E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Nimenrix is indicated for active immunisation of individuals from the age of 12 months and above against invasive meningococcal diseases caused by Neisseria meningitidis serogroup A, C, W-135 and Y. |
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E.1.1.1 | Medical condition in easily understood language |
Nimenrix is a vaccine that protects individuals against meningococcal infection caused by Neisseria meningitidis serogroup A, C, W-135 and Y which can infect the blood and fluid around the brain. |
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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 | 18.1 |
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 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
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 |
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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 2, 3, 4, 5, 6 years after booster vaccination of children with MenACWY-TT or Meningitec
•To evaluate the persistence of meningococcal antibodies in terms of the percentage of subjects with rSBA antibody titres ≥1:8 for each of the four serogroups. |
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E.2.2 | Secondary objectives of the trial |
Immunogenicity
Persistence
At 2, 3, 4, 5, 6 years after booster vaccination of children with MenACWY-TT or Meningitec
•To evaluate the persistence of meningococcal A, C, W-135 and Y antibodies in terms of the percentage of subjects with rSBA titres ≥1:128 and GMTs and hSBA titres ≥1:4 and ≥1:8 and GMTs for each of the four serogroups.
Safety
•To describe serious adverse events (SAEs) related to vaccination and any event related to lack of vaccine efficacy (i.e. meningococcal disease) from the subject’s last visit in study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036) up to each yearly visit in the current study in a retrospective manner. |
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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’ 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. return for follow-up visits).
•A male or female who has received primary and booster vaccination with the MenACWY-TT or Meningitec vaccines in studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036), respectively.
•Written informed consent obtained from the parent(s)/LAR(s) of the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study. |
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E.4 | Principal exclusion criteria |
The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
•Child in care
•History of meningococcal disease.
•Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine outside of studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036).
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Persistence of antibodies with respect to components of the investigational vaccine, 2, 3, 4, 5, 6 years after booster vaccination:
- rSBA-MenA titres ≥1:8.
- rSBA-MenC titres ≥1:8.
- rSBA-MenW-135 titres ≥1:8.
- rSBA-MenY titres ≥1:8. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Primary vaccination for 12 to 23 Months, and then a booster vaccination 4 years after that and then 6 years persistence
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E.5.2 | Secondary end point(s) |
•Persistence of antibodies with respect to components of the investigational vaccine, 2, 3, 4, 5, 6 years after booster vaccination:
- rSBA-MenA titres≥1:128 and GMTs.
- rSBA-MenC titres ≥ 1:128 and GMTs.
- rSBA-MenW-135 titres ≥ 1:128 and GMTs.
- rSBA-MenY titres ≥ 1:128 and GMTs.
- hSBA-MenA titres ≥ 1:4, ≥ 1:8 and GMTs.
- hSBA-MenC titres ≥ 1:4, ≥ 1:8 and GMTs.
- hSBA-MenW-135 titres ≥ 1:4, ≥ 1:8 and GMTs.
- hSBA-MenY titres ≥ 1:4, ≥ 1:8 and GMTs.
•Serious adverse events:
- Occurrence of serious adverse events related to vaccination and any event related to lack of vaccine efficacy (i.e. meningococcal disease) from the subject’s last visit in study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036) up to each yearly visit in the current study in a retrospective manner. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Persistence: 2, 3, 4, 5, 6 years after booster vaccination.
Serious adverse events: Up to each yearly visit. |
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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 | 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 |
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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 | 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 | 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 | 2 |
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 | 10 |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |