E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vaccination of children 2 to 10 years of age against invasive disease caused by meningococcal serogroups A, C, W-135, and Y. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027274 |
E.1.2 | Term | Meningococcal infection |
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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 |
Immunogenicity Persistence At 32, 44, 56 and 68 months after primary vaccination with MenACWY-TT or Menjugate. •To evaluate the persistence of meningococcal antibodies in terms of the percentage of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY titres ≥1:8.
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E.2.2 | Secondary objectives of the trial |
Immunogenicity at 32, 44, 56 and 68 months after primary vaccination in terms of •rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥1:128 and GMTs •Anti-PSA, anti-PSC, anti-PSW-135, and anti-PSY antibody concentrations ≥0.3 µg/mL, ≥2.0 µg/mL and GMCs. •hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY titres ≥1:4, ≥1:8 and GMTs. Immunogenicity at one month post-booster in terms of •rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titres ≥1:8, ≥1:128, GMTs and rSBA vaccine response. •Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY antibody concentrations ≥0.3µg/mL, ≥2.0µg/mL and GMCs. •hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titres ≥1:4, ≥1:8, GMTs and hSBA vaccine response. Evaluate safety on Days 0-3 following the booster vaccination •Occurrence of each solicited local and general symptom. Evaluate safety on Days 0-30 following the booster vaccination •Occurrence of unsolicited adverse events, SAEs and new onset of chronic illness.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All subjects must satisfy ALL the following criteria at study entry: •Subjects who the investigator believes that their parent(s)/LAR(s) can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study. •A male or female who was primed with MenACWY-TT or Menjugate in the primary vaccination study MENACWY-TT-081 PRI (111414). •Written informed consent obtained from the parent(s)/LAR(s) of the subject and written informed assent obtained from the subject (at investigator discretion). •Healthy subjects as established by medical history and clinical examination before entering into the study. All subjects must meet the additional following criteria prior to receiving the booster vaccination: •Subjects who had a blood sample taken at Visit 4 during the persistence epoch of the current study. •Female subjects of non-childbearing potential may be enrolled in the study. - Non-childbearing potential is defined as pre-menarche (absence of menses). •Female subjects of childbearing potential may be enrolled in the study, if the subject: - has practiced adequate contraception (including abstinence) for 30 days prior to vaccination, and - has a negative pregnancy test on the day of vaccination, and - has agreed to continue adequate contraception (including abstinence) during the entire treatment period and for 2 months after completion of the vaccination series. |
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E.4 | Principal exclusion criteria |
Persistence and Booster •Child in care. •Use of any investigational or non-registered product (drug or vaccine) •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs. (For corticosteroids, prednisone <10 mg/day, or equivalent, inhaled and topical steroids are allowed). •Concurrently participating in another clinical study or planned participation in another clinical study, at any time during the study period (from the time of the booster until the end of the study), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). •History of meningococcal disease •Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, B, C, W-135, and/or Y since the previous vaccination in the primary vaccination study •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 is required). •Serious chronic illness •Administration of immunoglobulins and/or any blood products •Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy. •Subjects in contact with somebody suffering from an invasive infection with meningococcal serogroups A, C, Y or W-135. •Subjects living in a geographic area where local outbreak with meningococcal serogroup C has occurred and would thus be likely to participate in a vaccination campaign against meningococcal serogroup C. Booster only: •Hypersensitivity to latex. •Planned administration/ administration of a vaccine not foreseen by the study protocol within the last 30 days of the dose of vaccine(s) with the exception of a licensed inactivated influenza vaccine. •Previous vaccination with tetanus toxoids within the last 30 days (i.e. Tdap, Td, and TT-containing vaccine). •A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. •History of any neurological disorders or seizures (although subjects with a prior history of a single episode of benign febrile seizures may be allowed to participate in the study). •Acute disease and/or fever at the time of vaccination. -Fever is defined as rectal temperature ≥38°C / axillary temperature ≥37.5°C / oral temperature of ≥37.5°C / tympanic temperature on oral setting ≥37.5°C. -Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator. •History of chronic alcohol consumption and/or drug abuse. •History of hypotonic-hyporesponsive episodes (HHEs) following vaccination. •Pregnant or lactating female. •Female of child-bearing potential 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) |
Persistence of antibodies in all subjects with respect to components of the investigational vaccine: •rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY titres ≥1:8 at 28, 40, 52 and 64 months after the primary 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 | Yes |
E.6.5 | Efficacy | Yes |
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 |
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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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 31 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |