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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dengue Dengue Hemorrhagic Fever Dengue Virus Dengue Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CYD Dengue Vaccine Group

Sanofi pasteur's CYD Dengue vaccine group (Dengvaxia®)

Group Type EXPERIMENTAL

CYD Dengue Vaccine

Intervention Type BIOLOGICAL

0.5 mL, Subcutaneous at Day 0, 6 and 12 months

Control Vaccine Group

Group Type SHAM_COMPARATOR

Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis

Intervention Type BIOLOGICAL

NaCl: 0.5 mL, Intramuscular at Day 0 and 6 months; Adacel®: 0.5 mL, Intramuscular at 12 months

Interventions

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CYD Dengue Vaccine

0.5 mL, Subcutaneous at Day 0, 6 and 12 months

Intervention Type BIOLOGICAL

Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis

NaCl: 0.5 mL, Intramuscular at Day 0 and 6 months; Adacel®: 0.5 mL, Intramuscular at 12 months

Intervention Type BIOLOGICAL

Other Intervention Names

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Dengvaxia® ADACEL® NaCl

Eligibility Criteria

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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.

Minimum Eligible Age

9 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes