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Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Subjects in Singapore

CompletedPhase 2

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Dengue Fever, Dengue Hemorrhagic Fever, Dengue Virus, Dengue Diseases

Interventions: CYD Dengue vaccine, NaCl + influenza virus or hepatitis A vaccine

Countries: Singapore

Primary Objectives: * To evaluate safety after each CYD Dengue vaccination in terms of injection site and systemic reactogenicity. * To evaluate the occurrence of Serious Adverse Events (SAEs) throughout the trial period. * To evaluate the humoral immune response to each CYD Dengue serotype after each vaccination in a subset of participants. Secondary Objectives: * To evaluate the persistence of the humoral immune response during 4 years after the last vaccination in a subset of participants.

Eligibility overview

Sex: ALL

Age: 2 Years to 45 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria :

* Aged from 2 to 45 years on the day of inclusion.
* Participant in good health, based on medical history and physical examination.
* Provision of informed consent form (and assent form for participants aged 6 to 12 years) signed by the participant and by the parent(s) or another legally acceptable representative for participants aged less than 21 years.
* Participants and parent(s)/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
* For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks before the first vaccination until 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 the first vaccination, according to Investigator judgment.
* For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of inclusion.
* Breast-feeding woman.
* Known systemic hypersensitivity to any of the components of the trial vaccines (especially egg proteins or neomycin) or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
* Personal or family history of thymic pathology or myasthenia.
* Previous hepatitis A vaccination (for children only).
* 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 corticosteroid therapy.
* 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 that might interfere with the assessment of immune response.
* 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 18 coming months.
* 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 an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
* Current or past alcohol abuse or drug addiction that may interfere with the participants ability to comply with trial procedures.
* Participant who plans to move to another country within the 18 coming months.

Locations (5)

Singapore, Singapore
Singapore, Singapore
Singapore, Singapore
Singapore, Singapore
Singapore, Singapore