E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers (active immunization against invasive meningogoccal
disease (IMD) caused by Meningococcal serogroups A, C, Y or W) |
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E.1.1.1 | Medical condition in easily understood language |
Invasive meningococcal disease (IMD) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027274 |
E.1.2 | Term | Meningococcal infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 demonstrate the non-inferiority of the vaccine seroresponse of meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW conjugate vaccine compared to that observed following the administration of a single dose of MENVEO® in children aged 2 to 9 years. |
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E.2.2 | Secondary objectives of the trial |
•To compare the hSBA antibody geometric mean titers (GMTs) of meningococcal serogroups A, C, Y, and W following the administration of MenACYW conjugate vaccine to those observed following the administration of MENVEO® in children 2 to 9 years of age
•To evaluate the hSBA antibody GMTs of meningococcal serogroups A, C, Y, and W following the administration of MenACYW conjugate vaccine and those observed following the administration of MENVEO® in children 2 to 5 years of age, and in children 6 to 9 years of age, respectively.
•To evaluate the hSBA vaccine seroresponse to meningococcal serogroups A, C, Y, and W before and 30 days (+14 days) post-vaccination in children 2 to 5 years of age, and in children 6 to 9 years of age, respectively.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Aged 2 to 9 years on the day of inclusion
•Assent form has been signed and dated by the participant (as required by local regulations) and informed consent form (ICF) has been signed and dated by parent(s) or guardian
•Participant and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
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E.4 | Principal exclusion criteria |
•Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche
•Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
•Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after the study investigational vaccines. This exception includes monovalent, multivalent, live, and attenuated influenza vaccines
•Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (ie., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, W; or meningococcal B serogroup containing vaccine)
•Receipt of immune globulins, blood or blood-derived products in the past 3 months
•Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
•History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
•At high risk for meningococcal infection during the trial (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease)
•Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
•Verbal report of thrombocytopenia, contraindicating intramuscular vaccination by the Investigator's judgment
•Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion
•Personal history of Guillain-Barré syndrome
•Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine
•Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
•Moderate or severe acute illness/infection (according to Investigator's judgment) on the day of vaccination or febrile illness (temperature ≥100.4°F). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
•Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
•Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
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E.5 End points |
E.5.1 | Primary end point(s) |
1.Antibody titers against meningococcal serogroups A, C, Y, and W at baseline and post-vaccination with either a single dose of MenACYW conjugate vaccine or MENVEO®
Meningococcal serogroups A, C, Y, and W antibodies will be measured by serum bactericidal assays using human complement (hSBA) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1.Geometric mean titers of antibodies against meningococcal serogroups A, C, Y, and W before and after vaccination with MenACYW conjugate vaccine or MENVEO®
Meningococcal serogroups A, C, Y, and W antibodies will be measured by serum bactericidal assays using human complement (hSBA)
2.Number of participants with seroresponse against meningococcal serogroups A, C, Y, and W after vaccination with MenACYW conjugate vaccine or MENVEO® Meningococcal serogroups A, C, Y, and W antibodies will be measured by serum bactericidal assays using human complement (hSBA)
3.Number of participants reporting solicited reactions, unsolicited adverse events, serious adverse events, and adverse events of special interest following vaccination with MenACYW conjugate vaccine or MENVEO®
Solicited injection site reactions and systemic reactions (Day 0 to Day 7 post each vaccination); unsolicited adverse events, including serious adverse events and adverse events of special interest will be collected throughout the study
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Day 30 post vaccination
2. Day 30 post vaccination
3. Day 180 post vaccination
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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 | 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 | Yes |
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) | 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 |
Will this trial be conducted at a single site globally?
| Yes |
E.8.4 | Will this trial be conducted at multiple sites globally? | No |
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 |
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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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial months | 8 |