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 each dengue serotype before and after each injection
Safety and reactogenicity |
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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 9 to 16 years on the day of inclusion
2) Subject in good health, based on medical history and physical examination
3) Provision of assent form/informed consent form signed by the subject and by the parent(s) or another legally acceptable representative
4) Subject and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and to comply with all trial procedures
5) For a female subject of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first injection until at least 4 weeks after the last injection |
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E.4 | Principal exclusion criteria |
1) Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia
2) For a female subject of child-bearing potential, known pregnancy or positive urine pregnancy test at V01
3) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial injection
4) Breast-feeding woman
5) Planned participation in another clinical trial during the present trial period
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
7) Known systemic hypersensitivity to any of the components of any of the trial vaccines or history of a life-threatening reaction to any of the trial vaccines or to a vaccine containing any of the same substances
8) Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
9) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures
10) Receipt of blood or blood-derived products in the preceding 3 months that might interfere with the assessment of immune response
11) Receipt of any vaccine in the 4 weeks preceding the first trial injection
12) Planned receipt of any vaccine in the 4 weeks following the first trial injection
13) Subject deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized without his/her consent
14) Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of injection, according to Investigator’s judgment |
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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 and serious adverse events |
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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: Adverse events up to D28 after each injection and serious adverse events throughout the study |
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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 |
Observer-blind (first and second injections), single-blind (third injection) |
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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 (NaCl 0.9%); At 12 Mo: Control Vaccine (Adacel) |
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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?
| 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 |
Colombia |
Honduras |
Mexico |
Puerto Rico |
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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 |