Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults 56 Years 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: NCT02842866
Recruitment Status : Completed
First Posted : July 25, 2016
Results First Posted : February 18, 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   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 Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined
Enrollment 907
Recruitment Details Study was conducted from 15-July-2016 to 13-February-2017 at 35 sites in the United States and Puerto Rico.
Pre-assignment Details Total 907 participants were enrolled in the study, out of which 906 were randomized. 1 participant was not randomized to either of the 2 treatment groups; this participant was not vaccinated and did not provide blood samples, therefore not counted in any analysis.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® Vaccine
Hide Arm/Group Description Healthy, adult participants aged greater than equal to (≥) 56 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate Vaccine on Day 0. Healthy, adult participants aged ≥56 years received a single dose of Meningococcal Polysaccharide Serogroups A, C, Y, and W-135 Combined (Menomune®) Vaccine on Day 0.
Period Title: Overall Study
Started [1] 451 455
Vaccinated 448 453
Completed 444 452
Not Completed 7 3
Reason Not Completed
Serious Adverse Event             0             1
Protocol Violation             4             2
Lost to Follow-up             2             0
Withdrawal by Subject             1             0
[1]
Randomized
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® Vaccine Total
Hide Arm/Group Description Healthy, adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0. Healthy, adult participants aged ≥56 years received a single dose of Menomune®- A/C/Y/W-135 Vaccine on Day 0. Total of all reporting groups
Overall Number of Baseline Participants 451 455 906
Hide Baseline Analysis Population Description
Analysis was performed on all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 451 participants 455 participants 906 participants
66.9  (7.51) 67.3  (7.53) 67.1  (7.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 451 participants 455 participants 906 participants
Female
259
  57.4%
261
  57.4%
520
  57.4%
Male
192
  42.6%
194
  42.6%
386
  42.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 451 participants 455 participants 906 participants
American Indian or Alaska Native
2
   0.4%
2
   0.4%
4
   0.4%
Asian
5
   1.1%
1
   0.2%
6
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.2%
1
   0.1%
Black or African American
54
  12.0%
47
  10.3%
101
  11.1%
White
389
  86.3%
404
  88.8%
793
  87.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   0.2%
0
   0.0%
1
   0.1%
1.Primary Outcome
Title Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menomune® Vaccine
Hide Description Vaccine seroresponse for serogroups A, C, Y, and W was measured by serum bactericidal assay using human complement (hSBA). It was defined as post-vaccination hSBA titers ≥1:16 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 per protocol analysis set which included all participants who received at least one dose of the study vaccine, had a valid post-vaccination serology result and had no protocol deviations.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® Vaccine
Hide Arm/Group Description:
Healthy, adult participants aged ≥56 years received a single dose of MenACYW Conjugate Vaccine on Day 0.
Healthy, adult participants aged ≥56 years received a single dose of Menomune®- A/C/Y/W-135 Vaccine on Day 0.
Overall Number of Participants Analyzed 433 431
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Serogroup A
58.2
(53.4 to 62.9)
42.5
(37.7 to 47.3)
Serogroup C
77.1
(72.9 to 81.0)
49.7
(44.8 to 54.5)
Serogroup Y
74.4
(70.0 to 78.4)
43.4
(38.7 to 48.2)
Serogroup W
62.6
(57.8 to 67.2)
44.8
(40.0 to 49.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: MenACYW Conjugate Vaccine, Group 2: Menomune® Vaccine
Comments Serogroup A
Type of Statistical Test Non-Inferiority
Comments The 95 percent (%) confidence internal (CI) of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was greater than (>) -10 percent (%) for all four serogroups.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 15.7
Confidence Interval (2-Sided) 95%
9.08 to 22.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1: MenACYW Conjugate Vaccine, Group 2: Menomune® Vaccine
Comments Serogroup C
Type of Statistical Test Non-Inferiority
Comments The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was >-10% for all four serogroups.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 27.5
Confidence Interval (2-Sided) 95%
21.2 to 33.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 1: MenACYW Conjugate Vaccine, Group 2: Menomune® Vaccine
Comments Serogroup Y
Type of Statistical Test Non-Inferiority
Comments The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was >-10% for all four serogroups.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 31.0
Confidence Interval (2-Sided) 95%
24.6 to 37.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group 1: MenACYW Conjugate Vaccine, Group 2: Menomune® Vaccine
Comments Serogroup W
Type of Statistical Test Non-Inferiority
Comments The 95% CI of the difference in percentage was computed using the Wilson Score method without continuity correction. The overall non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI was >-10% for all four serogroups.
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 17.8
Confidence Interval (2-Sided) 95%
11.2 to 24.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Hide Description GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA method.
Time Frame Day 30 (Post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on per-protocol analysis set.
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® Vaccine
Hide Arm/Group Description:
Healthy, adult participants aged ≥56 years received a single dose of MenACYW Conjugate Vaccine on Day 0.
Healthy, adult participants aged ≥56 years received a single dose of Menomune®- A/C/Y/W-135 Vaccine on Day 0.
Overall Number of Participants Analyzed 433 431
Geometric Mean (95% Confidence Interval)
Unit of Measure: titers (1/dilutions)
Serogroup A
55.1
(46.8 to 65.0)
31.4
(26.9 to 36.7)
Serogroup C
101
(83.8 to 123)
24.7
(20.7 to 29.5)
Serogroup Y
69.1
(58.7 to 81.4)
21.0
(17.4 to 25.3)
Serogroup W
28.1
(23.7 to 33.3)
15.5
(13.0 to 18.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1: MenACYW Conjugate Vaccine, Group 2: Menomune® Vaccine
Comments Serogroup A
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.75
Confidence Interval (2-Sided) 95%
1.40 to 2.20
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1: MenACYW Conjugate Vaccine, Group 2: Menomune® Vaccine
Comments Serogroup C
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 4.10
Confidence Interval (2-Sided) 95%
3.16 to 5.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 1: MenACYW Conjugate Vaccine, Group 2: Menomune® Vaccine
Comments Serogroup Y
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 3.30
Confidence Interval (2-Sided) 95%
2.57 to 4.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group 1: MenACYW Conjugate Vaccine, Group 2: Menomune® Vaccine
Comments Serogroup W
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio
Estimated Value 1.81
Confidence Interval (2-Sided) 95%
1.42 to 2.31
Estimation Comments [Not Specified]
Time Frame Unsolicited non-serious adverse events (AEs) were collected from Day 0 to Day 30 post-vaccination and solicited reactions (SR) were collected within 7 days post-vaccination. Serious Adverse Events were collected throughout the trial (up to 180 days post-vaccination).
Adverse Event Reporting Description An 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 which included participants who had received at least 1 dose of the study vaccine and have any safety data available.
 
Arm/Group Title Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® Vaccine
Hide Arm/Group Description Healthy, adult participants aged ≥56 years received a single dose of MenACYW Conjugate Vaccine on Day 0. Healthy, adult participants aged ≥56 years received a single dose of Menomune®- A/C/Y/W-135 Vaccine on Day 0.
All-Cause Mortality
Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® Vaccine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/448 (0.00%)      2/453 (0.44%)    
Hide Serious Adverse Events
Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/448 (3.35%)      15/453 (3.31%)    
Cardiac disorders     
Acute Myocardial Infarction  1  0/448 (0.00%)  0 2/453 (0.44%)  2
Atrial Fibrillation  1  1/448 (0.22%)  1 0/453 (0.00%)  0
Coronary Artery Disease  1  0/448 (0.00%)  0 1/453 (0.22%)  1
Myocardial Infarction  1  0/448 (0.00%)  0 1/453 (0.22%)  1
Gastrointestinal disorders     
Colitis Ischaemic  1  1/448 (0.22%)  1 0/453 (0.00%)  0
Pancreatitis Acute  1  0/448 (0.00%)  0 1/453 (0.22%)  1
Pancreatitis Relapsing  1  0/448 (0.00%)  0 1/453 (0.22%)  1
General disorders     
Non-Cardiac Chest Pain  1  1/448 (0.22%)  1 0/453 (0.00%)  0
Hepatobiliary disorders     
Bile Duct Stone  1  1/448 (0.22%)  1 0/453 (0.00%)  0
Biliary Colic  1  1/448 (0.22%)  1 0/453 (0.00%)  0
Infections and infestations     
Device Related Infection  1  0/448 (0.00%)  0 1/453 (0.22%)  1
Escherichia Sepsis  1  1/448 (0.22%)  1 0/453 (0.00%)  0
Influenza  1  0/448 (0.00%)  0 1/453 (0.22%)  1
Localised Infection  1  1/448 (0.22%)  1 0/453 (0.00%)  0
Osteomyelitis  1  0/448 (0.00%)  0 1/453 (0.22%)  1
Pneumonia  1  0/448 (0.00%)  0 1/453 (0.22%)  1
Sepsis  1  1/448 (0.22%)  1 1/453 (0.22%)  1
Injury, poisoning and procedural complications     
Multiple Fractures  1  0/448 (0.00%)  0 1/453 (0.22%)  1
Muscle Strain  1  1/448 (0.22%)  1 0/453 (0.00%)  0
Pelvic Fracture  1  0/448 (0.00%)  0 1/453 (0.22%)  1
Spinal Column Injury  1  0/448 (0.00%)  0 1/453 (0.22%)  1
Musculoskeletal and connective tissue disorders     
Foot Deformity  1  1/448 (0.22%)  1 0/453 (0.00%)  0
Joint Contracture  1  1/448 (0.22%)  1 0/453 (0.00%)  0
Osteoarthritis  1  2/448 (0.45%)  2 0/453 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Invasive Lobular Breast Carcinoma  1  1/448 (0.22%)  1 0/453 (0.00%)  0
Lung Adenocarcinoma  1  1/448 (0.22%)  1 0/453 (0.00%)  0
Lung Cancer Metastatic  1  0/448 (0.00%)  0 1/453 (0.22%)  1
Prostate Cancer  1  1/448 (0.22%)  1 0/453 (0.00%)  0
Nervous system disorders     
Ischaemic Stroke  1  0/448 (0.00%)  0 1/453 (0.22%)  1
Transient Ischaemic Attack  1  0/448 (0.00%)  0 1/453 (0.22%)  1
Product Issues     
Device Failure  1  1/448 (0.22%)  1 0/453 (0.00%)  0
Psychiatric disorders     
Depression Suicidal  1  0/448 (0.00%)  0 1/453 (0.22%)  1
Reproductive system and breast disorders     
Benign Prostatic Hyperplasia  1  1/448 (0.22%)  1 0/453 (0.00%)  0
Skin and subcutaneous tissue disorders     
Skin Ulcer  1  0/448 (0.00%)  0 1/453 (0.22%)  1
Vascular disorders     
Deep Vein Thrombosis  1  1/448 (0.22%)  1 0/453 (0.00%)  0
Peripheral Vascular Disorder  1  0/448 (0.00%)  0 1/453 (0.22%)  1
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
Group 1: MenACYW Conjugate Vaccine Group 2: Menomune® Vaccine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   182/448 (40.63%)      121/453 (26.71%)    
General disorders     
Injection Site Erythema  1  23/448 (5.13%)  23 0/453 (0.00%)  0
Injection Site Pain  1  113/448 (25.22%)  113 43/453 (9.49%)  43
Malaise  1  65/448 (14.51%)  66 51/453 (11.26%)  51
Musculoskeletal and connective tissue disorders     
Myalgia  1  98/448 (21.88%)  100 69/453 (15.23%)  69
Nervous system disorders     
Headache  1  85/448 (18.97%)  85 66/453 (14.57%)  66
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
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: NCT02842866    
Other Study ID Numbers: MET49
First Submitted: July 15, 2016
First Posted: July 25, 2016
Results First Submitted: February 5, 2020
Results First Posted: February 18, 2020
Last Update Posted: June 5, 2020