Meningococcal Immunisation (Healthy Volunteers)
Conditions
Brief summary
Primary Objective: To demonstrate: * the non-inferiority of the seroprotection rate (antibody titers greater than or equal to \[\>=\] 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate or Nimenrix® as measured by serum bactericidal assay using human complement (hSBA). If this non-inferiority was demonstrated, then * the non-inferiority of the antibody response (geometric mean titers \[GMT\]). If this non-inferiority was demonstrated, then * the superiority of the antibody response (GMT). If this superiority was demonstrated, then * the superiority of the seroprotection rate. Or to demonstrate: * the non-inferiority of the seroprotection rate (antibody titers \>= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate or NeisVac-C® as measured by serum bactericidal assay using baby rabbit complement (rSBA). If this non-inferiority was demonstrated, then * the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then * the superiority of the antibody response (GMT). Secondary Objective: To demonstrate: * the non-inferiority of the seroprotection rate (antibody titers \>= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate vaccine or Nimenrix® as measured by rSBA. If this non-inferiority was demonstrated, then * the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then * the superiority of the antibody response (GMT). Or to demonstrate: * the non-inferiority of the seroprotection rate (antibody titers \>= 1:8) to meningococcal serogroup C following the administration of MenACYW Conjugate vaccine or NeisVac-C® as measured by hSBA. If this non-inferiority was demonstrated, then * the non-inferiority of the antibody response (GMT). If this non-inferiority was demonstrated, then * the superiority of the antibody response (GMT) .
Detailed description
Study duration per participant was approximately 30 days including: 1 day of screening and vaccination, a phone call and a safety-follow up/end of study visit at Day 8 and Day 30 after vaccine administration, respectively. Safety assessment included solicited reactions within 7 days after vaccination, unsolicited adverse events up to 30 days after vaccination, serious adverse events and adverse event of special interest throughout the study.
Interventions
Pharmaceutical form: Liquid solution for injection Route of administration: Intramuscular
BIOLOGICALMeningococcal polysaccharide group A, C, W-135 and Y Conjugate vaccine
Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Intramuscular
BIOLOGICALMeningococcal group C polysaccharide Conjugate vaccine adsorbed
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Modified double-blind: the participant (or legally acceptable representative), and the Investigator remained unaware of the treatment assignments throughout the study. An unblinded vaccine administrator administered the appropriate vaccine but was not involved in safety data collection.
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 (12 to 23 months means from the 12th month after birth to the day before the 24th month after birth). * Informed consent form (ICF) had been signed and dated by the parent(s)/legally acceptable representative(s) and by an independent witness if required by local regulations. * Participant and parent/legally acceptable representative were able to attend all scheduled visits and complied with all trial procedures.
Exclusion criteria
* Participation in the 4 weeks (28 days) preceding the study vaccination or planned participation during the present study period in another clinical study 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 study 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. * 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, W, or Y; or meningococcal B vaccine). * 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 study 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. * Thrombocytopenia, as reported by the parent/ legally acceptable representative or suspected thrombocytopenia 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, 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 \>= 38.0 degree Celsius). 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. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Superiority Analysis) | Day 30 (post-vaccination) | GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution. |
| Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis) | Day 30 (post-vaccination) | Antibody titers against Meningococcal Serogroup C were measured by hSBA. |
| Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis) | Day 30 (post-vaccination) | GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution. |
| GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis) | Day 30 (post-vaccination) | GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution. |
| Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis) | Day 30 (post-vaccination) | Antibody titers against Meningococcal Serogroup C were measured by hSBA. |
| Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis) | Day 30 (post-vaccination) | Antibody titers against Meningococcal Serogroup C were measured by rSBA. |
| GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis) | Day 30 (post-vaccination) | GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis) | Day 30 (post-vaccination) | GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution. |
| GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis) | Day 30 (post-vaccination) | GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution. |
| Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis) | Day 30 (post-vaccination) | Antibody titers against Meningococcal Serogroup C were measured by hSBA. |
| GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA After Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis) | Day 30 (post-vaccination) | GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution. |
| GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Superiority Analysis) | Day 30 (post-vaccination) | GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution. |
| Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis) | Day 30 (post-vaccination) | Antibody titers against Meningococcal Serogroup C were measured by rSBA. |
Countries
Denmark, Finland, Germany
Participant flow
Recruitment details
Study participants were enrolled in 29 active centers in Denmark, Germany and Finland from 12 September 2019 to 03 September 2020.
Pre-assignment details
A total of 707 participants were enrolled and randomized in the study.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: MenACYW Conjugate Vaccine Healthy, toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0. | 232 |
| Group 2: Nimenrix® Vaccine Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0. | 235 |
| Group 3: NeisVac-C® Vaccine Healthy, toddlers aged 12 to 23 months received a single dose of NeisVac-C® vaccine on Day 0. | 240 |
| Total | 707 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 0 |
| Overall Study | Protocol deviation | 2 | 2 | 1 |
| Overall Study | Withdrawal by parent/guardian | 1 | 3 | 0 |
Baseline characteristics
| Characteristic | Group 1: MenACYW Conjugate Vaccine | Group 2: Nimenrix® Vaccine | Group 3: NeisVac-C® Vaccine | Total |
|---|---|---|---|---|
| Age, Continuous | 16.5 months STANDARD_DEVIATION 3.27 | 16.6 months STANDARD_DEVIATION 3.48 | 16.7 months STANDARD_DEVIATION 3.45 | 16.6 months STANDARD_DEVIATION 3.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 5 Participants | 1 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 225 Participants | 226 Participants | 236 Participants | 687 Participants |
| Sex: Female, Male Female | 115 Participants | 108 Participants | 109 Participants | 332 Participants |
| Sex: Female, Male Male | 117 Participants | 127 Participants | 131 Participants | 375 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 230 | 0 / 232 | 0 / 239 |
| other Total, other adverse events | 197 / 230 | 192 / 232 | 203 / 239 |
| serious Total, serious adverse events | 1 / 230 | 1 / 232 | 2 / 239 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)
GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on hSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 2, and not for Group 3.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis) | 515 titers |
| Group 2: Nimenrix® Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis) | 31.6 titers |
97.5% CI: [12.7, 21]
Primary
GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)
GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on hSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 2, and not for Group 3.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis) | 515 titers |
| Group 2: Nimenrix® Vaccine | GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis) | 31.6 titers |
97.5% CI: [12.7, 21]
Primary
GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis)
GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on rSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 3, and not for Group 2.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis) | 2143 titers |
| Group 2: Nimenrix® Vaccine | GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis) | 1624 titers |
97.5% CI: [1.06, 1.64]
Primary
GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Superiority Analysis)
GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on rSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 3, and not for Group 2.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Superiority Analysis) | 2143 titers |
| Group 2: Nimenrix® Vaccine | GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Superiority Analysis) | 1624 titers |
97.5% CI: [1.06, 1.64]
Primary
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)
Antibody titers against Meningococcal Serogroup C were measured by hSBA.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on hSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 2, and not for Group 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis) | 99.5 percentage of participants |
| Group 2: Nimenrix® Vaccine | Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis) | 89.1 percentage of participants |
97.5% CI: [5.68, 16.2]
Primary
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis)
Antibody titers against Meningococcal Serogroup C were measured by rSBA.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on rSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 3, and not for Group 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis) | 100 percentage of participants |
| Group 2: Nimenrix® Vaccine | Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis) | 100 percentage of participants |
97.5% CI: [-2.3, 2.28]
Primary
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)
Antibody titers against Meningococcal Serogroup C were measured by hSBA.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on hSBA per-protocol analysis set (PPAS) which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 2, and not for Group 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis) | 99.5 percentage of participants |
| Group 2: Nimenrix® Vaccine | Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis) | 89.1 percentage of participants |
97.5% CI: [5.68, 16.2]
Secondary
GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA After Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis)
GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on hSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 3, and not for Group 2.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA After Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis) | 515 titers |
| Group 2: Nimenrix® Vaccine | GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA After Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis) | 227 titers |
97.5% CI: [1.82, 2.84]
Secondary
GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Superiority Analysis)
GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on hSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 3, and not for Group 2.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Superiority Analysis) | 515 titers |
| Group 2: Nimenrix® Vaccine | GMTs of Antibodies Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Superiority Analysis) | 227 titers |
97.5% CI: [1.82, 2.84]
Secondary
GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)
GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on rSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 2, and not for Group 3.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis) | 2143 titers |
| Group 2: Nimenrix® Vaccine | GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis) | 315 titers |
97.5% CI: [5.04, 9.18]
Secondary
GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis)
GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on rSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 2, and not for Group 3.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis) | 2143 titers |
| Group 2: Nimenrix® Vaccine | GMTs of Antibodies Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Superiority Analysis) | 315 titers |
97.5% CI: [5.04, 9.18]
Secondary
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis)
Antibody titers against Meningococcal Serogroup C were measured by hSBA.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on hSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 3, and not for Group 2.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis) | 99.5 percentage of participants |
| Group 2: Nimenrix® Vaccine | Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or NeisVac-C® (Non-inferiority Analysis) | 99.5 percentage of participants |
97.5% CI: [-2.71, 2.67]
Secondary
Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis)
Antibody titers against Meningococcal Serogroup C were measured by rSBA.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on rSBA PPAS which was a subset that included all participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. The participants who presented protocol deviations were excluded from PPAS. Data for this outcome measure was planned to be collected and analyzed only for Group 1 and 2, and not for Group 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis) | 100 percentage of participants |
| Group 2: Nimenrix® Vaccine | Percentage of Participants With Antibody Titers >=1:8 Against Meningococcal Serogroup C Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Nimenrix® (Non-inferiority Analysis) | 94.8 percentage of participants |
97.5% CI: [1.83, 9.85]