| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Invasive disease caused by Neisseria meningitidis serogroups A, C W-135 and Y |
|
| E.1.1.1 | Medical condition in easily understood language |
| Inflammation of the brain and infection of the blood |
|
| 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 | 10028910 |
| E.1.2 | Term | Neisseria meningitides meningitis |
| 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 | 10051931 |
| E.1.2 | Term | Neisseria infection NOS |
| E.1.2 | System Organ Class | 100000004862 |
|
| 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 |
| To evaluate the long-term persistence of the immunogen-icity induced by MenACWY-TT vaccine as compared to Menactra at 11-25 years of age in terms of the percentage of subjects with N. meningitidis serogroup A (MenA), N. meningitidis serogroup C (MenC), N. meningitidis serogroup W-135 (MenW-135), and N. meningitidis serogroup Y (MenY) titers >= 1:8 as measured by a serum bactericidal assay using human complement (hSBA). |
|
| E.2.2 | Secondary objectives of the trial |
•persistence of MenACWY-TT or Menactra with respect to the percent of subjects with hSBA-MenA/C/W-135/Y titers ≥ 1:4 and GMTs 1, 3, and 5 years after vac-cination with MenACWY-TT and Menactra
•persistence of MenACWY-TT with respect serogroups A, C, W-135 and Y utilizing ELISA 1 year after vaccination with MenACWY-TT and Menactra
One month post primary (naïve control group) and booster vaccination with MenACWY-TT:
•immunogenicity of MenACWY-TT with respect to the per-cent of subjects with hSBA-MenA/C/W-135/Y titers ≥ 1:4, ≥ 1:8, GMTs and vaccine response
•immunogenicity of MenACWY-TT 5 years after a priming dose of MenACWY-TT compared to the immunogenicity of MenACWY-TT in subjects not previously vaccinated any meningococcal vaccine
•To evaluate the safety of MenACWY-TT after vaccination with respect to:
-Local and general solicited symptoms
-Unsolicited serious and non-serious adverse events
-Serious adverse events and new onset chronic illness(es)
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
Persistence phase:
•A male or female who was between and including 10 and 25 years of at the time of primary vaccination in the study with NCT number = 00454909.
•Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
•Healthy subjects as established by medical history.
•Having completed the active phase of the vaccination study with NCT number = 00454909..
Booster phase:
•Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
•Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
•Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
•If the subject is female, she must be of non-childbearing potential, i.e., pre-menarche, have a current tubal ligation, hysterectomy, oopherectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test on the day of vaccination and continue adequate contraception for 2 months after vaccination.
Additional inclusion criterion for the naïve control group:
•A male or female between, and including, 15 and 30 years of age (has not attained his/her 31st birthday) at the time of the vaccination. |
|
| E.4 | Principal exclusion criteria |
Persistence phase:
•Use of any investigational or non-registered product within 30 days of each persistence time point.
•Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C, W-135, and/or Y outside of study with NCT number = 00454909.
•History of any meningococcal disease due to serogroup A, B, C, W-135, or Y.
•Any confirmed or suspected immunosuppressive or im-munodeficient condition, based on medical history
•Administration of immunoglobulins and/or any blood prod-ucts within the three months preceding each persistence time point.
•Concurrently participating in another clinical study within 30 days of each persistence time point, in which the subject has been or will be exposed to an investigational or a non-investigational product
•Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
•Chronic alcohol or drug abuse.
•Subjects withdrew consent to be contacted for follow-up studies.
Booster phase (to be checked at Year 5 for all subject, including naïve control group):
•Child in care
•Not enrolled in the Kaiser Healthcare system.
•Use of any investigational or non-registered product within 30 days preceding administration of the study vaccine, or planned use throughout the extended safety follow-up period.
•Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to administration of the booster dose
•Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C, W-135, and/or Y outside of study with NCT number = 00454909.
•History of any meningococcal disease
•Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection based on medical history and physical examination
•Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration through Day 30 after vaccination.
•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
•Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
•History of chronic alcohol consumption and/ or drug abuse.
•Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before until 30 days after the day of administration of the dose of vaccine(s) with the exception of any licensed inactivated influenza vaccine
•Previous vaccination with tetanus and diphtheria toxoids within the last month.
•A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vac-cine recipient is demonstrated.
•History of allergic disease or any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, including latex.
•Major congenital defects or serious chronic illness.
•History of any neurological disorders or seizures.
•Previous history of Guillain-Barré syndrome
•Acute disease at the time of vaccination.
•Pregnant or lactating female.
•Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months after vaccination.
•For subjects who participated in the primary study NCT number = 00454909: Subjects withdrew consent to be contacted for follow-up studies
•Note: If the subject is female, prior to vaccination 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 on the day of vaccination and continue adequate contraception for 2 months after vaccination. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Meningococcal serum bactericidal titers using human complement antibody assay |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| One year, three years, and five years after primary vaccination |
|
| E.5.2 | Secondary end point(s) |
Meningococcal serum bactericidal titers using human complement antibody titers assay ≥ 1:4 and GMTs
Meningococcal serum bactericidal titers using human comple-ment antibody assay ≥ 1:4 , ≥ 1:8, GMTs and vaccine response
Meningococcal polysaccharides antibody concentration
Occurrence of solicited local and general symptoms
Occurrence of non-serious adverse events
Occurrence of serious adverse events and new onset chronic illness(es) |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 3 and 5 years post primary vaccination and 1 month post booster vaccination with GSK134612 vaccine at year 5 after primary vaccination and one month post-primary vaccination in newly enrolled
At one month post booster and at year 5 after primary vaccina-tion
One year after primary vaccination
4 days following vaccination
31 days following vaccination
6 months following vaccination |
|
| 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 | 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) | 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 | 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 | 4 |
| 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
|
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.2 | In all countries concerned by the trial years | 4 |
| 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 |
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