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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 February 2013 |
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Main ID: |
NCT01187433 |
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Date of registration:
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20/08/2010 |
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Primary sponsor: |
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Public title:
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Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South America
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Scientific title:
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Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in South America |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01187433 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi Pasteur Inc. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
9 Years
Age maximum:
16 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dengue
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Dengue Hemorrhagic Fever
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Intervention(s)
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Biological: Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus
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Biological: NaCl 0.9%
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Primary Outcome(s)
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Information concerning the immunogenicity of CYD dengue vaccine after primary vaccination.
[Time Frame: 28 days post-vaccination]
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Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events and serious adverse events post-vaccination with CYD dengue vaccine.
[Time Frame: 0-14 days post-vaccination and entire study duration]
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Secondary ID(s)
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CYD30
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UTN: U1111-1111-6073
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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