Status:
COMPLETED
Efficacy and Safety of Dengue Vaccine in Healthy Children
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Dengue Virus
Dengue Fever
Eligibility:
All Genders
4-11 years
Phase:
PHASE2
Brief Summary
The primary objective of the study was to assess the efficacy of CYD dengue vaccine after three injections in preventing symptomatic virologically-confirmed dengue (VCD) cases, regardless of the sever...
Detailed Description
Participants (both cohort 1 and 2) received 3 injections of CYD dengue vaccine. Participants (Cohort 1) received rabies vaccine at Month 0 and placebo at 6 and 12 months. Participants (cohort 2) recei...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Aged 4 to 11 years on the day of inclusion.
- Participant in good health, based on medical history and physical examination.
- Provision of assent form signed by the participants (for participants \>= 7 years old) and informed consent form signed by the parent or another legally acceptable representative.
- Participant and parent/ legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures.
- Participant attended one of the schools involved in the trial and living in the Ratchaburi Province.
- For a female participant 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.
- Exclusion Criteria :
- Febrile illness (temperature \>= 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.
- For a female participant of child-bearing potential (girls post-menarche), known pregnancy or positive urine pregnancy test on the day of the first trial vaccination.
- Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
- 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, or long-term systemic corticosteroids therapy.
- 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.
- 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.
- Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
- 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.e
- Participant who plans to attend another school (outside the trial area) or move to another city in the coming 30 months.
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
4002 Patients enrolled
Trial Details
Trial ID
NCT00842530
Start Date
February 1 2009
End Date
February 1 2014
Last Update
April 5 2022
Active Locations (1)
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1
Sanofi Pasteur Investigational Site
Bangkok, Thailand, 10400