Study of Sanofi Pasteur's Dengue Vaccine in Healthy Children and Adolescents in South America

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

• Registration Number: EUCTR2014-001715-39-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: 150

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 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 vaccination until at least 4 weeks after the last vaccination
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
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
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 vaccination
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 vaccination
12) Planned receipt of any vaccine in the 4 weeks following the first trial vaccination
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 vaccination, according to Investigator’s judgment

Study & Design

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