Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South America

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this study is to generate immunogenicity and safety data in preparation for efficacy studies in Latin America.

Primary Objectives:

* To describe the immune response to dengue viruses before and after each vaccination with CYD dengue vaccine.
* To evaluate the safety of each vaccination with CYD dengue vaccine.

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Detailed Description

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Participants in the Dengue Vaccine Group will receive 3 vaccinations with CYD Dengue vaccine. Participants in the Control Group will receive placebo vaccinations for the first 2 vaccinations, followed by tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (ADACEL®) (in Venezuela) or Meningococcal A+C vaccine (in Brazil) as a way of providing therapeutic benefit to the participants in the control group.

Conditions

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Dengue Dengue Hemorrhagic Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dengue Vaccine Group

Participants will receive Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus vaccine

Group Type EXPERIMENTAL

Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus

Intervention Type BIOLOGICAL

0.5 mL, Subcutaneous (SC)

Control Group

Participants will receive a placebo, NaCl 0.9%.

Group Type PLACEBO_COMPARATOR

NaCl 0.9%

Intervention Type BIOLOGICAL

0.5 mL, Subcutaneous

Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular

Meningococcal A+C vaccine

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular

Interventions

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Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus

0.5 mL, Subcutaneous (SC)

Intervention Type BIOLOGICAL

NaCl 0.9%

0.5 mL, Subcutaneous

Intervention Type BIOLOGICAL

Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed

0.5 mL, Intramuscular

Intervention Type BIOLOGICAL

Meningococcal A+C vaccine

0.5 mL, Intramuscular

Intervention Type BIOLOGICAL

Other Intervention Names

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CYD Dengue Vaccine ADACEL®

Eligibility Criteria

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Inclusion Criteria

* Aged 9 to 16 years on the day of inclusion
* Participant in good health, based on medical history and physical examination
* Provision of assent form/informed consent form signed by the participant and by the parent(s) or another legally acceptable representative
* Participant and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and to comply with all trial procedures
* For a female participant 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 participant 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 participant'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
* Participant deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized without his/her consent
* Febrile illness (temperature ≥ 38.0 ºC) 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