E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy subjects (active immunisation of individuals from the age of 12 months against invasive meningococcal diseases caused by Neisseria meningitidis serogroup A, C, W-135 and Y). |
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E.1.1.1 | Medical condition in easily understood language |
Inflammation of the brain and infection of the blood. |
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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 | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028911 |
E.1.2 | Term | Neisseria meningitidis infection NOS |
E.1.2 | System Organ Class | 100000004862 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10070124 |
E.1.2 | Term | Neisseria meningitidis test positive |
E.1.2 | System Organ Class | 100000004848 |
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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 evaluate the vaccine response induced by one dose of MenACWY-TT administered to MenC-primed and MenC unprimed subjects. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the immunogenicity of a booster vaccination in MenC-primed subjects and immunogenicity of MenACWY-TT vaccination in unprimed subjects with respect to the percentage of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titres ≥ 1:4, ≥ 1:8 and GMTs. To evaluate the immunogenicity of MenACWY-TT vaccination in terms of percentage of subjects with anti-TT concentrations ≥ 0.1 IU/mL, ≥ 1.0 IU/mL and geometric mean concentrations (GMCs). To evaluate the safety and reactogenicity of one dose of the MenACWY-TT conjugate vaccine in terms of solicited symptoms, unsolicited symptoms, serious adverse events (SAEs) and new onset of chronic illnesses (NOCIs). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol. • A male or female between, and including, 10 and 15 years of age at the time of vaccination. • For the MenC-TT group, a subject who has been vaccinated with a MenC-TT conjugate vaccine in infancy and/or at toddler age (i.e., according to schedule 3+1, 2+1, 1+1, 1), and for whom vaccination is documented. • For the MenC-CRM group, a subject who has been vaccinated with a MenC-CRM conjugate vaccine in infancy and/or at toddler age (i.e., according to schedule 3+1, 2+1, 1+1, 1), and for whom vaccination is documented. • For the noMenC group, a subject who has not previously received any dose of MenC vaccine per documentation. • Written informed consent obtained from the subject/subject’s parent(s)/LAR(s) as applicable according to local regulations. • Written informed assent obtained from the subjects when applicable according to local regulations. • Healthy subjects as established by medical history and clinical examination before entering into the study. • For female subjects of non-childbearing potential: These subjects may be enrolled in the study. - In this study, non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy or ovariectomy. • For female subjects of childbearing potential: These subjects may be enrolled in the study, if the subject: - has practiced adequate contraception for 30 days prior to vaccination, and - has a negative pregnancy test on the day of vaccination, and - has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series |
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E.4 | Principal exclusion criteria |
• Child in care • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period. • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. (For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day with an upper limit of 10 mg/kg or equivalent. Inhaled and topical steroids are allowed.) • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of vaccine (i.e., after blood sampling Visit 2), with the exception of a licensed inactivated influenza vaccine. • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device). • Previous vaccination against N. meningitidis with the exception of MenC vaccine for the MenC-TT and MenC-CRM groups. • For the MenC-TT and MenC-CRM groups, vaccination against N. meningitidis serogroup C after two years of age. • For the noMenC group, previous vaccination with any meningococcal vaccine. • Previous vaccination with any TT-containing vaccine within 30 days prior to the first visit. • History of, or intercurrent, meningococcal disease. • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). • Family history of congenital or hereditary immunodeficiency. • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. • Major congenital defects or serious chronic illness. • History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted. • Acute disease and/or fever at the time of enrolment. - Fever is defined as temperature >=37.5°C for oral, axillary or tympanic route, or >= 38.0°C on rectal route. The preferred route for recording temperature in this study will be axillary. The oral route is also allowed. - Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever, may be enrolled at the discretion of the investigator • Administration of immunoglobulins and/or any blood products within the three months preceding the study vaccination or planned administration during the study period. • History of chronic alcohol consumption and/or drug abuse. • Anaphylaxis following the administration of vaccine(s). • Pregnant or lactating female. • Female planning to become pregnant or planning to discontinue contraceptive precautions. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Immunogenicity with respect to the components of the investigational vaccine - hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY vaccine response |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
One month after vaccination with MenACWY-TT |
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E.5.2 | Secondary end point(s) |
1) Immunogenicity with respect to the components of the investigational vaccine - hSBA-MenA, hSBA-MenC, hSBA-MenW-135 an hSBA-MenY antibody titres ≥ 1:4, ≥ 1:8 and GMTs. - Anti-TT concentrations ≥ 0.1 IU/mL, ≥ 1.0 IU/mL and concentrations. 2) Solicited local and general symptoms - Occurrence of each solicited local symptoms - Occurrence of each solicited general symptoms 3) Unsolicited AEs - Occurrence of unsolicited AEs according to the Medical Dictionary for Regulatory Activities (MedDRA) classification. 4) SAEs - Occurrence of SAEs 5) New onset of chronic illness (NOCIs) - Occurrence of NOCI(s) (e.g. asthma, autoimmune disorders, type I diabetes, and allergies) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) Immunogenicity: Pre- and one month after vaccination with MenACWY-TT 2) Solicited local and general symptoms : Within 4 days (Days 0-3) after vaccination 3) Unsolicited AEs: Within 31 days (Days 0-30) after vaccination 4) SAEs: From study vaccine administration up to 6 months post study vaccination 5) New onset of chronic illness (NOCIs): From study vaccine administration up to 6 months post study 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 | 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 | No |
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 |
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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 | No |
E.8.1.2 | Open | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Active control (noMenC group) |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
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 | No |
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.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 17 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 17 |