Bacterial Meningitis
Conditions
Keywords
Meningococcal, ACWY, bacterial meningitis, conjugate vaccine, healthy, children, adolescents, Taiwan
Brief summary
This study will evaluate the immunogenicity and safety of a single injection of Novartis Meningococcal ACWY conjugate vaccine in healthy subjects from 2 to 18 years in Taiwan.
Interventions
BIOLOGICALMeningococcal ACWY conjugate vaccine
All subjects received a single dose of Meningococcal ACWY conjugate vaccine and had blood draw at day 1 and day 29.
Sponsors
Novartis Vaccines
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy subjects from 2 up to and including 18 years of age 2. Who are in good health as determined by : medical history, physical exam,clinical judgment of the investigator, who have a negative urine pregnancy test for female subjects ≥11 years of age
Exclusion criteria
Individuals not eligible to be enrolled in the study were those: 1. Who had a previous confirmed or suspected disease caused by N. meningitidis. 2. Who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrolment. 3. Who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational). 4. Who have received any vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 30 days from the study vaccines. 5. Who have experienced within the 7 days prior to enrolment significant acute infection or have experienced fever within 3 days prior to enrolment. 6. Who have any serious acute, chronic or progressive who have epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome. 7. Who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components. 8. Who have a known or suspected impairment/alteration of immune function, either congenital or acquired 9. Who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. 10. Who have Down's syndrome or other known cytogenic disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | Day 1 and Day 29 | Immunogenicity was measured as the percentage of subjects with hSBA seroresponse and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at 28 days after one vaccination of MenACWY-CRM (day 29). Seroresponse is defined as: 1. for subjects with a prevaccination hSBA titer \<1:4, a postvaccination hSBA titer ≥1:8. 2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | Day 1 and 29 | Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, before the vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall. |
| Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | Day 1 and Day 29 | Immunogenicity was measured as ratio of postvaccination GMTs to prevaccination GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, at 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall. |
| Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group | Day 1 and Day 29 | Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% CI, directed against N. meningitidis serogroups A, C, W and Y, at Day 29, by age groups. Seroresponse is defined as: 1. for subjects with a prevaccination hSBA titer \<1:4, a postvaccination hSBA titer ≥1:8. 2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer. |
| Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years | From day 1 through day 7 postvaccination | Safety was assessed as the number of subjects aged 2 to 5 years who reported solicited local and systemic adverse events (AEs) within days 1 through 7 after MenACWY-CRM vaccination. |
| Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | From day 1 through day 7 postvaccination | Safety was assessed as the number of subjects aged 6 to 18 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination. |
| Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | Day 1 and 29 | Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI, before vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), bye age group and overall. |
Countries
China
Participant flow
Recruitment details
Subjects were enrolled at three study centres in Taiwan.
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| 2-10 Years Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1. | 173 |
| 11-18 Years Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1. | 168 |
| Total | 341 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | 11-18 Years | 2-10 Years | Total |
|---|---|---|---|
| Age, Continuous | 14.0 Years STANDARD_DEVIATION 2.2 | 6.3 Years STANDARD_DEVIATION 2.6 | 10.1 Years STANDARD_DEVIATION 4.5 |
| Sex: Female, Male Female | 88 Participants | 92 Participants | 180 Participants |
| Sex: Female, Male Male | 80 Participants | 81 Participants | 161 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 | 110 / 173 | 98 / 167 | 208 / 340 |
| serious Total, serious adverse events | 1 / 173 | 0 / 167 | 1 / 340 |
Outcome results
Primary
Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
Immunogenicity was measured as the percentage of subjects with hSBA seroresponse and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at 28 days after one vaccination of MenACWY-CRM (day 29). Seroresponse is defined as: 1. for subjects with a prevaccination hSBA titer \<1:4, a postvaccination hSBA titer ≥1:8. 2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
Time frame: Day 1 and Day 29
Population: Analysis was done on modified intention-to-treat (MITT) population i.e subjects in the exposed population who provided evaluable serum samples whose assay results were available for at least one serogroup on day 1 and/or day 29.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall (2 to 18 Years) | Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenA (N=335) | 83 Percentages of Subjects |
| Overall (2 to 18 Years) | Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenC (N=333) | 93 Percentages of Subjects |
| Overall (2 to 18 Years) | Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenW (N=334) | 50 Percentages of Subjects |
| Overall (2 to 18 Years) | Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenY (N=333) | 65 Percentages of Subjects |
Secondary
Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
Immunogenicity was measured as ratio of postvaccination GMTs to prevaccination GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, at 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall.
Time frame: Day 1 and Day 29
Population: Analysis was done on MITT population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Overall (2 to 18 Years) | Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenA(N=170,165,335) | 16 Ratio |
| Overall (2 to 18 Years) | Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenC (N=167,166,333) | 44 Ratio |
| Overall (2 to 18 Years) | Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenW (N=168,166,334) | 6.66 Ratio |
| Overall (2 to 18 Years) | Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenY (N=167,166,333) | 8.02 Ratio |
| 11-18 Years | Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenY (N=167,166,333) | 14 Ratio |
| 11-18 Years | Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenA(N=170,165,335) | 40 Ratio |
| 11-18 Years | Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenW (N=168,166,334) | 6.91 Ratio |
| 11-18 Years | Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenC (N=167,166,333) | 75 Ratio |
| Overall (2 to 18 Years) | Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenY (N=167,166,333) | 11 Ratio |
| Overall (2 to 18 Years) | Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenC (N=167,166,333) | 57 Ratio |
| Overall (2 to 18 Years) | Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenW (N=168,166,334) | 6.78 Ratio |
| Overall (2 to 18 Years) | Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenA(N=170,165,335) | 25 Ratio |
Secondary
Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, before the vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall.
Time frame: Day 1 and 29
Population: Analysis was done on MITT population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Overall (2 to 18 Years) | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenA at Day 1(N=170,165,335) | 2.05 hSBA Titers |
| Overall (2 to 18 Years) | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenA at Day 29(N=170,165,335) | 32 hSBA Titers |
| Overall (2 to 18 Years) | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenC at Day 1 (N=167,166,333) | 2.66 hSBA Titers |
| Overall (2 to 18 Years) | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenC at Day 29 (N=167,166,333) | 117 hSBA Titers |
| Overall (2 to 18 Years) | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenW at Day 1 (N=168,166,334) | 7.32 hSBA Titers |
| Overall (2 to 18 Years) | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenW at Day 29 (N=168,166,334) | 49 hSBA Titers |
| Overall (2 to 18 Years) | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenY at Day 1 (N=167,166,333) | 3.21 hSBA Titers |
| Overall (2 to 18 Years) | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenY at Day 29 (N=167,166,333) | 26 hSBA Titers |
| 11-18 Years | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenC at Day 1 (N=167,166,333) | 3.64 hSBA Titers |
| 11-18 Years | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenY at Day 1 (N=167,166,333) | 3.95 hSBA Titers |
| 11-18 Years | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenC at Day 29 (N=167,166,333) | 273 hSBA Titers |
| 11-18 Years | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenW at Day 1 (N=168,166,334) | 15 hSBA Titers |
| 11-18 Years | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenW at Day 29 (N=168,166,334) | 104 hSBA Titers |
| 11-18 Years | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenA at Day 1(N=170,165,335) | 2.2 hSBA Titers |
| 11-18 Years | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenA at Day 29(N=170,165,335) | 88 hSBA Titers |
| 11-18 Years | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenY at Day 29 (N=167,166,333) | 56 hSBA Titers |
| Overall (2 to 18 Years) | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenC at Day 1 (N=167,166,333) | 3.11 hSBA Titers |
| Overall (2 to 18 Years) | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenA at Day 29(N=170,165,335) | 53 hSBA Titers |
| Overall (2 to 18 Years) | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenA at Day 1(N=170,165,335) | 2.12 hSBA Titers |
| Overall (2 to 18 Years) | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenC at Day 29 (N=167,166,333) | 179 hSBA Titers |
| Overall (2 to 18 Years) | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenY at Day 1 (N=167,166,333) | 3.56 hSBA Titers |
| Overall (2 to 18 Years) | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenW at Day 29 (N=168,166,334) | 71 hSBA Titers |
| Overall (2 to 18 Years) | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenW at Day 1 (N=168,166,334) | 10 hSBA Titers |
| Overall (2 to 18 Years) | Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenY at Day 29 (N=167,166,333) | 38 hSBA Titers |
Secondary
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years
Safety was assessed as the number of subjects aged 2 to 5 years who reported solicited local and systemic adverse events (AEs) within days 1 through 7 after MenACWY-CRM vaccination.
Time frame: From day 1 through day 7 postvaccination
Population: Analysis was done on safety population i.e. the subjects in the exposed population who provided post-baseline safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years | Injection site tenderness | 27 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years | Injection site erythema | 7 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years | Injection site induration | 6 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years | Change in eating habits | 2 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years | Sleepiness | 3 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years | Irritability | 5 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years | Vomiting | 7 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years | Diarrhea | 2 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years | Rash - Any | 4 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years | Rash - Urticarial | 1 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years | Fever (≥38°C) | 4 Subjects |
Secondary
Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years
Safety was assessed as the number of subjects aged 6 to 18 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination.
Time frame: From day 1 through day 7 postvaccination
Population: Analysis was done on safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Injection site induration | 14 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Rash - Any | 7 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Injection site pain | 37 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Rash - Urticarial | 3 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Chills | 2 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Fever (≥38°C) | 3 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Injection site erythema | 17 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Nausea | 10 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Malaise | 13 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Myalgia | 20 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Arthralgia | 3 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Headache | 11 Subjects |
| 11-18 Years | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Injection site pain | 62 Subjects |
| 11-18 Years | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Headache | 29 Subjects |
| 11-18 Years | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Injection site induration | 12 Subjects |
| 11-18 Years | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Arthralgia | 13 Subjects |
| 11-18 Years | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Rash - Any | 4 Subjects |
| 11-18 Years | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Nausea | 10 Subjects |
| 11-18 Years | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Injection site erythema | 17 Subjects |
| 11-18 Years | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Rash - Urticarial | 3 Subjects |
| 11-18 Years | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Myalgia | 49 Subjects |
| 11-18 Years | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Malaise | 35 Subjects |
| 11-18 Years | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Fever (≥38°C) | 2 Subjects |
| 11-18 Years | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Chills | 6 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Fever (≥38°C) | 5 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Injection site pain | 99 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Injection site erythema | 34 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Injection site induration | 26 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Chills | 8 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Nausea | 20 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Malaise | 48 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Arthralgia | 16 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Headache | 40 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Rash - Any | 11 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Rash - Urticarial | 6 Subjects |
| Overall (2 to 18 Years) | Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years | Myalgia | 69 Subjects |
Secondary
Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI, before vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), bye age group and overall.
Time frame: Day 1 and 29
Population: Analysis was done on MITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall (2 to 18 Years) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenA at Day 1 (N=170,165,335) | 1 Percentages of Subjects |
| Overall (2 to 18 Years) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenA at Day 29 (N=170,165,335) | 77 Percentages of Subjects |
| Overall (2 to 18 Years) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenC at Day 1 (N=167,166,333) | 11 Percentages of Subjects |
| Overall (2 to 18 Years) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenC at Day 29 (N=167,166,333) | 95 Percentages of Subjects |
| Overall (2 to 18 Years) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenW at Day 1 (N=168,166,334) | 47 Percentages of Subjects |
| Overall (2 to 18 Years) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenW at Day 29 (N=168,166,334) | 93 Percentages of Subjects |
| Overall (2 to 18 Years) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenY at Day 1 (N=167,166,333) | 22 Percentages of Subjects |
| Overall (2 to 18 Years) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenY at Day 29 (N=167,166,333) | 78 Percentages of Subjects |
| 11-18 Years | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenC at Day 1 (N=167,166,333) | 23 Percentages of Subjects |
| 11-18 Years | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenY at Day 1 (N=167,166,333) | 26 Percentages of Subjects |
| 11-18 Years | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenC at Day 29 (N=167,166,333) | 98 Percentages of Subjects |
| 11-18 Years | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenW at Day 1 (N=168,166,334) | 70 Percentages of Subjects |
| 11-18 Years | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenW at Day 29 (N=168,166,334) | 99 Percentages of Subjects |
| 11-18 Years | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenA at Day 1 (N=170,165,335) | 4 Percentages of Subjects |
| 11-18 Years | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenA at Day 29 (N=170,165,335) | 90 Percentages of Subjects |
| 11-18 Years | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenY at Day 29 (N=167,166,333) | 86 Percentages of Subjects |
| Overall (2 to 18 Years) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenC at Day 1 (N=167,166,333) | 17 Percentages of Subjects |
| Overall (2 to 18 Years) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenA at Day 29 (N=170,165,335) | 83 Percentages of Subjects |
| Overall (2 to 18 Years) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenA at Day 1 (N=170,165,335) | 3 Percentages of Subjects |
| Overall (2 to 18 Years) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenC at Day 29 (N=167,166,333) | 96 Percentages of Subjects |
| Overall (2 to 18 Years) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenY at Day 1 (N=167,166,333) | 24 Percentages of Subjects |
| Overall (2 to 18 Years) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenW at Day 29 (N=168,166,334) | 96 Percentages of Subjects |
| Overall (2 to 18 Years) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenW at Day 1 (N=168,166,334) | 58 Percentages of Subjects |
| Overall (2 to 18 Years) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination | MenY at Day 29 (N=167,166,333) | 82 Percentages of Subjects |
Secondary
Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group
Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% CI, directed against N. meningitidis serogroups A, C, W and Y, at Day 29, by age groups. Seroresponse is defined as: 1. for subjects with a prevaccination hSBA titer \<1:4, a postvaccination hSBA titer ≥1:8. 2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
Time frame: Day 1 and Day 29
Population: Analysis was done on MITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall (2 to 18 Years) | Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group | Men A (N=170,165) | 77 Percentages of Subjects |
| Overall (2 to 18 Years) | Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group | MenC (N=167,166) | 92 Percentages of Subjects |
| Overall (2 to 18 Years) | Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group | MenW (N=168,166) | 54 Percentages of Subjects |
| Overall (2 to 18 Years) | Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group | MenY (N=167,166) | 61 Percentages of Subjects |
| 11-18 Years | Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group | MenY (N=167,166) | 69 Percentages of Subjects |
| 11-18 Years | Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group | Men A (N=170,165) | 89 Percentages of Subjects |
| 11-18 Years | Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group | MenW (N=168,166) | 46 Percentages of Subjects |
| 11-18 Years | Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group | MenC (N=167,166) | 95 Percentages of Subjects |