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 |
Within 4 days after vaccination, in all subjects: - To demonstrate the non-inferiority of meningococcal vaccine GSK134612 as compared to the licensed Mencevax ACWY in terms of the incidence of any grade 3 systemic symptoms. One month after vaccination, in the immunogenicity subset corresponding to the first 1125 enrolled subjects: - To demonstrate the non-inferiority of the vaccine response induced by meningococcal vaccine GSK134612 when compared to the licensed Mencevax ACWY in terms of serum bactericidal antibodies. |
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E.2.2 | Secondary objectives of the trial |
One month after vaccination, in the immunogenicity subset corresponding to the first 1125 enrolled subjects: - To compare the immunogenicity of one dose of meningococcal vaccine GSK134612 to that of Mencevax ACWY. One month after vaccination, in all the subjects: - To evaluate the safety and reactogenicity of one dose of meningococcal vaccine GSK134612 compared to that of the Mencevax ACWY. Up to six months after vaccination, in all subjects: - To describe serious adverse events and specific adverse events of rash, new onset of chronic illness(es), ER/non-routine physician office visits and any event related to lack of vaccine efficacy (i.e. meningococcal disease) occurring up to 6 months after vaccination. Note: Conditions leading to physician office visits that were not related to well-being care, vaccination, injury, 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 their parents or guardians can and will comply with the requirements of the protocol. - A male or female between, and including, 2 and 10 years of age at the time of vaccination. - Written informed consent obtained from the parent or guardian of the subject. - Free of obvious health problems as established by medical history and clinical examination before entering into the study. - Previously completed routine childhood vaccinations to the best of his/her parents'/guardians' knowledge. |
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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 (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above). - Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups 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.. - 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 first dose of study vaccine or planned administration during the study period. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Occurrence of any grade 3 systemic symptoms in all subjects 2. Vaccine response to meningococcal antigens in a subset of subjects
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. During the 4-day follow-up period after vaccination 2. One month after vaccination |
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E.5.2 | Secondary end point(s) |
1. Meningococcal rSBA titres in a subset of subjects 2. Anti-Tetanus toxoid antibody concentrations in a subset of subjects 3. Anti-meningococcal polysaccharide concentrations in a randomized subset of subjects 4. Occurrence of solicited local and general symptoms in all subjects 5. Occurrence of unsolicited symptoms in all subjects 6. Occurrence of serious adverse events in all subjects 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 in all subjects 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 2. Prior to and one month after vaccination 3. Prior to and one month after vaccination 4. During the 4-day follow-up period after vaccination, in all subjects 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 |
India |
Lebanon |
Philippines |
Saudi Arabia |
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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 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 |