E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of invasive disease caused by Neisseria Meningitidis serogroup A, C, W-135 and Y |
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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 |
Immunogenicity Objective: To compare the functional immune response 28 days after administration of one dose of Men ACWY Ad- with that of a Men ACWY PS vaccine in healthy children aged 36-<60 months, as measured by the percentage of subjects with hSBA ≥1:4 (i.e., the percentage of responders) against N. meningitidis serogroups A, C, W and Y.
Safety Objective To evaluate the safety and tolerability of Men ACWY Ad+ or Men ACWY Ad- or Men ACWY PS when administered to healthy children 12-<60 months old.
Ad-: without adjuvant Ad+: with adjuvant |
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E.2.2 | Secondary objectives of the trial |
To compare the functional immune response 28 days after administration of one dose of Men ACWY Ad- with that of a Men ACWY PS vaccine, as measured by hSBA geometric mean titers (GMTs) and hSBA ≥1:8 against N. meningitidis serogroups A, C, W and Y.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. healthy 12-<60 month old children; 2. for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained; 3. available for all the visits scheduled in the study; 4. in good health as determined by: • medical history • physical examination • clinical judgment of the investigator. |
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E.4 | Principal exclusion criteria |
Children who should not be enrolled in the study are those: 1.whose parents/legal guardians are unwilling or unable to give written informed consent to participate in the study; 2.who have previously received any meningococcal vaccine; 3.who have a previous ascertained or suspected disease caused by N. meningitidis; 4.who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection; 5.who have a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component; 6.who have experienced significant acute or chronic infection within the previous 7 days or have experienced fever (axillary temperature ≥38.0°C or rectal temperature ≥38.5°C) within 3 days previous to immunization; 7.who have any present or suspected serious acute (e.g. leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac, renal failure, or severe malnutrition or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down’s syndrome) 8.who have received another vaccine within the past 30 days from first or second immunization or any blood draw 9.who have received any investigational agent (including vaccine) within the past 90 days from first or second immunization or any blood draw 10.who have a known or suspected autoimmune disease or impairment /alteration of immune function resulting from (for example): a)administration of any immunosuppressive therapy b)administration of any immunostimulants c)administration of any sytemic corticosteroid administered for more than 4 days in the previous 30 days 11.with a suspected or known HIV infection or HIV related disease; 12.who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation; 13.with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding; 14.who have a history of any seizure disorder; 15.who have taken systemic antibiotics (either oral or parenteral) within the previous 14 days (EXCEPTION: subjects who have received an oral or parenteral β-lactam antibiotic [examples: penicillin, amoxicillin, ceftriaxone, cefuroxime, cephalexin, etc.] may be enrolled 7 days following the last dose of antibiotic); 16.who with their parents/legal guardians are planning to leave the area of the study site before the end of the study period; 17.with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Immunogenicity after a single dose either of Chiron MenACWY Ad- Conjugate Vaccine or MenACWY PS vaccine, as measured by the % of subject with hSBA titer ≥1:4 at 28 days after vaccination in subject 36-<60 months old. |
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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 | Information not present in EudraCT |
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 |
immunogenicity as surrogate marker of efficacy |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
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A follow up safety phone call performed six months after any vaccination or subject withdrawal. |
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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 | 18 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 18 |