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Trial record 1 of 1 for:    EFC16335
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Study of a Quadrivalent Meningococcal Conjugate Vaccine as a Single Dose Compared With a Single Dose of a Meningococcal Reference Vaccine in Children, Adolescents, and Adults 2 to 55 Years of Age

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: NCT04368429
Recruitment Status : Completed
First Posted : April 29, 2020
Results First Posted : October 6, 2021
Last Update Posted : April 11, 2022
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Meningococcal Infection (Healthy Volunteers)
Interventions Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate Vaccine)
Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Enrollment 360
Recruitment Details Study participants were enrolled at 4 active centers in Japan from 22 May 2020 to 05 October 2020.
Pre-assignment Details A total of 360 participants were enrolled and randomized in the study.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menactra® Vaccine
Hide Arm/Group Description Participants received a single intramuscular (IM) dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate vaccine (MenACYW Conjugate vaccine) on Day 0. Participants received a single IM dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra® vaccine) on Day 0.
Period Title: Overall Study
Started 180 180
Safety Analysis Set [1] 179 180
Completed 179 180
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
[1]
Participants who received at least one dose of the study vaccine and had any safety data available; analyzed according to the vaccine they actually received.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menactra® Vaccine Total
Hide Arm/Group Description Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0. Participants received a single IM dose of Menactra® vaccine on Day 0. Total of all reporting groups
Overall Number of Baseline Participants 180 180 360
Hide Baseline Analysis Population Description
Analysis was performed on all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 180 participants 180 participants 360 participants
25.1  (11.09) 24.1  (10.27) 24.6  (10.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 180 participants 360 participants
Female
84
  46.7%
95
  52.8%
179
  49.7%
Male
96
  53.3%
85
  47.2%
181
  50.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 180 participants 180 participants 360 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
180
 100.0%
180
 100.0%
360
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine: Non-Inferiority Analysis
Hide Description Antibody titers against meningococcal serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (>=) 1:16 for participants with pre-vaccination hSBA titer less than (<) 1:8, or a >= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer >= 1:8.
Time Frame Day 30 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Per-Protocol Analysis Set (PPAS) population that included participants who received 1 dose of the study vaccine and had a valid post-vaccination blood sample result with no relevant protocol deviations. Here, 'number analyzed'=participants with available data for each specified category.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menactra® Vaccine
Hide Arm/Group Description:
Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
Participants received a single IM dose of Menactra® vaccine on Day 0.
Overall Number of Participants Analyzed 174 179
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Serogroup A Number Analyzed 174 participants 179 participants
85.6
(79.5 to 90.5)
65.4
(57.9 to 72.3)
Serogroup C Number Analyzed 174 participants 179 participants
96.6
(92.6 to 98.7)
62.6
(55.0 to 69.7)
Serogroup Y Number Analyzed 174 participants 178 participants
97.7
(94.2 to 99.4)
63.5
(56.0 to 70.6)
Serogroup W Number Analyzed 174 participants 179 participants
87.4
(81.5 to 91.9)
49.2
(41.6 to 56.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: MenACYW Conjugate Vaccine, Group 2: Menactra® Vaccine
Comments Serogroup A
Type of Statistical Test Non-Inferiority
Comments The non-inferiority was demonstrated if the lower limit of the 2-sided 95% Confidence Interval (CI) of the difference in percentage was greater than (>) -10% for the serogroup A.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 20.27
Confidence Interval (2-Sided) 95%
11.38 to 28.75
Estimation Comments 95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1: MenACYW Conjugate Vaccine, Group 2: Menactra® Vaccine
Comments Serogroup C
Type of Statistical Test Non-Inferiority
Comments The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in percentage was >-10% for the serogroup C.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 33.98
Confidence Interval (2-Sided) 95%
26.20 to 41.50
Estimation Comments 95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 1: MenACYW Conjugate Vaccine, Group 2: Menactra® Vaccine
Comments Serogroup Y
Type of Statistical Test Non-Inferiority
Comments The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in percentage was >-10% for the serogroup Y.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 34.22
Confidence Interval (2-Sided) 95%
26.66 to 41.64
Estimation Comments 95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group 1: MenACYW Conjugate Vaccine, Group 2: Menactra® Vaccine
Comments Serogroup W
Type of Statistical Test Non-Inferiority
Comments The non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference in percentage was >-10% for the serogroup W.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 38.19
Confidence Interval (2-Sided) 95%
28.93 to 46.53
Estimation Comments 95% CI of the difference in percentage was calculated from the Wilson Score method without continuity correction.
2.Secondary Outcome
Title Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Hide Description Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer >=1:16 for participants with pre-vaccination hSBA titer <1:8, or a >= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer >= 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: Menactra® Vaccine
Hide Arm/Group Description:
Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
Participants received a single IM dose of Menactra® vaccine on Day 0.
Overall Number of Participants Analyzed 174 179
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Serogroup A Number Analyzed 174 participants 179 participants
85.6
(79.5 to 90.5)
65.4
(57.9 to 72.3)
Serogroup C Number Analyzed 174 participants 179 participants
96.6
(92.6 to 98.7)
62.6
(55.0 to 69.7)
Serogroup Y Number Analyzed 174 participants 178 participants
97.7
(94.2 to 99.4)
63.5
(56.0 to 70.6)
Serogroup W Number Analyzed 174 participants 179 participants
87.4
(81.5 to 91.9)
49.2
(41.6 to 56.7)
3.Secondary Outcome
Title Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Hide Description Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Percentage of participants With hSBA antibody titers >=1:4 and >=1:8 for serogroups A, C, Y, and W were reported in the outcome measure.
Time Frame Day 0 (pre-vaccination); 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: Menactra® Vaccine
Hide Arm/Group Description:
Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
Participants received a single IM dose of Menactra® vaccine on Day 0.
Overall Number of Participants Analyzed 174 179
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Serogroup A: >= 1:4: Day 0 Number Analyzed 174 participants 179 participants
82.8
(76.3 to 88.1)
82.1
(75.7 to 87.4)
Serogroup A: >= 1:8: Day 0 Number Analyzed 174 participants 179 participants
42.5
(35.1 to 50.2)
46.9
(39.4 to 54.5)
Serogroup A: >= 1:4: Day 30 Number Analyzed 174 participants 179 participants
98.3
(95.0 to 99.6)
98.9
(96.0 to 99.9)
Serogroup A: >= 1:8: Day 30 Number Analyzed 174 participants 179 participants
96.6
(92.6 to 98.7)
92.7
(87.9 to 96.1)
Serogroup C: >= 1:4: Day 0 Number Analyzed 174 participants 179 participants
55.2
(47.5 to 62.7)
65.9
(58.5 to 72.8)
Serogroup C: >= 1:8: Day 0 Number Analyzed 174 participants 179 participants
31.6
(24.8 to 39.1)
38.5
(31.4 to 46.1)
Serogroup C: >= 1:4: Day 30 Number Analyzed 174 participants 179 participants
100
(97.9 to 100)
90.5
(85.2 to 94.4)
Serogroup C: >= 1:8: Day 30 Number Analyzed 174 participants 179 participants
98.9
(95.9 to 99.9)
81.0
(74.5 to 86.5)
Serogroup Y: >= 1:4: Day 0 Number Analyzed 174 participants 178 participants
39.7
(32.3 to 47.3)
44.9
(37.5 to 52.6)
Serogroup Y: >= 1:8: Day 0 Number Analyzed 174 participants 178 participants
27.0
(20.6 to 34.3)
29.2
(22.7 to 36.5)
Serogroup Y: >= 1:4: Day 30 Number Analyzed 174 participants 179 participants
100
(97.9 to 100)
97.2
(93.6 to 99.1)
Serogroup Y: >= 1:8: Day 30 Number Analyzed 174 participants 179 participants
100
(97.9 to 100)
89.4
(83.9 to 93.5)
Serogroup W: >= 1:4: Day 0 Number Analyzed 174 participants 179 participants
73.0
(65.7 to 79.4)
76.0
(69.0 to 82.0)
Serogroup W: >= 1:8: Day 0 Number Analyzed 174 participants 179 participants
51.1
(43.5 to 58.8)
58.7
(51.1 to 66.0)
Serogroup W: >= 1:4: Day 30 Number Analyzed 174 participants 179 participants
100
(97.9 to 100)
96.6
(92.8 to 98.8)
Serogroup W: >= 1:8: Day 30 Number Analyzed 174 participants 179 participants
99.4
(96.8 to 100)
91.1
(85.9 to 94.8)
4.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Hide Description GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
Time Frame Day 0 (pre-vaccination); 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: Menactra® Vaccine
Hide Arm/Group Description:
Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
Participants received a single IM dose of Menactra® vaccine on Day 0.
Overall Number of Participants Analyzed 174 179
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers
Serogroup A: Day 0 Number Analyzed 174 participants 179 participants
5.79
(5.06 to 6.63)
5.96
(5.28 to 6.73)
Serogroup A: Day 30 Number Analyzed 174 participants 179 participants
123
(99.4 to 152)
41.3
(33.3 to 51.3)
Serogroup C: Day 0 Number Analyzed 174 participants 179 participants
4.47
(3.86 to 5.18)
5.27
(4.53 to 6.12)
Serogroup C: Day 30 Number Analyzed 174 participants 179 participants
544
(431 to 685)
36.6
(28.3 to 47.5)
Serogroup Y: Day 0 Number Analyzed 174 participants 178 participants
3.95
(3.36 to 4.65)
4.29
(3.62 to 5.08)
Serogroup Y: Day 30 Number Analyzed 174 participants 179 participants
221
(183 to 267)
41.5
(32.7 to 52.6)
Serogroup W: Day 0 Number Analyzed 174 participants 179 participants
7.39
(6.21 to 8.79)
8.41
(7.09 to 9.98)
Serogroup W: Day 30 Number Analyzed 174 participants 179 participants
125
(104 to 151)
36.5
(29.3 to 45.5)
5.Secondary Outcome
Title Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Hide Description Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Percentage of participants with hSBA titers <1:4, 1:4, 1:8, 1:16,1:32, 1:64, 1:128, 1:256, 1:512, 1:1024, 1:2048 and 1:4096 for serogroups A, C, Y, and W; with hSBA titers of 1:8192 for serogroup Y; and with hSBA titers of 1:8192, 1:16384, 1:32768 for serogroup C were reported.
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: Menactra® Vaccine
Hide Arm/Group Description:
Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
Participants received a single IM dose of Menactra® vaccine on Day 0.
Overall Number of Participants Analyzed 174 179
Measure Type: Number
Unit of Measure: percentage of participants
Serogroup A:<1:4 1.7 1.1
Serogroup A: 1:4 1.7 6.1
Serogroup A: 1:8 2.9 12.3
Serogroup A: 1:16 4.6 18.4
Serogroup A: 1:32 11.5 17.9
Serogroup A: 1:64 13.2 14.5
Serogroup A: 1:128 24.1 13.4
Serogroup A: 1:256 16.1 8.9
Serogroup A: 1:512 15.5 2.8
Serogroup A: 1:1024 7.5 3.9
Serogroup A: 1:2048 0.6 0
Serogroup A: 1:4096 0.6 0.6
Serogroup C:<1:4 0 9.5
Serogroup C: 1:4 1.1 9.5
Serogroup C: 1:8 0.6 8.9
Serogroup C: 1:16 2.3 10.1
Serogroup C: 1:32 3.4 15.1
Serogroup C: 1:64 4.0 14.0
Serogroup C: 1:128 7.5 14.5
Serogroup C: 1:256 12.6 8.4
Serogroup C: 1:512 22.4 5.6
Serogroup C: 1:1024 25.9 3.9
Serogroup C: 1:2048 8.6 0
Serogroup C: 1:4096 7.5 0.6
Serogroup C: 1:8192 1.7 0
Serogroup C: 1:16384 1.1 0
Serogroup C: 1:32768 1.1 0
Serogroup Y:<1:4 0 2.8
Serogroup Y:1:4 0 7.8
Serogroup Y:1:8 0.6 11.7
Serogroup Y: 1:16 1.7 15.1
Serogroup Y: 1:32 6.9 16.8
Serogroup Y: 1:64 16.1 19.0
Serogroup Y: 1:128 20.7 7.8
Serogroup Y: 1:256 20.7 6.1
Serogroup Y: 1:512 14.4 8.4
Serogroup Y: 1:1024 12.6 2.8
Serogroup Y: 1:2048 4.0 1.7
Serogroup Y: 1:4096 1.1 0
Serogroup Y: 1:8192 1.1 0
Serogroup W:<1:4 0 3.4
Serogroup W:1:4 0.6 5.6
Serogroup W:1:8 1.7 10.1
Serogroup W:1:16 5.2 19.6
Serogroup W:1:32 13.8 24.6
Serogroup W:1:64 16.1 14.5
Serogroup W:1:128 25.3 9.5
Serogroup W:1:256 19.0 3.4
Serogroup W:1:512 10.3 2.2
Serogroup W:1:1024 6.3 7.3
Serogroup W:1:2048 1.1 0
Serogroup W:1:4096 0.6 0
6.Secondary Outcome
Title Percentage of Participants With >=4-Fold Rise In hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Hide Description Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.
Time Frame From Baseline (Day 0) to 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: Menactra® Vaccine
Hide Arm/Group Description:
Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
Participants received a single IM dose of Menactra® vaccine on Day 0.
Overall Number of Participants Analyzed 174 179
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Serogroup A Number Analyzed 174 participants 179 participants
85.6
(79.5 to 90.5)
65.4
(57.9 to 72.3)
Serogroup C Number Analyzed 174 participants 179 participants
96.6
(92.6 to 98.7)
62.6
(55.0 to 69.7)
Serogroup Y Number Analyzed 174 participants 178 participants
97.7
(94.2 to 99.4)
63.5
(56.0 to 70.6)
Serogroup W Number Analyzed 174 participants 179 participants
87.4
(81.5 to 91.9)
49.2
(41.6 to 56.7)
7.Secondary Outcome
Title Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Hide Description An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Time Frame Within 30 minutes post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety Analysis Set which included participants who received at least one dose of the study vaccine and had any safety data available; analyzed according to the vaccine they actually received.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menactra® Vaccine
Hide Arm/Group Description:
Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
Participants received a single IM dose of Menactra® vaccine on Day 0.
Overall Number of Participants Analyzed 179 180
Measure Type: Count of Participants
Unit of Measure: Participants
0 0
8.Secondary Outcome
Title Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Hide Description A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited injection site reactions included pain, erythema, swelling, and induration. Solicited systemic reactions included fever, headache, malaise and myalgia.
Time Frame Within 7 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety Analysis Set.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menactra® Vaccine
Hide Arm/Group Description:
Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
Participants received a single IM dose of Menactra® vaccine on Day 0.
Overall Number of Participants Analyzed 179 180
Measure Type: Count of Participants
Unit of Measure: Participants
Injection site pain 72 66
Injection site erythema 16 8
Injection site swelling 14 6
Injection site induration 6 5
Fever 3 1
Headache 34 17
Malaise 22 9
Myalgia 38 30
9.Secondary Outcome
Title Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Hide Description An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination.
Time Frame Up to 30 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety Analysis Set.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menactra® Vaccine
Hide Arm/Group Description:
Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
Participants received a single IM dose of Menactra® vaccine on Day 0.
Overall Number of Participants Analyzed 179 180
Measure Type: Count of Participants
Unit of Measure: Participants
15 11
10.Secondary Outcome
Title Number of Participants Reporting Serious Adverse Events (SAEs) Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Hide Description 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.
Time Frame From Day 0 up to 30 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety Analysis Set.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menactra® Vaccine
Hide Arm/Group Description:
Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0.
Participants received a single IM dose of Menactra® vaccine on Day 0.
Overall Number of Participants Analyzed 179 180
Measure Type: Count of Participants
Unit of Measure: Participants
0 0
Time Frame Unsolicited AE data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). Solicited reactions were collected within 7 days post-vaccination. Serious AEs data were collected throughout the trial (i.e., up to 30 days post-vaccination).
Adverse Event Reporting Description Analysis was performed on Safety Analysis Set.
 
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menactra® Vaccine
Hide Arm/Group Description Participants received a single IM dose of MenACYW Conjugate vaccine on Day 0. Participants received a single IM dose of Menactra® vaccine on Day 0.
All-Cause Mortality
Group 1: MenACYW Conjugate Vaccine Group 2: Menactra® Vaccine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/179 (0.00%)      0/180 (0.00%)    
Hide Serious Adverse Events
Group 1: MenACYW Conjugate Vaccine Group 2: Menactra® Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/179 (0.00%)      0/180 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: MenACYW Conjugate Vaccine Group 2: Menactra® Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   98/179 (54.75%)      83/180 (46.11%)    
General disorders     
Injection Site Erythema † 1  16/179 (8.94%)  16 8/180 (4.44%)  8
Injection Site Pain † 1  72/179 (40.22%)  72 66/180 (36.67%)  66
Injection Site Swelling † 1  14/179 (7.82%)  14 6/180 (3.33%)  6
Malaise † 1  22/179 (12.29%)  22 9/180 (5.00%)  9
Musculoskeletal and connective tissue disorders     
Myalgia † 1  38/179 (21.23%)  38 30/180 (16.67%)  30
Nervous system disorders     
Headache † 1 [1]  36/179 (20.11%)  36 17/180 (9.44%)  17
1
Term from vocabulary, MedDRA-23.1
†
Indicates events were collected by systematic assessment
[1]
Headache events that occurred after 7 days post-vaccination were considered as unsolicited AE.
[Not Specified]
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 6#
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT04368429    
Other Study ID Numbers: EFC16335
MEQ00068 ( UTN )
U1111-1241-8382 ( Other Identifier: UTN )
First Submitted: April 20, 2020
First Posted: April 29, 2020
Results First Submitted: September 9, 2021
Results First Posted: October 6, 2021
Last Update Posted: April 11, 2022