Meningococcal Infections
Conditions
Keywords
vaccine, children, healthy, meningitis, meningococcal, prevention of meningococcal disease serogroups ACWY, Menveo
Brief summary
To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.
Interventions
BIOLOGICALMenACWY-CRM
1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly
BIOLOGICALLicensed meningococcal ACWY vaccine
1 injection of the licensed meningococcal ACWY was administered intramuscularly
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy 2-10 years of age children, inclusive and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent * who are available for all visits and telephone calls scheduled for the study * who are up-to-date with age-appropriate routine childhood vaccinations
Exclusion criteria
* whose parent or legal guardian is unwilling or unable to give written informed consent * who had a previous or suspected disease caused by N. meningitidis; * who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) * who have received any investigational agents or vaccines within 90 days prior to enrollment * who have any serious acute, chronic or progressive disease * who have epilepsy or any progressive neurological disease or history of Guillain Barré Syndrome * who have a history of anaphylaxis, serious vaccine reactions * who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from * who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time * who have Down's syndrome or other known cytogenic disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age | 1 month postvaccination | The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. |
| Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age. | 1 month postvaccination | The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenatages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age. | 1 month postvaccination | The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bactericidal Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y. |
| Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age. | 1 month postvaccination | The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenategs of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. |
| Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age. | 1 month postvaccination | The immunogenicity of a single dose of the Novartis MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bacterial Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y. |
| Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose) | 1 month postvaccination | The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. |
| Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age. | 1 month postvaccination | The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. |
| GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) | 1 month postvaccination | The immunogenicity of two doses of the Novartis MenACWY-CRM vaccine, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM vaccine, in terms of hSBA (human Serum Bactericidal Activity) GMTs (Geometric Mean Titers) against N. meningitidis serogroups A, C, W-135, and Y. ANOVA model used for the analysis of this outcome is different compare to ANOVA model used for the other outcome. The computed model components vary according to the variance observed due to the different datasets. |
| Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Study days 1 to 7 | Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group, after 1 dose treatment. |
| Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Study days 1 to 7 | Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group after 1 dose treatment. |
| Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment. | day 1 to study termination (day 240) | Safety was assessed in terms of the percentage of subjects with unsolicited AEs occurring throughout the entire study period, after 1 dose treatment. |
| Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) | 1 month postvaccination | The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. |
| Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age | 1 month postvaccination | The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. |
Countries
Canada, United States
Participant flow
Recruitment details
Participants were enrolled at 67 centers in the USA and Canada.
Pre-assignment details
All subjects enrolled were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| MenACWY-CRM (2 Doses) 2 injections of the Novartis MenACWY-CRM vaccine administered on study days 1 and 61 in children 2 to 5 years of age. | 359 |
| MenACWY-CRM (1 Dose) 1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study day1. | 1,278 |
| Licensed Polysaccharide Vaccine 1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1. | 1,270 |
| Total | 2,907 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative reason | 1 | 0 | 0 |
| Overall Study | Inappropriate enrollment | 3 | 0 | 1 |
| Overall Study | Lost to Follow-up | 12 | 26 | 30 |
| Overall Study | Protocol Violation | 0 | 1 | 2 |
| Overall Study | Unable to classify | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 9 | 11 | 8 |
Baseline characteristics
| Characteristic | MenACWY-CRM (2 Doses) | MenACWY-CRM (1 Dose) | Licensed Polysaccharide Vaccine | Total |
|---|---|---|---|---|
| Age, Continuous | 3.5 years STANDARD_DEVIATION 1.1 | 5.5 years STANDARD_DEVIATION 2.5 | 5.6 years STANDARD_DEVIATION 2.6 | 5.3 years STANDARD_DEVIATION 2.5 |
| Sex: Female, Male Female | 171 Participants | 622 Participants | 580 Participants | 1373 Participants |
| Sex: Female, Male Male | 188 Participants | 656 Participants | 690 Participants | 1534 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 253 / 351 | 424 / 693 | 340 / 582 | 419 / 684 | 342 / 571 |
| serious Total, serious adverse events | 2 / 351 | 5 / 693 | 3 / 582 | 5 / 684 | 2 / 571 |
Outcome results
Primary
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Time frame: 1 month postvaccination
Population: The analysis was performed on the per-protocol (PP) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age | Serogroup A (N=606, 611) | 72 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age | Serogroup C (N=607, 615) | 60 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age | Serogroup W (N=594, 605) | 72 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age | Serogroup Y (N=593, 600) | 66 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age | Serogroup Y (N=593, 600) | 45 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age | Serogroup A (N=606, 611) | 77 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age | Serogroup W (N=594, 605) | 58 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age | Serogroup C (N=607, 615) | 56 Percentages of subjects |
Primary
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age.
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenatages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Time frame: 1 month postvaccination
Population: The analysis was performed on the per-protocol (PP) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age. | Serogroup A (N=551, 541) | 77 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age. | Serogroup W (N=542, 533) | 57 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age. | Serogroup Y (N=545, 539) | 58 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age. | Serogroup C (N=554, 539) | 63 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age. | Serogroup Y (N=545, 539) | 39 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age. | Serogroup A (N=551, 541) | 83 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age. | Serogroup C (N=554, 539) | 57 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age. | Serogroup W (N=542, 533) | 44 Percentages of subjects |
Secondary
Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age.
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bactericidal Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.
Time frame: 1 month postvaccination
Population: The analysis was performed on the per-protocol (PP) population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-CRM (1 Dose) | Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age. | Serogroup A (N=1157, 1152) | 30 Titers |
| MenACWY-CRM (1 Dose) | Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age. | Serogroup C (N=1161, 1154) | 23 Titers |
| MenACWY-CRM (1 Dose) | Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age. | Serogroup W (N=1136, 1138) | 49 Titers |
| MenACWY-CRM (1 Dose) | Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age. | Serogroup Y (N=1138, 1139) | 29 Titers |
| Licensed Polysaccharide Vaccine | Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age. | Serogroup Y (N=1138, 1139) | 12 Titers |
| Licensed Polysaccharide Vaccine | Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age. | Serogroup A (N=1157, 1152) | 29 Titers |
| Licensed Polysaccharide Vaccine | Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age. | Serogroup W (N=1136, 1138) | 26 Titers |
| Licensed Polysaccharide Vaccine | Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age. | Serogroup C (N=1161, 1154) | 17 Titers |
Secondary
Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age.
The immunogenicity of a single dose of the Novartis MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bacterial Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.
Time frame: 1 month postvaccination
Population: The analysis was performed on the per-protocol (PP) population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-CRM (1 Dose) | Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup A (N=606, 611, 551, 541) | 26 Titers |
| MenACWY-CRM (1 Dose) | Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup C (N=607, 615, 554, 539) | 18 Titers |
| MenACWY-CRM (1 Dose) | Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup W (N=594, 605, 542, 533) | 43 Titers |
| MenACWY-CRM (1 Dose) | Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup Y (N=593, 600, 545, 539) | 24 Titers |
| Licensed Polysaccharide Vaccine | Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup C (N=607, 615, 554, 539) | 13 Titers |
| Licensed Polysaccharide Vaccine | Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup W (N=594, 605, 542, 533) | 21 Titers |
| Licensed Polysaccharide Vaccine | Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup Y (N=593, 600, 545, 539) | 10 Titers |
| Licensed Polysaccharide Vaccine | Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup A (N=606, 611, 551, 541) | 25 Titers |
| MenACWY-CRM (6 to 10 Yoa) | Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup W (N=594, 605, 542, 533) | 61 Titers |
| MenACWY-CRM (6 to 10 Yoa) | Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup C (N=607, 615, 554, 539) | 36 Titers |
| MenACWY-CRM (6 to 10 Yoa) | Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup Y (N=593, 600, 545, 539) | 34 Titers |
| MenACWY-CRM (6 to 10 Yoa) | Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup A (N=606, 611, 551, 541) | 35 Titers |
| Licensed Polysaccharide Vaccine (6 to 10 Yoa) | Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup Y (N=593, 600, 545, 539) | 14 Titers |
| Licensed Polysaccharide Vaccine (6 to 10 Yoa) | Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup C (N=607, 615, 554, 539) | 27 Titers |
| Licensed Polysaccharide Vaccine (6 to 10 Yoa) | Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup A (N=606, 611, 551, 541) | 35 Titers |
| Licensed Polysaccharide Vaccine (6 to 10 Yoa) | Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup W (N=594, 605, 542, 533) | 35 Titers |
Secondary
GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)
The immunogenicity of two doses of the Novartis MenACWY-CRM vaccine, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM vaccine, in terms of hSBA (human Serum Bactericidal Activity) GMTs (Geometric Mean Titers) against N. meningitidis serogroups A, C, W-135, and Y. ANOVA model used for the analysis of this outcome is different compare to ANOVA model used for the other outcome. The computed model components vary according to the variance observed due to the different datasets.
Time frame: 1 month postvaccination
Population: The analysis was performed on the per-protocol (PP) population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-CRM (1 Dose) | GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) | Serogroup W (N=288, 594) | 132 Titers |
| MenACWY-CRM (1 Dose) | GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) | Serogroup C (N=293, 607) | 144 Titers |
| MenACWY-CRM (1 Dose) | GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) | Serogroup Y (N=286, 593) | 102 Titers |
| MenACWY-CRM (1 Dose) | GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) | Serogroup A (N=291, 606) | 64 Titers |
| Licensed Polysaccharide Vaccine | GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) | Serogroup Y (N=286, 593) | 23 Titers |
| Licensed Polysaccharide Vaccine | GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) | Serogroup C (N=293, 607) | 18 Titers |
| Licensed Polysaccharide Vaccine | GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) | Serogroup W (N=288, 594) | 41 Titers |
| Licensed Polysaccharide Vaccine | GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) | Serogroup A (N=291, 606) | 27 Titers |
Secondary
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.
Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group, after 1 dose treatment.
Time frame: Study days 1 to 7
Population: The analysis was performed on the safety population. Only groups receiving 1 dose vaccine are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Change in Eating Habits (N=683, 671) | 9 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Diarrhea (N=692, 684) | 7 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Injection site pain | 33 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Arthralgia | 3 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Sleepiness (N=692, 684) | 16 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Headache | 5 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Injection site induration | 18 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Rash | 4 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Irritability (N=692, 684) | 21 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Fever ( ≥ 38C ; N=692, 684) | 2 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Injection site erythema | 27 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Stayed home (N=682, 670) | 3 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Vomiting (N=692, 684) | 3 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Analgesic/Antipyretic medication used | 11 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Fever ( ≥ 40.0C ) | 0 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Analgesic/Antipyretic medication used | 13 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Fever ( ≥ 40.0C ) | 0 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Injection site pain | 35 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Injection site erythema | 18 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Injection site induration | 18 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Change in Eating Habits (N=683, 671) | 10 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Sleepiness (N=692, 684) | 18 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Irritability (N=692, 684) | 22 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Vomiting (N=692, 684) | 3 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Diarrhea (N=692, 684) | 8 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Arthralgia | 4 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Headache | 6 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Rash | 5 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Fever ( ≥ 38C ; N=692, 684) | 2 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. | Stayed home (N=682, 670) | 2 Percentages of subjects |
Secondary
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.
Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group after 1 dose treatment.
Time frame: Study days 1 to 7
Population: The analysis was performed on the safety population. Only groups receiving 1 dose vaccine are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Arthralgia | 6 Percenatage of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Injection site pain | 39 Percenatage of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Injection site erythema | 28 Percenatage of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Injection site induration | 17 Percenatage of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Chills | 5 Percenatage of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Nausea | 8 Percenatage of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Malaise | 14 Percenatage of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Myalgia | 10 Percenatage of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Headache | 18 Percenatage of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Rash | 5 Percenatage of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Fever ( ≥ 38C ; N=582, 570) | 2 Percenatage of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Fever ( ≥ 40.0C ; N=582, 570) | 0 Percenatage of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Stayed home (N=575, 566) | 3 Percenatage of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Analgesic/Antipyretic medication used | 9 Percenatage of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Fever ( ≥ 38C ; N=582, 570) | 2 Percenatage of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Arthralgia | 4 Percenatage of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Myalgia | 10 Percenatage of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Injection site pain | 45 Percenatage of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Stayed home (N=575, 566) | 2 Percenatage of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Injection site erythema | 22 Percenatage of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Headache | 13 Percenatage of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Injection site induration | 13 Percenatage of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Fever ( ≥ 40.0C ; N=582, 570) | 1 Percenatage of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Chills | 5 Percenatage of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Rash | 3 Percenatage of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Nausea | 6 Percenatage of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Analgesic/Antipyretic medication used | 10 Percenatage of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. | Malaise | 11 Percenatage of subjects |
Secondary
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Time frame: 1 month postvaccination
Population: The analysis was performed on the per-protocol (PP) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age | Serogroup W (N=1136, 1138) | 90 Percentage of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age | Serogroup A (N=1157, 1152) | 75 Percentage of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age | Serogroup Y (N=1138, 1139) | 77 Percentage of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age | Serogroup C (N=1161, 1154) | 72 Percentage of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age | Serogroup Y (N=1138, 1139) | 79 Percentage of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age | Serogroup A (N=1157, 1152) | 80 Percentage of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age | Serogroup W (N=1136, 1138) | 60 Percentage of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age | Serogroup C (N=1161, 1154) | 68 Percentage of subjects |
Secondary
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age.
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenategs of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.
Time frame: 1 month postvaccination
Population: The analysis was performed on the per-protocol (PP) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup C (N=607, 615, 554, 539) | 68 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup A (N=606, 611, 551, 541) | 72 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup W (N=594, 605, 542, 533) | 90 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup Y (N=593, 600, 545, 539) | 76 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup C (N=607, 615, 554, 539) | 64 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup W (N=594, 605, 542, 533) | 75 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup A (N=606, 611, 551, 541) | 78 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup Y (N=593, 600, 545, 539) | 57 Percentages of subjects |
| MenACWY-CRM (6 to 10 Yoa) | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup A (N=606, 611, 551, 541) | 77 Percentages of subjects |
| MenACWY-CRM (6 to 10 Yoa) | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup C (N=607, 615, 554, 539) | 77 Percentages of subjects |
| MenACWY-CRM (6 to 10 Yoa) | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup Y (N=593, 600, 545, 539) | 79 Percentages of subjects |
| MenACWY-CRM (6 to 10 Yoa) | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup W (N=594, 605, 542, 533) | 91 Percentages of subjects |
| Licensed Polysaccharide Vaccine (6 to 10 Yoa) | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup Y (N=593, 600, 545, 539) | 63 Percentages of subjects |
| Licensed Polysaccharide Vaccine (6 to 10 Yoa) | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup W (N=594, 605, 542, 533) | 84 Percentages of subjects |
| Licensed Polysaccharide Vaccine (6 to 10 Yoa) | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup C (N=607, 615, 554, 539) | 74 Percentages of subjects |
| Licensed Polysaccharide Vaccine (6 to 10 Yoa) | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age. | Serogroup A (N=606, 611, 551, 541) | 83 Percentages of subjects |
Secondary
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)
The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Time frame: 1 month postvaccination
Population: The analysis was performed on the per-protocol (PP) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) | Serogroup A (N=291, 606) | 91 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) | Serogroup C (N=293, 607) | 99 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) | Serogroup W (N=288, 594) | 99 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) | Serogroup Y (N=286, 593) | 98 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) | Serogroup Y (N=286, 593) | 76 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) | Serogroup A (N=291, 606) | 72 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) | Serogroup W (N=288, 594) | 90 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) | Serogroup C (N=293, 607) | 68 Percentages of subjects |
Secondary
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age.
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Time frame: 1 month postvaccination
Population: The analysis was performed on the per-protocol (PP) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age. | Serogroup A (N=1157, 1152) | 74 Percenatage of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age. | Serogroup C (N=1161, 1154) | 61 Percenatage of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age. | Serogroup W (N=1136, 1138) | 65 Percenatage of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age. | Serogroup Y (N=1138, 1139) | 62 Percenatage of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age. | Serogroup Y (N=1138, 1139) | 42 Percenatage of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age. | Serogroup A (N=1157, 1152) | 80 Percenatage of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age. | Serogroup W (N=1136, 1138) | 51 Percenatage of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age. | Serogroup C (N=1161, 1154) | 57 Percenatage of subjects |
Secondary
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose)
The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Time frame: 1 month postvaccination
Population: The analysis was performed on the per-protocol (PP) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose) | Serogroup A (N=291, 606) | 91 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose) | Serogroup C (N=293, 607) | 98 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose) | Serogroup W (N=288, 594) | 89 Percentages of subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose) | Serogroup Y (N=286, 593) | 95 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose) | Serogroup Y (N=286, 593) | 66 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose) | Serogroup A (N=291, 606) | 72 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose) | Serogroup W (N=288, 594) | 72 Percentages of subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose) | Serogroup C (N=293, 607) | 60 Percentages of subjects |
Secondary
Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment.
Safety was assessed in terms of the percentage of subjects with unsolicited AEs occurring throughout the entire study period, after 1 dose treatment.
Time frame: day 1 to study termination (day 240)
Population: The analysis was performed on safety population. Only groups receiving 1 dose vaccine are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM (1 Dose) | Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment. | Any AEs | 26 Percentage of Subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment. | Possibly probably related AEs | 5 Percentage of Subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment. | SAEs | 1 Percentage of Subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment. | AEs leading to discontinuation | 0 Percentage of Subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment. | Possibly probably related SAEs | 0 Percentage of Subjects |
| MenACWY-CRM (1 Dose) | Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment. | Death | 0 Percentage of Subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment. | Possibly probably related SAEs | 0 Percentage of Subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment. | Any AEs | 24 Percentage of Subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment. | AEs leading to discontinuation | 0 Percentage of Subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment. | Possibly probably related AEs | 5 Percentage of Subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment. | Death | 0 Percentage of Subjects |
| Licensed Polysaccharide Vaccine | Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment. | SAEs | 1 Percentage of Subjects |