Meningitis, Meningococcal Meningitis, Meningococcal Infections
Conditions
Keywords
Meningitis, Meningococcal Meningitis, MenACYW Conjugate vaccine, Nimenrix®, Menjugate®
Brief summary
The purpose of the study was to evaluate the immunogenicity and describe the safety of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed Meningococcal polysaccharide groups A, C, W-135 and Y (Nimenrix®) Conjugate vaccine in toddlers 12 to 23 months of age in the European Union (EU). The toddlers were either meningococcal vaccine naïve or had received monovalent meningococcal C (MenC) vaccination during infancy to evaluate any potential impact of the meningococcal vaccine background on the immunogenicity and safety profile of the investigational product. Primary Objectives: * To demonstrate the non-inferiority of the antibody response to meningococcal serogroups A, C, Y, and W after a single dose of MenACYW Conjugate vaccine or Nimenrix® in toddlers who either were meningococcal vaccine naïve or had received monovalent MenC vaccination during infancy. * To demonstrate the non-inferiority of the antibody response to meningococcal serogroups A, C, Y, and W after a single dose of MenACYW Conjugate vaccine or Nimenrix® in meningococcal vaccine naïve toddlers. Secondary Objectives: * To compare the antibody responses (geometric mean titers \[GMTs\]) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW Conjugate vaccine or Nimenrix® as measured by serum bactericidal assay using human complement (hSBA) in toddlers who either were meningococcal vaccine naïve or had received monovalent MenC vaccination during infancy. * To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW Conjugate vaccine or Nimenrix® as measured by hSBA in meningococcal vaccine naïve toddlers. * To compare the antibody responses (GMTs) to meningococcal serogroups A, C, Y, and W after a dose of MenACYW Conjugate vaccine or Nimenrix® as measured by hSBA in toddlers who received monovalent MenC vaccination during infancy.
Detailed description
Healthy toddlers were randomized depending on their meningococcal priming vaccination background (either meningococcal vaccine naïve or primed with MenC) and received a single dose of either MenACYW Conjugate vaccine or Nimenrix®. They were assessed for immunogenicity at baseline (pre-vaccination) and 30 to 44 days post-vaccination. Safety information were collected post-vaccination and throughout the entire study.
Interventions
0.5 milliliter (mL), Intramuscular
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
12 Months to 23 Months
Healthy volunteers
Yes
Inclusion criteria
* Aged 12 to 23 months on the day of the first study visit. * Participants had received all recommended standard-of-care non-meningococcal vaccinations according to his/her age as per local regulations. * Informed consent form (ICF) had been signed and dated by the parent/legally acceptable representative. * Participant and parent/legally acceptable representative were able to attend all scheduled visits and complied with all trial procedures. * Covered by health insurance if required by local regulations. * Participants had received any meningococcal vaccine in the second year of life (i.e., from 12 months of age). * For Inclusion in Groups 1 and 2: Participants must not had received any vaccination against meningococcal disease with either a trial vaccine or a licensed meningococcal vaccine (i.e., polyvalent, polysaccharide, or Conjugate meningococcal vaccine containing serogroups A, C, W, Y, B; or any monovalent or bivalent meningococcal vaccine). * For Inclusion in Groups 3 and 4: Participants must had previously received at least 1 dose of licensed monovalent meningococcal C Conjugate (MenC) vaccine during infancy (i.e., before 12 months of age).
Exclusion criteria
* 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 study investigational vaccines. This exception included monovalent pandemic influenza vaccines and multivalent influenza vaccines. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * For Groups 1 and 2 only: Vaccination against meningococcal disease with either a trial vaccine or a licensed meningococcal vaccine (i.e., polyvalent, polysaccharide, or Conjugate meningococcal vaccine containing serogroups A, C, W, Y, B; or any monovalent or bivalent meningococcal vaccine). * For Groups 3 and 4 only: Vaccination against meningococcal disease with either a trial vaccine or a licensed meningococcal vaccine (i.e., polyvalent, polysaccharide, or Conjugate meningococcal vaccine containing serogroups A, C, W, Y, B; or any monovalent B meningococcal vaccine), except licensed monovalent meningococcal C Conjugate (MenC) vaccination received during infancy. * 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 travelling 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. * Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine. * Personal history of Guillain-Barré Syndrome. * Verbal report of thrombocytopenia, as reported by the parent/legally acceptable representative 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. * Chronic illness that, in the opinion of the Investigator, is 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 ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has 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 With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy | Day 30 (post-vaccination) | Antibody titers against Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Data for this outcome measure were planned to be analyzed for the pooled population of MenACYW Conjugate vaccine and Nimenrix® reporting groups. |
| Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Meningococcal Vaccine Naïve Toddlers | Day 30 (post-vaccination) | Antibody titers against Meningococcal Serogroups A, C, Y, and W were measured by hSBA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy | 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 Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Vaccine Naive Toddlers | 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 Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Toddlers Who Had Received Monovalent MenC Vaccination During Infancy | Day 30 (post-vaccination) | Antibody titers against Meningococcal Serogroups A, C, Y, and W were measured by hSBA. |
Countries
Finland, Germany, Hungary, Spain
Participant flow
Recruitment details
Study participants were enrolled in 34 centers in Spain, Hungary, Germany and Finland from 24 February 2017 to 21 September 2017.
Pre-assignment details
A total of 918 participants were enrolled and randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0. | 306 |
| Group 2 (Meningococcal Vaccine-Naive): Nimenrix® Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0. | 306 |
| Group 3 (MenC-Primed): MenACYW Conjugate Vaccine Healthy, meningococcal C vaccine primed toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0. | 203 |
| Group 4 (MenC-Primed): Nimenrix® Healthy, meningococcal C vaccine primed toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0. | 103 |
| Total | 918 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | Group 2 (Meningococcal Vaccine-Naive): Nimenrix® | Group 3 (MenC-Primed): MenACYW Conjugate Vaccine | Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine | Group 4 (MenC-Primed): Nimenrix® | Total |
|---|---|---|---|---|---|
| Age, Continuous | 16.2 months STANDARD_DEVIATION 3.19 | 14.0 months STANDARD_DEVIATION 3.01 | 16.1 months STANDARD_DEVIATION 3.32 | 13.8 months STANDARD_DEVIATION 2.72 | 15.4 months STANDARD_DEVIATION 3.31 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 5 Participants | 2 Participants | 2 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 168 Participants | 0 Participants | 188 Participants | 0 Participants | 356 Participants |
| Race (NIH/OMB) White | 132 Participants | 197 Participants | 115 Participants | 99 Participants | 543 Participants |
| Region of Enrollment Finland | 168 Participants | 0 Participants | 188 Participants | 0 Participants | 356 Participants |
| Region of Enrollment Germany | 138 Participants | 0 Participants | 118 Participants | 0 Participants | 256 Participants |
| Region of Enrollment Hungary | 0 Participants | 95 Participants | 0 Participants | 50 Participants | 145 Participants |
| Region of Enrollment Spain | 0 Participants | 108 Participants | 0 Participants | 53 Participants | 161 Participants |
| Sex: Female, Male Female | 145 Participants | 97 Participants | 140 Participants | 53 Participants | 435 Participants |
| Sex: Female, Male Male | 161 Participants | 106 Participants | 166 Participants | 50 Participants | 483 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 / 303 | 0 / 306 | 0 / 203 | 0 / 102 |
| other Total, other adverse events | 261 / 303 | 266 / 306 | 151 / 203 | 65 / 102 |
| serious Total, serious adverse events | 2 / 303 | 1 / 306 | 2 / 203 | 2 / 102 |
Outcome results
Primary
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Meningococcal Vaccine Naïve Toddlers
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. Data for this outcome measure were not planned to be collected and analyzed for MenC-primed reporting groups (Groups 3 and 4).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACYW Conjugate Vaccine (Groups 1 and 3) | Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Meningococcal Vaccine Naïve Toddlers | Serogroup A | 90.8 percentage of participants |
| MenACYW Conjugate Vaccine (Groups 1 and 3) | Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Meningococcal Vaccine Naïve Toddlers | Serogroup C | 99.3 percentage of participants |
| MenACYW Conjugate Vaccine (Groups 1 and 3) | Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Meningococcal Vaccine Naïve Toddlers | Serogroup Y | 93.2 percentage of participants |
| MenACYW Conjugate Vaccine (Groups 1 and 3) | Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Meningococcal Vaccine Naïve Toddlers | Serogroup W | 83.6 percentage of participants |
| Nimenrix® (Groups 2 and 4) | Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Meningococcal Vaccine Naïve Toddlers | Serogroup W | 83.4 percentage of participants |
| Nimenrix® (Groups 2 and 4) | Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Meningococcal Vaccine Naïve Toddlers | Serogroup A | 89.5 percentage of participants |
| Nimenrix® (Groups 2 and 4) | Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Meningococcal Vaccine Naïve Toddlers | Serogroup Y | 91.6 percentage of participants |
| Nimenrix® (Groups 2 and 4) | Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Meningococcal Vaccine Naïve Toddlers | Serogroup C | 81.4 percentage of participants |
Comparison: Serogroup A95% CI: [-3.6, 6.2]
Comparison: Serogroup C95% CI: [13.6, 22.8]
Comparison: Serogroup Y95% CI: [-2.76, 6.03]
Comparison: Serogroup W95% CI: [-5.85, 6.18]
Primary
Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy
Antibody titers against Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Data for this outcome measure were planned to be analyzed for the pooled population of MenACYW Conjugate vaccine and Nimenrix® reporting groups.
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 and had a valid post-vaccination serology result. Participants with pre-defined protocol deviations were excluded. Here, Number analyzed = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACYW Conjugate Vaccine (Groups 1 and 3) | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy | Serogroup A | 90.4 percentage of participants |
| MenACYW Conjugate Vaccine (Groups 1 and 3) | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy | Serogroup C | 99.2 percentage of participants |
| MenACYW Conjugate Vaccine (Groups 1 and 3) | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy | Serogroup Y | 94.3 percentage of participants |
| MenACYW Conjugate Vaccine (Groups 1 and 3) | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy | Serogroup W | 84.9 percentage of participants |
| Nimenrix® (Groups 2 and 4) | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy | Serogroup W | 84.0 percentage of participants |
| Nimenrix® (Groups 2 and 4) | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy | Serogroup A | 91.6 percentage of participants |
| Nimenrix® (Groups 2 and 4) | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy | Serogroup Y | 91.6 percentage of participants |
| Nimenrix® (Groups 2 and 4) | Percentage of Participants With Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy | Serogroup C | 85.5 percentage of participants |
Comparison: Serogroup A95% CI: [-5.84, 1.78]
Comparison: Serogroup C95% CI: [8.16, 16.1]
Comparison: Serogroup Y95% CI: [-1.34, 6.19]
Comparison: Serogroup W95% CI: [-4.37, 5.28]
Secondary
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy
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. Data for this outcome measure were planned to be analyzed for the pooled population of MenACYW Conjugate vaccine and Nimenrix® reporting groups.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACYW Conjugate Vaccine (Groups 1 and 3) | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy | Serogroup A | 29.9 titers (1/dilution) |
| MenACYW Conjugate Vaccine (Groups 1 and 3) | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy | Serogroup C | 880 titers (1/dilution) |
| MenACYW Conjugate Vaccine (Groups 1 and 3) | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy | Serogroup Y | 41.7 titers (1/dilution) |
| MenACYW Conjugate Vaccine (Groups 1 and 3) | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy | Serogroup W | 24.4 titers (1/dilution) |
| Nimenrix® (Groups 2 and 4) | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy | Serogroup W | 17.7 titers (1/dilution) |
| Nimenrix® (Groups 2 and 4) | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy | Serogroup A | 34.5 titers (1/dilution) |
| Nimenrix® (Groups 2 and 4) | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy | Serogroup Y | 31.9 titers (1/dilution) |
| Nimenrix® (Groups 2 and 4) | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W in Toddlers Who Either Were Meningococcal Vaccine Naïve or Had Received Monovalent MenC Vaccination During Infancy | Serogroup C | 77.1 titers (1/dilution) |
Comparison: Serogroup A95% CI: [0.697, 0.963]
Comparison: Serogroup C95% CI: [6.05, 9.52]
Comparison: Serogroup Y95% CI: [1.09, 1.51]
Comparison: Serogroup W95% CI: [1.12, 1.56]
Secondary
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Toddlers Who Had Received Monovalent MenC Vaccination During Infancy
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) |
|---|---|---|---|
| MenACYW Conjugate Vaccine (Groups 1 and 3) | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Toddlers Who Had Received Monovalent MenC Vaccination During Infancy | Serogroup Y | 48.0 titers (1/dilution) |
| MenACYW Conjugate Vaccine (Groups 1 and 3) | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Toddlers Who Had Received Monovalent MenC Vaccination During Infancy | Serogroup A | 31.8 titers (1/dilution) |
| MenACYW Conjugate Vaccine (Groups 1 and 3) | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Toddlers Who Had Received Monovalent MenC Vaccination During Infancy | Serogroup C | 2514 titers (1/dilution) |
| MenACYW Conjugate Vaccine (Groups 1 and 3) | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Toddlers Who Had Received Monovalent MenC Vaccination During Infancy | Serogroup W | 28.7 titers (1/dilution) |
| Nimenrix® (Groups 2 and 4) | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Toddlers Who Had Received Monovalent MenC Vaccination During Infancy | Serogroup W | 22.3 titers (1/dilution) |
| Nimenrix® (Groups 2 and 4) | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Toddlers Who Had Received Monovalent MenC Vaccination During Infancy | Serogroup Y | 31.3 titers (1/dilution) |
| Nimenrix® (Groups 2 and 4) | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Toddlers Who Had Received Monovalent MenC Vaccination During Infancy | Serogroup C | 1883 titers (1/dilution) |
| Nimenrix® (Groups 2 and 4) | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Toddlers Who Had Received Monovalent MenC Vaccination During Infancy | Serogroup A | 64.0 titers (1/dilution) |
Comparison: Serogroup A95% CI: [0.367, 0.672]
Comparison: Serogroup C95% CI: [0.814, 2.19]
Comparison: Serogroup Y95% CI: [1.15, 2.04]
Comparison: Serogroup W95% CI: [0.944, 1.75]
Secondary
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Vaccine Naive Toddlers
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) |
|---|---|---|---|
| MenACYW Conjugate Vaccine (Groups 1 and 3) | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Vaccine Naive Toddlers | Serogroup A | 28.7 titers (1/dilution) |
| MenACYW Conjugate Vaccine (Groups 1 and 3) | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Vaccine Naive Toddlers | Serogroup C | 436 titers (1/dilution) |
| MenACYW Conjugate Vaccine (Groups 1 and 3) | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Vaccine Naive Toddlers | Serogroup Y | 38.0 titers (1/dilution) |
| MenACYW Conjugate Vaccine (Groups 1 and 3) | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Vaccine Naive Toddlers | Serogroup W | 22.0 titers (1/dilution) |
| Nimenrix® (Groups 2 and 4) | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Vaccine Naive Toddlers | Serogroup W | 16.4 titers (1/dilution) |
| Nimenrix® (Groups 2 and 4) | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Vaccine Naive Toddlers | Serogroup A | 28.0 titers (1/dilution) |
| Nimenrix® (Groups 2 and 4) | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Vaccine Naive Toddlers | Serogroup Y | 32.2 titers (1/dilution) |
| Nimenrix® (Groups 2 and 4) | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® in Vaccine Naive Toddlers | Serogroup C | 26.4 titers (1/dilution) |
Comparison: Serogroup W95% CI: [1.1, 1.63]
Comparison: Serogroup A95% CI: [0.85, 1.24]
Comparison: Serogroup C95% CI: [13.4, 20.4]
Comparison: Serogroup Y95% CI: [0.97, 1.44]