Study of Sanofi Pasteur's dengue vaccine in Healthy Children Aged 4 to 11 Years in Thailand to evaluate its efficacy

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

• Registration Number: EUCTR2014-001710-25-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: 4002

Inclusion Criteria

1) Aged 4 to 11 years on the day of inclusion.
2) Subject in good health, based on medical history and physical examination.
3) Provision of assent form signed by the subject (for subjects = 7 years old) and informed consent form signed by the parent or another legally acceptable representative.
4) Subject and parent/legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures.
5) Subject attending one of the schools involved in the trial and living in the Ratchaburi Province.
6) 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 4002
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) Febrile illness (temperature = 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.
2) For a female subject of child-bearing potential (girls post-menarche), known pregnancy or positive urine pregnancy test on the day of the first trial vaccination.
3) Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
4) Planned participation in another clinical trial during the present trial period.
5) Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, or long-term systemic corticosteroids therapy.
6) 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.
7) Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
8) Receipt of blood or blood-derived products in the past 3 months.
9) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
10) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
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 who planned to attend another school (outside the trial area) or move to another city in the coming 30 months.

Study & Design

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