Meningococcal Disease, Meningococcal Meningitis
Conditions
Keywords
Meningococcal, ACWY, Conjugate Vaccine, Meningitis, Infants, Persistence
Brief summary
The purpose of this study was to assess immunogenicity of a 3-dose versus 4-dose infant vaccination schedule including kinetics of immune response in the early phases of the series.
Interventions
BIOLOGICALMenACWY-CRM
This group received a 3-dose primary series at 2, 4, and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
BIOLOGICALRoutine Vaccines
Each 0.5 mL dose of the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) is formulated to contain approximately 2.2 μg of each of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Days to 89 Days
Healthy volunteers
Yes
Inclusion criteria
* Infants of both genders who are in generally good health will be eligible for this study. For infants to be enrolled, the parents/legal representatives need to provide written informed consent and to be available for all study visits.
Exclusion criteria
* Serious, acute, or chronic illnesses are reasons for exclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination. | 13 months of age | The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4, 6 and 12 months of age. |
| Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination. | 13 months of age | The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4,6 and 12 months of age and 3 doses of Men ACWY given to infants at 2, 4 and 12 months of age. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY. | 12 months of age. | Percentage of subjects with hSBA ≥1:8 against N meningitis serogroups A, C, W and Y was assessed following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age. |
| Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY. | 12 months of age | The immune response was assessed in terms of GMTs against N. meningitidis serogroups A, C, W and Y following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age. |
| GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY. | 13 months of age | Immune response was assessed in terms of GMTs against N meningitis serogroups A, C, W and Y at 1 month after completion of a 3- and 4- dose series of MenACWY. |
| Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age. | 13 months of age | The immune response was assessed in terms of percentage of subjects with 4-fold increase in hSBA titers between post and pre toddler dose against N meningitis serogroups A, C, W and Y, 1 month after completing a 3- or 4-dose series of MenACWY. |
| Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Baseline (2 months of age), 3 months, 4 months , 5 months and 7 months of age | Antibody levels were assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y at baseline (2 months of age) and at 3, 4, 5 and 7 months of age. |
| Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 13 months of age. | Geometric mean concentrations (GMCs) of antibodies against PCV-13 vaccine antigens at 13 months of age following concomitant administration of a 3- or 4-dose series of MenACWY with PCV-13. |
| Percentage Of Subjects Reporting at Least One Severe Systemic Solicited Adverse Event. | Within 7 days | Safety was assessed as the percentages of subjects who reported severe solicited systemic adverse events within 30 minutes through day 7 of MenACWY administration with concomitant vaccines vs. concomitant vaccines alone. |
| Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Day 1 through Day 7 | Safety was assessed as the number of subjects who reported solicited local or systemic adverse events between 6 hours and day 7 after administration of MenACWY with concomitant vaccines vs. concomitant vaccines alone. |
| Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | 13 months of age | — |
| Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 7 months of age. | Percentage of subjects with IgG concentration ≥ 0.35 μg/mL against pneumococcal conjugate vaccine (PCV-13) antigens at 7 Months of age following concomitant administration of 2 or 3 doses of MenACWY with PCV-13. |
| Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Baseline(2 months of age), 3 months, 4 months , 5 months and 7 months of age. | Antibody levels were assessed in terms of geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W and Y at baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. |
Countries
Canada, United States
Participant flow
Recruitment details
Subjects were enrolled at 3 sites in Canada and 37 sites in United States of America.
Pre-assignment details
All the enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| MenACWY3 Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age. | 249 |
| MenACWY4 All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4. | 256 |
| Routine Vaccines Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age. | 246 |
| Total | 751 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative Reason | 2 | 6 | 4 |
| Overall Study | Adverse Event | 1 | 2 | 1 |
| Overall Study | Death | 0 | 0 | 1 |
| Overall Study | Inappropriate Enrolment | 0 | 1 | 2 |
| Overall Study | Lost to Follow-up | 20 | 15 | 21 |
| Overall Study | Protocol Violation | 3 | 1 | 5 |
| Overall Study | Unable to Classify | 1 | 3 | 0 |
| Overall Study | Withdrawal by Subject | 27 | 36 | 28 |
Baseline characteristics
| Characteristic | MenACWY3 | MenACWY4 | Routine Vaccines | Total |
|---|---|---|---|---|
| Age, Continuous | 66.4 Days STANDARD_DEVIATION 7.1 | 66.7 Days STANDARD_DEVIATION 7.4 | 66.7 Days STANDARD_DEVIATION 7 | 66.6 Days STANDARD_DEVIATION 7.2 |
| Sex: Female, Male Female | 126 Participants | 123 Participants | 106 Participants | 355 Participants |
| Sex: Female, Male Male | 123 Participants | 133 Participants | 140 Participants | 396 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 238 / 242 | 233 / 252 | 228 / 239 |
| serious Total, serious adverse events | 11 / 242 | 19 / 252 | 11 / 239 |
Outcome results
Primary
Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination.
The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4,6 and 12 months of age and 3 doses of Men ACWY given to infants at 2, 4 and 12 months of age.
Time frame: 13 months of age
Population: Analysis was done on Toddler PPS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY4 | Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination. | Serogroup A (N=146,141) | 88 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination. | Serogroup W (N=153,138) | 99 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination. | Serogroup C | 95 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination. | Serogroup Y (N=154,146) | 100 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination. | Serogroup Y (N=154,146) | 99 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination. | Serogroup W (N=153,138) | 99 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination. | Serogroup A (N=146,141) | 96 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination. | Serogroup C | 99 Percentage of subjects |
Comparison: Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup A at 13 months of age.95% CI: [-14, -1]Miettinen and Nurminen method
Comparison: Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup C at 13 months of age.95% CI: [-8, 0]Miettinen and Nurminen method
Comparison: Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup W at 13 months of age.95% CI: [-3, 3]Miettinen and Nurminen method
Comparison: Non-inferiority of Men ACWY 3-dose series (doses at 2, 4 and 12 months) to 4-dose series (doses at 2, 4, 6 and 12 months of age) against serogroup Y at 13 months of age.95% CI: [-2, 4]Miettinen and Nurminen method
Primary
Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination.
The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4, 6 and 12 months of age.
Time frame: 13 months of age
Population: Analysis was done on the Toddler Per Protocol Population (PPS) - all subjects who received all doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding through 13 month timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY4 | Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination. | Serogroup A (N=141) | 96 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination. | Serogroup C | 99 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination. | Serogroup W (N=138) | 99 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination. | Serogroup Y (N=146) | 99 Percentage of subjects |
Secondary
Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age.
Percentage of subjects with IgG concentration ≥ 0.35 μg/mL against pneumococcal conjugate vaccine (PCV-13) antigens at 7 Months of age following concomitant administration of 2 or 3 doses of MenACWY with PCV-13.
Time frame: 7 months of age.
Population: Analysis was done on the Infant PPS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 9V (N=159,136,157) | 89.3 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 14 (N=158,136,158) | 99.4 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 19A (N=158,135,156) | 95.6 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 18C (N=158,136,157) | 97.5 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 4 (N=160,137,157) | 94.4 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 23F (N=158,136,158) | 93 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 1 (N=159,136,156) | 93.7 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 5 (N=156,133,154) | 84 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 6A (N=159,136,156) | 98.1 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 19F (N=159,136,158) | 100 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 6B (N=160,137,157) | 84.4 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 7F (N=158,136,156) | 100 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 3 (N=150,129,147) | 79.3 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 19A (N=158,135,156) | 92.6 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 9V (N=159,136,157) | 96.3 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 3 (N=150,129,147) | 87.6 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 7F (N=158,136,156) | 100 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 14 (N=158,136,158) | 100 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 5 (N=156,133,154) | 93.2 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 1 (N=159,136,156) | 100 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 18C (N=158,136,157) | 97.8 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 6B (N=160,137,157) | 94.9 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 4 (N=160,137,157) | 97.1 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 6A (N=159,136,156) | 99.3 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 23F (N=158,136,158) | 95.6 Percentage of subjects |
| MenACWY4 | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 19F (N=159,136,158) | 100 Percentage of subjects |
| Routine Vaccines | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 23F (N=158,136,158) | 91.1 Percentage of subjects |
| Routine Vaccines | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 1 (N=159,136,156) | 94.2 Percentage of subjects |
| Routine Vaccines | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 19A (N=158,135,156) | 98.1 Percentage of subjects |
| Routine Vaccines | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 3 (N=150,129,147) | 82.3 Percentage of subjects |
| Routine Vaccines | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 4 (N=160,137,157) | 96.8 Percentage of subjects |
| Routine Vaccines | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 5 (N=156,133,154) | 88.3 Percentage of subjects |
| Routine Vaccines | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 6A (N=159,136,156) | 98.1 Percentage of subjects |
| Routine Vaccines | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 6B (N=160,137,157) | 84.7 Percentage of subjects |
| Routine Vaccines | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 7F (N=158,136,156) | 99.4 Percentage of subjects |
| Routine Vaccines | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 9V (N=159,136,157) | 92.4 Percentage of subjects |
| Routine Vaccines | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 14 (N=158,136,158) | 97.5 Percentage of subjects |
| Routine Vaccines | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 18C (N=158,136,157) | 100 Percentage of subjects |
| Routine Vaccines | Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. | 19F (N=159,136,158) | 99.4 Percentage of subjects |
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 1.95% CI: [-6.1, 5]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 1.95% CI: [3, 10.5]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 3.95% CI: [-11.9, 6]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 3.95% CI: [-3.3, 13.7]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 4.95% CI: [-7.5, 2.3]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 4.95% CI: [-4.4, 4.7]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 5.95% CI: [-12.1, 3.4]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 5.95% CI: [-1.9, 11.8]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6A.95% CI: [-3.7, 3.8]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6A.95% CI: [-2.2, 4.8]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6B.95% CI: [-8.4, 7.7]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 6B.95% CI: [3.4, 17.2]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 7F.95% CI: [-1.7, 3.5]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 7F.95% CI: [-2.1, 3.5]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 9V.95% CI: [-9.7, 3.4]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 9V.95% CI: [-1.5, 9.7]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 14.95% CI: [-1.2, 5.7]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 14.95% CI: [-0.2, 6.3]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 18C.95% CI: [-6.3, -0.2]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 18C.95% CI: [-6.2, 0.2]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19A.95% CI: [-7.1, 1.6]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19A.95% CI: [-11.3, -0.9]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19F.95% CI: [-1.7, 3.4]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 19F.95% CI: [-2.1, 3.4]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 2 doses of MenACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 23F.95% CI: [-4.2, 8.2]Miettinen and Nurminen method
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 7 months of age for Serotype 23F.95% CI: [-1.4, 10.5]Miettinen and Nurminen method
Secondary
Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age.
Geometric mean concentrations (GMCs) of antibodies against PCV-13 vaccine antigens at 13 months of age following concomitant administration of a 3- or 4-dose series of MenACWY with PCV-13.
Time frame: 13 months of age.
Population: Analysis was done on the Toddler PPS.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 6B (N=147,117,124) | 4.29 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 7F (N=147,116,123) | 3.96 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 3 (N=139,113,118) | 0.88 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 23F (N=147,117,124) | 4.21 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 5 (N=140,114,117) | 1.29 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 4 (N=146,117,123) | 1.19 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 6A (N=146,117,124) | 6.89 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 18C (N=146,116,123) | 1.52 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 19F (N=147,117,124) | 5.79 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 19A (N=144,114,124) | 5.51 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 14 (N=147,117,124) | 7.76 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 9V (N=146,117,123) | 1.37 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 1 (N=145,116,123) | 2 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 4 (N=146,117,123) | 1.45 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 6A (N=146,117,124) | 9.01 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 6B (N=147,117,124) | 5.23 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 14 (N=147,117,124) | 7.86 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 19A (N=144,114,124) | 5.23 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 1 (N=145,116,123) | 2.16 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 3 (N=139,113,118) | 0.97 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 5 (N=140,114,117) | 1.35 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 7F (N=147,116,123) | 5.14 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 9V (N=146,117,123) | 1.85 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 18C (N=146,116,123) | 2.34 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 19F (N=147,117,124) | 6.19 µg/mL |
| MenACWY4 | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 23F (N=147,117,124) | 4.84 µg/mL |
| Routine Vaccines | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 1 (N=145,116,123) | 2.14 µg/mL |
| Routine Vaccines | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 23F (N=147,117,124) | 5.44 µg/mL |
| Routine Vaccines | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 7F (N=147,116,123) | 4.95 µg/mL |
| Routine Vaccines | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 19A (N=144,114,124) | 5.39 µg/mL |
| Routine Vaccines | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 19F (N=147,117,124) | 5.8 µg/mL |
| Routine Vaccines | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 9V (N=146,117,123) | 1.73 µg/mL |
| Routine Vaccines | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 14 (N=147,117,124) | 7.54 µg/mL |
| Routine Vaccines | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 4 (N=146,117,123) | 1.53 µg/mL |
| Routine Vaccines | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 3 (N=139,113,118) | 0.77 µg/mL |
| Routine Vaccines | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 18C (N=146,116,123) | 2.13 µg/mL |
| Routine Vaccines | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 5 (N=140,114,117) | 1.26 µg/mL |
| Routine Vaccines | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 6A (N=146,117,124) | 8.16 µg/mL |
| Routine Vaccines | Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. | 6B (N=147,117,124) | 5.04 µg/mL |
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 1.95% CI: [0.77, 1.13]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 1.95% CI: [0.83, 1.25]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 3.95% CI: [0.93, 1.4]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 3.95% CI: [1.01, 1.55]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 4.95% CI: [0.62, 0.96]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 4.95% CI: [0.75, 1.18]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 5.95% CI: [0.86, 1.21]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 5.95% CI: [0.89, 1.29]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6A.95% CI: [0.69, 1.04]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6A.95% CI: [0.88, 1.37]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6B.95% CI: [0.69, 1.05]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 6B.95% CI: [0.83, 1.3]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 7F.95% CI: [0.67, 0.95]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 7F.95% CI: [0.87, 1.25]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 9V.95% CI: [0.66, 0.96]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 9V.95% CI: [0.87, 1.31]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 14.95% CI: [0.84, 1.27]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 14.95% CI: [0.83, 1.3]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 18C.95% CI: [0.59, 0.87]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 18C.95% CI: [0.89, 1.36]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19A.95% CI: [0.83, 1.27]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19A.95% CI: [0.77, 1.21]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19F.95% CI: [0.82, 1.22]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 19F.95% CI: [0.86, 1.32]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 3 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 23F.95% CI: [0.62, 0.97]ANOVA
Comparison: To demonstrate non-inferiority of immune response to PCV-13 antigens after concomitant administration of 4 doses of Men ACWY with routine vaccines including PCV-13, versus administration of routine vaccines only, at 13 months of age for Serotype 23F.95% CI: [0.7, 1.13]ANOVA
Secondary
Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.
Antibody levels were assessed in terms of geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W and Y at baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.
Time frame: Baseline(2 months of age), 3 months, 4 months , 5 months and 7 months of age.
Population: Analysis was done on the Infant PPS.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (4 months; N=0,70,0) | NA Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (baseline; N=0,0,150) | NA Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (5 months; N=162,0,0) | 55 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (3 months; N=0,85,0) | NA Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (3 months; N=0,80,0) | NA Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (7 months; N=169,157,171) | 3.68 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (baseline; N=0,0,167) | NA Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (4 months; N=0,69,0) | NA Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (5 months; N=157,0,0) | 7.09 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (3 months; N=0,82,0) | NA Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (4 months; N=0,70,0) | NA Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (4 months;N=0,71,0) | NA Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (5 months; N=170,0,0) | 50 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (7 months; N=170,163,173) | 7.56 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (baseline; N=0,0,166) | NA Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (7 months) | 17 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (baseline; N=0,0,157) | NA Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (3 months; N=0,84,0) | NA Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (7 months; N=179,162,181) | 17 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (5 months; N=152,0,0) | 20 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (3 months; N=0,84,0) | 3 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (baseline; N=0,0,166) | NA Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (3 months; N=0,82,0) | 2.63 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (7 months; N=169,157,171) | 28 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (baseline; N=0,0,167) | NA Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (4 months; N=0,70,0) | 6.44 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (5 months; N=170,0,0) | NA Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (4 months;N=0,71,0) | 4.38 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (7 months; N=179,162,181) | 90 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (baseline; N=0,0,150) | NA Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (3 months; N=0,80,0) | 2.5 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (4 months; N=0,70,0) | 2.18 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (5 months; N=157,0,0) | NA Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (3 months; N=0,85,0) | 4.79 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (7 months) | 86 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (baseline; N=0,0,157) | NA Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (5 months; N=162,0,0) | NA Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (4 months; N=0,69,0) | 2.46 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (5 months; N=152,0,0) | NA Titers |
| MenACWY4 | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (7 months; N=170,163,173) | 52 Titers |
| Routine Vaccines | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (4 months; N=0,70,0) | NA Titers |
| Routine Vaccines | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (7 months) | 2.03 Titers |
| Routine Vaccines | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (7 months; N=170,163,173) | 2 Titers |
| Routine Vaccines | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (baseline; N=0,0,157) | 3.32 Titers |
| Routine Vaccines | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (3 months; N=0,84,0) | NA Titers |
| Routine Vaccines | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (5 months; N=170,0,0) | NA Titers |
| Routine Vaccines | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (4 months; N=0,70,0) | NA Titers |
| Routine Vaccines | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (4 months;N=0,71,0) | NA Titers |
| Routine Vaccines | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (baseline; N=0,0,167) | 2.52 Titers |
| Routine Vaccines | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (5 months; N=152,0,0) | NA Titers |
| Routine Vaccines | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (5 months; N=162,0,0) | NA Titers |
| Routine Vaccines | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (7 months; N=169,157,171) | 2.02 Titers |
| Routine Vaccines | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (baseline; N=0,0,166) | 2.18 Titers |
| Routine Vaccines | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (3 months; N=0,82,0) | NA Titers |
| Routine Vaccines | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (5 months; N=157,0,0) | NA Titers |
| Routine Vaccines | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (3 months; N=0,80,0) | NA Titers |
| Routine Vaccines | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (baseline; N=0,0,150) | 2.47 Titers |
| Routine Vaccines | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (4 months; N=0,69,0) | NA Titers |
| Routine Vaccines | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (3 months; N=0,85,0) | NA Titers |
| Routine Vaccines | Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (7 months; N=179,162,181) | 2.04 Titers |
Secondary
Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY.
The immune response was assessed in terms of GMTs against N. meningitidis serogroups A, C, W and Y following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age.
Time frame: 12 months of age
Population: Analysis was done on the Toddler PPS.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY4 | Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY. | Serogroup W (N=149,142) | 5.41 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY. | Serogroup Y (N=145,139) | 3.82 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY. | Serogroup A (N=141,138) | 2.28 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY. | Serogroup C | 3.54 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY. | Serogroup C | 8.55 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY. | Serogroup W (N=149,142) | 13 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY. | Serogroup A (N=141,138) | 3.65 Titers |
| MenACWY4 | Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY. | Serogroup Y (N=145,139) | 9.65 Titers |
Secondary
GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY.
Immune response was assessed in terms of GMTs against N meningitis serogroups A, C, W and Y at 1 month after completion of a 3- and 4- dose series of MenACWY.
Time frame: 13 months of age
Population: Analysis was done on the Toddler PPS.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY4 | GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY. | Serogroup A (N=146,141) | 59 Titers |
| MenACWY4 | GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY. | Serogroup C | 124 Titers |
| MenACWY4 | GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY. | Serogroup W (N=153,138) | 248 Titers |
| MenACWY4 | GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY. | Serogroup Y (N=154,146) | 212 Titers |
| MenACWY4 | GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY. | Serogroup Y (N=154,146) | 254 Titers |
| MenACWY4 | GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY. | Serogroup A (N=146,141) | 94 Titers |
| MenACWY4 | GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY. | Serogroup W (N=153,138) | 244 Titers |
| MenACWY4 | GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY. | Serogroup C | 160 Titers |
Secondary
Number Of Subjects Reporting Solicited Local or Systemic Adverse Events.
Safety was assessed as the number of subjects who reported solicited local or systemic adverse events between 6 hours and day 7 after administration of MenACWY with concomitant vaccines vs. concomitant vaccines alone.
Time frame: Day 1 through Day 7
Population: Analysis was done on Solicited Safety Set - All subjects in the Exposed Set with solicited adverse event data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Irritability | 173 Subjects |
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Rash | 23 Subjects |
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Vomiting | 68 Subjects |
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Diarrhea | 89 Subjects |
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Injection site erythema | 72 Subjects |
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Use of analgesic/antipyretic | 162 Subjects |
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Sleepiness | 153 Subjects |
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Injection site induration | 60 Subjects |
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Fever (≥38.0°C) | 55 Subjects |
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Tenderness | 117 Subjects |
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Persistent crying | 140 Subjects |
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Change in eating habits (N=238,238,229) | 104 Subjects |
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Change in eating habits (N=238,238,229) | 104 Subjects |
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Sleepiness | 147 Subjects |
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Injection site induration | 40 Subjects |
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Vomiting | 52 Subjects |
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Rash | 19 Subjects |
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Fever (≥38.0°C) | 52 Subjects |
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Diarrhea | 69 Subjects |
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Persistent crying | 137 Subjects |
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Irritability | 171 Subjects |
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Tenderness | 127 Subjects |
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Use of analgesic/antipyretic | 173 Subjects |
| MenACWY4 | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Injection site erythema | 64 Subjects |
| Routine Vaccines | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Use of analgesic/antipyretic | 153 Subjects |
| Routine Vaccines | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Change in eating habits (N=238,238,229) | 93 Subjects |
| Routine Vaccines | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Fever (≥38.0°C) | 41 Subjects |
| Routine Vaccines | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Injection site erythema | 79 Subjects |
| Routine Vaccines | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Injection site induration | 74 Subjects |
| Routine Vaccines | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Sleepiness | 149 Subjects |
| Routine Vaccines | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Persistent crying | 112 Subjects |
| Routine Vaccines | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Irritability | 152 Subjects |
| Routine Vaccines | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Vomiting | 54 Subjects |
| Routine Vaccines | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Diarrhea | 68 Subjects |
| Routine Vaccines | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Rash | 18 Subjects |
| Routine Vaccines | Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. | Tenderness | 126 Subjects |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
Time frame: 13 months of age
Population: Analysis was done on the Unsolicited Safety Set - All subjects in the Exposed Set with unsolicited adverse event data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY4 | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Medically attended AEs | 210 Subjects |
| MenACWY4 | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | At least possibly related AEs | 24 Subjects |
| MenACWY4 | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | AEs resulting in premature withdrawal | 1 Subjects |
| MenACWY4 | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | SAEs | 11 Subjects |
| MenACWY4 | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Deaths | 0 Subjects |
| MenACWY4 | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Any AE | 219 Subjects |
| MenACWY4 | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Any AE | 220 Subjects |
| MenACWY4 | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Medically attended AEs | 211 Subjects |
| MenACWY4 | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Deaths | 0 Subjects |
| MenACWY4 | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | SAEs | 19 Subjects |
| MenACWY4 | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | AEs resulting in premature withdrawal | 2 Subjects |
| MenACWY4 | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | At least possibly related AEs | 32 Subjects |
| Routine Vaccines | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | AEs resulting in premature withdrawal | 2 Subjects |
| Routine Vaccines | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Any AE | 209 Subjects |
| Routine Vaccines | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | At least possibly related AEs | 10 Subjects |
| Routine Vaccines | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Deaths | 1 Subjects |
| Routine Vaccines | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | Medically attended AEs | 198 Subjects |
| Routine Vaccines | Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. | SAEs | 11 Subjects |
Secondary
Percentage Of Subjects Reporting at Least One Severe Systemic Solicited Adverse Event.
Safety was assessed as the percentages of subjects who reported severe solicited systemic adverse events within 30 minutes through day 7 of MenACWY administration with concomitant vaccines vs. concomitant vaccines alone.
Time frame: Within 7 days
Population: Analysis was done on the Solicited Safety Set - All subjects in the Exposed Set with solicited adverse event data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MenACWY4 | Percentage Of Subjects Reporting at Least One Severe Systemic Solicited Adverse Event. | 18 Percentage of subjects |
| MenACWY4 | Percentage Of Subjects Reporting at Least One Severe Systemic Solicited Adverse Event. | 21 Percentage of subjects |
| Routine Vaccines | Percentage Of Subjects Reporting at Least One Severe Systemic Solicited Adverse Event. | 18 Percentage of subjects |
Secondary
Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age.
The immune response was assessed in terms of percentage of subjects with 4-fold increase in hSBA titers between post and pre toddler dose against N meningitis serogroups A, C, W and Y, 1 month after completing a 3- or 4-dose series of MenACWY.
Time frame: 13 months of age
Population: Analysis was done on the Toddler PPS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY4 | Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age. | Serogroup Y (N=139,136) | 100 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age. | Serogroup A (N=127,129) | 88 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age. | Serogroup C | 93 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age. | Serogroup W (N=140,131) | 98 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age. | Serogroup W (N=140,131) | 90 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age. | Serogroup Y (N=139,136) | 96 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age. | Serogroup C | 91 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age. | Serogroup A (N=127,129) | 95 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.
Antibody levels were assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y at baseline (2 months of age) and at 3, 4, 5 and 7 months of age.
Time frame: Baseline (2 months of age), 3 months, 4 months , 5 months and 7 months of age
Population: Analysis was done on Infant PPS - all subjects who received all doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol violation as defined prior to unblinding, through the 7 month timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (3 months; N=0,80,0) | NA Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (4 months; N=0,70,0) | NA Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (7 months; N=169,157,171) | 23 Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (4 months; N=0,70,0) | NA Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (5 months; N=157,0,0) | 43 Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (7 months; N=170,163,173) | 48 Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (baseline; N=0,0,157) | NA Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (3 months; N=0,82,0) | NA Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (baseline; N=0,0,166) | NA Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (5 months; N=162,0,0) | 86 Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (7 months; N=179,162,181) | 74 Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (3 months; N=0,84,0) | NA Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (4 months; N=0,69,0) | NA Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (3 months; N=0,85,0) | NA Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (7 months) | 71 Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (5 months; N=152,0,0) | 67 Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (5 months; N=170,0,0) | 86 Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (baseline; N=0,0,150) | NA Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (4 months; N=0,71,0) | NA Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (baseline; N=0,0,167) | NA Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (5 months; N=170,0,0) | NA Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (3 months; N=0,85,0) | 28 Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (4 months; N=0,70,0) | 41 Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (7 months; N=179,162,181) | 99 Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (4 months; N=0,69,0) | 7 Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (baseline; N=0,0,150) | NA Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (3 months; N=0,80,0) | 8 Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (5 months; N=152,0,0) | NA Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (7 months; N=170,163,173) | 94 Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (baseline; N=0,0,166) | NA Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (4 months; N=0,70,0) | 4 Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (5 months; N=157,0,0) | NA Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (7 months; N=169,157,171) | 84 Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (baseline; N=0,0,167) | NA Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (3 months; N=0,82,0) | 9 Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (7 months) | 95 Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (baseline; N=0,0,157) | NA Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (3 months; N=0,84,0) | 15 Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (4 months; N=0,71,0) | 35 Percentages of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (5 months; N=162,0,0) | NA Percentages of subjects |
| Routine Vaccines | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (baseline; N=0,0,150) | 7 Percentages of subjects |
| Routine Vaccines | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (4 months; N=0,71,0) | NA Percentages of subjects |
| Routine Vaccines | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (3 months; N=0,85,0) | NA Percentages of subjects |
| Routine Vaccines | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (4 months; N=0,70,0) | NA Percentages of subjects |
| Routine Vaccines | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (7 months; N=179,162,181) | 1 Percentages of subjects |
| Routine Vaccines | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (3 months; N=0,84,0) | NA Percentages of subjects |
| Routine Vaccines | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (5 months; N=170,0,0) | NA Percentages of subjects |
| Routine Vaccines | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (4 months; N=0,69,0) | NA Percentages of subjects |
| Routine Vaccines | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (3 months; N=0,82,0) | NA Percentages of subjects |
| Routine Vaccines | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (7 months) | 1 Percentages of subjects |
| Routine Vaccines | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (baseline; N=0,0,166) | 4 Percentages of subjects |
| Routine Vaccines | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (7 months; N=170,163,173) | 0 Percentages of subjects |
| Routine Vaccines | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (5 months; N=162,0,0) | NA Percentages of subjects |
| Routine Vaccines | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (4 months; N=0,70,0) | NA Percentages of subjects |
| Routine Vaccines | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (5 months; N=152,0,0) | NA Percentages of subjects |
| Routine Vaccines | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup W (baseline; N=0,0,157) | 20 Percentages of subjects |
| Routine Vaccines | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (5 months; N=157,0,0) | NA Percentages of subjects |
| Routine Vaccines | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup Y (3 months; N=0,80,0) | NA Percentages of subjects |
| Routine Vaccines | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup C (baseline; N=0,0,167) | 9 Percentages of subjects |
| Routine Vaccines | Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. | Serogroup A (7 months; N=169,157,171) | 1 Percentages of subjects |
Secondary
Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY.
Percentage of subjects with hSBA ≥1:8 against N meningitis serogroups A, C, W and Y was assessed following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age.
Time frame: 12 months of age.
Population: Analysis was done on the Toddler PPS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY. | Serogroup C | 19 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY. | Serogroup A (N=141,138) | 6 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY. | Serogroup Y (N=145,139) | 25 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY. | Serogroup W (N=149,142) | 33 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY. | Serogroup Y (N=145,139) | 55 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY. | Serogroup A (N=141,138) | 22 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY. | Serogroup W (N=149,142) | 66 Percentage of subjects |
| MenACWY4 | Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY. | Serogroup C | 48 Percentage of subjects |