E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 immunogenicity of a single dose of MenACYW conjugate vaccine compared to Menactra® in adolescents and children aged 2 to 17 years in terms of serum bactericidal assay using human complement (hSBA) titers. |
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E.2.2 | Secondary objectives of the trial |
1 - To describe the antibody titers to the meningococcal serogroups A, C, Y, and W before and at Day (D) D30 (+14 days) after vaccination with MenACYW conjugate vaccine or a licensed meningococcal vaccine in adults in India aged 18 to 55 years (Menactra®) or ≥ 56 years (Quadri Meningo™) 2 - To describe the antibody titers to the meningococcal serogroups A, C, Y, and W before and at D30 (+14 days) after vaccination with MenACYW conjugate vaccine or Menactra® in children and adolescents aged 2 to 17 years in India and/or Republic of South Africa (RSA) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age in the defined range on the day of inclusion - For Adults: Aged ≥ 18 years on the day of inclusion - For Children and Adolescents: Aged 2 to 17 years on the day of inclusion - Z-score of ≥ -2 standard deviations (SD) on the Weight-for-height table of the World Health Organization (WHO) Child Growth Standards - For children : Children aged 2 to 5 years must have a Z-score of ≥ -2 SD on the Weight-forheight table of the WHO Child Growth Standards - Informed consent obtained - For adults: Informed consent form has been signed and dated by the subject and by an independent witness, if required by local regulations - For children and adolescents: Assent form has been signed and dated by the subject (for subjects 7 to 17 years of age), and informed consent form has been signed and dated by the parent(s) or legally acceptable representative and by an independent witness, if required by local regulations - Able to attend all scheduled visits and to comply with all trial procedures - For adults: Able to attend all scheduled visits and to comply with all trial procedures - For children and adolescents: Participants and parent / legally acceptable representative 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, or post-menopausal for at least 1 year, or surgically sterile - Participation at the time of study enrollment (or 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 in the 4 weeks following vaccination except for oral poliovirus vaccine (OPV) in India, received during national immunization days. In India, OPV may be received with a gap of at least 2 weeks before the study vaccine. This exception includes monovalent and bivalent OPV. - 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 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, 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 latex or to any of the vaccine components, or history of a lifethreatening reaction to the vaccine(s) 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 / legally acceptable representative, 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-Barré 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 - Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives. - Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination, febrile illness (temperature ≥ 38.0°C), persistent diarrhea, vomiting. 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 - Antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W : % of participants achieving antibody titers ≥ predefined threshold of 1:8. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
[1] : D30 after vaccination |
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E.5.2 | Secondary end point(s) |
[1] : Antibody titers against meningococcal serogroups A, C, Y, and W : Antibody titers are measured by hSBA and summarized as geometric mean titers (GMTs) [2] : Antibody titers against meningococcal serogroups A, C, Y, and W : Antibody titers are measured by rSBA and summarized as GMTs [3] : Antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, Y, and W : Antibody titers are measured by hSBA and summarized as % of participants achieving antibody titers ≥ predefined thresholds [4] : Antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, Y, and W : Antibody titers are measured by rSBA and summarized as % of participants achieving antibody titers ≥ predefined thresholds |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
[1], [2], [3], [4] : D0 and D30 after 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 | Yes |
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 | 8 |
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 years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |