Study of Sanofi Pasteur's dengue vaccine in Healthy Peruvian Children Aged 2 to 11 Years

• Conditions: Therapeutic area: Diseases [C] - Virus Diseases [C02]; Prevention of symptomatic dengue disease

• Registration Number: EUCTR2014-001711-40-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-26
• Last Update Posted: 2 June 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 300

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.)
Are the trial subjects under 18? yes
Number of subjects for this age range: 300
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified