Study of Sanofi Pasteur's dengue vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America to evaluate its efficacy
- Conditions
- Prevention of symptomatic dengue diseaseTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-001716-19-Outside-EU/EEA
- Lead Sponsor
- Sanofi Pasteur SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 20875
An individual must fulfill all of the following criteria in order to be eligible for trial enrolment:
1) Aged 9 to 16 years on the day of inclusion and resident of the site zone
2) Subject in good health, based on medical history and physical examination
3) Assent form or informed consent form has been signed and dated by the subject (based on local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations)
4) Subject able to attend all scheduled visits and to comply with all trial procedures
Are the trial subjects under 18? yes
Number of subjects for this age range: 20875
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
An individual fulfilling any of the following criteria is to be excluded from trial enrolment:
1) Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination)
2) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
3) Planned participation in another clinical trial during the present trial period
4) Self-reported 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)
5) Self-reported seropositivity for Human Immunodeficiency Virus (HIV) infection
6) Self-reported systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
7) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
8) Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
9) Planned receipt of any vaccine in the 4 weeks following any trial vaccination
10) Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily
11) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures
12) Identified as a site employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as a family member (i.e., immediate, husband, wife and their children, adopted or natural) of the site employees or the Investigator
Temporary Contraindications
A prospective subject should not be included in the study until the following condition and/or symptoms are resolved:
13) Febrile illness (temperature = 38.0°C) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination
14) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method