E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary immunisation against Ebola Zaire virus on healthy volunteers |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
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 assess the safety and reactogenicity of a single IM dose of the ChAd3 EBO-Z vaccine, overall and in children aged 1 to 5, 6 to 12, and 13 to 17 years, separately. |
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E.2.2 | Secondary objectives of the trial |
To assess the humoral immunogenicity of a single IM dose of the ChAd3 EBO-Z vaccine, in terms of anti-GP EBOV antibody responses, overall and in children aged 1 to 5, 6 to 12, and 13 to 17 years separately. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Subject’s 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. availability for Diary Card completion, return for follow-up visits, availa-bility for clinical follow-up throughout the study period).
•Written/ thumb printed informed consent obtained from the subject’ parent(s)/ LAR[s] prior to performing any study specific procedure. In addition, written/ thumb printed informed assent should be obtained if appropriate (from all subjects aged 13 to 17 years and from younger subjects as per local requirements).
•A male or female child aged 1 to 17 years inclusive at the time of Screening.
•Subjects with a negative RDT test for Malaria within 30 days prior to randomisation into the study.
OR
Subjects with a positive RDT test for Malaria who completed antimalarial treatment at least 5 days prior to randomisation into the study.
•Healthy subjects as per Investigator judgement, as established by medical history, clinical examination and haematology/ biochemistry laboratory parameters screening before entering into the study.
•Female subjects of non-childbearing potential may be enrolled in the study.
- Non-childbearing potential is defined as premenarche or ovariectomy.
•Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to the Day 0 visit, and
- has a negative pregnancy test at the Day 0 visit, and
- has agreed to continue adequate contraception until 30 days after the Month 6 visit |
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E.4 | Principal exclusion criteria |
•Child in care.
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the Day 0 visit, or planned use during the study period.
•Previous vaccination with an investigational EBOV or Marburg vaccine, or previous vaccination with a chimpanzee adenoviral vectored investigational vaccine.
•Known prior EBOV or SUDV disease.
•Travel to country affected by the EBOV epidemic or direct contact with person with EVD within 21 days prior to the Day 0 visit.
•History of any reaction or hypersensitivity (such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain) likely to be exacerbated by any component of the study vaccine.
•Planned administration/ administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after each vaccination visit.
•Acute or chronic illness determined by medical history, clinical examination and laboratory screening tests including, but not limited to:
•Clinically significant immunosuppressive or immunodeficient condition (e.g. clinical acquired immune deficiency syndrome [AIDS]).
•Major congenital defects.
•Malnutrition (defined as weight for age Z-score less than -3, or other clinical signs of malnutrition).
•Any clinically significant haematological or biochemical laboratory abnormality.
•Pregnant female.
•Any condition that in the Investigator’s opinion may potentially compromise subject safety or interfere with subject assessment or compliance. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Occurrence of each solicited local and general AE
2. Occurrence of any unsolicited AE
3. Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) and biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities
4. Occurrence of clinical symptoms of thrombocytopenia (AE of specific interest)
5. Occurrence of any SAE, in all subjects, in both groups. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. At Day 7 after each vaccination (i.e. the day of vaccination and 6 subsequent days) in all subjects, in both groups.
2. At 30 days after each vaccination (i.e. the day of vaccination and 29 subsequent days), in all subjects, in both groups.
3. At Screening, Day 3, Day 6, Day 30, Month 6, Month 6+6 days, Month 6+30 days, Month 12
4. At Day 7 after vaccination (i.e. Day 0 up to Day 6), in all subjects, in both groups
5. For the whole study duration (from Day 0 to Month 12) |
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E.5.2 | Secondary end point(s) |
Anti-GP EBOV antibody titres, as measured by enzyme-linked immunosorbent assay (ELISA) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At Day 0 and Day 30 in all subjects in both groups.
At Month 6 and Month 6 + 30 days in all subjects, in the Group MENACWY TT/ EBO-Z |
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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 | 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) | 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 | Yes |
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 |
Cameroon |
Ghana |
Mali |
Nigeria |
Senegal |
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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.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 26 |