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Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine

Sponsor
Sanofi Pasteur, a Sanofi Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02842853
Collaborator
(none)
3,344
Enrollment
89
Locations
4
Arms
7.5
Actual Duration (Months)
37.6
Patients Per Site
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study was to evaluate immune lot consistency of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine and the immune non-inferiority compared to the licensed vaccine Menactra®, and describe the safety and additional immunogenicity of these study vaccines in adolescents and adults 10 to 55 years of age in the United States (US).

Primary Objectives:

  • To demonstrate the immune lot consistency of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine with respect to serum bactericidal assay using human complement (hSBA) geometric mean titers (GMTs).

  • To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of Menactra®.

Secondary Objective:

  • To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of Menactra® in the adult population (18 to 55 years old).

  • To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of Menactra® in the adolescent population (10 to 17 years old).

  • To compare the hSBA vaccine seroresponses of meningococcal serogroups A, C, Y, and W for each of 3 lots of MenACYW Conjugate vaccine 30 days (+14 days) after vaccination.

  • To compare the hSBA antibody GMTs of meningococcal serogroups A, C, Y, and W following the administration of MenACYW Conjugate vaccine to those observed following the administration of Menactra®.

Observational Objectives:
  • To describe the safety profile of MenACYW Conjugate vaccine and that of the licensed Menactra®.
Condition or Disease Intervention/Treatment Phase
  • 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
 Phase 3

Detailed Description

Healthy meningococcal-vaccine naïve adolescents and adults were randomized and received a single dose of either MenACYW Conjugate vaccine from 1 of the 3 lots (Lot 1, Lot 2, or Lot 3) or Menactra®. They were assessed for immunogenicity at baseline (pre-vaccination) and at 30 to 44 days post-vaccination. Safety information were collected post-vaccination and throughout the entire study.

Study Design

Study Type:
Interventional
Actual Enrollment :
3344 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults Aged 10 to 55 Years
Actual Study Start Date :
Jul 15, 2016
Actual Primary Completion Date :
Feb 28, 2017
Actual Study Completion Date :
Feb 28, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: MenACYW Conjugate Vaccine Lot 1

Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW conjugate vaccine from lot 1 on Day 0.

Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
0.5 mL, Intramuscular
Other Names:
  • MenACYW conjugate vaccine

    		•
    Experimental: MenACYW Conjugate Vaccine Lot 2

    Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW conjugate vaccine from lot 2 on Day 0.

    Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
    0.5 mL, Intramuscular
    Other Names:
  • MenACYW conjugate vaccine

    		•
    Experimental: MenACYW Conjugate Vaccine Lot 3

    Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW conjugate vaccine from lot 3 on Day 0.

    Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
    0.5 mL, Intramuscular
    Other Names:
  • MenACYW conjugate vaccine

    		•
    Active Comparator: Menactra®

    Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra® on Day 0.

    Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
    0.5 mL, Intramuscular
    Other Names:
  • Menactra®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine [Day 30 (post-vaccination)]

      Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Data for this outcome measure were not planned to be collected and analyzed for the Menactra® reporting group.

    2. Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine [Day 30 (post-vaccination)]

      Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. 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.

    Secondary Outcome Measures

    1. Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adults [Day 30 (post-vaccination)]

      Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. 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. Only adults aged 18-55 years who received a single dose of Menactra® (Group 4b) or MenACYW Conjugate vaccine (Group 1b-3b) from any of the lots 1, 2 or 3, were included in this outcome measure.

    2. Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adolescents [Day 30 (post-vaccination)]

      Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. 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. Only adolescents aged 10-17 years who received a single dose of Menactra® (Group 4a) or MenACYW Conjugate vaccine (Group 1a-3a) from any of the lots 1, 2 or 3, were included in this outcome measure.

    3. Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine [Day 30 (post-vaccination)]

      Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. 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.

    4. Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With MenACYW Conjugate and Menactra® [Day 30 (post-vaccination)]

      Antibody titers of meningococcal serogroups A, C, Y, and W were measured by hSBA.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Aged 10 to 55 years on the day of inclusion.

    • Informed consent form was signed and dated by the participant (aged 18 to 55 years) or assent form was signed and dated by the participant and informed consent form was signed and dated by the parent(s) or guardian (for participants aged 10 to < 18 years).

    • Participant (>= 18 years) or participant (10 to < 18 years) and parent / guardian were able to attend all scheduled visits and comply with all trial procedures.

    Exclusion Criteria:

    • Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must have been pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination).

    • Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.

    • Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after the study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.

    • Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B vaccine).

    • Receipt of immune globulins, blood or blood-derived products in the past 3 months.

    • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).

    • History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.

    • At high risk for meningococcal infection during the trial (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease).

    • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.

    • Verbal report of thrombocytopenia, as reported by the participant or the participant's parent / guardian, contraindicating intramuscular vaccination in the Investigator's opinion.

    • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion.

    • Personal history of Guillain-Barre syndrome.

    • Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within 10 years of the proposed study vaccination.

    • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.

    • Current alcohol abuse or drug addiction.

    • Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion.

    • Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature >= 100.4 degree Fahrenheit [°F]). A prospective participant was not be included in the study until the condition was resolved or the febrile event had subsided.

    • Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.

    • Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Alabama United States 35205
    2 Dothan Alabama United States 36305
    3 Mobile Alabama United States 36608
    4 Glendale Arizona United States 85308
    5 Mesa Arizona United States 85213
    6 Phoenix Arizona United States 85018
    7 Harrisburg Arkansas United States 72432
    8 Jonesboro Arkansas United States 72401
    9 Anaheim California United States 92804
    10 Downey California United States 90241
    11 Los Angeles California United States 90057
    12 Paramount California United States 90723
    13 Redding California United States 96001
    14 Sacramento California United States 95825
    15 San Diego California United States 92102
    16 San Diego California United States 92103
    17 San Diego California United States 96001
    18 Santa Rosa California United States 95405
    19 Upland California United States 91786
    20 West Covina California United States 91790
    21 Littleton Colorado United States 80128
    22 DeLand Florida United States 32720
    23 Hialeah Florida United States 33012
    24 Hialeah Florida United States 33016
    25 Miami Florida United States 33142
    26 Orlando Florida United States 32806
    27 Saint Petersburg Florida United States 33710
    28 Sarasota Florida United States 34239
    29 South Miami Florida United States 33143
    30 West Palm Beach Florida United States 33409
    31 Savannah Georgia United States 31406
    32 Meridian Idaho United States 83642
    33 Council Bluffs Iowa United States 51503
    34 Lenexa Kansas United States 66219
    35 Newton Kansas United States 67114
    36 Park City Kansas United States 67219
    37 Wichita Kansas United States 67205
    38 Wichita Kansas United States 67207
    39 Bardstown Kentucky United States 40004
    40 Metairie Louisiana United States 70006
    41 Bridgeton Missouri United States 63044
    42 Kansas City Missouri United States 64114
    43 Saint Louis Missouri United States 63141
    44 Lincoln Nebraska United States 60505
    45 Lincoln Nebraska United States 68522
    46 Omaha Nebraska United States 68114
    47 Omaha Nebraska United States 68134
    48 Charlotte North Carolina United States 28209
    49 Raleigh North Carolina United States 27609
    50 Raleigh North Carolina United States 27612
    51 Salisbury North Carolina United States 28144
    52 Fargo North Dakota United States 58104
    53 Cincinnati Ohio United States 45245
    54 Cincinnati Ohio United States 45246
    55 Cleveland Ohio United States 44122
    56 Dayton Ohio United States 45414
    57 Dayton Ohio United States 45419
    58 Corvallis Oregon United States 97330
    59 Grants Pass Oregon United States 97527
    60 Erie Pennsylvania United States 16505
    61 Hermitage Pennsylvania United States 16148
    62 McMurray Pennsylvania United States 15317
    63 Upper Saint Clair Pennsylvania United States 15241
    64 Warwick Rhode Island United States 02886
    65 Charleston South Carolina United States 29407
    66 Charleston South Carolina United States 29414
    67 Mount Pleasant South Carolina United States 29464
    68 Jackson Tennessee United States 38305
    69 Nashville Tennessee United States 37203
    70 Tullahoma Tennessee United States 37388
    71 Corpus Christi Texas United States 78413
    72 Fort Worth Texas United States 76104
    73 Fort Worth Texas United States 76107
    74 San Antonio Texas United States 78229
    75 Waxahachie Texas United States 75165
    76 Draper Utah United States 84020
    77 Layton Utah United States 84041
    78 Murray Utah United States 84123
    79 Orem Utah United States 84058
    80 Salt Lake City Utah United States 84109
    81 Salt Lake City Utah United States 84121
    82 South Jordan Utah United States 84095
    83 West Jordan Utah United States 83642
    84 West Jordan Utah United States 84088
    85 Burke Virginia United States 22015
    86 Charlottesville Virginia United States 22911
    87 Charlottesville Virginia United States 29902
    88 Midlothian Virginia United States 23113
    89 Richmond Virginia United States 23294

    Sponsors and Collaborators

    • Sanofi Pasteur, a Sanofi Company

    Investigators

    • Study Director: Medical Director, Sanofi Pasteur Inc.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi Pasteur, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT02842853
    Other Study ID Numbers:
    • MET43
    • U1111-1161-3060
    First Posted:
    Jul 25, 2016
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sanofi Pasteur, a Sanofi Company
    Meningitis
    Meningococcal Meningitis
    Meningococcal Infections
    MenACYW Conjugate vaccine
    Licensed MCV4 vaccine
    Additional relevant MeSH terms:
    Meningococcal Infections
    Meningitis, Meningococcal
    Meningitis
    Vaccines

    Study Results

    Participant Flow

    Recruitment Details Study participants were enrolled in 90 centers in the United States (US) from 15 July 2016 to 16 August 2016.
    Pre-assignment Detail A total of 3344 participants who met all inclusion and none of the exclusion criteria were enrolled and randomized in the study.
    Arm/Group Title MenACYW Conjugate Vaccine Lot 1 MenACYW Conjugate Vaccine Lot 2 MenACYW Conjugate Vaccine Lot 3 Menactra®
    Arm/Group Description Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine from lot 1 on Day 0. Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW Conjugate vaccine from lot 2 on Day 0. Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW Conjugate vaccine from lot 3 on Day 0. Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra® on Day 0.
    Period Title: Overall Study
    STARTED 902 895 906 641
    Vaccinated 895 886 900 636
    Safety Analysis Set (SafAS) 895 883 898 635
    COMPLETED 879 861 885 617
    NOT COMPLETED 23 34 21 24

    Baseline Characteristics

    Arm/Group Title MenACYW Conjugate Vaccine Lot 1 MenACYW Conjugate Vaccine Lot 2 MenACYW Conjugate Vaccine Lot 3 Menactra® Total
    Arm/Group Description Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW Conjugate vaccine from lot 1 on Day 0. Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW Conjugate vaccine from lot 2 on Day 0. Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW Conjugate vaccine from lot 3 on Day 0. Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra® on Day 0. Total of all reporting groups
    Overall Participants 902 895 906 641 3344
    Age (Count of Participants)
    <=18 years
    402
    44.6%
    400
    44.7%
    397
    43.8%
    329
    51.3%
    1528
    45.7%
    Between 18 and 65 years
    500
    55.4%
    495
    55.3%
    509
    56.2%
    312
    48.7%
    1816
    54.3%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    27.4
    (15.6)
    27.1
    (15.7)
    27.3
    (15.5)
    25.6
    (15.4)
    27.0
    (15.6)
    Sex: Female, Male (Count of Participants)
    Female
    535
    59.3%
    531
    59.3%
    496
    54.7%
    357
    55.7%
    1919
    57.4%
    Male
    367
    40.7%
    364
    40.7%
    410
    45.3%
    284
    44.3%
    1425
    42.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    191
    21.2%
    207
    23.1%
    188
    20.8%
    141
    22%
    727
    21.7%
    Not Hispanic or Latino
    710
    78.7%
    685
    76.5%
    716
    79%
    500
    78%
    2611
    78.1%
    Unknown or Not Reported
    1
    0.1%
    3
    0.3%
    2
    0.2%
    0
    0%
    6
    0.2%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    1
    0.1%
    7
    0.8%
    5
    0.6%
    3
    0.5%
    16
    0.5%
    Asian
    9
    1%
    19
    2.1%
    19
    2.1%
    14
    2.2%
    61
    1.8%
    Native Hawaiian or Other Pacific Islander
    6
    0.7%
    4
    0.4%
    3
    0.3%
    2
    0.3%
    15
    0.4%
    Black or African American
    175
    19.4%
    186
    20.8%
    166
    18.3%
    121
    18.9%
    648
    19.4%
    White
    680
    75.4%
    647
    72.3%
    683
    75.4%
    478
    74.6%
    2488
    74.4%
    More than one race
    30
    3.3%
    29
    3.2%
    30
    3.3%
    21
    3.3%
    110
    3.3%
    Unknown or Not Reported
    1
    0.1%
    3
    0.3%
    0
    0%
    2
    0.3%
    6
    0.2%
    Region of Enrollment (Count of Participants)
    United States
    902
    100%
    895
    100%
    906
    100%
    641
    100%
    3344
    100%

    Outcome Measures

    1. Primary Outcome
    Title Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine
    Description Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Data for this outcome measure were not planned to be collected and analyzed for the Menactra® reporting group.
    Time Frame Day 30 (post-vaccination)

    Outcome Measure Data

    Analysis Population Description
    Per-Protocol Analysis Set (PPAS) defined for accessing ACYW immune response data for participants who received at least one dose of study vaccine & had a valid post-vaccination serology result. Participants who presented pre-defined protocol deviations were excluded. Here, "Number analyzed" = participants with available data for specified category.
    Arm/Group Title MenACYW Conjugate Vaccine Lot 1 MenACYW Conjugate Vaccine Lot 2 MenACYW Conjugate Vaccine Lot 3
    Arm/Group Description Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW Conjugate vaccine from lot 1 on Day 0. Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW Conjugate vaccine from lot 2 on Day 0. Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW Conjugate vaccine from lot 3 on Day 0.
    Measure Participants 843 820 845
    Serogroup A
    84.9
    96.5
    97.9
    Serogroup C
    326
    305
    352
    Serogroup Y
    213
    210
    218
    Serogroup W
    84.5
    81.6
    87.2
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    Comments Serogroup A: Lot 1 vs Lot 2
    Type of Statistical Test Equivalence
    Comments Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% Confidence Interval (CI) for the ratio of the GMTs lies between 1/2 and 2.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT Ratio
    Estimated Value 0.880
    Confidence Interval (2-Sided) 95%
    0.751 to 1.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 2, MenACYW Conjugate Vaccine Lot 3
    Comments Serogroup A: Lot 2 vs Lot 3
    Type of Statistical Test Equivalence
    Comments Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT Ratio
    Estimated Value 0.985
    Confidence Interval (2-Sided) 95%
    0.843 to 1.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 3
    Comments Serogroup A: Lot 1 vs Lot 3
    Type of Statistical Test Equivalence
    Comments Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT Ratio
    Estimated Value 0.867
    Confidence Interval (2-Sided) 95%
    0.740 to 1.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    Comments Serogroup C: Lot 1 vs Lot 2
    Type of Statistical Test Equivalence
    Comments Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT Ratio
    Estimated Value 1.07
    Confidence Interval (2-Sided) 95%
    0.888 to 1.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 2, MenACYW Conjugate Vaccine Lot 3
    Comments Serogroup C: Lot 2 vs Lot 3
    Type of Statistical Test Equivalence
    Comments Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT Ratio
    Estimated Value 0.866
    Confidence Interval (2-Sided) 95%
    0.714 to 1.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 3
    Comments Serogroup C: Lot 1 vs Lot 3
    Type of Statistical Test Equivalence
    Comments Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT Ratio
    Estimated Value 0.927
    Confidence Interval (2-Sided) 95%
    0.766 to 1.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    Comments Serogroup Y: Lot 1 vs Lot 2
    Type of Statistical Test Equivalence
    Comments Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT Ratio
    Estimated Value 1.02
    Confidence Interval (2-Sided) 95%
    0.869 to 1.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 2, MenACYW Conjugate Vaccine Lot 3
    Comments Serogroup Y: Lot 2 vs Lot 3
    Type of Statistical Test Equivalence
    Comments Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT Ratio
    Estimated Value 0.961
    Confidence Interval (2-Sided) 95%
    0.816 to 1.13
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 3
    Comments Serogroup Y: Lot 1 vs Lot 3
    Type of Statistical Test Equivalence
    Comments Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT Ratio
    Estimated Value 0.975
    Confidence Interval (2-Sided) 95%
    0.829 to 1.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    Comments Serogroup W: Lot 1 vs Lot 2
    Type of Statistical Test Equivalence
    Comments Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT Ratio
    Estimated Value 1.04
    Confidence Interval (2-Sided) 95%
    0.878 to 1.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 2, MenACYW Conjugate Vaccine Lot 3
    Comments Serogroup W: Lot 2 vs Lot 3
    Type of Statistical Test Equivalence
    Comments Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT Ratio
    Estimated Value 0.936
    Confidence Interval (2-Sided) 95%
    0.791 to 1.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 3
    Comments Serogroup W: Lot 1 vs Lot 3
    Type of Statistical Test Equivalence
    Comments Lot consistency was demonstrated across the 3 lots, if, for each pair of lots and each antigen, the 2-sided 95% CI for the ratio of the GMTs lies between 1/2 and 2.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT Ratio
    Estimated Value 0.970
    Confidence Interval (2-Sided) 95%
    0.818 to 1.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Primary Outcome
    Title Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine
    Description Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. 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 30 (post-vaccination)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on PPAS. Here, "Number analyzed"=participants with available data for specified category. Data for this outcome measure were planned to be analyzed for the pooled population of MenACYW Conjugate vaccine reporting groups.
    Arm/Group Title MenACYW Conjugate Vaccine (Groups 1, 2, 3 Pooled) Menactra®
    Arm/Group Description Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years and adults aged 18 to 55 years received single dose of MenACYW Conjugate vaccine from any of the lots 1, 2 or 3 on Day 0. Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra® on Day 0.
    Measure Participants 2508 593
    Serogroup A
    73.8
    8.2%
    54.6
    6.1%
    Serogroup C
    88.8
    9.8%
    47.9
    5.4%
    Serogroup Y
    91.4
    10.1%
    73.4
    8.2%
    Serogroup W
    80.3
    8.9%
    61.2
    6.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    Comments Serogroup A
    Type of Statistical Test Non-Inferiority
    Comments 95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value 19.1
    Confidence Interval (2-Sided) 95%
    14.8 to 23.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    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. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value 40.9
    Confidence Interval (2-Sided) 95%
    36.7 to 45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    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. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value 18.1
    Confidence Interval (2-Sided) 95%
    14.5 to 21.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    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. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value 19.1
    Confidence Interval (2-Sided) 95%
    14.9 to 23.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adults
    Description Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. 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. Only adults aged 18-55 years who received a single dose of Menactra® (Group 4b) or MenACYW Conjugate vaccine (Group 1b-3b) from any of the lots 1, 2 or 3, were included in this outcome measure.
    Time Frame Day 30 (post-vaccination)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on PPAS. Here, "Overall number of participants analyzed" = participants evaluable for this outcome measure; and "Number analyzed"= participants with available data for specified category. Data for this outcome measure were planned to be analyzed for the pooled population of MenACYW Conjugate vaccine reporting groups.
    Arm/Group Title MenACYW Conjugate Vaccine (Groups 1, 2, 3 Pooled) Menactra®
    Arm/Group Description Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years and adults aged 18 to 55 years received single dose of MenACYW Conjugate vaccine from any of the lots 1, 2 or 3 on Day 0. Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra® on Day 0.
    Measure Participants 1410 293
    Serogroup A
    73.5
    8.1%
    53.9
    6%
    Serogroup C
    83.4
    9.2%
    42.3
    4.7%
    Serogroup Y
    88.1
    9.8%
    60.8
    6.8%
    Serogroup W
    77.0
    8.5%
    50.2
    5.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    Comments Serogroup A
    Type of Statistical Test Non-Inferiority
    Comments 95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value 19.6
    Confidence Interval (2-Sided) 95%
    13.5 to 25.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    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. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value 41.1
    Confidence Interval (2-Sided) 95%
    35.0 to 46.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    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. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value 27.4
    Confidence Interval (2-Sided) 95%
    21.7 to 33.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    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. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value 26.8
    Confidence Interval (2-Sided) 95%
    20.7 to 32.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adolescents
    Description Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. 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. Only adolescents aged 10-17 years who received a single dose of Menactra® (Group 4a) or MenACYW Conjugate vaccine (Group 1a-3a) from any of the lots 1, 2 or 3, were included in this outcome measure.
    Time Frame Day 30 (post-vaccination)

    Outcome Measure Data

    Analysis Population Description
    Analysis performed on PPAS. Here, "Overall number of participants analyzed" = participants evaluable for this outcome measure; and "Number analyzed" = participants with available data for specified category. Data for this outcome measure were planned to be analyzed for the pooled population of MenACYW Conjugate vaccine reporting groups.
    Arm/Group Title MenACYW Conjugate Vaccine (Groups 1, 2, 3 Pooled) Menactra®
    Arm/Group Description Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years and adults aged 18 to 55 years received single dose of MenACYW Conjugate vaccine from any of the lots 1, 2 or 3 on Day 0. Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra® on Day 0.
    Measure Participants 1098 300
    Serogroup A
    74.0
    8.2%
    55.3
    6.2%
    Serogroup C
    95.6
    10.6%
    53.3
    6%
    Serogroup Y
    95.6
    10.6%
    85.7
    9.6%
    Serogroup W
    84.5
    9.4%
    72.0
    8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    Comments Serogroup A
    Type of Statistical Test Non-Inferiority
    Comments 95% CI of the difference was calculated from the Wilson Score Method without continuity correction. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value 18.7
    Confidence Interval (2-Sided) 95%
    12.5 to 24.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    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. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value 42.3
    Confidence Interval (2-Sided) 95%
    36.6 to 48.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    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. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value 10.0
    Confidence Interval (2-Sided) 95%
    6.18 to 14.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    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. Non-inferiority was demonstrated if the lower limit of the 2-sided 95% CI of the difference is > -10% for all serogroups.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value 12.5
    Confidence Interval (2-Sided) 95%
    7.22 to 18.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine
    Description Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. 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 30 (post-vaccination)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on PPAS. Here, "Number analyzed" = participants with available data for specified category. Data for this outcome measure were not planned to be collected and analyzed for the Menactra® reporting group.
    Arm/Group Title MenACYW Conjugate Vaccine Lot 1 MenACYW Conjugate Vaccine Lot 2 MenACYW Conjugate Vaccine Lot 3
    Arm/Group Description Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW Conjugate vaccine from lot 1 on Day 0. Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW Conjugate vaccine from lot 2 on Day 0. Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW Conjugate vaccine from lot 3 on Day 0.
    Measure Participants 843 820 845
    Serogroup A
    71.1
    7.9%
    76.5
    8.5%
    73.7
    8.1%
    Serogroup C
    90.5
    10%
    89.1
    10%
    86.7
    9.6%
    Serogroup Y
    92.4
    10.2%
    91.9
    10.3%
    89.9
    9.9%
    Serogroup W
    81.5
    9%
    80.7
    9%
    78.7
    8.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    Comments Serogroup A: Lot 1 vs Lot 2
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value -5.4
    Confidence Interval (2-Sided) 95%
    -9.59 to -1.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 2, MenACYW Conjugate Vaccine Lot 3
    Comments Serogroup A: Lot 2 vs Lot 3
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value 2.9
    Confidence Interval (2-Sided) 95%
    -1.3 to 7.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 3
    Comments Serogroup A: Lot 1 vs Lot 3
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value -2.5
    Confidence Interval (2-Sided) 95%
    -6.78 to 1.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    Comments Serogroup C: Lot 1 vs Lot 2
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value 1.3
    Confidence Interval (2-Sided) 95%
    -1.58 to 4.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 2, MenACYW Conjugate Vaccine Lot 3
    Comments Serogroup C: Lot 2 vs Lot 3
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value 2.4
    Confidence Interval (2-Sided) 95%
    -0.740 to 5.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 3
    Comments Serogroup C: Lot 1 vs Lot 3
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value 3.7
    Confidence Interval (2-Sided) 95%
    0.708 to 6.79
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    Comments Serogroup Y: Lot 1 vs Lot 2
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value 0.5
    Confidence Interval (2-Sided) 95%
    -2.14 to 3.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 2, MenACYW Conjugate Vaccine Lot 3
    Comments Serogroup Y: Lot 2 vs Lot 3
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value 2.0
    Confidence Interval (2-Sided) 95%
    -0.763 to 4.79
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 3
    Comments Serogroup Y: Lot 1 vs Lot 3
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value 2.5
    Confidence Interval (2-Sided) 95%
    -0.248 to 5.20
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    Comments Serogroup W: Lot 1 vs Lot 2
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value 0.8
    Confidence Interval (2-Sided) 95%
    -3.00 to 4.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 2, MenACYW Conjugate Vaccine Lot 3
    Comments Serogroup W: Lot 2 vs Lot 3
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value 2.0
    Confidence Interval (2-Sided) 95%
    -1.84 to 5.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 3
    Comments Serogroup W: Lot 1 vs Lot 3
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Percentage Difference
    Estimated Value 2.8
    Confidence Interval (2-Sided) 95%
    -1.02 to 6.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With MenACYW Conjugate and Menactra®
    Description Antibody titers of meningococcal serogroups A, C, Y, and W were measured by hSBA.
    Time Frame Day 30 (post-vaccination)

    Outcome Measure Data

    Analysis Population Description
    Analysis performed on PPAS. Here, "Overall number of participants analyzed" = participants evaluable for this outcome measure; and "Number analyzed"= number of participants with available data for specified category. Data for this outcome measure were planned to be analyzed for the pooled population of MenACYW Conjugate vaccine reporting groups.
    Arm/Group Title MenACYW Conjugate Vaccine (Groups 1, 2, 3 Pooled) Menactra®
    Arm/Group Description Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years and adults aged 18 to 55 years received 0.5 mL of MenACYW Conjugate vaccine from any of the lots 1, 2 or 3 on Day 0. Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra® on Day 0.
    Measure Participants 2508 593
    Serogroup A
    92.9
    48.1
    Serogroup C
    328
    40.7
    Serogroup Y
    214
    66.4
    Serogroup W
    84.4
    44.5
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    Comments Serogroup A
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT Ratio
    Estimated Value 1.93
    Confidence Interval (2-Sided) 95%
    1.67 to 2.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    Comments Serogroup C
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT Ratio
    Estimated Value 8.05
    Confidence Interval (2-Sided) 95%
    6.58 to 9.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    Comments Serogroup Y
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT Ratio
    Estimated Value 3.22
    Confidence Interval (2-Sided) 95%
    2.71 to 3.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection MenACYW Conjugate Vaccine Lot 1, MenACYW Conjugate Vaccine Lot 2
    Comments Serogroup W
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter GMT Ratio
    Estimated Value 1.90
    Confidence Interval (2-Sided) 95%
    1.61 to 2.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame Adverse event (AE) data were collected from Day 0 (post-vaccination) up to 30 days after vaccination. Solicited reaction (SR) data were collected within 7 days after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 180 days after vaccination).
    Adverse Event Reporting Description Analysis was performed on Safety Analysis Set. 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 (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
    Arm/Group Title MenACYW Conjugate Vaccine Lot 1 MenACYW Conjugate Vaccine Lot 2 MenACYW Conjugate Vaccine Lot 3 Menactra
    Arm/Group Description Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW Conjugate vaccine from lot 1 on Day 0. Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW Conjugate vaccine from lot 2 on Day 0. Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW Conjugate vaccine from lot 3 on Day 0. Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra® on Day 0.
    All Cause Mortality
    MenACYW Conjugate Vaccine Lot 1 MenACYW Conjugate Vaccine Lot 2 MenACYW Conjugate Vaccine Lot 3 Menactra
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/895 (0%) 0/883 (0%) 0/898 (0%) 0/635 (0%)
    Serious Adverse Events
    MenACYW Conjugate Vaccine Lot 1 MenACYW Conjugate Vaccine Lot 2 MenACYW Conjugate Vaccine Lot 3 Menactra
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 9/895 (1%) 13/883 (1.5%) 6/898 (0.7%) 5/635 (0.8%)
    Cardiac disorders
    Coronary artery disease 0/895 (0%) 1/883 (0.1%) 0/898 (0%) 0/635 (0%)
    Gastrointestinal disorders
    Gastrointestinal ulcer perforation 0/895 (0%) 0/883 (0%) 1/898 (0.1%) 0/635 (0%)
    Pancreatitis acute 1/895 (0.1%) 0/883 (0%) 0/898 (0%) 0/635 (0%)
    General disorders
    Chest pain 1/895 (0.1%) 1/883 (0.1%) 0/898 (0%) 0/635 (0%)
    Hepatobiliary disorders
    Cholelithiasis 0/895 (0%) 0/883 (0%) 1/898 (0.1%) 0/635 (0%)
    Infections and infestations
    Abdominal abscess 0/895 (0%) 0/883 (0%) 1/898 (0.1%) 0/635 (0%)
    Appendicitis 1/895 (0.1%) 2/883 (0.2%) 0/898 (0%) 0/635 (0%)
    Appendicitis perforated 0/895 (0%) 1/883 (0.1%) 0/898 (0%) 0/635 (0%)
    Gastroenteritis norovirus 0/895 (0%) 0/883 (0%) 0/898 (0%) 1/635 (0.2%)
    Pneumonia pseudomonal 1/895 (0.1%) 0/883 (0%) 0/898 (0%) 0/635 (0%)
    Pyelonephritis 1/895 (0.1%) 0/883 (0%) 0/898 (0%) 0/635 (0%)
    Injury, poisoning and procedural complications
    Craniocerebral injury 0/895 (0%) 1/883 (0.1%) 0/898 (0%) 0/635 (0%)
    Foot fracture 1/895 (0.1%) 0/883 (0%) 0/898 (0%) 0/635 (0%)
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control 0/895 (0%) 0/883 (0%) 0/898 (0%) 1/635 (0.2%)
    Type 2 diabetes mellitus 1/895 (0.1%) 0/883 (0%) 0/898 (0%) 0/635 (0%)
    Musculoskeletal and connective tissue disorders
    Back pain 0/895 (0%) 1/883 (0.1%) 0/898 (0%) 0/635 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma 1/895 (0.1%) 0/883 (0%) 0/898 (0%) 0/635 (0%)
    Nervous system disorders
    Alcoholic seizure 0/895 (0%) 1/883 (0.1%) 0/898 (0%) 0/635 (0%)
    Migraine 0/895 (0%) 0/883 (0%) 1/898 (0.1%) 0/635 (0%)
    Multiple sclerosis 0/895 (0%) 1/883 (0.1%) 0/898 (0%) 0/635 (0%)
    Paraesthesia 1/895 (0.1%) 0/883 (0%) 0/898 (0%) 0/635 (0%)
    Presyncope 0/895 (0%) 0/883 (0%) 1/898 (0.1%) 0/635 (0%)
    Status epilepticus 0/895 (0%) 1/883 (0.1%) 0/898 (0%) 0/635 (0%)
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous 0/895 (0%) 1/883 (0.1%) 0/898 (0%) 0/635 (0%)
    Abortion spontaneous incomplete 0/895 (0%) 1/883 (0.1%) 0/898 (0%) 0/635 (0%)
    Psychiatric disorders
    Conversion disorder 0/895 (0%) 0/883 (0%) 1/898 (0.1%) 0/635 (0%)
    Depression 0/895 (0%) 1/883 (0.1%) 0/898 (0%) 0/635 (0%)
    Disruptive mood dysregulation disorder 0/895 (0%) 0/883 (0%) 0/898 (0%) 1/635 (0.2%)
    Somatic symptom disorder 0/895 (0%) 1/883 (0.1%) 0/898 (0%) 0/635 (0%)
    Suicidal ideation 0/895 (0%) 0/883 (0%) 1/898 (0.1%) 0/635 (0%)
    Renal and urinary disorders
    Nephrolithiasis 0/895 (0%) 0/883 (0%) 0/898 (0%) 1/635 (0.2%)
    Respiratory, thoracic and mediastinal disorders
    Asthma 1/895 (0.1%) 0/883 (0%) 0/898 (0%) 0/635 (0%)
    Chronic obstructive pulmonary disease 1/895 (0.1%) 0/883 (0%) 0/898 (0%) 0/635 (0%)
    Throat tightness 0/895 (0%) 0/883 (0%) 0/898 (0%) 1/635 (0.2%)
    Skin and subcutaneous tissue disorders
    Henoch-Schonlein purpura 0/895 (0%) 0/883 (0%) 0/898 (0%) 1/635 (0.2%)
    Other (Not Including Serious) Adverse Events
    MenACYW Conjugate Vaccine Lot 1 MenACYW Conjugate Vaccine Lot 2 MenACYW Conjugate Vaccine Lot 3 Menactra
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 477/895 (53.3%) 485/883 (54.9%) 489/898 (54.5%) 353/635 (55.6%)
    General disorders
    Injection site erythema 45/895 (5%) 39/883 (4.4%) 43/898 (4.8%) 25/635 (3.9%)
    Injection site pain 344/895 (38.4%) 339/883 (38.4%) 333/898 (37.1%) 235/635 (37%)
    Malaise 184/895 (20.6%) 186/883 (21.1%) 189/898 (21%) 132/635 (20.8%)
    Musculoskeletal and connective tissue disorders
    Myalgia 278/895 (31.1%) 271/883 (30.7%) 294/898 (32.7%) 192/635 (30.2%)
    Nervous system disorders
    Headache 247/895 (27.6%) 248/883 (28.1%) 253/898 (28.2%) 175/635 (27.6%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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

    Name/Title Trial Transparency Team
    Organization Sanofi Pasteur Inc.
    Phone 800-633-1610 ext 1#
    Email Contact-US@sanofi.com
    Responsible Party:
    Sanofi Pasteur, a Sanofi Company
    ClinicalTrials.gov Identifier:
    NCT02842853
    Other Study ID Numbers:
    • MET43
    • U1111-1161-3060
    First Posted:
    Jul 25, 2016
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Mar 1, 2022