E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers (for one dose primary immunization against meningococcal serogroups A, C, W-135 and Y diseases in healthy subjects aged 10 through 25 years) |
|
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 | 18.0 |
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 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
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 |
|
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 MenACWY-TT (Lot A) when compared to Menactra® in terms of the percentage of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY vaccine response one month after vaccination |
|
E.2.2 | Secondary objectives of the trial |
At one month after primary vaccination with MenACWY-TT Lot A, Lot B or Menactra®:
• To evaluate the clinical comparability of the two lots of MenACWY-TT conjugate vaccine with respect to serum bactericidal antibody geometric mean titers (hSBA GMTs) for N. meningitidis serogroups A, C, W-135, and Y
• To evaluate the immunogenicity in terms of percentage of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY titers and GMTs
• To evaluate the immunogenicity of Lot B in terms of per-centage of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY vaccine response
To evaluate the safety of MenACWY-TT Lot A, Lot B, and Menactra® vaccines with respect to:
• Local and general solicited symptoms during the 4-day period following vaccination
• Unsolicited non-serious adverse events during the 31-day period following vaccination
• Serious adverse events and new onset of chronic ill-ness(es) from administration of study vaccines through 6 months after vaccination |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Subjects whom the investigator believes that they and/or their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
• A male or female between, and including, 10 and 25 years of age at the time of the vaccination.
• Written informed consent obtained from the subject/from the parent or Legally Acceptable Representative(s) of the subject. Assent will be obtained from subjects who are still legally minors in line with local rules and regulations.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Previously completed routine childhood vaccinations to the best of subject’s/Legally Acceptable Representative(s)’s knowledge.
• Female subjects of non-childbearing potential may be enrolled in the study.
• Female subjects of childbearing potential 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 vaccina-tion, and
- has agreed to continue adequate contraception for 2 months after vaccination. |
|
E.4 | Principal exclusion criteria |
• Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the 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 vaccination.
• Planned administration/administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine, with the exception of any licensed inactivated influenza vaccine.
• Previous vaccination with meningococcal polysaccharide or conjugate vaccine.
• Previous vaccination with TT or a TT-containing vaccine within the last month.
• History of meningococcal disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus 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 allergic reactions or disease likely to be exacerbated by any component of either vaccine, or by dry natural rubber latex.
• History of any neurologic disorders, including Guillain-Barré Syndrome.
• Major congenital defects or serious chronic illness.
• Acute disease at the time of enrollment.
• 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.
• Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
• Child in care.
• 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 product. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Immunogenicity in all subjects with respect to com-ponents of the vaccines |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
One month after vaccination |
|
E.5.2 | Secondary end point(s) |
• Immunogenicity in all subjects with respect to components of the vaccines (on secondary readouts)
• Occurrence of solicited local and general symptoms
• Occurrence of unsolicited non-serious adverse events
• Occurrence of new onset of chronic illness(es) (NOCI) and serious adverse events (SAEs) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
• Prior to (Month 0) and one month after vaccination
• Within 4 days (Day 0 to 3) following vaccination
• Within 31 days (Day 0 to 30) following vaccination
• From Month 0 through Month 6 |
|
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 |
Immunogenicity, reactogenicity |
|
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
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 | 3 |
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 |
|
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
|
Last subject/last phone call |
|
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 |