Status:
COMPLETED
Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Subjects in Singapore
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Dengue Fever
Dengue Hemorrhagic Fever
Eligibility:
All Genders
2-45 years
Phase:
PHASE2
Brief Summary
Primary Objectives: * To evaluate safety after each CYD Dengue vaccination in terms of injection site and systemic reactogenicity. * To evaluate the occurrence of Serious Adverse Events (SAEs) throug...
Detailed Description
This was a multicenter trial involving three vaccinations one each at 0, 6 and 12 months over a period of 1 year, and a 4-year follow-up following the last vaccination.
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Aged from 2 to 45 years on the day of inclusion.
- Participant in good health, based on medical history and physical examination.
- Provision of informed consent form (and assent form for participants aged 6 to 12 years) signed by the participant and by the parent(s) or another legally acceptable representative for participants aged less than 21 years.
- Participants and parent(s)/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
- For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks before the first vaccination until 4 weeks after the last vaccination.
- Exclusion Criteria :
- Febrile illness (temperature \>= 37.5°C) or moderate or severe acute illness/infection on the day of the first vaccination, according to Investigator judgment.
- For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of inclusion.
- Breast-feeding woman.
- Known systemic hypersensitivity to any of the components of the trial vaccines (especially egg proteins or neomycin) or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
- Personal or family history of thymic pathology or myasthenia.
- Previous hepatitis A vaccination (for children only).
- 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 corticosteroid therapy.
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
- Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response.
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
- Planned participation in another clinical trial during the 18 coming months.
- 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 an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- Current or past alcohol abuse or drug addiction that may interfere with the participants ability to comply with trial procedures.
- Participant who plans to move to another country within the 18 coming months.
Exclusion
Key Trial Info
Start Date :
April 7 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2014
Estimated Enrollment :
1198 Patients enrolled
Trial Details
Trial ID
NCT00880893
Start Date
April 7 2009
End Date
October 14 2014
Last Update
March 21 2022
Active Locations (5)
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1
Singapore, Singapore, 119074
2
Singapore, Singapore, 169608
3
Singapore, Singapore, 229899
4
Singapore, Singapore, 308433