| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| prevention of invasive disease caused by Neisseria meningitidis serogroups A, C, W-135, and Y in healthy subjects aged 11 to 55 years of age) |
|
| 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.1.3 | 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 serum bactericidal (antibody) titers induced by MenACWY-TT vaccine as compared to Mencevax ACWY when administered to individuals 11-55 years of age in terms of the percentage of subjects with Neisseria meningitidis serogroup A (MenA), serogroup C (MenC), serogroup W-135 (MenW-135), and serogroup Y (MenY) titers ≥ 1:8, ≥ 1:128 and Geometric mean titres (GMTs) as measured by a serum bactericidal assay using rabbit complement (rSBA) |
|
| E.2.2 | Secondary objectives of the trial |
• To evaluate the immunogenicity of a booster vaccination of MenACWY-TT with respect to the percentage of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY antibody titers ≥ 1:8, ≥1:128 and GMTs
• To evaluate the immunogenicity of booster vaccination in terms of the percentage of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY vaccine response*.
*rSBA vaccine response defined as:
- rSBA antibody titers ≥1:32 1 month after vaccination, for subjects with pre-vaccination titer <1:8
- rSBA antibody titers at least 4 times the pre-vaccination antibody titers, 1 month after vaccination, for subjects with pre-vaccination titer ≥1:8
• To evaluate the percentage of subjects with anti-TT con-centrations ≥ 0.1 IU/mL, ≥ 1.0 IU/mL and GMCs
• To evaluate the safety and reactogenicity of a booster vaccination dose of MenACWY-TT in terms of solicited symptoms, unsolicited symptoms, Serious Adverse Events (SAEs) and New Onset of Chronic Illnesses (NOCIs) |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). Or /and 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 (e.g. completion of the diary cards, return for follow-up visits).
• A male or female between and including 17 and 66 years of age at the time of entry into the present study.
• Has completed the vaccination phase of the vaccination study MENACWY-TT-015 (i.e., not withdrawn, had received one dose of study vaccine).
• In alignment with local laws and regulations, written informed consent obtained from parents/LAR(s) 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. The subjects ≥18 years of age at the time of enrolment will sign the informed consent form, even if the parent/ LAR previously signed the ICF before the subject reached the legal age of consent.
• Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
Additional inclusion criteria for the booster phase:
• Female subjects of non-childbearing potential may be enrolled in the study.
- Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
• 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 vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series. |
|
| E.4 | Principal exclusion criteria |
• Child in care
• Previous vaccination with meningococcal polysaccharide or conjugate vaccine outside of study MENACWY-TT-015.
• History of meningococcal disease due to serogroup A, C, W-135 or Y.
• Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including Human Immunodeficiency Virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).
• Major congenital defects or serious chronic illness.
• Family history of congenital or hereditary immunodeficiency.
• History of chronic alcohol consumption and/or drug abuse
Additional exclusion criteria for the booster phase:
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the follow-up period.
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose (for corticosteroids, this will mean prednisone ≥ 10 mg/day, or equivalent). Inhaled and topical steroids are allowed.
• Administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the booster dose of study vaccine or planned administration within 30 days after vaccination (with the day of vaccination considered Day 0), with the exception of a licensed inactivated influenza vaccine.
• Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration during the follow-up period.
• 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 with tetanus toxoids within the last month (i.e., TT-containing vaccine within the last month).
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• 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.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Immunogenicity with respect to the components of the investigational vaccine: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titres ≥ 1:8, ≥1:128 and GMTs.
|
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Six, seven, eight, nine and ten years after primary vaccination in study MENACWY-TT-015 |
|
| E.5.2 | Secondary end point(s) |
1. Immunogenicity with respect to the components of the investigational vaccine:
• rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥1:8, ≥1:128, GMTs and rSBA vaccine response.
• Anti-TT concentrations ≥0.1 IU/mL, ≥1.0 IU/mL and GMCs.
2. Occurrence of solicited local and general symptoms.
3. Occurrence of unsolicited symptoms.
4. Occurrence of SAEs, and new onset chronic illness(es) (e.g. autoimmune disorders, asthma, type 1 diabetes and allergies), GBS and meningococcal disease.
|
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. One month post booster vaccination at 10 years after primary vaccination
2. On days 0-3 following the booster vaccination
3. Up to 31 days following booster vaccination
4. From administration of the vaccine dose until study end |
|
| 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 | 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) | 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 |
|
| 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
|
| phone contact at Month 126 |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.2 | In all countries concerned by the trial years | 3 |
| E.8.9.2 | In all countries concerned by the trial months | 11 |
| E.8.9.2 | In all countries concerned by the trial days | 23 |
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