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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: |
NCT01254422 |
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Date of registration:
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03/12/2010 |
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Primary sponsor: |
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Public title:
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Study of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia
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Scientific title:
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Safety and Immunogenicity of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia |
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Date of first enrolment:
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December 2010 |
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Target sample size:
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250 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01254422 |
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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: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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Malaysia
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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 Singapore |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Aged 2 to 11 years on the day of inclusion
- Assent form has been signed and dated by the subject (for subjects = 7 years) and
informed consent form has been signed and dated by the parent(s) or another legally
acceptable representative, and by an independent witness if the two parents or
legally acceptable representative are illiterate
- Subject and parent/legally acceptable representative are able to attend all scheduled
visits and to comply with all trial procedures
- Subject in good health, based on medical history and physical examination
- For a female subject of childbearing potential, use of an effective method of
contraception or abstinence for at least 4 weeks prior to the first vaccination,
until at least 4 weeks after the last vaccination
Exclusion Criteria:
- Known pregnancy, or a positive urine pregnancy test (for female subject of
child-bearing potential only)
- Participation in another clinical trial investigating a vaccine, drug, medical
device, or medical procedure in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Planned receipt of any vaccine in the 4 weeks following the trial first vaccination,
except for pandemic influenza vaccination
- receipt of blood or blood-derived products in the past 3 months, which might
interfere with assessment of the immune response
- Known or suspected congenital or acquired immunodeficiency; or receipt of
immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy
within the preceding 6 months; or long-term systemic corticosteroid therapy
(prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Seropositivity for human immunodeficiency virus (HIV) reported by the parent/legally
acceptable representative
- Known systemic hypersensitivity to any of the vaccine components, or history of a
life-threatening reaction to the vaccine(s) used in the trial or to a vaccine
containing any of the same substances
- Chronic illness that, in the opinion of the investigator, is at a stage where it
might interfere with trial conduct or completion
- Subjects who plan to move to another country/region within the 18 coming months
- Identified as a child (adopted or natural) of the Investigator or of site employees
of the Investigator or study center, with direct involvement in the proposed study or
other studies under the direction of that Investigator or study center.
Age minimum:
2 Years
Age maximum:
11 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dengue Fever
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Dengue Hemorrhagic Fever
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Intervention(s)
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Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus
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Biological: Placebo: NaCl 0.9%
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Primary Outcome(s)
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Information concerning the safety of CYD Dengue vaccine following each dose of vaccine
[Time Frame: Up to 6 months post-dose 3]
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Information on the antibody levels against each of the four parental dengue virus strains of CYD dengue vaccine constructs post Dose 2 and post Dose 3
[Time Frame: 28 days post dose 2 and 3, respectively.]
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Secondary ID(s)
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CYD32
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UTN: U1111-1115-6579
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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