E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Study to asses immunogenicity, safety and 1 year persistence of antibodies after one or two doses of Novartis Meningococcal ACWY Conjugate Vaccine, administered to healthy children 2 to 10 years of age. |
|
E.1.1.1 | Medical condition in easily understood language |
Study to asses immunogenicity, safety and 1 year persistence of antibodies after one or two doses of Menveo in healthy children 2 to 10 years of age. |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027202 |
E.1.2 | Term | Meningitis bacterial |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Immunogenicity objectives:
Primary
1. To assess the immunogenicity of either one or two doses of MenACWY-CRM vaccine (given 2 months apart) when administered to healthy children 2 to 5 years of age, as measured by the percentage of subjects with hSBA seroresponse directed against N. meningitidis serogroups A, C, W and Y, at 1 month after last vaccination.
2. To assess the immunogenicity of either one or two doses of MenACWY-CRM vaccine (given 2 months apart) when administered to healthy children 6 to 10 years of age, as measured by the percentage of subjects with hSBA seroresponse directed against N. meningitidis serogroups A, C, W and Y, at 1 month after last vaccination.
Safety objectives:
•All adverse events (AEs) reported during days 1 to 7 after each vaccination;
•All medically attended AEs reported from study day 1 to study termination/early termination;
•All Serious adverse events (SAEs) reported from study day 1 to study
|
|
E.2.2 | Secondary objectives of the trial |
Immunogenicity objectives:
Secondary
1. To assess the immunogenicity of either one or two doses of MenACWY-CRM vaccine (given 2 months apart) when administered to healthy children in two age cohorts (2 to 5 and 6 to 10 years of age), as measured by the percentage of subjects with hSBA ≥1:8 and hSBA GMTs, directed against N. meningitidis serogroups A, C, W and Y (overall, and stratified according to a pre-vaccination hSBA <1:4 or ≥1:4), at 1 month after last vaccination.
2. To assess the immunity against N. meningitidis serogroups A, C, W and Y at 12 months after either one or two doses (given 2 months apart) of MenACWY-CRM vaccine, when administered to healthy children in two age cohorts (2 to 5 and 6 to 10 years of age), as measured by the percentage of subjects with hSBA ≥1:8 and by hSBA GMTs (overall, and stratified according to a pre-vaccination hSBA <1:4 or hSBA ≥1:4).
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria: Children from 2 to 10 years of age with up to date routine childhood vaccination (to the best knowledge of subjects’ parents/legal representatives), generally in good health, and available for all study visits, whose legally acceptable representative has given written informed consent at the time of enrollment. |
|
E.4 | Principal exclusion criteria |
Exclusion criteria: Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis. Previous immunization with meningococcal any vaccine. Exposure within 60 days to individuals with culture proven meningococcal disease. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
All immunogenicity endpoints refer to each N. meningitidis serogroups A, C, W, Y.
Primary:
Percentage of subjects with hSBA seroresponse, defined as:
• for subjects with pre-vaccination hSBA <1:4, post vaccination hSBA ≥1:8
• for subjects with pre-vaccination hSBA ≥1:4, an increase of at least four times of the pre-vaccination hSBA.
• Safety will be assessed for all subjects in terms of the frequency and percentage of reported adverse events (AEs), medically attended AEs and serious adverse events (SAEs).
- All AEs will be collected for 7 days following each administration of the study vaccine.
- Medically attended AEs, AEs resulting in premature withdrawal from the study and SAEs will be collected from the time the subject signs the informed consent until he/she stops study participation.
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
one month and one year after last vaccination |
|
E.5.2 | Secondary end point(s) |
Secondary:
• Percentage of subjects with hSBA ≥1:8.
• hSBA GMTs.
Safety Endpoints
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
one month and one year after last vaccination |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |