Meningococcal Meningitis
Conditions
Keywords
meningitis, children, vaccine
Brief summary
To assess the immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY conjugate vaccine (MenACWY) when administered as a two-dose schedule at 6 and 12 months of age.
Interventions
BIOLOGICALMenACWY-CRM
Subjects received the full dose (0.5 mL) of MenACWY-CRM, obtained by extemporaneous mixing of lyophilized MenA powder component and the MenCWY suspension, administered by IM injection into the anterolateral area of the right thigh.
BIOLOGICALMenC-CRM
One dose (0.5 mL) of MenC-CRM was obtained by extemporaneous mixing just before injection of the lyophilized MenC component and a saline solvent, administered by IM injection into the arm region.
BIOLOGICALDTaP-Hib-IPV
BIOLOGICALPC7
One dose (0.5 mL) of PC7, supplied in pre-filled syringe, administered by IM injection into the anterolateral area of the left thigh.
BIOLOGICALMMR
BIOLOGICALVaricella
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Months
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria for Groups I (MenACWY-CRM\_6-12 M) and II (MenACWY-CRM\_12 M) Subjects eligible for enrollment in the study were healthy infants: 1. who were 6 months old and who were born after full-term pregnancy with an estimated gestational age of 37 weeks or greater and a birth weight 2.5 kg or greater; 2. who previously received two doses of PC7 and DTaP-Hib-IPV vaccines; 3. for whom a parent/legal guardian gave written informed consent, after the nature of the study was explained; 4. who were available for all the visits scheduled in the study; 5. who were in good health as determined by medical history, physical examination, and clinical judgment of the investigator. Inclusion criteria for Group III (MenC-CRM\_12 M\_MenACWY-CRM\_18 M) Subjects eligible for enrollment in the study were healthy infants: 1. who were 12 months old; 2. who previously received three doses of DTaP-Hib-IPV (Pentacel) vaccines; 3. for whom a parent/legal guardian gave written informed consent, after the nature of the study was explained; 4. who were available for all the visits scheduled in the study; 5. who were in good health as determined by medical history, physical examination, and clinical judgment of the investigator.
Exclusion criteria
Subjects were not to be included in this study if: 1. their parents/legal guardians were unwilling or unable to give written informed consent to participate in the study; 2. they previously received any meningococcal vaccine; 3. they had a previously ascertained or suspected disease caused by Neisseria meningitidis (N meningitidis); 4. they had a history of any anaphylactic shock, asthma, urticaria, or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component; 5. they had experienced significant acute or chronic infection within the previous 7 days or had experienced fever (38.0ºC or greater) within the previous 3 days; 6. they had any present or suspected serious acute disease (e.g., leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac failure, renal failure, severe malnutrition, or insulin-dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down's syndrome), or who had a diagnosed cardiac defect or abnormality of hemodynamic significance (e.g., ventricular septal defect, patent ductus arteriosus, or atrial septal defect); 7. they had a known or suspected autoimmune disease or impairment /alteration of immune function resulting from use of (for example): * any immunosuppressive therapy since birth; * immunostimulants since birth; * any systemic corticosteroid administered for more than 5 days or in a daily dose of greater than 1 mg/kg/day prednisone or equivalent for 5 days or less in the previous 30 days; 8. they had a suspected or known HIV infection or HIV-related disease; 9. they had received parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 90 days and were expected to receive it for the full length of the study; 10. they had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time; 11. they had a history of seizure disorder: * febrile seizure; * any other seizure disorder; 12. they had taken systemic antibiotics (either oral or parenteral) within the previous 14 days (EXCEPTION: subjects who had received an oral or parenteral β-lactam antibiotic \[e.g.: penicillin, amoxicillin, ceftriaxone, cefuroxime or cephalexin\] could have been enrolled 7 days following the last dose); 13. their parents/legal guardians were planning to leave the area of the study center before the end of the study period; 14. they had any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Before and 1 month after 2-dose or 1-dose schedule | Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM\_6-12 M group) or 1-dose schedule administered at 12 months (MenACWY-CRM\_12 M group) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Before and 1 month after 2-dose or 1-dose schedule | The immune response was measured as the hSBA geometric mean titers (GMTs) against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM\_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM\_12 M group) |
| Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Before and 1 month after 2-dose or 1-dose schedule | Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM\_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM\_12 M) |
| Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age | Before and 1 month after MenC-CRM vaccination at 12 months | Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age |
| Geometric Mean hSBA Titers Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age | Before and 1 month after MenC-CRM vaccination at 12 months | The immune response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age |
| Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | Before and 1 month after MenACWY-CRM vaccination at 18 months | Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age |
| hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | Before and 1 month after MenACWY-CRM vaccination at 18 months | The immune response was measured as the hSBA GMTs against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age |
| Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age | Before and 1 month after MenACWY-CRM vaccination at 18 months | Booster response was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age |
| hSBA GMT Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age | Before and 1 month after MenACWY-CRM vaccination at 18 months | Booster response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age |
| Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | From day 1 through day 7 after any vaccination | The safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 following any vaccination of MenACWY-CRM, MenC-CRM and concomitant vaccination |
Countries
Canada
Participant flow
Recruitment details
Subjects were enrolled at three sites in Canada.
Pre-assignment details
All enrolled subjects were included in the study.
Participants by arm
| Arm | Count |
|---|---|
| MenACWY-CRM_6-12 M Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months). | 64 |
| MenACWY-CRM_12 M Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months). | 61 |
| MenC-CRM_12 M_MenACWY-CRM_18 M Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).
Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months). | 50 |
| Total | 175 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Inappropriate enrollment | 1 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 2 | 6 |
| Overall Study | Unable to classify | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 2 |
Baseline characteristics
| Characteristic | MenACWY-CRM_6-12 M | MenACWY-CRM_12 M | MenC-CRM_12 M_MenACWY-CRM_18 M | Total |
|---|---|---|---|---|
| Age, Continuous | 6.0 Months STANDARD_DEVIATION 0.2 | 6.0 Months STANDARD_DEVIATION 0 | 12.1 Months STANDARD_DEVIATION 0.2 | 7.7 Months STANDARD_DEVIATION 2.8 |
| Sex: Female, Male Female | 25 Participants | 31 Participants | 21 Participants | 77 Participants |
| Sex: Female, Male Male | 39 Participants | 30 Participants | 29 Participants | 98 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 | 62 / 64 | 58 / 61 | 50 / 50 |
| serious Total, serious adverse events | 3 / 64 | 2 / 61 | 2 / 50 |
Outcome results
Primary
Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule
Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM\_6-12 M group) or 1-dose schedule administered at 12 months (MenACWY-CRM\_12 M group)
Time frame: Before and 1 month after 2-dose or 1-dose schedule
Population: Analysis was done on per protocol (PP) population, i.e subjects in the exposed population who received all the relevant doses of vaccines correctly; and provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to unblinding.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup A - Prevaccination (N=50,53) | 10 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup A - Postvaccination (N=50,53) | 88 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup C - Prevaccination | 85 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup C - Postvaccination | 100 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup W - Prevaccination (N=40,41) | 85 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup W - Postvaccination (N=40,41) | 100 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup Y - Prevaccination (N=53,54) | 72 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup Y - Postvaccination (N=53,54) | 100 Percentage of subjects |
| MenACWY-CRM_12 M | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup Y - Postvaccination (N=53,54) | 78 Percentage of subjects |
| MenACWY-CRM_12 M | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup A - Prevaccination (N=50,53) | 0 Percentage of subjects |
| MenACWY-CRM_12 M | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup W - Prevaccination (N=40,41) | 2 Percentage of subjects |
| MenACWY-CRM_12 M | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup A - Postvaccination (N=50,53) | 74 Percentage of subjects |
| MenACWY-CRM_12 M | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup Y - Prevaccination (N=53,54) | 0 Percentage of subjects |
| MenACWY-CRM_12 M | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup C - Prevaccination | 2 Percentage of subjects |
| MenACWY-CRM_12 M | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup W - Postvaccination (N=40,41) | 95 Percentage of subjects |
| MenACWY-CRM_12 M | Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup C - Postvaccination | 96 Percentage of subjects |
Secondary
Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule
The immune response was measured as the hSBA geometric mean titers (GMTs) against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM\_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM\_12 M group)
Time frame: Before and 1 month after 2-dose or 1-dose schedule
Population: Analysis was done on PP population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-CRM_6-12 M | Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup W-Postvaccination (N=40,41) | 220 Geometric mean titers |
| MenACWY-CRM_6-12 M | Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup C - Postvaccination | 302 Geometric mean titers |
| MenACWY-CRM_6-12 M | Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup A - Postvaccination (N=50,53) | 44 Geometric mean titers |
| MenACWY-CRM_6-12 M | Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup W - Prevaccination (N=40,41) | 15 Geometric mean titers |
| MenACWY-CRM_6-12 M | Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup A - Prevaccination (N=50,53) | 2.41 Geometric mean titers |
| MenACWY-CRM_6-12 M | Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup Y - Prevaccination | 7.91 Geometric mean titers |
| MenACWY-CRM_6-12 M | Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup Y - Postvaccination | 136 Geometric mean titers |
| MenACWY-CRM_6-12 M | Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup C - Prevaccination | 19 Geometric mean titers |
| MenACWY-CRM_12 M | Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup Y - Postvaccination | 10 Geometric mean titers |
| MenACWY-CRM_12 M | Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup Y - Prevaccination | 2.02 Geometric mean titers |
| MenACWY-CRM_12 M | Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup A - Prevaccination (N=50,53) | 1.99 Geometric mean titers |
| MenACWY-CRM_12 M | Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup A - Postvaccination (N=50,53) | 11 Geometric mean titers |
| MenACWY-CRM_12 M | Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup C - Prevaccination | 2.06 Geometric mean titers |
| MenACWY-CRM_12 M | Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup C - Postvaccination | 40 Geometric mean titers |
| MenACWY-CRM_12 M | Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup W-Postvaccination (N=40,41) | 30 Geometric mean titers |
| MenACWY-CRM_12 M | Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup W - Prevaccination (N=40,41) | 2.09 Geometric mean titers |
Secondary
Geometric Mean hSBA Titers Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age
The immune response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age
Time frame: Before and 1 month after MenC-CRM vaccination at 12 months
Population: Analysis was done on PP population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-CRM_6-12 M | Geometric Mean hSBA Titers Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age | hSBA GMTs - Prevaccination | 2 Geometric mean titers |
| MenACWY-CRM_6-12 M | Geometric Mean hSBA Titers Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age | hSBA GMTs - Postvaccination | 39 Geometric mean titers |
Secondary
hSBA GMT Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age
Booster response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age
Time frame: Before and 1 month after MenACWY-CRM vaccination at 18 months
Population: Analysis was done on PP population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-CRM_6-12 M | hSBA GMT Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age | hSBA GMTs - Prevaccination | 29 Geometric mean titers |
| MenACWY-CRM_6-12 M | hSBA GMT Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age | hSBA GMTs - Postvaccination | 667 Geometric mean titers |
Secondary
hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age
The immune response was measured as the hSBA GMTs against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age
Time frame: Before and 1 month after MenACWY-CRM vaccination at 18 months
Population: Analysis was done on PP population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-CRM_6-12 M | hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | Serogroup A - Prevaccination | 2 Geometric mean titers |
| MenACWY-CRM_6-12 M | hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | Serogroup A - Postvaccination | 8.05 Geometric mean titers |
| MenACWY-CRM_6-12 M | hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | Serogroup W - Prevaccination (N=37) | 2.09 Geometric mean titers |
| MenACWY-CRM_6-12 M | hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | Serogroup W - Postvaccination (N=37) | 17 Geometric mean titers |
| MenACWY-CRM_6-12 M | hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | Serogroup Y - Prevaccination | 2 Geometric mean titers |
| MenACWY-CRM_6-12 M | hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | Serogroup Y - Postvaccination | 13 Geometric mean titers |
Secondary
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination
The safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 following any vaccination of MenACWY-CRM, MenC-CRM and concomitant vaccination
Time frame: From day 1 through day 7 after any vaccination
Population: Analysis was done on the safety population, i.e. all subjects who had at least one vaccination and some postbaseline safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM_6-12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Change in eating habits (N=62,60,50) | 28 participants |
| MenACWY-CRM_6-12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | DTaP-Hib-IPV Tenderness (N=64,61,44) | 23 participants |
| MenACWY-CRM_6-12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | MenACWY MenC Induration (N=64,56,50) | 29 participants |
| MenACWY-CRM_6-12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Fever (≥38 °C) | 6 participants |
| MenACWY-CRM_6-12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | DTaP-Hib-IPV Erythema (N=64,61,44) | 33 participants |
| MenACWY-CRM_6-12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | DTaP-Hib-IPV Induration (N=64,61,44) | 28 participants |
| MenACWY-CRM_6-12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Diarrhea | 12 participants |
| MenACWY-CRM_6-12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | MenACWY MenC Tenderness (N=64,56,50) | 25 participants |
| MenACWY-CRM_6-12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | PCV7 Tenderness | 32 participants |
| MenACWY-CRM_6-12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Irritability | 57 participants |
| MenACWY-CRM_6-12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Sleepiness | 35 participants |
| MenACWY-CRM_6-12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Any local reactions | 53 participants |
| MenACWY-CRM_6-12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | PC7 Erythema | 39 participants |
| MenACWY-CRM_6-12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | PC7 Induration | 31 participants |
| MenACWY-CRM_6-12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Analgesic Antipyretic Medicines Used | 42 participants |
| MenACWY-CRM_6-12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Vomiting | 9 participants |
| MenACWY-CRM_6-12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Any systemic reactions | 59 participants |
| MenACWY-CRM_6-12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | MenACWY MenC Erythema (N=64,56,50) | 33 participants |
| MenACWY-CRM_12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Any systemic reactions | 55 participants |
| MenACWY-CRM_12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Change in eating habits (N=62,60,50) | 21 participants |
| MenACWY-CRM_12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | MenACWY MenC Erythema (N=64,56,50) | 25 participants |
| MenACWY-CRM_12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Sleepiness | 32 participants |
| MenACWY-CRM_12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Irritability | 45 participants |
| MenACWY-CRM_12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Vomiting | 11 participants |
| MenACWY-CRM_12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Diarrhea | 18 participants |
| MenACWY-CRM_12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Fever (≥38 °C) | 12 participants |
| MenACWY-CRM_12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | MenACWY MenC Induration (N=64,56,50) | 20 participants |
| MenACWY-CRM_12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Analgesic Antipyretic Medicines Used | 35 participants |
| MenACWY-CRM_12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Any local reactions | 49 participants |
| MenACWY-CRM_12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | DTaP-Hib-IPV Tenderness (N=64,61,44) | 22 participants |
| MenACWY-CRM_12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | DTaP-Hib-IPV Induration (N=64,61,44) | 20 participants |
| MenACWY-CRM_12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | PCV7 Tenderness | 33 participants |
| MenACWY-CRM_12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | MenACWY MenC Tenderness (N=64,56,50) | 24 participants |
| MenACWY-CRM_12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | PC7 Erythema | 31 participants |
| MenACWY-CRM_12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | PC7 Induration | 32 participants |
| MenACWY-CRM_12 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | DTaP-Hib-IPV Erythema (N=64,61,44) | 25 participants |
| MenC-CRM_12 M_MenACWY-CRM_18 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | PC7 Induration | 19 participants |
| MenC-CRM_12 M_MenACWY-CRM_18 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | DTaP-Hib-IPV Erythema (N=64,61,44) | 23 participants |
| MenC-CRM_12 M_MenACWY-CRM_18 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Sleepiness | 22 participants |
| MenC-CRM_12 M_MenACWY-CRM_18 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Diarrhea | 11 participants |
| MenC-CRM_12 M_MenACWY-CRM_18 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Analgesic Antipyretic Medicines Used | 29 participants |
| MenC-CRM_12 M_MenACWY-CRM_18 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Any local reactions | 47 participants |
| MenC-CRM_12 M_MenACWY-CRM_18 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | MenACWY MenC Tenderness (N=64,56,50) | 30 participants |
| MenC-CRM_12 M_MenACWY-CRM_18 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | MenACWY MenC Erythema (N=64,56,50) | 28 participants |
| MenC-CRM_12 M_MenACWY-CRM_18 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | MenACWY MenC Induration (N=64,56,50) | 23 participants |
| MenC-CRM_12 M_MenACWY-CRM_18 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | DTaP-Hib-IPV Tenderness (N=64,61,44) | 27 participants |
| MenC-CRM_12 M_MenACWY-CRM_18 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | DTaP-Hib-IPV Induration (N=64,61,44) | 17 participants |
| MenC-CRM_12 M_MenACWY-CRM_18 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | PCV7 Tenderness | 16 participants |
| MenC-CRM_12 M_MenACWY-CRM_18 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | PC7 Erythema | 28 participants |
| MenC-CRM_12 M_MenACWY-CRM_18 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Any systemic reactions | 43 participants |
| MenC-CRM_12 M_MenACWY-CRM_18 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Change in eating habits (N=62,60,50) | 21 participants |
| MenC-CRM_12 M_MenACWY-CRM_18 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Irritability | 38 participants |
| MenC-CRM_12 M_MenACWY-CRM_18 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Vomiting | 6 participants |
| MenC-CRM_12 M_MenACWY-CRM_18 M | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | Fever (≥38 °C) | 12 participants |
Secondary
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age
Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age
Time frame: Before and 1 month after MenACWY-CRM vaccination at 18 months
Population: Analysis was done on PP population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | Serogroup A - hSBA ≥1:4 - Prevaccination | 0 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | Serogroup A - hSBA ≥1:4 - Postvaccination | 63 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | Serogroup W - hSBA ≥1:4 - Prevaccination (N=37) | 3 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | Serogroup W - hSBA ≥1:4 - Postvaccination (N=37) | 81 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | Serogroup Y - hSBA ≥1:4 - Prevaccination | 0 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | Serogroup Y - hSBA ≥1:4 - Postvaccination | 79 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | Serogroup A - hSBA ≥1:8 - Prevaccination | 0 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | Serogroup A - hSBA ≥1:8 - Postvaccination | 50 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | Serogroup W - hSBA ≥1:8 - Prevaccination (N=37) | 3 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | Serogroup W - hSBA ≥1:8 - Postvaccination (N=37) | 76 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | Serogroup Y - hSBA ≥1:8 - Prevaccination | 0 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | Serogroup Y - hSBA ≥1:8 - Postvaccination | 63 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age
Booster response was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age
Time frame: Before and 1 month after MenACWY-CRM vaccination at 18 months
Population: Analysis was done on PP population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age | hSBA ≥1:4 - Prevaccination | 89 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age | hSBA ≥1:4 - Postvaccination | 100 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age | hSBA ≥1:8 - Prevaccination | 82 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age | hSBA ≥1:8 - Postvaccination | 100 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age
Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age
Time frame: Before and 1 month after MenC-CRM vaccination at 12 months
Population: Analysis was done on PP population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age | hSBA titers ≥1:4 - Prevaccination | 0 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age | hSBA titers ≥1:4 - Postvaccination | 93 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age | hSBA titers ≥1:8 - Prevaccination | 0 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age | hSBA titers ≥1:8 - Postvaccination | 88 Percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule
Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM\_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM\_12 M)
Time frame: Before and 1 month after 2-dose or 1-dose schedule
Population: Analysis was done on PP population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup A - Prevaccination (N=50,53) | 8 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup A - Postvaccination (N=50,53) | 84 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup C - Prevaccination | 75 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup C - Postvaccination | 100 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup W - Prevaccination (N=40,41) | 73 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup W - Postvaccination (N=40,41) | 100 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup Y - Prevaccination (N=53,54) | 55 Percentage of subjects |
| MenACWY-CRM_6-12 M | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup Y - Postvaccination (N=53,54) | 100 Percentage of subjects |
| MenACWY-CRM_12 M | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup Y - Postvaccination (N=53,54) | 67 Percentage of subjects |
| MenACWY-CRM_12 M | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup A - Prevaccination (N=50,53) | 0 Percentage of subjects |
| MenACWY-CRM_12 M | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup W - Prevaccination (N=40,41) | 2 Percentage of subjects |
| MenACWY-CRM_12 M | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup A - Postvaccination (N=50,53) | 60 Percentage of subjects |
| MenACWY-CRM_12 M | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup Y - Prevaccination (N=53,54) | 0 Percentage of subjects |
| MenACWY-CRM_12 M | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup C - Prevaccination | 2 Percentage of subjects |
| MenACWY-CRM_12 M | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup W - Postvaccination (N=40,41) | 93 Percentage of subjects |
| MenACWY-CRM_12 M | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Serogroup C - Postvaccination | 93 Percentage of subjects |