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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.
Register: ClinicalTrials.gov
Last refreshed on: 3 February 2014
Main ID:  NCT00875524
Date of registration: 02/04/2009
Primary sponsor: Sanofi Pasteur, a Sanofi Company
Public title: Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects
Scientific title: Immunogenicity and Safety of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Viet Nam
Date of first enrolment: March 2009
Target sample size: 180
Recruitment status: Active, not recruiting
URL:  http://clinicaltrials.gov/show/NCT00875524
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention  
Countries of recruitment
Vietnam
Contacts
Name:   Medical Monitor
Address: 
Telephone:
Email:
Affiliation:  Sanofi Pasteur Inc
Key inclusion & exclusion criteria

Inclusion Criteria :

- Aged 2 to 45 years on the day of inclusion.

- Provision of Informed Consent/Assent Form signed by the subject (and/or by the parent
or another legally acceptable representative for subjects <18 years).

- Subject (and parent/guardian for subjects <18 years) able to attend all scheduled
visits and to comply with all trial procedures.

- For a female subject of child-bearing potential, avoid becoming pregnant (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.

- Subject in good health, based on medical history, physical examination and laboratory
parameters.

Exclusion Criteria :

- Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.

- For a female subject of child-bearing potential, known pregnancy or positive serum
pregnancy test at Screening.

- For a female subject of child-bearing potential, known pregnancy or positive urine
pregnancy test on the day of the first injection.

- Breast-feeding female subject.

- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.

- Human immunodeficiency virus, hepatitis B, or hepatitis C seropositivity in the blood
sample taken at screening.

- Planned participation in another clinical trial during the first year of the study.

- 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 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.

- Current alcohol abuse or drug addiction that may interfere with the subject's ability
to comply with trial procedures.

- Receipt of blood or blood-derived products in the past 3 months that might interfere
with the assessment of immune response.

- Subject deprived of freedom by an administrative or court order, or in an emergency
setting, or hospitalized without his/her consent.

- Laboratory abnormalities of at least moderate severity or clinically significant
according to the Investigator 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 receipt of any vaccine in the 4 weeks following the first trial vaccination.

- Familial atopy medical history (parents, brothers, or sisters).

- Previous vaccination with meningococcal A+C or typhoid vaccines within 3 years prior
to inclusion.

- History of meningococcal or typhoid infections (confirmed either clinically,
serologically or microbiologically).



Age minimum: 2 Years
Age maximum: 45 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Dengue Disease
Dengue Fever
Dengue Hemorrhagic Fever
Dengue Virus
Intervention(s)
Biological: Chimeric dengue serotypes (1, 2, 3, 4).
Biological: Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide
Primary Outcome(s)
Immunogenicity: To provide information concerning the immune response to ChimeriVax™ tetravalent dengue vaccine [Time Frame: 28 days post-vaccination]
Safety: To provide information concerning the safety of ChimeriVax™ tetravalent dengue vaccine [Time Frame: 28 days post-vaccination and entire study duration]
Secondary Outcome(s)
Secondary ID(s)
CYD22
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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