Meningitis, Meningococcal Meningitis, Meningococcal Infections
Conditions
Keywords
Meningitis, Meningococcal Meningitis, MenACYW Conjugate vaccine, MENVEO®
Brief summary
The purpose of the study was to evaluate the immunogenicity and describe the safety of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®) vaccine in children 2 to 9 years of age in the United States (US) and Puerto Rico. Primary objective: \- To demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine compared to that observed following the administration of a single dose of MENVEO® in children aged 2 to 9 years. Secondary objectives: * To compare the serum bactericidal assay using human complement (hSBA) antibody geometric mean titers (GMTs) of meningococcal serogroups A, C, Y, and W following the administration of MenACYW Conjugate vaccine to those observed following the administration of MENVEO® in children 2 to 9 years of age. * To evaluate the hSBA antibody GMTs of meningococcal serogroups A, C, Y, and W following the administration of MenACYW Conjugate vaccine and those observed following the administration of MENVEO® in children 2 to 5 years of age, and in children 6 to 9 years of age, respectively. * To evaluate the hSBA vaccine seroresponse to meningococcal serogroups A, C, Y, and W before and 30 days (+14 days) post-vaccination in children 2 to 5 years of age, and in children 6 to 9 years of age, respectively. Observational objective: \- To describe the safety profile of MenACYW Conjugate vaccine and that of the licensed MENVEO®.
Detailed description
Healthy children were randomized and received a single dose of either MenACYW Conjugate vaccine or MENVEO®. They were assessed for immunogenicity at baseline (pre-vaccination) and at 30-44 days post-vaccination. Safety information were collected post-vaccination and throughout the entire study.
Interventions
BIOLOGICALMeningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate
0.5 milliliter (mL), Intramuscular
BIOLOGICALMeningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 9 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 2 to 9 years on the day of inclusion. * Assent form had been signed and dated by the participant (as required by local regulations) and informed consent form had been signed and dated by parent(s) or guardian. * Participant and parent/guardian were able to attend all scheduled visits and complied with all trial procedures.
Exclusion criteria
* Participant was pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche. * 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 might be received at least 2 weeks before or after the study investigational vaccines. This exception included monovalent, multivalent, live, and attenuated influenza vaccines. * Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (ie., mono- or polyvalent, polysaccharide, or Conjugate meningococcal vaccine containing serogroups A, C, Y, W; or meningococcal B serogroup containing 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, contraindicating intramuscular vaccination by the Investigator's judgment. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion. * Personal history of Guillain-Barré syndrome. * Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine. * 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's judgment) on the day of vaccination or febrile illness (temperature ≥100.4°F). A prospective participant should not be included in the study until the condition had 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 a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine | Day 30 (post-vaccination) | Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titers greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titers less than (\<) 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 9 Years of Age | Day 30 (post-vaccination) | Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. |
| Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age | Day 30 (post-vaccination) | Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. |
| Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years of Age | Day 30 (post-vaccination) | Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. |
| Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age | Day 30 (post-vaccination) | Antibody titers against meningococcal serogroups A, C, Y, and W were 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. |
| Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years Age | Day 30 (post-vaccination) | Antibody titers against meningococcal serogroups A, C, Y, and W were 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. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
Study participants were enrolled in 36 centers in the United States (US) and Puerto Rico from 17 February 2017 to 30 March 2017.
Pre-assignment details
A total of 1000 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: MenACYW Conjugate Vaccine Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MenACYW Conjugate vaccine on Day 0. | 499 |
| Group 2: MENVEO® Vaccine Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MENVEO® Conjugate vaccine on Day 0. | 501 |
| Total | 1,000 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 3 |
| Overall Study | Protocol Violation | 3 | 5 |
| Overall Study | Withdrawal by Subject | 3 | 6 |
Baseline characteristics
| Characteristic | Group 1: MenACYW Conjugate Vaccine | Total | Group 2: MENVEO® Vaccine |
|---|---|---|---|
| Age, Continuous | 6.0 years STANDARD_DEVIATION 2.33 | 6.0 years STANDARD_DEVIATION 2.34 | 6.0 years STANDARD_DEVIATION 2.36 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 66 Participants | 127 Participants | 61 Participants |
| Race (NIH/OMB) More than one race | 21 Participants | 42 Participants | 21 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) White | 402 Participants | 819 Participants | 417 Participants |
| Region of Enrollment United States | 499 Participants | 1000 Participants | 501 Participants |
| Sex: Female, Male Female | 245 Participants | 481 Participants | 236 Participants |
| Sex: Female, Male Male | 254 Participants | 519 Participants | 265 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 498 | 0 / 494 |
| other Total, other adverse events | 304 / 498 | 335 / 494 |
| serious Total, serious adverse events | 7 / 498 | 3 / 494 |
Outcome results
Primary
Percentage of Participants Achieving Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titers greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titers less than (\<) 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8.
Time frame: Day 30 (post-vaccination)
Population: Per-protocol analysis set (PPAS) defined for accessing ACYW immune response data for participants who received at least 1 dose of study vaccine and had valid post-vaccination serology result. Participants who presented pre-defined protocol deviations were excluded. Here,'Number analyzed'=participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants Achieving Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine | Serogroup Y | 91.5 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants Achieving Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine | Serogroup C | 95.2 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants Achieving Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine | Serogroup W | 78.8 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants Achieving Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine | Serogroup A | 55.4 percentage of participants |
| Group 2: MENVEO® Vaccine | Percentage of Participants Achieving Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine | Serogroup W | 64.1 percentage of participants |
| Group 2: MENVEO® Vaccine | Percentage of Participants Achieving Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine | Serogroup C | 47.8 percentage of participants |
| Group 2: MENVEO® Vaccine | Percentage of Participants Achieving Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine | Serogroup Y | 79.3 percentage of participants |
| Group 2: MENVEO® Vaccine | Percentage of Participants Achieving Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine | Serogroup A | 47.8 percentage of participants |
Comparison: Serogroup A95% CI: [1.1, 14]
Comparison: Serogroup C95% CI: [42.2, 52.2]
Comparison: Serogroup Y95% CI: [7.7, 16.7]
Comparison: Serogroup W95% CI: [8.9, 20.5]
Secondary
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 9 Years of Age
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on PPAS. Here 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 9 Years of Age | Serogroup A | 24.8 titers (1/dilution) |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 9 Years of Age | Serogroup W | 37.5 titers (1/dilution) |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 9 Years of Age | Serogroup C | 238 titers (1/dilution) |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 9 Years of Age | Serogroup Y | 68.8 titers (1/dilution) |
| Group 2: MENVEO® Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 9 Years of Age | Serogroup W | 26.2 titers (1/dilution) |
| Group 2: MENVEO® Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 9 Years of Age | Serogroup A | 22.6 titers (1/dilution) |
| Group 2: MENVEO® Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 9 Years of Age | Serogroup Y | 43.5 titers (1/dilution) |
| Group 2: MENVEO® Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 9 Years of Age | Serogroup C | 17.0 titers (1/dilution) |
Comparison: Serogroup A95% CI: [0.91, 1.32]
Comparison: Serogroup C95% CI: [11.3, 17.3]
Comparison: Serogroup Y95% CI: [1.31, 1.9]
Comparison: Serogroup W95% CI: [1.21, 1.69]
Secondary
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age
Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on PPAS. Here 'Overall number of participants analyzed' = number of participants in the PPAS aged 2-5 years, and 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age | Serogroup A | 21.6 titers (1/dilution) |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age | Serogroup Y | 49.8 titers (1/dilution) |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age | Serogroup C | 208 titers (1/dilution) |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age | Serogroup W | 28.8 titers (1/dilution) |
| Group 2: MENVEO® Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age | Serogroup W | 20.1 titers (1/dilution) |
| Group 2: MENVEO® Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age | Serogroup A | 18.9 titers (1/dilution) |
| Group 2: MENVEO® Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age | Serogroup C | 11.9 titers (1/dilution) |
| Group 2: MENVEO® Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age | Serogroup Y | 36.1 titers (1/dilution) |
Comparison: Serogroup A95% CI: [0.883, 1.47]
Comparison: Serogroup C95% CI: [13.4, 22.6]
Comparison: Serogroup Y95% CI: [1.07, 1.78]
Comparison: Serogroup W95% CI: [1.12, 1.83]
Secondary
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years of Age
Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on PPAS. Here 'Overall number of participants analyzed' = number of participants in the PPAS aged 6-9 years, and 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years of Age | Serogroup A | 28.4 titers (1/dilution) |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years of Age | Serogroup C | 272 titers (1/dilution) |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years of Age | Serogroup W | 48.9 titers (1/dilution) |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years of Age | Serogroup Y | 95.1 titers (1/dilution) |
| Group 2: MENVEO® Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years of Age | Serogroup W | 33.6 titers (1/dilution) |
| Group 2: MENVEO® Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years of Age | Serogroup A | 26.8 titers (1/dilution) |
| Group 2: MENVEO® Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years of Age | Serogroup C | 23.7 titers (1/dilution) |
| Group 2: MENVEO® Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years of Age | Serogroup Y | 51.8 titers (1/dilution) |
Comparison: Serogroup A95% CI: [0.816, 1.38]
Comparison: Serogroup C95% CI: [8.24, 16]
Comparison: Serogroup Y95% CI: [1.41, 2.38]
Comparison: Serogroup W95% CI: [1.16, 1.82]
Secondary
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age
Antibody titers against meningococcal serogroups A, C, Y, and W were 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 'Overall number of participants analyzed' = number of participants in the PPAS aged 2-5 years, and 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age | Serogroup A | 52.4 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age | Serogroup C | 94.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age | Serogroup Y | 88.2 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age | Serogroup W | 73.8 percentage of participants |
| Group 2: MENVEO® Vaccine | Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age | Serogroup W | 61.3 percentage of participants |
| Group 2: MENVEO® Vaccine | Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age | Serogroup A | 44.8 percentage of participants |
| Group 2: MENVEO® Vaccine | Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age | Serogroup Y | 77.0 percentage of participants |
| Group 2: MENVEO® Vaccine | Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age | Serogroup C | 43.2 percentage of participants |
Comparison: Serogroup A95% CI: [-1.6, 16.7]
Comparison: Serogroup C95% CI: [43.5, 57.8]
Comparison: Serogroup Y95% CI: [4.2, 18.1]
Comparison: Serogroup W95% CI: [3.9, 20.9]
Secondary
Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years Age
Antibody titers against meningococcal serogroups A, C, Y, and W were 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 'Overall number of participants analyzed' = number of participants in the PPAS aged 6-9 years, and 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years Age | Serogroup A | 58.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years Age | Serogroup Y | 94.8 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years Age | Serogroup C | 96.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years Age | Serogroup W | 83.8 percentage of participants |
| Group 2: MENVEO® Vaccine | Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years Age | Serogroup W | 66.7 percentage of participants |
| Group 2: MENVEO® Vaccine | Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years Age | Serogroup A | 50.6 percentage of participants |
| Group 2: MENVEO® Vaccine | Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years Age | Serogroup C | 52.1 percentage of participants |
| Group 2: MENVEO® Vaccine | Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years Age | Serogroup Y | 81.4 percentage of participants |
Comparison: Serogroup A95% CI: [-1.3, 16.6]
Comparison: Serogroup C95% CI: [36.8, 50.6]
Comparison: Serogroup Y95% CI: [7.6, 19.2]
Comparison: Serogroup W95% CI: [9.4, 24.7]