Meningitis, Meningococcal Meningitis, Meningococcal Infections
Conditions
Keywords
Meningitis, Meningococcal Meningitis, Meningococcal Infections, MenACYW Conjugate vaccine, Licensed MCV4 vaccine
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®.
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.
Interventions
0.5 mL, Intramuscular
BIOLOGICALMeningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to 55 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
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 details
A total of 3344 participants who met all inclusion and none of the exclusion criteria were enrolled and randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 902 |
| 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. | 895 |
| 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. | 906 |
| 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. | 641 |
| Total | 3,344 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 13 | 10 | 11 |
| Overall Study | Non-compliance with the protocol | 3 | 7 | 2 | 5 |
| Overall Study | Subject met exclusion criteria | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 11 | 13 | 9 | 8 |
Baseline characteristics
| Characteristic | MenACYW Conjugate Vaccine Lot 1 | MenACYW Conjugate Vaccine Lot 2 | MenACYW Conjugate Vaccine Lot 3 | Menactra® | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 402 Participants | 400 Participants | 397 Participants | 329 Participants | 1528 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 500 Participants | 495 Participants | 509 Participants | 312 Participants | 1816 Participants |
| Age, Continuous | 27.4 years STANDARD_DEVIATION 15.6 | 27.1 years STANDARD_DEVIATION 15.7 | 27.3 years STANDARD_DEVIATION 15.5 | 25.6 years STANDARD_DEVIATION 15.4 | 27.0 years STANDARD_DEVIATION 15.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 191 Participants | 207 Participants | 188 Participants | 141 Participants | 727 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 710 Participants | 685 Participants | 716 Participants | 500 Participants | 2611 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 7 Participants | 5 Participants | 3 Participants | 16 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 19 Participants | 19 Participants | 14 Participants | 61 Participants |
| Race (NIH/OMB) Black or African American | 175 Participants | 186 Participants | 166 Participants | 121 Participants | 648 Participants |
| Race (NIH/OMB) More than one race | 30 Participants | 29 Participants | 30 Participants | 21 Participants | 110 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 6 Participants | 4 Participants | 3 Participants | 2 Participants | 15 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 0 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) White | 680 Participants | 647 Participants | 683 Participants | 478 Participants | 2488 Participants |
| Region of Enrollment United States | 902 Participants | 895 Participants | 906 Participants | 641 Participants | 3344 Participants |
| Sex: Female, Male Female | 535 Participants | 531 Participants | 496 Participants | 357 Participants | 1919 Participants |
| Sex: Female, Male Male | 367 Participants | 364 Participants | 410 Participants | 284 Participants | 1425 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 895 | 0 / 883 | 0 / 898 | 0 / 635 |
| other Total, other adverse events | 477 / 895 | 485 / 883 | 489 / 898 | 353 / 635 |
| serious Total, serious adverse events | 9 / 895 | 13 / 883 | 6 / 898 | 5 / 635 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine
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)
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACYW Conjugate Vaccine Lot 1 | Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine | Serogroup Y | 213 Titer (1/dilution) |
| MenACYW Conjugate Vaccine Lot 1 | Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine | Serogroup A | 84.9 Titer (1/dilution) |
| MenACYW Conjugate Vaccine Lot 1 | Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine | Serogroup W | 84.5 Titer (1/dilution) |
| MenACYW Conjugate Vaccine Lot 1 | Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine | Serogroup C | 326 Titer (1/dilution) |
| MenACYW Conjugate Vaccine Lot 2 | Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine | Serogroup Y | 210 Titer (1/dilution) |
| MenACYW Conjugate Vaccine Lot 2 | Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine | Serogroup C | 305 Titer (1/dilution) |
| MenACYW Conjugate Vaccine Lot 2 | Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine | Serogroup A | 96.5 Titer (1/dilution) |
| MenACYW Conjugate Vaccine Lot 2 | Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine | Serogroup W | 81.6 Titer (1/dilution) |
| MenACYW Conjugate Vaccine Lot 3 | Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine | Serogroup C | 352 Titer (1/dilution) |
| MenACYW Conjugate Vaccine Lot 3 | Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine | Serogroup A | 97.9 Titer (1/dilution) |
| MenACYW Conjugate Vaccine Lot 3 | Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine | Serogroup W | 87.2 Titer (1/dilution) |
| MenACYW Conjugate Vaccine Lot 3 | Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine | Serogroup Y | 218 Titer (1/dilution) |
Comparison: Serogroup A: Lot 1 vs Lot 295% CI: [0.751, 1.03]
Comparison: Serogroup A: Lot 2 vs Lot 395% CI: [0.843, 1.15]
Comparison: Serogroup A: Lot 1 vs Lot 395% CI: [0.74, 1.02]
Comparison: Serogroup C: Lot 1 vs Lot 295% CI: [0.888, 1.29]
Comparison: Serogroup C: Lot 2 vs Lot 395% CI: [0.714, 1.05]
Comparison: Serogroup C: Lot 1 vs Lot 395% CI: [0.766, 1.12]
Comparison: Serogroup Y: Lot 1 vs Lot 295% CI: [0.869, 1.19]
Comparison: Serogroup Y: Lot 2 vs Lot 395% CI: [0.816, 1.13]
Comparison: Serogroup Y: Lot 1 vs Lot 395% CI: [0.829, 1.15]
Comparison: Serogroup W: Lot 1 vs Lot 295% CI: [0.878, 1.22]
Comparison: Serogroup W: Lot 2 vs Lot 395% CI: [0.791, 1.11]
Comparison: Serogroup W: Lot 1 vs Lot 395% CI: [0.818, 1.15]
Primary
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
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)
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACYW Conjugate Vaccine Lot 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 | Serogroup A | 73.8 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 | Serogroup C | 88.8 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 | Serogroup Y | 91.4 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 | Serogroup W | 80.3 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 | Serogroup W | 61.2 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 | Serogroup A | 54.6 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 | Serogroup Y | 73.4 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 | Serogroup C | 47.9 percentage of participants |
Comparison: Serogroup A95% CI: [14.8, 23.5]
Comparison: Serogroup C95% CI: [36.7, 45]
Comparison: Serogroup Y95% CI: [14.5, 21.9]
Comparison: Serogroup W95% CI: [14.9, 23.3]
Secondary
Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With MenACYW Conjugate and Menactra®
Antibody titers of meningococcal serogroups A, C, Y, and W were measured by hSBA.
Time frame: Day 30 (post-vaccination)
Population: 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 | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACYW Conjugate Vaccine Lot 1 | Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With MenACYW Conjugate and Menactra® | Serogroup A | 92.9 Titer (1/dilution) |
| MenACYW Conjugate Vaccine Lot 1 | Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With MenACYW Conjugate and Menactra® | Serogroup C | 328 Titer (1/dilution) |
| MenACYW Conjugate Vaccine Lot 1 | Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With MenACYW Conjugate and Menactra® | Serogroup Y | 214 Titer (1/dilution) |
| MenACYW Conjugate Vaccine Lot 1 | Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With MenACYW Conjugate and Menactra® | Serogroup W | 84.4 Titer (1/dilution) |
| MenACYW Conjugate Vaccine Lot 2 | Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With MenACYW Conjugate and Menactra® | Serogroup W | 44.5 Titer (1/dilution) |
| MenACYW Conjugate Vaccine Lot 2 | Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With MenACYW Conjugate and Menactra® | Serogroup A | 48.1 Titer (1/dilution) |
| MenACYW Conjugate Vaccine Lot 2 | Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With MenACYW Conjugate and Menactra® | Serogroup Y | 66.4 Titer (1/dilution) |
| MenACYW Conjugate Vaccine Lot 2 | Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With MenACYW Conjugate and Menactra® | Serogroup C | 40.7 Titer (1/dilution) |
Comparison: Serogroup C95% CI: [6.58, 9.84]
Comparison: Serogroup A95% CI: [1.67, 2.24]
Comparison: Serogroup Y95% CI: [2.71, 3.84]
Comparison: Serogroup W95% CI: [1.61, 2.24]
Secondary
Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine
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)
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACYW Conjugate Vaccine Lot 1 | Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine | Serogroup A | 71.1 percentage of participants |
| MenACYW Conjugate Vaccine Lot 1 | Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine | Serogroup C | 90.5 percentage of participants |
| MenACYW Conjugate Vaccine Lot 1 | Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine | Serogroup Y | 92.4 percentage of participants |
| MenACYW Conjugate Vaccine Lot 1 | Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine | Serogroup W | 81.5 percentage of participants |
| MenACYW Conjugate Vaccine Lot 2 | Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine | Serogroup W | 80.7 percentage of participants |
| MenACYW Conjugate Vaccine Lot 2 | Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine | Serogroup A | 76.5 percentage of participants |
| MenACYW Conjugate Vaccine Lot 2 | Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine | Serogroup Y | 91.9 percentage of participants |
| MenACYW Conjugate Vaccine Lot 2 | Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine | Serogroup C | 89.1 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 | Serogroup W | 78.7 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 | Serogroup C | 86.7 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 | Serogroup Y | 89.9 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 | Serogroup A | 73.7 percentage of participants |
Comparison: Serogroup A: Lot 1 vs Lot 295% CI: [-9.59, -1.16]
Comparison: Serogroup A: Lot 2 vs Lot 395% CI: [-1.3, 7.01]
Comparison: Serogroup A: Lot 1 vs Lot 395% CI: [-6.78, 1.74]
Comparison: Serogroup C: Lot 1 vs Lot 295% CI: [-1.58, 4.28]
Comparison: Serogroup C: Lot 2 vs Lot 395% CI: [-0.74, 5.54]
Comparison: Serogroup C: Lot 1 vs Lot 395% CI: [0.708, 6.79]
Comparison: Serogroup Y: Lot 1 vs Lot 295% CI: [-2.14, 3.07]
Comparison: Serogroup Y: Lot 2 vs Lot 395% CI: [-0.763, 4.79]
Comparison: Serogroup Y: Lot 1 vs Lot 395% CI: [-0.248, 5.2]
Comparison: Serogroup W: Lot 1 vs Lot 295% CI: [-3, 4.54]
Comparison: Serogroup W: Lot 2 vs Lot 395% CI: [-1.84, 5.89]
Comparison: Serogroup W: Lot 1 vs Lot 395% CI: [-1.02, 6.61]
Secondary
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
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)
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACYW Conjugate Vaccine Lot 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 Adolescents | Serogroup A | 74.0 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 Adolescents | Serogroup C | 95.6 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 Adolescents | Serogroup Y | 95.6 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 Adolescents | Serogroup W | 84.5 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 | Serogroup W | 72.0 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 | Serogroup A | 55.3 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 | Serogroup Y | 85.7 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 | Serogroup C | 53.3 percentage of participants |
Comparison: Serogroup A95% CI: [12.5, 24.9]
Comparison: Serogroup C95% CI: [36.6, 48]
Comparison: Serogroup Y95% CI: [6.18, 14.5]
Comparison: Serogroup W95% CI: [7.22, 18.2]
Secondary
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
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)
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACYW Conjugate Vaccine Lot 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 | Serogroup A | 73.5 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 | Serogroup C | 83.4 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 | Serogroup Y | 88.1 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 | Serogroup W | 77.0 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 Adults | Serogroup W | 50.2 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 Adults | Serogroup A | 53.9 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 Adults | Serogroup Y | 60.8 percentage of participants |
| MenACYW Conjugate Vaccine Lot 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 Adults | Serogroup C | 42.3 percentage of participants |
Comparison: Serogroup A95% CI: [13.5, 25.8]
Comparison: Serogroup C95% CI: [35, 46.9]
Comparison: Serogroup Y95% CI: [21.7, 33.3]
Comparison: Serogroup W95% CI: [20.7, 32.9]