Status:
COMPLETED
Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South America
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Dengue
Dengue Hemorrhagic Fever
Eligibility:
All Genders
9-16 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to generate immunogenicity and safety data in preparation for efficacy studies in Latin America. Primary Objectives: * To describe the immune response to dengue viruses ...
Detailed Description
Participants in the Dengue Vaccine Group will receive 3 vaccinations with CYD Dengue vaccine. Participants in the Control Group will receive placebo vaccinations for the first 2 vaccinations, followed...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Aged 9 to 16 years on the day of inclusion
- Participant in good health, based on medical history and physical examination
- Provision of assent form/informed consent form signed by the participant and by the parent(s) or another legally acceptable representative
- Participant and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and to comply with all trial procedures
- For a female participant 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
- Exclusion Criteria :
- Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia
- For a female participant of child-bearing potential, known pregnancy or positive urine pregnancy test at Visit 1
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- Breast-feeding woman
- Planned participation in another clinical trial during the present trial period
- 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
- 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
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
- Current alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures
- Receipt of blood or blood-derived products in the preceding 3 months that might interfere with the assessment of immune response
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
- Planned receipt of any vaccine in the 4 weeks following the first trial vaccination
- Participant deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized without his/her consent
- Febrile illness (temperature ≥ 38.0 ºC) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
- Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
- Severe diseases with or without fever, convulsions or neurological abnormalities without treatment or in progression.
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01187433
Start Date
August 1 2010
End Date
December 1 2012
Last Update
March 21 2022
Active Locations (1)
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1
Vitória, Brazil, ES, 29040-091