| 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 of CYD dengue vaccine after each injection; first injection given alone or co-administered with MMR vaccine (Trimovax).
Dengue vaccinal viremia |
|
| E.2.2 | Secondary objectives of the trial |
Immunogenicity of CYD dengue vaccine after each injection; first injection given alone or co-administered with MMR vaccine.
Immunogenicity of MMR vaccine, given alone or co-administered with CYD dengue vaccine. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1) Toddler in good health based on medical history and medical examination (Scr.+V_MV)
2) Toddler aged 12 to 15 months on the day of inclusion (Scr.)
3) Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg (Scr.)
4) Provision of informed consent form signed by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations) (Scr.)
5) Subject and parent/delegate able to attend all scheduled visits and comply with all trial procedures (Scr.)
6) Completion of previous vaccination program according to the national immunization schedule, except for measles (Scr.) |
|
| E.4 | Principal exclusion criteria |
1) Family members from the Investigator or from the staff involved in the trial (Scr.)
2) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion (Scr.)
3) 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 corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) (Scr.)
4) History of central nervous system disorder or disease, including seizures (Scr.)
5) History of varicella, measles, mumps, rubella and hepatitis A; confirmed either clinically, serologically, or microbiologically (Scr.)
6) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion (Scr.)
7) Previous vaccination against MMR, hepatitis A or varicella (Scr.)
8) Previous vaccination against FV diseases (Scr.)
9) Known systemic hypersensitivity to any of the components of the vaccines, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances (Scr.)
10) Planned participation in another clinical trial during the present trial period (Scr.)
11) Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination (Scr.+V_MV)
12) Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response (Scr.+V_MV)
13) Planned receipt of any vaccine in the 4 weeks following the first trial vaccination (V_MV)
14) Human immunodeficiency virus (HIV) seropositivity in the blood sample taken at screening visit (V_MV)
15) Clinically significant laboratory abnormalities, as judged by the Investigator, in blood sample taken at screening visit (V_MV)
Should one of the conditions listed below occur, the Investigator was to postpone vaccination until the condition was resolved:
16) Febrile illness (temperature ≥ 38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator’s judgment (Scr.+V_MV)
17) Receipt of oral or injected antibiotic therapy within 72 hours prior to the vaccination (Scr.+V_MV)
18) Any vaccination received in the 4 weeks preceding vaccination (Scr.+V_MV) |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
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 |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
Safety and reactogenicity:
- Up to day 28 (D28) after each CYD dengue vaccine injection for AEs
- Throughout the trial for SAEs
- At baseline (screening visit) and D8 after the first CYD dengue vaccine injection for Biological abnormalities.
Viremia:
- On D8 after the first CYD dengue vaccine |
|
| E.5.2 | Secondary end point(s) |
Dengue Immune response (serotype specific neutralizing antibodies)
Immune response (antibody levels) against measles, rubella, and mumps |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
Dengue Immune response: at baseline (screening visit) and on D28 after the first, second and third CYD dengue vaccine injections .
Immune response against measles, rubella, and mump: at baseline (screening visit) and at D28 after MMR vaccination in Groups 3 and 4. |
|
| 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 injection) and open-label (second and third injections) |
|
| 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 |
| Control vaccines: varicella vaccine (OKAVAX), Hepatitis A vaccine (AVAXIM 80); Placebo (NaCl 0.9%) |
|
| E.8.2.4 | Number of treatment arms in the trial | 4 |
| 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 | 19 |
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