Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America

Sanofi

Status and phase

Completed

Phase 2

Conditions

Dengue Hemorrhagic Fever

Dengue Fever

Dengue

Dengue Virus

Treatments

Biological: Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis

Biological: CYD Dengue Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00993447

UTN: U1111-1111-5511

CYD13

Details and patient eligibility

About

Primary objectives:

To describe the immune response to each dengue serotype before and after each vaccination with sanofi pasteur's CYD dengue vaccine.
To evaluate the safety of each vaccination with sanofi pasteur's CYD dengue vaccine.

Full description

The antibody levels against each serotype will be measured before and after each vaccination. The subjects will be followed for 28 days after each vaccination for solicited and unsolicited safety parameters. Serious adverse events (SAEs) will be collected throughout the study.

Enrollment

600 patients

Sex

All

Ages

9 to 16 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

Aged 9 to 16 years on the day of inclusion
Subject in good health, based on medical history and physical examination
Provision of assent form/informed consent form signed by the subject and by the parent(s) or another legally acceptable representative
Subject and parent(s)/legally acceptable representative(s) 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 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 subject 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 subject'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
Subject deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized without his/her consent
Febrile illness (temperature ≥38.0°C) 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.