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 immune lot consistency of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW conjugate vaccine with respect to serum bactericidal assay using human complement (hSBA) geometric mean titers.
•To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of licensed MCV4 vaccine.
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E.2.2 | Secondary objectives of the trial |
•To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of licensed MCV4 vaccine in the adult population (18 to 55 years old)
•To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of licensed MCV4 vaccine in the adolescent population (10 to 17 years old)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Aged 10 to 55 years on the day of inclusion
•Informed consent form has been signed and dated by the subject (aged 18 to 55 years) or assent form has been signed and dated by the subject and informed consent form has been signed and dated by the parent(s) or guardian (for subjects aged 10 to < 18 years)
•Subject (≥ 18 years) or subject (10 to < 18 years) 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 |
•Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination)
•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 pandemic influenza vaccines and multivalent influenza vaccines
•Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B 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, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects 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, as reported by the subject or the subject's parent / guardian, contraindicating intramuscular vaccination in the Investigator's opinion
•Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion
•Personal history of Guillain-Barre syndrome
•Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within 10 years of the proposed study vaccination
•Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
•Current alcohol abuse or drug addiction
•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 judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4°F]). A prospective subject 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 an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, 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.Geometric mean titer ratios (GMTRs) of antibodies against meningococcal serogroups A, C, Y, and W measured by hSBA post-vaccination between lots for immune lot consistency
2.Number of participants with seroresponse to meningococcal serogroups A, C, Y, and W following vaccination with a single dose of MenACYW conjugate vaccine or Licensed MCV4 vaccine
Meningococcal serogroups A, C, Y, and W will be assessed by serum bactericidal assay using human complement
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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.Number of adolescent participants with seroresponse to meningococcal serogroups A, C, Y, and W post-vaccination with a single dose of MenACYW conjugate vaccine or Licensed MCV4 vaccine
Meningococcal serogroups A, C, Y, and W will be assessed by serum bactericidal assay using human complement
2.Number of adults participants with seroresponse to meningococcal serogroups A, C, Y, and W post-vaccination with a single dose of MenACYW conjugate vaccine or Licensed MCV4 vaccine
Meningococcal serogroups A, C, Y, and W will be assessed by serum bactericidal assay using human complement
3.Number of participants reporting solicited reactions, unsolicited adverse events and serious adverse events following vaccination with a lot of MenACYW conjugate vaccine or Licensed MCV4 vaccine
Solicited injection site and systemic reactions (Day 0 to Day 7 post-vaccination); unsolicited adverse events, including serious adverse events 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 0 up to 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 | 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 |
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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 | 7 |