine on Day 0.
Period Title: Overall Study
Started [1] 201 100
Safety Analysis Set (SafAS) [2] 199 100
Completed 200 100
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
[1]
Randomized and vaccinated.
[2]
Participants who received at least 1 dose of study or control vaccine and had safety data available.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® A/C/Y/W 135 Vaccine Total
Hide Arm/Group Description Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0. Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0. Total of all reporting groups
Overall Number of Baseline Participants 201 100 301
Hide Baseline Analysis Population Description
Analysis was performed on all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 201 participants 100 participants 301 participants
66.0  (7.15) 65.8  (6.58) 65.9  (6.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants 100 participants 301 participants
Female
121
  60.2%
55
  55.0%
176
  58.5%
Male
80
  39.8%
45
  45.0%
125
  41.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants 100 participants 301 participants
American Indian or Alaska Native
1
   0.5%
0
   0.0%
1
   0.3%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
   3.5%
2
   2.0%
9
   3.0%
White
190
  94.5%
97
  97.0%
287
  95.3%
More than one race
3
   1.5%
1
   1.0%
4
   1.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title 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® Vaccine
Hide Description Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Time Frame Day 0 (pre-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Per-Protocol Analysis Set (PPAS) population which included participants who received at least one dose of the study vaccine, had any valid serology result, and no protocol deviations.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® A/C/Y/W 135 Vaccine
Hide Arm/Group Description:
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
Overall Number of Participants Analyzed 195 94
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Serogroup A: ≥1:4
95.9
(92.1 to 98.2)
96.8
(91.0 to 99.3)
Serogroup A: ≥1:8
76.4
(69.8 to 82.2)
79.8
(70.2 to 87.4)
Serogroup C: ≥1:4
27.7
(21.5 to 34.5)
30.9
(21.7 to 41.2)
Serogroup C: ≥1:8
17.4
(12.4 to 23.5)
10.6
(5.2 to 18.7)
Serogroup Y: ≥1:4
22.1
(16.4 to 28.5)
26.6
(18.0 to 36.7)
Serogroup Y: ≥1:8
13.3
(8.9 to 18.9)
24.5
(16.2 to 34.4)
Serogroup W 135: ≥1:4
26.2
(20.1 to 32.9)
26.6
(18.0 to 36.7)
Serogroup W 135: ≥1:8
13.3
(8.9 to 18.9)
8.5
(3.7 to 16.1)
2.Primary Outcome
Title 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® Vaccine
Hide Description Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Time Frame Day 30 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPAS population.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® A/C/Y/W 135 Vaccine
Hide Arm/Group Description:
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
Overall Number of Participants Analyzed 195 94
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Serogroup A: ≥1:4
97.4
(94.1 to 99.2)
93.6
(86.6 to 97.6)
Serogroup A: ≥1:8
93.8
(89.5 to 96.8)
85.1
(76.3 to 91.6)
Serogroup C: ≥1:4
85.6
(79.9 to 90.2)
79.8
(70.2 to 87.4)
Serogroup C: ≥1:8
74.9
(68.2 to 80.8)
62.8
(52.2 to 72.5)
Serogroup Y: ≥1:4
87.2
(81.7 to 91.5)
73.4
(63.3 to 82.0)
Serogroup Y: ≥1:8
80.5
(74.2 to 85.8)
59.6
(49.0 to 69.6)
Serogroup W 135: ≥1:4
88.7
(83.4 to 92.8)
77.7
(67.9 to 85.6)
Serogroup W 135: ≥1:8
79.5
(73.1 to 84.9)
60.6
(50.0 to 70.6)
3.Primary Outcome
Title 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® Vaccine
Hide Description 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.
Time Frame Day 30 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPAS population.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® A/C/Y/W 135 Vaccine
Hide Arm/Group Description:
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
Overall Number of Participants Analyzed 195 94
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Serogroup A
65.1
(58.0 to 71.8)
46.8
(36.4 to 57.4)
Serogroup C
70.8
(63.8 to 77.0)
59.6
(49.0 to 69.6)
Serogroup Y
75.4
(68.7 to 81.3)
48.9
(38.5 to 59.5)
Serogroup W 135
74.4
(67.6 to 80.3)
55.3
(44.7 to 65.6)
4.Primary Outcome
Title 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® Vaccine
Hide Description GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Time Frame Day 0 (pre-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPAS population.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® A/C/Y/W 135 Vaccine
Hide Arm/Group Description:
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
Overall Number of Participants Analyzed 195 94
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers (1/dilution)
Serogroup A
9.73
(8.65 to 10.9)
10.4
(8.58 to 12.5)
Serogroup C
3.32
(2.87 to 3.85)
2.87
(2.49 to 3.31)
Serogroup Y
3.02
(2.63 to 3.47)
3.53
(2.84 to 4.38)
Serogroup W 135
2.83
(2.56 to 3.14)
2.83
(2.40 to 3.33)
5.Primary Outcome
Title 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® Vaccine
Hide Description GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Time Frame Day 30 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPAS population.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® A/C/Y/W 135 Vaccine
Hide Arm/Group Description:
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
Overall Number of Participants Analyzed 195 94
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers (1/dilution)
Serogroup A
51.0
(40.7 to 63.9)
31.8
(22.5 to 44.9)
Serogroup C
48.3
(34.8 to 67.1)
18.5
(12.1 to 28.3)
Serogroup Y
41.9
(31.8 to 55.3)
16.6
(11.3 to 24.5)
Serogroup W 135
29.0
(22.5 to 37.3)
17.1
(11.6 to 25.2)
6.Primary Outcome
Title 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®
Hide Description Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.
Time Frame Day 0 (pre-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPAS population. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® A/C/Y/W 135 Vaccine
Hide Arm/Group Description:
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
Overall Number of Participants Analyzed 195 94
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Serogroup A: ≥1:8 Number Analyzed 195 participants 93 participants
28.2
(22.0 to 35.1)
26.9
(18.2 to 37.1)
Serogroup A: ≥1:128 Number Analyzed 195 participants 93 participants
22.1
(16.4 to 28.5)
22.6
(14.6 to 32.4)
Serogroup C: ≥1:8 Number Analyzed 195 participants 94 participants
12.3
(8.0 to 17.8)
9.6
(4.5 to 17.4)
Serogroup C: ≥1:128 Number Analyzed 195 participants 94 participants
8.2
(4.8 to 13.0)
4.3
(1.2 to 10.5)
Serogroup Y: ≥1:8 Number Analyzed 195 participants 94 participants
50.3
(43.0 to 57.5)
50.0
(39.5 to 60.5)
Serogroup Y: ≥1:128 Number Analyzed 195 participants 94 participants
27.7
(21.5 to 34.5)
20.2
(12.6 to 29.8)
Serogroup W 135: ≥1:8 Number Analyzed 195 participants 94 participants
20.0
(14.6 to 26.3)
27.7
(18.9 to 37.8)
Serogroup W 135: ≥1:128 Number Analyzed 195 participants 94 participants
12.8
(8.5 to 18.3)
14.9
(8.4 to 23.7)
7.Primary Outcome
Title 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®
Hide Description Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.
Time Frame Day 30 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPAS population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® A/C/Y/W 135 Vaccine
Hide Arm/Group Description:
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
Overall Number of Participants Analyzed 193 94
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Serogroup A: ≥1:8
95.9
(92.0 to 98.2)
94.7
(88.0 to 98.3)
Serogroup A: ≥1:128
94.3
(90.0 to 97.1)
89.4
(81.3 to 94.8)
Serogroup C: ≥1:8
95.9
(92.0 to 98.2)
87.2
(78.8 to 93.2)
Serogroup C: ≥1:128
93.3
(88.8 to 96.4)
77.7
(67.9 to 85.6)
Serogroup Y: ≥1:8
97.4
(94.1 to 99.2)
94.7
(88.0 to 98.3)
Serogroup Y: ≥1:128
88.1
(82.7 to 92.3)
73.4
(63.3 to 82.0)
Serogroup W 135: ≥1:8
98.4
(95.5 to 99.7)
94.7
(88.0 to 98.3)
Serogroup W 135: ≥1:128
94.3
(90.0 to 97.1)
79.8
(70.2 to 87.4)
8.Primary Outcome
Title 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® Vaccine
Hide Description 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.
Time Frame Day 30 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPAS population. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® A/C/Y/W 135 Vaccine
Hide Arm/Group Description:
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
Overall Number of Participants Analyzed 195 94
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Serogroup A Number Analyzed 193 participants 93 participants
90.2
(85.1 to 94.0)
89.2
(81.1 to 94.7)
Serogroup C Number Analyzed 193 participants 94 participants
94.8
(90.7 to 97.5)
86.2
(77.5 to 92.4)
Serogroup Y Number Analyzed 193 participants 94 participants
86.5
(80.9 to 91.0)
75.5
(65.6 to 83.8)
Serogroup W 135 Number Analyzed 193 participants 94 participants
95.3
(91.3 to 97.8)
90.4
(82.6 to 95.5)
9.Primary Outcome
Title 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® Vaccine
Hide Description GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.
Time Frame Day 0 (pre-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPAS population. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® A/C/Y/W 135 Vaccine
Hide Arm/Group Description:
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
Overall Number of Participants Analyzed 195 94
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers (1/dilution)
Serogroup A Number Analyzed 195 participants 93 participants
7.75
(5.65 to 10.6)
7.32
(4.62 to 11.6)
Serogroup C Number Analyzed 195 participants 94 participants
3.40
(2.76 to 4.18)
2.93
(2.28 to 3.77)
Serogroup Y Number Analyzed 195 participants 94 participants
15.3
(11.4 to 20.7)
13.1
(8.63 to 19.9)
Serogroup W 135 Number Analyzed 195 participants 94 participants
4.74
(3.68 to 6.12)
6.05
(4.11 to 8.89)
10.Primary Outcome
Title 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® Vaccine
Hide Description GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.
Time Frame Day 30 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPAS population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® A/C/Y/W 135 Vaccine
Hide Arm/Group Description:
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
Overall Number of Participants Analyzed 193 94
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers (1/dilution)
Serogroup A
1054
(825 to 1346)
746
(501 to 1109)
Serogroup C
1559
(1140 to 2131)
445
(255 to 776)
Serogroup Y
591
(464 to 753)
260
(177 to 382)
Serogroup W 135
910
(728 to 1136)
493
(316 to 772)
11.Primary Outcome
Title Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Vaccination
Hide Description 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 observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF.
Time Frame Within 30 minutes after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on SafAS population which included participants who received at least one dose of the study or control vaccine and had safety data available.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® A/C/Y/W 135 Vaccine
Hide Arm/Group Description:
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
Overall Number of Participants Analyzed 199 100
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
12.Primary Outcome
Title Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination
Hide Description 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.
Time Frame Within 7 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on SafAS population. Here, 'Number analyzed' = participants with available data for each specified category.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® A/C/Y/W 135 Vaccine
Hide Arm/Group Description:
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
Overall Number of Participants Analyzed 199 100
Measure Type: Count of Participants
Unit of Measure: Participants
Pain Number Analyzed 199 participants 100 participants
61
  30.7%
32
  32.0%
Erythema Number Analyzed 199 participants 100 participants
23
  11.6%
5
   5.0%
Swelling Number Analyzed 198 participants 100 participants
15
   7.6%
2
   2.0%
Fever Number Analyzed 197 participants 99 participants
3
   1.5%
1
   1.0%
Headache Number Analyzed 199 participants 100 participants
47
  23.6%
28
  28.0%
Malaise Number Analyzed 199 participants 100 participants
44
  22.1%
15
  15.0%
Myalgia Number Analyzed 199 participants 100 participants
70
  35.2%
26
  26.0%
13.Primary Outcome
Title Number of Participants With Unsolicited Adverse Events After Vaccination
Hide Description An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRF in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. An 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. Non-serious AE (AE excluding SAE) which was significant and prevented daily activity was considered as Grade 3 unsolicited non-serious AE.
Time Frame Within 30 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the SafAS population.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® A/C/Y/W 135 Vaccine
Hide Arm/Group Description:
Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.
Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
Overall Number of Participants Analyzed 199 100
Measure Type: Count of Participants
Unit of Measure: Participants
Unsolicited AE
41
  20.6%
17
  17.0%
Unsolicited non-serious AE
41
  20.6%
17
  17.0%
Grade 3 unsolicited non-serious AE
2
   1.0%
3
   3.0%
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).
Adverse Event Reporting Description A SR was an AE observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRF and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on SafAS population.
 
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® A/C/Y/W 135 Vaccine
Hide Arm/Group Description Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0. Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0.
All-Cause Mortality
Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® A/C/Y/W 135 Vaccine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/199 (0.00%)      0/100 (0.00%)    
Hide Serious Adverse Events
Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® A/C/Y/W 135 Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/199 (0.00%)      0/100 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® A/C/Y/W 135 Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   114/199 (57.29%)      54/100 (54.00%)    
General disorders     
Injection Site Erythema  1  23/199 (11.56%)  23 5/100 (5.00%)  5
Injection Site Pain  1  61/199 (30.65%)  61 32/100 (32.00%)  32
Injection Site Swelling  1  15/199 (7.54%)  15 2/100 (2.00%)  2
Malaise  1  44/199 (22.11%)  44 15/100 (15.00%)  15
Musculoskeletal and connective tissue disorders     
Myalgia  1  70/199 (35.18%)  70 26/100 (26.00%)  26
Nervous system disorders     
Headache  1 [1]  47/199 (23.62%)  48 29/100 (29.00%)  30
1
Term from vocabulary, MedDRA 15.0
Indicates events were collected by systematic assessment
[1]
1 Headache event which occurred 7 days post-vaccination was considered as an unsolicited AE.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi Pasteur
Phone: 800-633-1610 ext 1#
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01732627    
Other Study ID Numbers: MET44
U1111-1127-6804 ( Other Identifier: WHO )
First Submitted: November 13, 2012
First Posted: November 26, 2012
Results First Submitted: May 19, 2020
Results First Posted: June 9, 2020
Last Update Posted: June 9, 2020