Study of Sanofi Pasteur's dengue vaccine in Healthy Subjects Aged 2 to 45 Years in Viet Nam

Active, not recruiting

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

Registration Number: EUCTR2014-001709-41-Outside-EU/EEA

Lead Sponsor: Sanofi Pasteur SA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active

Sex: All

Target Recruitment: 180

Inclusion Criteria

1) Aged 2 to 45 years on the day of inclusion. (Scr.)
2) Provision of Informed Consent/Assent Form signed by the subject (and/or by the parent or another legally acceptable representative for subjects <18 years). (Scr.)
3) Subject (and parent/guardian for subjects <18 years) able to attend all scheduled visits and to comply with all trial procedures. (Scr. + V01)
4) 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 the first vaccination, until at least 4 weeks after the last vaccination. (Scr. + V01)
5) Subject in good health, based on medical history, physical examination and laboratory parameters. (Scr. + V01)
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
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, known pregnancy or positive serum pregnancy test at Screening. (Scr.)
3) For a female subject of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of the first injection. (V01)
4) Breast-feeding female subject. (Scr.)
5) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination. (Scr.)
6) Human immunodeficiency virus, hepatitis B, or hepatitis C seropositivity in the blood sample taken at screening. (V01)
7) Planned participation in another clinical trial during the first year of the study. (Scr.)
8) Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the past 6 months, or long-term systemic corticosteroids therapy. (Scr.)
9) Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances. (Scr.)
10) Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator. (Scr.)
11) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures. (Scr.)
12) Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response. (Scr.)
13) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent. (Scr.)
14) Laboratory abnormalities of at least moderate severity or clinically significant according to the Investigator in blood sample taken at screening. (V01)
15) 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)
16) Planned receipt of any vaccine in the 4 weeks following the first trial vaccination. (V01)
17) Familial atopy medical history (parents, brothers, or sisters). (Scr.)
18) Previous vaccination with meningococcal A + C or typhoid vaccines within 3 years prior to inclusion. (Scr.)
The exclusion criterion #18 was modified at the time of Amendment 1 (protocol Version 3.0 dated 08 April 2008) for accuracy.
19) History of meningococcal or typhoid infections (confirmed either clinically, serologically or microbiologically). (Scr.)