Study of Sanofi Pasteur's dengue vaccine in Subjects Aged 2 to 45 Years in Mexico

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

• Registration Number: EUCTR2014-001706-17-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: 126

Inclusion Criteria

1) Aged 2 to 45 years on the day of inclusion (Scr.).
2) Informed consent form signed by the subject, by two independent witnesses, and by the parent(s) or legal representative(s) for subjects under 18 years old (Scr.).
3) For a woman, inability to bear a child or negative serum pregnancy test at screening (Scr.).
4) Able to attend all scheduled visits and to comply with all trial procedures (Scr.+V01).
5) For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least four weeks prior to the first vaccination and at least four weeks after each vaccination (Scr.+V01).
6) For a woman, inability to bear a child or negative urine pregnancy test on the day of the first injection (V01).
Are the trial subjects under 18? yes
Number of subjects for this age range: 108
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) History of thymic pathology (thymoma), thymectomy, or myasthenia (Scr.).
2) Breast-feeding (Scr.).
3) Systemic hypersensitivity to any of the vaccine components or history of a lifethreatening reaction to the trial vaccine or a vaccine containing the same substances (Scr.).
4) Previous vaccination against flavivirus diseases (including Japanese encephalitis and YF) (Scr.).
5) Current abuse of alcohol or drug addiction that might interfere with the subjects ability to comply with trial procedures (Scr.).
6) Planned participation in another clinical trial during the present trial period (Scr.+V01).
7) History of flavivirus infection (confirmed either clinically, serologically or microbiologically) (Scr.+V01).
8) 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.+V01).
9) Chronic illness at a stage that could interfere with trial conduct or completion (Scr.+V01).
10) Blood or blood-derived products received in the past three months (Scr.+V01).
11) Vaccination planned in the four weeks following any trial vaccination (Scr.+V01).
12) Flavivirus vaccination planned during the present trial period (Scr.+V01).
13) Planned travel during the present trial period to areas with high dengue infection endemicity (Scr.+V01).
14) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent (Scr.+V01).
15) Participation in another clinical trial in the four weeks preceding the first trial vaccination (V01).
16) Any vaccination in the four weeks preceding the first trial vaccination (V01).
17) Human Immunodeficiency Virus (HIV), hepatitis B (Ag HBs) or hepatitis C (HC) seropositivity in blood sample taken at Screening (V01).
18) Clinically significant laboratory abnormalities (as determined by the Investigator) in blood sample taken at Screening (V01).

Study & Design

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