E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of symptomatic dengue disease |
|
E.1.1.1 | Medical condition in easily understood language |
Prevention of dengue disease with clinical symptoms |
|
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 |
Safety and reactogenicity
Humoral immune response to dengue after the second and third injections |
|
E.2.2 | Secondary objectives of the trial |
Safety and reactogenicity according to the flavivirus (FV) immune status at baseline
Humoral immune response to dengue after the second and third injections according to the FV immune status at baseline |
|
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
2) Assent form has been signed and dated by the subject (for subjects ≥ 7 years) and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative, and by an independent witness if the two parents or legally acceptable representative are illiterate)
3) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
4) Subject in good health, based on medical history and physical examination
5) For a female subject of childbearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination |
|
E.4 | Principal exclusion criteria |
1) Known pregnancy, or a positive urine pregnancy test (for female subject of childbearing potential only)
2) Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
3) Planned participation in another clinical trial during the present trial period
4) Planned receipt of any vaccine in the 4 weeks following the trial first vaccination, except for pandemic influenza vaccination
5) Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
6) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
7) Seropositivity for human immunodeficiency virus (HIV) reported by the parent/legally acceptable representative
8) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
9) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
10) Subjects who plan to move to another country/region within the 18 coming months
11) Identified as a child (adopted or natural) of the Investigator or of site employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center
Temporary Exclusion Criteria:
A prospective subject was not to be included in the study until the following conditions and/or symptoms were resolved:
12) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination, except for pandemic influenza vaccination, which may be received at least 2 weeks before study vaccines
13) Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection (according to Investigator’s judgment) on the day of vaccination |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Safety and reactogenicity: Adverse events including non-serious adverse events of special interest (AESIs), and serious adverse events, including serious AESIs
Humoral immune response : Dengue immune response (serotype specific neutralizing antibodies) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Safety and reactogenicity:
- AEs up to day 28 (D28) after each injection.
- Non-serious AESIs up to 7 days after each injection.
- SAEs, including serious AESIs, throughout the study.
Humoral immune response : after the second and third injections. |
|
E.5.2 | Secondary end point(s) |
FV (dengue and Japanese encephalitis [JE]) serology: Neutralizing Antibody level against FV (dengue and JE)
The primary endpoints of safety and immunogenicity were used to evaluate the secondary objectives. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
FV serology on blood sample taken before first injection
For safety and humoral immune response timepoints: same as for primary objective |
|
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) | 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 | 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 |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
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 |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial months | 18 |