Status:
COMPLETED
Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Dengue Virus
Dengue Fever
Eligibility:
All Genders
2-11 years
Phase:
PHASE2
Brief Summary
The aim of the trial was to evaluate the use of a tetravalent vaccine, CYD dengue vaccine, against dengue disease. Primary Objectives: * To describe the humoral immune response to dengue before and ...
Detailed Description
Participants were randomized to receive either three injections of CYD dengue vaccine or two injections of placebo, and one injection of a pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and ...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Aged 2 to 11 years on the day of inclusion.
- Participant in good health, based on medical history, physical examination and laboratory parameters.
- Provision of Assent Form signed by the participants (for participants \>=8 years old) and Informed Consent Form signed by the parents or another legally acceptable representative (and by an independent witness for illiterate parent\[s\]).
- Participant and parents/legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures.
- 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.
- Documented receipt of yellow fever vaccine since at least one month before the first vaccination.
- Exclusion Criteria :
- Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
- For a female participant of child-bearing potential (girls post-menarche), known pregnancy.
- For a female participant of child-bearing potential (girls post-menarche), known pregnancy or positive pregnancy test in blood sample taken at Screening.
- 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 trial.
- 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 vaccines components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
- Systemic hypersensitivity to YF vaccine or history of a life-threatening reaction to YF vaccine.
- Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
- Current or past alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures.
- Receipt of any blood or blood-derived products in the past 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.
- Human Immunodeficiency Virus, hepatitis B antigen, or hepatitis C seropositivity in blood sample taken at Screening.
- Clinically significant laboratory abnormalities (as determined by the Investigator) in blood sample taken at Screening.
- Known previous vaccination with pneumococcal polysaccharide vaccine.
Exclusion
Key Trial Info
Start Date :
September 26 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2010
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00788151
Start Date
September 26 2008
End Date
August 16 2010
Last Update
April 5 2022
Active Locations (1)
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1
Chulucanas Morropon, Piura, Peru