Meningococcal Disease, Infections, Meningococcal
Conditions
Keywords
Prevention of meningococcal disease, children, vaccine
Brief summary
This study was designed to conduct a comparative trial to further evaluate the safety, immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine, given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2 through 10 years of age.
Interventions
BIOLOGICALMenACWY-CRM
The investigational meningococcal (groups A, C, Y, and W-135 vaccine) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM) was administered intramuscularly in the nondominant arm
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy children, 2 to 10 years of age who have up to date routine childhood vaccination, according to U.S. ACIP recommendations
Exclusion criteria
1. Unwilling or unable to give written informed assent or consent to participate in the study. 2. Perceived to be unreliable or unavailable for the duration of the study period. 3. Previous confirmed or suspected disease caused by N. meningitidis. 4. Previously immunized with a meningococcal vaccine (licensed or investigational). 5. Receipt of any investigational or non-registered product within 30 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study. 6. Receipt or plan to receive any vaccines within 30 days before and after administration of each dose of the study vaccine. (certain exceptions influenza vaccines apply) 7. Significant acute infection within the 7 days prior to enrolment or body temperature of 38°C or greater within 3 days prior to enrolment. 8. Previous serious acute, chronic or progressive disease, epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome. 9. History of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components 10. Impairment/alteration of immune function, either congenital or acquired or resulting from (for example): * receipt of immunosuppressive therapy, * receipt of immunostimulants, * receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives. 11. Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | One Month After Last Vaccination ( day 86) | Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 97.5% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, by serum bactericidal assay using human complement (hSBA) at 1 month after one vaccination or two vaccinations of MenACWY-CRM given two months apart. Seroresponse is defined as: a. postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer \<1:4; b. for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer. |
| Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | One Month After Last Vaccination (day 86) | Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 95% CI, directed against N. meningitidis serogroups A, C, W and Y, by hSBA at 1 month after one vaccination or two vaccinations of MenACWY-CRM. Seroresponse -postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer \<1:4 and for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | One year after one vaccination or two vaccinations (day 422). | Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI at one year after one vaccination or two vaccinations of MenACWY-CRM. |
| Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | One year after one vaccination or two vaccinations (day 422). | Immunogenicity was measured as hSBA GMTs and 95% CI against N. meningitidis serogroups A, C, W and Y at one year after one vaccination or two vaccinations of MenACWY-CRM. |
| Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | One Month After Last Vaccination (day 86) | Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 and associated 95% CI, at one month after one vaccination or two vaccinations of MenACWY-CRM. |
| Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | From Days 1-7 after each vaccination | Safety was assessed as the number of 6 to 10 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM |
| Number of Subjects Who Reported Selected AEs After Any Vaccination | Day 1 to Day 86 | Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 86 after one or two vaccination(s) of MenACWY-CRM |
| Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | From Days 1-7 after each vaccination | Safety was assessed as the number of 2 to 5 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM |
| Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | One Month After Last Vaccination (day 86) | Immunogenicity was measured as hSBA geometric mean titers (GMTs) and 95% CI against N. meningitidis serogroups A, C, W and Y, one month after one vaccination or two vaccinations of MenACWY-CRM. |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled at 22 locations
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| 2 Through 5 Years (2 Vac) Subjects 2-5 years of age received two MenACWY-CRM vaccinations | 176 |
| 2 Through 5 Years (1 Vac) Subjects 2-5 years of age received one MenACWY-CRM vaccination | 183 |
| 6 Through 10 Years (2 Vac) Subjects 6-10 years of age received two MenACWY-CRM vaccinations | 180 |
| 6 Through 10 Years (1 Vac) Subjects 6-10 years of age received one MenACWY-CRM vaccination | 176 |
| Total | 715 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Administrative reason | 4 | 4 | 0 | 3 |
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 11 | 15 | 9 | 11 |
| Overall Study | Other | 1 | 0 | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 1 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | 2 Through 5 Years (2 Vac) | 2 Through 5 Years (1 Vac) | 6 Through 10 Years (2 Vac) | 6 Through 10 Years (1 Vac) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 3.5 year STANDARD_DEVIATION 1.1 | 3.6 year STANDARD_DEVIATION 1.2 | 7.8 year STANDARD_DEVIATION 1.4 | 7.8 year STANDARD_DEVIATION 1.4 | 5.7 year STANDARD_DEVIATION 2.5 |
| Sex: Female, Male Female | 84 Participants | 88 Participants | 97 Participants | 87 Participants | 356 Participants |
| Sex: Female, Male Male | 92 Participants | 95 Participants | 83 Participants | 89 Participants | 359 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 148 / 179 | 142 / 179 | 153 / 181 | 133 / 174 | 576 / 713 |
| serious Total, serious adverse events | 2 / 179 | 1 / 179 | 1 / 181 | 1 / 174 | 5 / 713 |
Outcome results
Primary
Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination
Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 97.5% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, by serum bactericidal assay using human complement (hSBA) at 1 month after one vaccination or two vaccinations of MenACWY-CRM given two months apart. Seroresponse is defined as: a. postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer \<1:4; b. for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.
Time frame: One Month After Last Vaccination ( day 86)
Population: Analysis was done on the primary per-protocol (PP) dataset, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 Through 5 Years (2 Vac) | Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenA(N=135,143,152,142) | 94 percentage of subjects |
| 2 Through 5 Years (2 Vac) | Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenC(N=131,140,149,142) | 92 percentage of subjects |
| 2 Through 5 Years (2 Vac) | Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenW(N=128,135,148,138) | 75 percentage of subjects |
| 2 Through 5 Years (2 Vac) | Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenY(N=128,133,148,142) | 91 percentage of subjects |
| 2 Through 5 Years (1 Vac) | Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenC(N=131,140,149,142) | 65 percentage of subjects |
| 2 Through 5 Years (1 Vac) | Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenW(N=128,135,148,138) | 61 percentage of subjects |
| 2 Through 5 Years (1 Vac) | Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenY(N=128,133,148,142) | 64 percentage of subjects |
| 2 Through 5 Years (1 Vac) | Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenA(N=135,143,152,142) | 75 percentage of subjects |
| 6 Through 10 Years (2 Vac) | Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenW(N=128,135,148,138) | 58 percentage of subjects |
| 6 Through 10 Years (2 Vac) | Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenC(N=131,140,149,142) | 93 percentage of subjects |
| 6 Through 10 Years (2 Vac) | Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenY(N=128,133,148,142) | 89 percentage of subjects |
| 6 Through 10 Years (2 Vac) | Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenA(N=135,143,152,142) | 89 percentage of subjects |
| 6 Through 10 Years (1 Vac) | Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenY(N=128,133,148,142) | 60 percentage of subjects |
| 6 Through 10 Years (1 Vac) | Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenC(N=131,140,149,142) | 73 percentage of subjects |
| 6 Through 10 Years (1 Vac) | Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenA(N=135,143,152,142) | 77 percentage of subjects |
| 6 Through 10 Years (1 Vac) | Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenW(N=128,135,148,138) | 54 percentage of subjects |
Comparison: Non-inferiority of seroresponse of two vaccinations vs.one vaccination for age cohort (2 to 5 years of age) for MenA97.5% CI: [10, 28.9]MN method
Comparison: Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenC97.5% CI: [16.9, 37.7]MN method
Comparison: Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenW97.5% CI: [1.4, 26.7]MN method
Comparison: Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (2 to 5 years of age) for MenY97.5% CI: [15.6, 37.6]MN method
Comparison: Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenA97.5% CI: [1.7, 21.3]MN method
Comparison: Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenC97.5% CI: [9.9, 29.2]MN method
Comparison: Non-inferiority of seroresponse of two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenW97.5% CI: [-8.6, 17.4]MN method
Comparison: Non-inferiority of seroresponse for two vaccinations vs. one vaccination for age cohort (6 to 10 years of age) for MenY97.5% CI: [18.4, 40]MN method
Primary
Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination
Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 95% CI, directed against N. meningitidis serogroups A, C, W and Y, by hSBA at 1 month after one vaccination or two vaccinations of MenACWY-CRM. Seroresponse -postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer \<1:4 and for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.
Time frame: One Month After Last Vaccination (day 86)
Population: Analysis was done on the FAS dataset - All subjects in the exposed dataset who provided evaluable serum samples whose assay results were available for at least 1 serogroup on day 1 and 1 post baseline visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 Through 5 Years (2 Vac) | Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenA(N=158,163,171,163) | 95 percentage of subjects |
| 2 Through 5 Years (2 Vac) | Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenC(N=154,157,167,162) | 93 percentage of subjects |
| 2 Through 5 Years (2 Vac) | Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenW(N=150,154,167,159) | 75 percentage of subjects |
| 2 Through 5 Years (2 Vac) | Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenY(N=150,153,167,163) | 90 percentage of subjects |
| 2 Through 5 Years (1 Vac) | Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenC(N=154,157,167,162) | 65 percentage of subjects |
| 2 Through 5 Years (1 Vac) | Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenW(N=150,154,167,159) | 61 percentage of subjects |
| 2 Through 5 Years (1 Vac) | Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenY(N=150,153,167,163) | 62 percentage of subjects |
| 2 Through 5 Years (1 Vac) | Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenA(N=158,163,171,163) | 77 percentage of subjects |
| 6 Through 10 Years (2 Vac) | Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenW(N=150,154,167,159) | 57 percentage of subjects |
| 6 Through 10 Years (2 Vac) | Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenC(N=154,157,167,162) | 93 percentage of subjects |
| 6 Through 10 Years (2 Vac) | Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenY(N=150,153,167,163) | 89 percentage of subjects |
| 6 Through 10 Years (2 Vac) | Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenA(N=158,163,171,163) | 89 percentage of subjects |
| 6 Through 10 Years (1 Vac) | Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenY(N=150,153,167,163) | 60 percentage of subjects |
| 6 Through 10 Years (1 Vac) | Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenC(N=154,157,167,162) | 75 percentage of subjects |
| 6 Through 10 Years (1 Vac) | Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenA(N=158,163,171,163) | 79 percentage of subjects |
| 6 Through 10 Years (1 Vac) | Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination | MenW(N=150,154,167,159) | 52 percentage of subjects |
Comparison: Superiority for age cohort (2 through 5 years of age) for MenA was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenA98.75% CI: [9.1, 28]MN method
Comparison: Superiority for age cohort (2 through 5 years of age) for MenC was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenC98.75% CI: [17.1, 38.7]MN method
Comparison: Superiority for age cohort (2 through 5 years of age) for MenW was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenW98.75% CI: [1, 27.1]MN method
Comparison: Superiority for age cohort (2 through 5 years of age) for MenY was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenY98.75% CI: [16.2, 39.3]MN method
Comparison: Superiority for age cohort (6 through 10 years of age) for MenA was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenA98.75% CI: [1, 21.2]MN method
Comparison: Superiority for age cohort (6 through 10 years of age) for MenC was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenC97.5% CI: [9.5, 27.1]MN method
Comparison: Superiority for age cohort (6 through 10 years of age) for MenW was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenW98.75% CI: [-8.4, 18.8]MN method
Comparison: Superiority for age cohort (6 through 10 years of age) for MenY was demonstrated if the lower limit of the 2-sided (1-2α) % CI for seroresponse increase between the 2-dose vaccination schedule and the 1-dose vaccination schedule was above 10% for MenY98.75% CI: [17, 39.6]MN method
Secondary
Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM
Immunogenicity was measured as hSBA geometric mean titers (GMTs) and 95% CI against N. meningitidis serogroups A, C, W and Y, one month after one vaccination or two vaccinations of MenACWY-CRM.
Time frame: One Month After Last Vaccination (day 86)
Population: Analysis was done on the primary PP dataset
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2 Through 5 Years (2 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenA(N=135,143,152,142) | 68 Titer |
| 2 Through 5 Years (2 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenC(N=131,140,149,142) | 146 Titer |
| 2 Through 5 Years (2 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenW(N=128,135,148,138) | 191 Titer |
| 2 Through 5 Years (2 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenY(N=128,133,148,142) | 70 Titer |
| 2 Through 5 Years (1 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenC(N=131,140,149,142) | 22 Titer |
| 2 Through 5 Years (1 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenW(N=128,135,148,138) | 104 Titer |
| 2 Through 5 Years (1 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenY(N=128,133,148,142) | 15 Titer |
| 2 Through 5 Years (1 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenA(N=135,143,152,142) | 21 Titer |
| 6 Through 10 Years (2 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenW(N=128,135,148,138) | 169 Titer |
| 6 Through 10 Years (2 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenC(N=131,140,149,142) | 165 Titer |
| 6 Through 10 Years (2 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenY(N=128,133,148,142) | 76 Titer |
| 6 Through 10 Years (2 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenA(N=135,143,152,142) | 67 Titer |
| 6 Through 10 Years (1 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenY(N=128,133,148,142) | 26 Titer |
| 6 Through 10 Years (1 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenC(N=131,140,149,142) | 67 Titer |
| 6 Through 10 Years (1 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenA(N=135,143,152,142) | 36 Titer |
| 6 Through 10 Years (1 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenW(N=128,135,148,138) | 95 Titer |
Secondary
Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM
Immunogenicity was measured as hSBA GMTs and 95% CI against N. meningitidis serogroups A, C, W and Y at one year after one vaccination or two vaccinations of MenACWY-CRM.
Time frame: One year after one vaccination or two vaccinations (day 422).
Population: Analysis was done on the persistence PP dataset
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 2 Through 5 Years (2 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenA(N=122,131,142,130) | 4.72 Titers |
| 2 Through 5 Years (2 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenC(N=123,128,141,130) | 10 Titers |
| 2 Through 5 Years (2 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenW(N=121,127,139,130) | 49 Titers |
| 2 Through 5 Years (2 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenY(N=121,122,140,130) | 14 Titers |
| 2 Through 5 Years (1 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenC(N=123,128,141,130) | 7.03 Titers |
| 2 Through 5 Years (1 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenW(N=121,127,139,130) | 39 Titers |
| 2 Through 5 Years (1 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenY(N=121,122,140,130) | 9.88 Titers |
| 2 Through 5 Years (1 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenA(N=122,131,142,130) | 2.66 Titers |
| 6 Through 10 Years (2 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenW(N=121,127,139,130) | 64 Titers |
| 6 Through 10 Years (2 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenC(N=123,128,141,130) | 24 Titers |
| 6 Through 10 Years (2 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenY(N=121,122,140,130) | 20 Titers |
| 6 Through 10 Years (2 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenA(N=122,131,142,130) | 4.66 Titers |
| 6 Through 10 Years (1 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenY(N=121,122,140,130) | 13 Titers |
| 6 Through 10 Years (1 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenC(N=123,128,141,130) | 15 Titers |
| 6 Through 10 Years (1 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenA(N=122,131,142,130) | 3.56 Titers |
| 6 Through 10 Years (1 Vac) | Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenW(N=121,127,139,130) | 47 Titers |
Secondary
Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Safety was assessed as the number of 2 to 5 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM
Time frame: From Days 1-7 after each vaccination
Population: Analysis was done on the safety dataset i.e. the subjects in the exposed population who provided postvaccination safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 Through 5 Years (2 Vac) | Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Tenderness (N=174,175) | 84 subjects |
| 2 Through 5 Years (2 Vac) | Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Sleepiness(N=173,175) | 49 subjects |
| 2 Through 5 Years (2 Vac) | Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Erythema(N=173,175) | 25 subjects |
| 2 Through 5 Years (2 Vac) | Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Irritability(N=173,175) | 51 subjects |
| 2 Through 5 Years (2 Vac) | Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Change in Eating Habits(N=173,175) | 26 subjects |
| 2 Through 5 Years (2 Vac) | Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Body Temperature >=38.0(N=174,175) | 9 subjects |
| 2 Through 5 Years (2 Vac) | Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Induration(N=173,175) | 19 subjects |
| 2 Through 5 Years (1 Vac) | Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Body Temperature >=38.0(N=174,175) | 12 subjects |
| 2 Through 5 Years (1 Vac) | Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Erythema(N=173,175) | 11 subjects |
| 2 Through 5 Years (1 Vac) | Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Induration(N=173,175) | 7 subjects |
| 2 Through 5 Years (1 Vac) | Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Tenderness (N=174,175) | 79 subjects |
| 2 Through 5 Years (1 Vac) | Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Change in Eating Habits(N=173,175) | 30 subjects |
| 2 Through 5 Years (1 Vac) | Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Sleepiness(N=173,175) | 46 subjects |
| 2 Through 5 Years (1 Vac) | Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Irritability(N=173,175) | 50 subjects |
Comparison: The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced erythema in the two doses versus in the one dose of MenACWY-CRM95% CI: [1.17, 4.53]
Comparison: The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced induration in the two doses versus in the one dose of MenACWY-CRM95% CI: [1.18, 6.36]
Comparison: The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced tenderness in the two doses versus in the one dose of MenACWY-CRM95% CI: [0.85, 1.34]
Comparison: The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced change in eating habits in the two doses versus in the one dose of MenACWY-CRM95% CI: [0.54, 1.42]
Comparison: The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced sleepiness in the two doses versus in the one dose of MenACWY-CRM95% CI: [0.76, 1.52]
Comparison: The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced irritability in the two doses versus in the one dose of MenACWY-CRM95% CI: [0.74, 1.43]
Comparison: The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fever (≥38 °C) in the two doses versus in the one dose of MenACWY-CRM95% CI: [0.33, 1.74]
Secondary
Number of Subjects Who Reported Selected AEs After Any Vaccination
Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 422 after one or two vaccination(s) of MenACWY-CRM
Time frame: Day 1 to Day 422
Population: Analysis was done on safety set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 Through 5 Years (2 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | SAEs | 2 Subjects |
| 2 Through 5 Years (2 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | At least possibly related medically attended AEs | 1 Subjects |
| 2 Through 5 Years (2 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | Deaths | 0 Subjects |
| 2 Through 5 Years (2 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | AEs resulting in premature withdrawal | 0 Subjects |
| 2 Through 5 Years (2 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | Medically attended AEs | 103 Subjects |
| 2 Through 5 Years (1 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | AEs resulting in premature withdrawal | 0 Subjects |
| 2 Through 5 Years (1 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | SAEs | 1 Subjects |
| 2 Through 5 Years (1 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | Deaths | 0 Subjects |
| 2 Through 5 Years (1 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | At least possibly related medically attended AEs | 4 Subjects |
| 2 Through 5 Years (1 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | Medically attended AEs | 101 Subjects |
| 6 Through 10 Years (2 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | AEs resulting in premature withdrawal | 0 Subjects |
| 6 Through 10 Years (2 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | Medically attended AEs | 95 Subjects |
| 6 Through 10 Years (2 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | At least possibly related medically attended AEs | 1 Subjects |
| 6 Through 10 Years (2 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | SAEs | 1 Subjects |
| 6 Through 10 Years (2 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | Deaths | 0 Subjects |
| 6 Through 10 Years (1 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | SAEs | 1 Subjects |
| 6 Through 10 Years (1 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | At least possibly related medically attended AEs | 2 Subjects |
| 6 Through 10 Years (1 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | Medically attended AEs | 97 Subjects |
| 6 Through 10 Years (1 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | AEs resulting in premature withdrawal | 1 Subjects |
| 6 Through 10 Years (1 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | Deaths | 0 Subjects |
Secondary
Number of Subjects Who Reported Selected AEs After Any Vaccination
Safety was assessed as the number subjects who reported Selected AEs from day 1 up to day 86 after one or two vaccination(s) of MenACWY-CRM
Time frame: Day 1 to Day 86
Population: Analysis was done on Safety Set Unsolicited AEs
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 Through 5 Years (2 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | Medically attended AEs | 50 Subjects |
| 2 Through 5 Years (2 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | SAEs | 1 Subjects |
| 2 Through 5 Years (2 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | At least possibly related SAEs | 0 Subjects |
| 2 Through 5 Years (2 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | At least possibly related medically attended AEs | 0 Subjects |
| 2 Through 5 Years (2 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | AEs resulting in premature withdrawal | 0 Subjects |
| 2 Through 5 Years (2 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | Deaths | 0 Subjects |
| 2 Through 5 Years (1 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | AEs resulting in premature withdrawal | 0 Subjects |
| 2 Through 5 Years (1 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | SAEs | 0 Subjects |
| 2 Through 5 Years (1 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | At least possibly related SAEs | 0 Subjects |
| 2 Through 5 Years (1 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | Deaths | 0 Subjects |
| 2 Through 5 Years (1 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | At least possibly related medically attended AEs | 3 Subjects |
| 2 Through 5 Years (1 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | Medically attended AEs | 55 Subjects |
| 6 Through 10 Years (2 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | AEs resulting in premature withdrawal | 0 Subjects |
| 6 Through 10 Years (2 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | Medically attended AEs | 46 Subjects |
| 6 Through 10 Years (2 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | Deaths | 0 Subjects |
| 6 Through 10 Years (2 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | SAEs | 0 Subjects |
| 6 Through 10 Years (2 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | At least possibly related SAEs | 0 Subjects |
| 6 Through 10 Years (2 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | At least possibly related medically attended AEs | 1 Subjects |
| 6 Through 10 Years (1 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | Deaths | 0 Subjects |
| 6 Through 10 Years (1 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | At least possibly related SAEs | 0 Subjects |
| 6 Through 10 Years (1 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | Medically attended AEs | 46 Subjects |
| 6 Through 10 Years (1 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | At least possibly related medically attended AEs | 1 Subjects |
| 6 Through 10 Years (1 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | AEs resulting in premature withdrawal | 1 Subjects |
| 6 Through 10 Years (1 Vac) | Number of Subjects Who Reported Selected AEs After Any Vaccination | SAEs | 0 Subjects |
Secondary
Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Safety was assessed as the number of 6 to 10 years-old subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after one or two vaccination(s) of MenACWY-CRM
Time frame: From Days 1-7 after each vaccination
Population: Analysis was done on the safety dataset
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 Through 5 Years (2 Vac) | Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Erythema(N=178,166) | 23 Subjects |
| 2 Through 5 Years (2 Vac) | Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Induration(N=178,166) | 24 Subjects |
| 2 Through 5 Years (2 Vac) | Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Pain(N=178,166) | 106 Subjects |
| 2 Through 5 Years (2 Vac) | Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss of Appetite(N=177,166) | 27 Subjects |
| 2 Through 5 Years (2 Vac) | Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea(N=177,165) | 29 Subjects |
| 2 Through 5 Years (2 Vac) | Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue(N=177,166) | 44 Subjects |
| 2 Through 5 Years (2 Vac) | Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Myalgia(N=177,165) | 63 Subjects |
| 2 Through 5 Years (2 Vac) | Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Arthralgia(N=177,165) | 20 Subjects |
| 2 Through 5 Years (2 Vac) | Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache(N=177,165) | 55 Subjects |
| 2 Through 5 Years (2 Vac) | Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Body Temperature>=38.0(N=178,166) | 11 Subjects |
| 2 Through 5 Years (1 Vac) | Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Arthralgia(N=177,165) | 9 Subjects |
| 2 Through 5 Years (1 Vac) | Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Erythema(N=178,166) | 15 Subjects |
| 2 Through 5 Years (1 Vac) | Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fatigue(N=177,166) | 25 Subjects |
| 2 Through 5 Years (1 Vac) | Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Induration(N=178,166) | 15 Subjects |
| 2 Through 5 Years (1 Vac) | Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Body Temperature>=38.0(N=178,166) | 9 Subjects |
| 2 Through 5 Years (1 Vac) | Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Pain(N=178,166) | 78 Subjects |
| 2 Through 5 Years (1 Vac) | Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Myalgia(N=177,165) | 43 Subjects |
| 2 Through 5 Years (1 Vac) | Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Loss of Appetite(N=177,166) | 14 Subjects |
| 2 Through 5 Years (1 Vac) | Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Headache(N=177,165) | 28 Subjects |
| 2 Through 5 Years (1 Vac) | Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Nausea(N=177,165) | 21 Subjects |
Comparison: The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced erythema in the two doses versus in the one dose of MenACWY-CRM95% CI: [0.77, 2.65]
Comparison: The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced induration in the two doses versus in the one dose of MenACWY-CRM95% CI: [0.81, 2.74]
Comparison: The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced pain in the two doses versus in the one dose of MenACWY-CRM95% CI: [1.04, 1.55]
Comparison: The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced loss of appetite in the two doses versus in the one dose of MenACWY-CRM95% CI: [0.98, 3.33]
Comparison: The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced nausea in the two doses versus in the one dose of MenACWY-CRM95% CI: [0.77, 2.17]
Comparison: The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fatigue in the two doses versus in the one dose of MenACWY-CRM95% CI: [1.06, 2.57]
Comparison: The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced myalgia in the two doses versus in the one dose of MenACWY-CRM95% CI: [0.99, 1.89]
Comparison: The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced arthralgia in the two doses versus in the one dose of MenACWY-CRM95% CI: [0.97, 4.42]
Comparison: The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced headache in the two doses versus in the one dose of MenACWY-CRM95% CI: [1.22, 2.74]
Comparison: The safety of two vaccine groups was compared by calculating risk ratio of the proportions of subjects who experienced fever (≥38 °C) in the two doses versus in the one dose of MenACWY-CRM95% CI: [0.48, 2.68]
Secondary
Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM
Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 and associated 95% CI, at one month after one vaccination or two vaccinations of MenACWY-CRM.
Time frame: One Month After Last Vaccination (day 86)
Population: Analysis was done on the primary PP dataset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 Through 5 Years (2 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenA(N=135,143,152,142) | 95 percentage of subjects |
| 2 Through 5 Years (2 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenC(N=131,140,149,142) | 98 percentage of subjects |
| 2 Through 5 Years (2 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenW(N=128,135,148,138) | 99 percentage of subjects |
| 2 Through 5 Years (2 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenY(N=128,133,148,142) | 96 percentage of subjects |
| 2 Through 5 Years (1 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenC(N=131,140,149,142) | 76 percentage of subjects |
| 2 Through 5 Years (1 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenW(N=128,135,148,138) | 92 percentage of subjects |
| 2 Through 5 Years (1 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenY(N=128,133,148,142) | 69 percentage of subjects |
| 2 Through 5 Years (1 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenA(N=135,143,152,142) | 76 percentage of subjects |
| 6 Through 10 Years (2 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenW(N=128,135,148,138) | 99 percentage of subjects |
| 6 Through 10 Years (2 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenC(N=131,140,149,142) | 99 percentage of subjects |
| 6 Through 10 Years (2 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenY(N=128,133,148,142) | 96 percentage of subjects |
| 6 Through 10 Years (2 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenA(N=135,143,152,142) | 91 percentage of subjects |
| 6 Through 10 Years (1 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenY(N=128,133,148,142) | 73 percentage of subjects |
| 6 Through 10 Years (1 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenC(N=131,140,149,142) | 89 percentage of subjects |
| 6 Through 10 Years (1 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenA(N=135,143,152,142) | 80 percentage of subjects |
| 6 Through 10 Years (1 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM | MenW(N=128,135,148,138) | 96 percentage of subjects |
Secondary
Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM
Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI at one year after one vaccination or two vaccinations of MenACWY-CRM.
Time frame: One year after one vaccination or two vaccinations (day 422).
Population: Analysis was done on the persistence PP dataset
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 Through 5 Years (2 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenA(N=122,131,142,130) | 30 percentages of subjects |
| 2 Through 5 Years (2 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenC(N=123,128,141,130) | 61 percentages of subjects |
| 2 Through 5 Years (2 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenW(N=121,127,139,130) | 92 percentages of subjects |
| 2 Through 5 Years (2 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenY(N=121,122,140,130) | 67 percentages of subjects |
| 2 Through 5 Years (1 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenC(N=123,128,141,130) | 41 percentages of subjects |
| 2 Through 5 Years (1 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenW(N=121,127,139,130) | 91 percentages of subjects |
| 2 Through 5 Years (1 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenY(N=121,122,140,130) | 57 percentages of subjects |
| 2 Through 5 Years (1 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenA(N=122,131,142,130) | 11 percentages of subjects |
| 6 Through 10 Years (2 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenW(N=121,127,139,130) | 94 percentages of subjects |
| 6 Through 10 Years (2 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenC(N=123,128,141,130) | 81 percentages of subjects |
| 6 Through 10 Years (2 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenY(N=121,122,140,130) | 75 percentages of subjects |
| 6 Through 10 Years (2 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenA(N=122,131,142,130) | 30 percentages of subjects |
| 6 Through 10 Years (1 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenY(N=121,122,140,130) | 65 percentages of subjects |
| 6 Through 10 Years (1 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenC(N=123,128,141,130) | 55 percentages of subjects |
| 6 Through 10 Years (1 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenA(N=122,131,142,130) | 20 percentages of subjects |
| 6 Through 10 Years (1 Vac) | Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM | MenW(N=121,127,139,130) | 90 percentages of subjects |