E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To demonstrate non-inferiority of MenACWY vaccine to that of MenC vaccine
given to healthy toddlers, as measured by the percentage of subjects with serum
bactericidal assay using human complement (hSBA) titers ≥8 against N.
meningitidis serogroup C, at 28 days after the vaccination. |
|
E.1.1.1 | Medical condition in easily understood language |
To demonstrate non-inferiority of MenACWY vaccine to that of MenC vaccine given to healthy toddlers. |
|
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 | 16.0 |
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
1.To demonstrate non-inferiority of MenACWY vaccine to that of MenC vaccine
given to healthy toddlers, as measured by the percentage of subjects with serum
bactericidal assay using human complement (hSBA) titers ≥8 against N.
meningitidis serogroup C, at 28 days after the vaccination.
Safety objectives:
1. To assess the safety and reactogenicity of MenACWY and MenC vaccines. |
|
E.2.2 | Secondary objectives of the trial |
1 Assess immunogenicity of 1 dose of MenACWY, as measured by the % of subj. with hSBA titers ≥8 against N.meningitidis serogr. A, W and Y, at 28 days post vacc.
2 Assess and compare immunogenicity of 1 dose of MenACWY to that of MenC as measured by the % of subj. with hSBA seroresponse against N.meningitidis serogr. C, at 28 days post vacc.
3 Assess and compare immunogenicity of 1 dose of MenACWY to that of MenC as measured by hSBA geometric mean titers (GMTs) against N.meningitidis serogr. C, at 28 days post vacc.
4 Assess immunogenicity of 1 dose of MenACWY, as measured by the % of subj. with seroresponse and by hSBA GMTs against N.meningitidis serogr. A, W and Y, at 28 days post vacc.
5 Assess immunogenicity of 1 dose of MenACWY and 1 dose of MenC, as measured by the % of subj. with serum bactericidal assay using rabbit complement rSBA titers≥8, the % of subj. with rSBA titers≥128 and by rSBA GMTs against N.meningitidis serogr. A,C,W,Y at 28 days post vacc. (in subset of subj.) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to participate in this study, all subjects must meet ALL of the inclusion criteria
described.
1. Male and female children between 12 months and 15 months old inclusive (minimum
365 days of age and maximum 15 months plus 29 days of age), who were born with
an estimated gestational age ≥ 37 weeks;
2. For whom parent(s)/legal guardian(s) have given written informed consent after the
nature of the study has been explained according to local regulatory requirements;
3. Who the investigator believes that their parents/ guardians will be available for all the
visits and would comply with the requirements of the protocol (e.g., completion of the
Diary Cards, availability for study visits / safety phone calls);
4. Individuals in good health as determined by the outcome of medical history, physical
examination and clinical judgment of the investigator; |
|
E.4 | Principal exclusion criteria |
described.
1. Subjects that had a previous confirmed or suspected disease caused by N.
meningitidis.
2. Who were previously exposed to clinically proven meningococcal disease or clinical
bacterial meningitis without further microbiologic characterization, i.e. possible
meningococcal disease.
3. Who have previously been immunized with a meningococcal vaccine or vaccine
containing meningococcal antigen(s) (licensed or investigational).
4. Who have received within 90 days prior to enrolment or are expected to receive
during the study period any investigational or non-registered product (drug or
vaccine).
5. Who have received or who are planning to receive any vaccines within 14 days before
and 30 days after administration of the study vaccine (Exception: Injectable influenza
vaccine may be administered up to 14 days prior to study vaccination and at least 14
days after study vaccination).
6. Who have a major congenital defect or a serious chronic disease.
7. Who have a history of any anaphylaxis, severe vaccine reactions, or allergy to any
vaccine components including diphtheria toxoid (CRM197) and latex.
8. Who required chronic administration (defined as more than 14 days) of
immunosuppressants or other immune-modifying drugs within six months prior to
the study vaccination. (For corticosteroids, this means prednisone, or equivalent, ≥
0.5 mg/kg/day. Inhaled and topical steroids are allowed).
9. Who received immunoglobulins and/or any blood products within 90 days prior study
vaccination or who have administration planned during the study period.
10. Who have any confirmed or suspected immunosuppressive or immunodeficient
condition, based on medical history and physical examination.
11. Who have any bleeding disorder which consider as a contraindication to intramuscular
injection or blood draw.
12. Who have experienced a significant acute infection or fever (defined as temperature ≥
38°C) within 3 days prior enrolment.
13. Who have received systemic antibiotic treatment within 7 days prior to enrolment.
There may be instances when individuals meet all entry criteria except one that relates to
transient clinical circumstances (e.g., body temperature elevation or recent use of
excluded medication or vaccine). Under these circumstances, a subject may be considered
eligible for study enrollment if the appropriate window for delay has passed,
inclusion/exclusion criteria have been rechecked, and if the subject is confirmed to be
eligible. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary Immunogenicity Endpoint
- Percentage of subjects with hSBA ≥1:8 against serogroup C at Day 30 post vaccination.
Safety Endpoints
Safety data will be summarized by vaccination group:
- Solicited local and systemic AEs reported from Day 1 (6 hours) to Day 7 after
vaccination |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Primary Immunogenicity Endpoint
- Percentage of subjects with hSBA ≥1:8 against serogroup C at Day 30 post vaccination.
Safety Endpoints
Safety data will be summarized by vaccination group:
- Solicited local and systemic AEs reported from Day 1 (6 hours) to Day 7 after
vaccination |
|
E.5.2 | Secondary end point(s) |
- Percentage of subjects with hSBA titers ≥8 against serogroups A, W and Y at Day 29
post vaccination.
- Percentage of subjects with hSBA seroresponse[1] against serogroups A, C, W and Y
at Day 29 post vaccination.
- hSBA GMTs for serogroups A, C, W and Y at Day 29 post vaccination.
- Percentage of subjects with rSBA titer ≥8 against serogroups A, C, W and Y at Day
29 post vaccination.
- Percentage of subjects with rSBA titers ≥128 against serogroups A, C, W and Y at
Day 29 post vaccination.
- rSBA GMT for serogroups A, C, W and Y at Day 29 post vaccination. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Percentage of subjects with hSBA titers ≥8 against serogroups A, W and Y at Day 29
post vaccination.
- Percentage of subjects with hSBA seroresponse[1] against serogroups A, C, W and Y
at Day 29 post vaccination.
- hSBA GMTs for serogroups A, C, W and Y at Day 29 post vaccination.
- Percentage of subjects with rSBA titer ≥8 against serogroups A, C, W and Y at Day
29 post vaccination.
- Percentage of subjects with rSBA titers ≥128 against serogroups A, C, W and Y at
Day 29 post vaccination.
- rSBA GMT for serogroups A, C, W and Y at Day 29 post 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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 30 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
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 | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |