E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prophylaxis for Neisseria meningitidis serogroup A, C,W-135, and Y. |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
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 |
To evaluate the persistence of the antibody response in children of 40 and 60 months of age previously vaccinated with MenACWY in study V59P14, as measured by percentage of subjects with human Serum Bactericidal Assay (hSBA) titers 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y. |
|
E.2.2 | Secondary objectives of the trial |
1.To evaluate the persistence of the antibody response in children of 40 and 60 months of age previously vaccinated with MenACWY in study V59P14.
2.To evaluate the functional antibody levels in children of 40 and 60 months of age that were not previously vaccinated with meningococcal vaccine.
3.To evaluate the antibody response of MenACWY given at 60 months of age in children who had previously received at least one dose of Novartis MenACWY vaccine in study V59P14 compared to the antibody response to one dose of MenACWY in meningococcal vaccine-naive subjects at 1 month post-vaccination.
4.To assess the safety and tolerability of a booster dose of MenACWY in subjects who were previously vaccinated with MenACWY.
5. To assess the safety and tolerability of a single dose of MenACWY in meningococcal vaccine naive subjects 60 months of age. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Children eligible to be enrolled in the study are those whose parents provide written informed consent, and are in generally good health based on the clinical judgment of the investigators.
•Group 1 and 2 (Follow up) subjects must be 40 +/- 3 months of age at the time of enrollment and participated in the original V59P14 study.
•Group 3 and 4 (Naïve) subjects must be healthy, meningococcal vaccine-naïve children ages 40 +/- 3 months (Group 3) or 60 +/-3 months (Group 4) at the time of enrollment, respectively.
|
|
E.4 | Principal exclusion criteria |
•Serious acute, or chronic illnesses are reasons for exclusion.
•Subjects who have received any vaccine (excluding influenza vaccines) 28 days preceding enrollment visit. Influenza vaccines (including FluMist®) are excluded for the 14 days prior to the enrollment visit.
•Subjects who have received any meningococcal vaccine since birth (Groups 3 & 4 -naive) or last study dose in V59P14 trial (Groups 1 & 2 - follow on).
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
1.Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y in subjects 40 months of age
2.Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y in subjects 60 months of age |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1.Percentages of Subjects With hSBA Titers ≥ 1:4 against N. Meningitidis Serogroups A, C, W-135, and Y
2.hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W-135, and Y
3.Percentages of Subjects With hSBA Titers ≥ 1:8 against N. Meningitidis Serogroups A, C, W-135, and Y
4.Percentage of Subjects With Seroresponse against N. Meningitidis Serogroups A, C, W-135, and Y
5. Percentages of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
6.Percentages of Subjects Reporting Unsolicited AEs and SAEs |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. 40 and 60 months of age, and 1 month post-booster
2. 40 and 60 months of age, and 1 month post-booster
3. 40 and 60 months of age, and 1 month post-booster
4. 1 month post-booster
5. Day 1 to Day 7 after vaccination
6. Day 1 to study termination |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
|
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 | Yes |
E.8.1.1 | Randomised | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
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.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 9 |