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 |
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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027275 |
E.1.2 | Term | Meningococcal infection, unspecified |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
One month after vaccination: - To demonstrate the non-inferiority of the vaccine response induced by meningococcal vaccine GSK134612 compared to the licensed Mencevax ACWY measured by serum bactericidal antibodies using baby rabbit complement. - To demonstrate the non-inferiority of meningococcal vaccine GSK 134612 compared to the licensed Mencevax ACWY in terms of the incidence of any grade 3 systemic symptom within four days after vaccination based on the analysis of pooled safety and reactogenicity data of this present study and study 109067 (MenACWY-TT-035). |
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E.2.2 | Secondary objectives of the trial |
- To assess the safety profile of meningococcal vaccine GSK134612 as compared to the licensed Mencevax ACWY in terms of the incidence of any grade 3 systemic symptoms within four days after vaccination. One month after vaccination: - To compare the immunogenicity of one dose of meningococcal vaccine GSK134612 to that of Mencevax ACWY. - To evaluate the safety and reactogenicity of one dose of meningococcal vaccine GSK134612 to that of Mencevax ACWY. Up to six months after vaccination: - To describe serious adverse events and specific adverse events of rash, new onset chronic illness(es), and emergency room/non-routine physician office visits occurring up to six months after vaccination. Note: Conditions leading to physician office visits that were not related to well-being care, vaccination, injury or common acute illness were recorded during the study; however, these data were not analysed nor reported.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol. - A male or female between, and including, 11 and 17 years of age at the time of the vaccination. - Written informed assent/consent obtained from the subject/ from the parent or guardian of the subject. -Healthy subjects as established by medical history and clinical examination before entering into the study. -Previously completed routine childhood vaccinations to the best of the subject's/the subject's parent's/guardian's knowledge. -If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after vaccination. |
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E.4 | Principal exclusion criteria |
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. - Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. - Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine. - Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y within the last five years. - Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W-135 and/or Y. - Previous vaccination with tetanus toxoid within the last month. - History of meningococcal disease. - Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination. - A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. - History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s). - Major congenital defects or serious chronic illness. - Acute disease at the time of enrolment - Administration of immunoglobulins and/or any blood products within the three months preceding the dose of study vaccine or planned administration during the study period. - Pregnant or lactating female. - History of chronic alcohol consumption and/or drug abuse. - 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) |
1. Vaccine response to meningococcal antigens 2. Occurrence of any grade 3 systemic symptom |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. one month after vaccination 2. during the 4-day follow-up period after vaccination |
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E.5.2 | Secondary end point(s) |
1. Meningococcal rSBA titres 2. Anti-tetanus toxoid antibody concentration 3. Anti-meningococcal polysaccharide concentrations 4. Occurrence of solicited local and general symptoms 5. Occurrence of unsolicited symptoms 6. Occurrence of serious adverse events 7. Occurrence of specific adverse events of rash, new onset of chronic illness(es) and conditions prompting emergency room visits and physician office visits not related to common illnesses. Note: Conditions leading to physician office visits that were not related to well-being care, vaccination, injury or common acute illness were recorded during the study; however, these data were not analysed nor reported. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Prior to and one month after vaccination, in all subjects 2. Prior to and one month after vaccination, in all subjects 3. Prior to and one month after vaccination, in a randomized subset of subjects 4. During the 4-day follow-up period after vaccination 5. Up to one month after vaccination 6. Up to six months after vaccination 7. Up to six months 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 | No |
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 | 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 | 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) | 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?
| 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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Last contact of the last subject undergoing the trial at 6 months after vaccination. This contact can be a visit or a phone contact. |
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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 | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |