E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy adolescents and adults who had received 1 dose of a quadrivalent meningococcal conjugate vaccine 4 to 10 years previously |
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E.1.1.1 | Medical condition in easily understood language |
Healthy adolescents and adults who had received 1 dose of a quadrivalent meningococcal conjugate vaccine 4 to 10 years previously |
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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 booster dose of MenACYW conjugate vaccine compared to those observed following the administration of a booster dose of a licensed Meningococcal Conjugate Vaccine (MCV4) in subjects who were first vaccinated with 1 dose of MCV4, 4 to 10 years before the booster dose. |
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E.2.2 | Secondary objectives of the trial |
•To evaluate the vaccine seroresponse of meningococcal serogroups A, C, Y, and W measured using human serum bactericidal assay (hSBA) in serum specimens collected 6 days after vaccination in a subset of subjects
•To evaluate the antibody responses (geometric mean titers) to serogroups A, C, Y, and W measured using hSBA on Day 0 (pre-vaccination) and Day 30 after vaccination
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Aged ≥ 15 years on the day of inclusion
•Subject has documented record of having received 1 dose of a quadrivalent meningococcal conjugate vaccine 4 to 10 years prior to enrollment
•Subject aged 15 to < 18 years: assent form signed and dated by the subject and informed consent form (ICF) signed and dated by the parent or guardian
•Subject aged ≥ 18 years: ICF signed and dated by the subject
•Subjects aged 15 to < 18 years: both the subject and parent / guardian are able to attend all scheduled visits and to comply with all trial procedures
•Subjects aged ≥ 18 years: 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, 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 before Day 30 visit except for influenza vaccination, which may be received at least 2 weeks before study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
•Previous vaccination against meningococcal disease with either an investigational or approved 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 travelling 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 vaccine(s) used in the trial or to a vaccine containing any of the same substances
•Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine
•Personal history of Guillain-Barré syndrome
•Verbal report of thrombocytopenia, 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
•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 the Investigator's 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.Percentage of participants with seroresponse to meningococcal serogroups A, C, Y, and W at baseline and post vaccination with a single dose of MenACYW conjugate vaccine or a licensed MCV4
Seroresponse is based on antibody titers against meningococcal serogroups A, C, Y, and W that will be assessed by human serum bactericidal assay |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 0 (pre vaccination) and Day 30 post vaccination |
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E.5.2 | Secondary end point(s) |
1.Number of participants with seroresponse to meningococcal serogroups A, C, Y, and W at baseline and post vaccination with a single dose of MenACYW conjugate vaccine or a licensed MCV4 Meningococcal serogroups A, C, Y, and W will be assessed by serum bactericidal assay using human complement
2.Geometric mean titer ratios (GMTRs) of antibodies against meningococcal serogroups A, C, Y, and W measured by hSBA after vaccination with MenACYW conjugate vaccine or a licensed MCV4
The antibody titers against Meningococcal serogroups A, C, Y, and W will be assessed by hSBA
3.Number of participants reporting solicited reactions, unsolicited adverse events and serious adverse events following vaccination with a lot of MenACYW conjugate vaccine or a licensed MCV4
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 6 post vaccination
2.Day 0 (pre vaccination) and 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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 9 |