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Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine

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ClinicalTrials.gov Identifier: NCT02752906
Recruitment Status : Completed
First Posted : April 27, 2016
Results First Posted : June 5, 2020
Last Update Posted : June 5, 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: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Meningitis
Meningococcal Meningitis
Meningococcal Infections
Interventions Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Enrollment 810
Recruitment Details Study participants were enrolled in 30 centers from 15 April 2016 to 02 August 2016.
Pre-assignment Details A total of 810 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized in the study.
Arm/Group Title MenACYW Conjugate Vaccine Menactra ®
Hide Arm/Group Description Healthy, meningococcal vaccine-primed adolescents (greater than or equal to [>=] 15 to less than [<] 18 years) or adults (>= 18 years) received a single dose of a Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0. Healthy, meningococcal-vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single 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 403 407
Vaccinated 402 407
Completed 396 402
Not Completed 7 5
Reason Not Completed
Protocol Violation             2             1
Withdrawal by Subject             2             2
Lost to Follow-up             3             2
Arm/Group Title MenACYW Conjugate Vaccine Menactra ® Total
Hide Arm/Group Description Healthy, meningococcal vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0. Healthy, meningococcal-vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of Menactra ® vaccine on Day 0. Total of all reporting groups
Overall Number of Baseline Participants 403 407 810
Hide Baseline Analysis Population Description
Analysis was performed on all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 403 participants 407 participants 810 participants
20.0  (5.96) 19.9  (5.59) 20.0  (5.77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 403 participants 407 participants 810 participants
Female
207
  51.4%
200
  49.1%
407
  50.2%
Male
196
  48.6%
207
  50.9%
403
  49.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 403 participants 407 participants 810 participants
American Indian or Alaska Native
1
   0.2%
0
   0.0%
1
   0.1%
Asian
11
   2.7%
3
   0.7%
14
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.2%
1
   0.1%
Black or African American
40
   9.9%
46
  11.3%
86
  10.6%
White
342
  84.9%
340
  83.5%
682
  84.2%
More than one race
8
   2.0%
17
   4.2%
25
   3.1%
Unknown or Not Reported
1
   0.2%
0
   0.0%
1
   0.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 403 participants 407 participants 810 participants
403
 100.0%
407
 100.0%
810
 100.0%
1.Primary Outcome
Title Percentage of Participants With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine
Hide Description The serum bactericidal assay using human complement (hSBA) vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers >= 1:16 for participants with pre-vaccination hSBA titers < 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
Per-Protocol Analysis Set-2 (PPAS2): included all participants who had no protocol deviations (not meet inclusion/exclusion criteria, participant did not received vaccine, administration of vaccine not done as per-protocol). PPAS2 defined for evaluating the immune response of MenACYW vaccine measured by hSBA assessed at Day 30 after vaccination.
Arm/Group Title MenACYW Conjugate Vaccine Menactra ®
Hide Arm/Group Description:
Healthy, meningococcal vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0.
Healthy, meningococcal-vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of Menactra ® vaccine on Day 0.
Overall Number of Participants Analyzed 384 389
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Serogroup A
92.2
(89.0 to 94.7)
87.1
(83.4 to 90.3)
Serogroup C
97.1
(94.9 to 98.6)
91.8
(88.6 to 94.3)
Serogroup Y
97.4
(95.3 to 98.7)
95.6
(93.1 to 97.4)
Serogroup W
98.2
(96.3 to 99.3)
90.7
(87.4 to 93.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine, Menactra ®
Comments Serogroup A
Type of Statistical Test Non-Inferiority
Comments 95% confidence interval (CI) of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was > -10%, the non- inferiority assumption was rejected.
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 5.0
Confidence Interval (2-Sided) 95%
0.735 to 9.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine, Menactra ®
Comments Serogroup C
Type of Statistical Test Non-Inferiority
Comments 95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was > -10%, the non-inferiority assumption was rejected.
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 5.4
Confidence Interval (2-Sided) 95%
2.16 to 8.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine, Menactra ®
Comments Serogroup Y
Type of Statistical Test Non-Inferiority
Comments 95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was > -10%, the non-inferiority assumption was rejected.
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 1.8
Confidence Interval (2-Sided) 95%
-0.907 to 4.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine, Menactra ®
Comments Serogroup W
Type of Statistical Test Non-Inferiority
Comments 95% CI of the difference was calculated from the Wilson Score Method without continuity correction. If the lower limit of the 2-sided 95% CI of the difference between the 2 percentage was > -10%, the non-inferiority assumption was rejected.
Method of Estimation Estimation Parameter Percentage Difference
Estimated Value 7.4
Confidence Interval (2-Sided) 95%
4.30 to 10.9
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine at Day 6 After Vaccination
Hide Description The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers >= 1:16 for participants with pre-vaccination hSBA titers < 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 6 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Analysis Set-1 (PPAS1): included all participants who received at least 1 dose of study vaccine(s) and had no protocol deviations (not meet inclusion/exclusion criteria, participant did not received vaccine). PPAS1 defined for evaluating the immune response of MenACYW vaccine measured by hSBA assessed at Day 6 after vaccination.
Arm/Group Title MenACYW Conjugate Vaccine Menactra ®
Hide Arm/Group Description:
Healthy, meningococcal vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0.
Healthy, meningococcal-vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of Menactra ® vaccine on Day 0.
Overall Number of Participants Analyzed 55 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Serogroup A
72.7
(59.0 to 83.9)
66.1
(53.0 to 77.7)
Serogroup C
83.6
(71.2 to 92.2)
87.1
(76.1 to 94.3)
Serogroup Y
90.9
(80.0 to 97.0)
83.9
(72.3 to 92.0)
Serogroup W
94.5
(84.9 to 98.9)
83.9
(72.3 to 92.0)
3.Secondary Outcome
Title Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine
Hide Description Meningococcal antibody responses against Serogroups A, C, Y, and W were measured by hSBA.
Time Frame Day 30 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PPAS2.
Arm/Group Title MenACYW Conjugate Vaccine Menactra ®
Hide Arm/Group Description:
Healthy, meningococcal vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0.
Healthy, meningococcal-vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of Menactra ® vaccine on Day 0.
Overall Number of Participants Analyzed 384 389
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers (1/dilution)
Serogroup A
497
(436 to 568)
296
(256 to 343)
Serogroup C
2618
(2227 to 3078)
599
(504 to 711)
Serogroup Y
2070
(1807 to 2371)
811
(699 to 941)
Serogroup W
1747
(1508 to 2025)
723
(614 to 853)
4.Secondary Outcome
Title Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine
Hide Description A Solicited Reaction (SR) was an Adverse Event (AE) that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity), erythema and swelling (Grade 1: >=25 millimeter [mm] to <= 50 mm, Grade 2: >=51 to <=100 mm, Grade 3: > 100 mm). Solicited systemic reactions: Fever (Grade 1: >=38.0 degree Celsius (°C) to <=38.4°C, Grade 2: >=38.5°C to <=38.9 °C, Grade 3: >= 39°C), headache, malaise, and myalgia (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significant; prevents daily activity. Number of participants with any of the Grade (1, 2 or 3) and with each Grade (1, 2 and 3) solicited injection-site and systemic reactions were reported.
Time Frame Within 7 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Safety Analysis Set which included participants who have received at least one dose of the study vaccine and have any safety data available. Here 'number analyzed' signifies number of participants with available data for specified category.
Arm/Group Title MenACYW Conjugate Vaccine Menactra ®
Hide Arm/Group Description:
Healthy, meningococcal vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0.
Healthy, meningococcal-vaccine-primed adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of Menactra ® vaccine on Day 0.
Overall Number of Participants Analyzed 402 407
Measure Type: Count of Participants
Unit of Measure: Participants
Pain-Any Grade Number Analyzed 398 participants 402 participants
178 196
Pain-Grade 1 Number Analyzed 398 participants 402 participants
141 154
Pain-Grade 2 Number Analyzed 398 participants 402 participants
33 34
Pain-Grade 3 Number Analyzed 398 participants 402 participants
4 8
Erythema-Any Grade Number Analyzed 398 participants 402 participants
20 6
Erythema-Grade 1 Number Analyzed 398 participants 402 participants
18 5
Erythema-Grade 2 Number Analyzed 398 participants 402 participants
2 1
Erythema-Grade 3 Number Analyzed 398 participants 402 participants
0 0
Swelling-Any Grade Number Analyzed 398 participants 402 participants
16 3
Swelling-Grade 1 Number Analyzed 398 participants 402 participants
13 1
Swelling-Grade 2 Number Analyzed 398 participants 402 participants
3 2
Swelling-Grade 3 Number Analyzed 398 participants 402 participants
0 0
Fever-Any Grade Number Analyzed 390 participants 395 participants
0 2
Fever-Grade 1 Number Analyzed 390 participants 395 participants
0 0
Fever-Grade 2 Number Analyzed 390 participants 395 participants
0 1
Fever-Grade 3 Number Analyzed 390 participants 395 participants
0 1
Headache-Any Grade Number Analyzed 398 participants 402 participants
151 134
Headache-Grade 1 Number Analyzed 398 participants 402 participants
90 73
Headache-Grade 2 Number Analyzed 398 participants 402 participants
52 47
Headache-Grade 3 Number Analyzed 398 participants 402 participants
9 14
Malaise-Any Grade Number Analyzed 398 participants 402 participants
110 108
Malaise-Grade 1 Number Analyzed 398 participants 402 participants
62 64
Malaise-Grade 2 Number Analyzed 398 participants 402 participants
37 30
Malaise-Grade 3 Number Analyzed 398 participants 402 participants
11 14
Myalgia-Any Grade Number Analyzed 398 participants 402 participants
146 156
Myalgia-Grade 1 Number Analyzed 398 participants 402 participants
98 120
Myalgia-Grade 2 Number Analyzed 398 participants 402 participants
40 27
Myalgia-Grade 3 Number Analyzed 398 participants 402 participants
8 9
Time Frame Adverse event (AE) data were collected from Day 0 up to Day 30 post-vaccination. Solicited Reaction (SR) were collected from Day 0 up to Day 7 post-vaccination.
Adverse Event Reporting Description A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety Analysis Set.
 
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menactra ®
Hide Arm/Group Description Healthy, meningococcal-vaccine naive adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0. Healthy, meningococcal-vaccine naive adolescents (>= 15 to < 18 years) or adults (>= 18 years) received a single dose of Menactra vaccine on Day 0.
All-Cause Mortality
Group 1: MenACYW Conjugate Vaccine Group 2: Menactra ®
Affected / at Risk (%) Affected / at Risk (%)
Total   0/402 (0.00%)      0/407 (0.00%)    
Hide Serious Adverse Events
Group 1: MenACYW Conjugate Vaccine Group 2: Menactra ®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/402 (1.24%)      4/407 (0.98%)    
Gastrointestinal disorders     
Intestinal Perforation  1  0/402 (0.00%)  0 1/407 (0.25%)  1
General disorders     
Chest Pain  1  0/402 (0.00%)  0 1/407 (0.25%)  1
Hepatobiliary disorders     
Cholelithiasis  1  1/402 (0.25%)  1 0/407 (0.00%)  0
Immune system disorders     
Allergy To Arthropod Sting  1  1/402 (0.25%)  1 0/407 (0.00%)  0
Infections and infestations     
Appendicitis  1  1/402 (0.25%)  1 0/407 (0.00%)  0
Injury, poisoning and procedural complications     
Clavicle Fracture  1  1/402 (0.25%)  1 0/407 (0.00%)  0
Psychiatric disorders     
Major Depression  1  0/402 (0.00%)  0 1/407 (0.25%)  1
Suicidal Ideation  1  0/402 (0.00%)  0 1/407 (0.25%)  1
Respiratory, thoracic and mediastinal disorders     
Pulmonary Embolism  1  1/402 (0.25%)  1 0/407 (0.00%)  0
1
Term from vocabulary, MedDra 18.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1: MenACYW Conjugate Vaccine Group 2: Menactra ®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   255/402 (63.43%)      263/407 (64.62%)    
General disorders     
Injection Site Pain  1  178/402 (44.28%)  178 196/407 (48.16%)  196
Malaise  1  110/402 (27.36%)  110 108/407 (26.54%)  108
Musculoskeletal and connective tissue disorders     
Myalgia  1 [1]  147/402 (36.57%)  148 158/407 (38.82%)  161
Nervous system disorders     
Headache  1 [2]  155/402 (38.56%)  168 137/407 (33.66%)  152
1
Term from vocabulary, MedDra 18.0
Indicates events were collected by systematic assessment
[1]
Myalgia events that occurred after 7 days post-vaccination were considered as unsolicited AE.
[2]
Headache events that occurred after 7 days post-vaccination were considered as 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 Inc.
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: NCT02752906    
Other Study ID Numbers: MET56
U1111-1161-2710 ( Other Identifier: WHO )
2018-001470-18 ( EudraCT Number )
First Submitted: April 22, 2016
First Posted: April 27, 2016
Results First Submitted: May 19, 2020
Results First Posted: June 5, 2020
Last Update Posted: June 5, 2020