E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of symptomatic dengue disease |
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E.1.1.1 | Medical condition in easily understood language |
Prevention of dengue disease with clinical symptoms |
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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 | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Humoral immune response to dengue before and after each vaccination with dengue vaccine in children previously vaccinated with yellow fever (YF) vaccine
Safety and reactogenicity
Viremia after the first and second vaccinations in a subset |
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E.2.2 | Secondary objectives of the trial |
Detection of symptomatic dengue cases occurring at any time in the study |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Aged 2 to 11 years on the day of inclusion (Scr.)
2) Subject in good health, based on medical history, physical examination and laboratory parameters (Scr. + V01)
3) Provision of Assent Form signed by the subject (for subjects ≥ 8 years old) and Informed Consent Form signed by the parents or another legally acceptable representative (and by an independent witness for illiterate parent[s]) (Scr.)
4) Subject and parents/legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures (Scr. + V01)
5) For a female subject of child-bearing potential (girls post-menarche), avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination, until at least 4 weeks after the last vaccination (Scr.+V01)
6) Documented receipt of YF vaccine since at least 1 month before the first vaccination (Scr.) |
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E.4 | Principal exclusion criteria |
1) Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia (Scr.)
2) For a female subject of child-bearing potential (girls post-menarche), known pregnancy (Scr.)
3) For a female subject of child-bearing potential (girls post-menarche), known pregnancy or positive pregnancy test in blood sample taken at Scr. (V01)
4) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination (Scr.+V01)
5) Planned participation in another clinical trial during the trial (Scr.)
6) Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy (Scr.)
7) Known systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances (Scr.)
8) Systemic hypersensitivity to YF vaccine or history of a life-threatening reaction to YF vaccine (Scr.)
9) Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator (Scr.)
10) Current or past alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures (Scr.)
11) Receipt of any blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response (Scr.)
12) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (Scr. + V01) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Humoral immune response: Dengue immune response (serotype specific neutralizing antibodies)
Safety and reactogenicity: Adverse events, serious adverse events and biological abnormalities (out-of-normal-range biological test results)
Viremia: Dengue vaccine viruses levels in serum |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Humoral immune response: Prior to and 28 days (D28) after each injection
Safety and reactogenicity:
- Up to day 28 (D28) after each CYD dengue vaccine injection for AEs
- Throughout the trial for SAEs
- On D8 and D15 after the first and second CYD dengue vaccine injection for Biological abnormalities.
Viremia:
- On D8 and D15 after the first and second CYD dengue vaccine injection |
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E.5.2 | Secondary end point(s) |
Detection of symptomatic dengue cases |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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 | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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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 | Yes |
E.8.2.3.1 | Comparator description |
At 0 and 6 Mo: Placebo; at 12 Mo: control vaccine (Pneumo23) |
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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?
| Yes |
E.8.4 | Will this trial be conducted at multiple sites globally? | No |
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 |
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E.8.7 | Trial has a data monitoring committee | Yes |
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 months | 18 |