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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00993447
First received: October 9, 2009
Last updated: April 16, 2012
Last verified: April 2012

October 9, 2009
April 16, 2012
October 2009
September 2011   (final data collection date for primary outcome measure)
  • Immunogenicity: To provide information concerning the immunogenicity of Sanofi Pasteur's CYD Dengue Vaccine [ Time Frame: 28 days post-vaccination ] [ Designated as safety issue: No ]
  • Safety: To provide information concerning the safety of Sanofi Pasteur's CYD Dengue Vaccine [ Time Frame: 28 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00993447 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America
Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America

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.

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. SAEs will be collected throughout the study.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Dengue
  • Dengue Hemorrhagic Fever
  • Dengue Virus
  • Dengue Fever
  • Biological: CYD Dengue Vaccine
    0.5 mL, Subcutaneous at Day 0, 6 and 12 months
    Other Name: sanofi pasteur's CYD Dengue Vaccine
  • 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
    Other Names:
    • ADACEL®
    • NaCl
  • Experimental: CYD Dengue Vaccine Group
    Sanofi pasteur's CYD Dengue vaccine group
    Intervention: Biological: CYD Dengue Vaccine
  • Sham Comparator: Control Vaccine Group
    Intervention: Biological: Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis
Villar LÁ, Rivera-Medina DM, Arredondo-García JL, Boaz M, Starr-Spires L, Thakur M, Zambrano B, Miranda MC, Rivas E, Dayan GH. Safety and immunogenicity of a recombinant tetravalent dengue vaccine in 9-16 year olds: a randomized, controlled, phase II trial in Latin America. Pediatr Infect Dis J. 2013 Oct;32(10):1102-9. doi: 10.1097/INF.0b013e31829b8022.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
March 2012
September 2011   (final data collection date for primary outcome measure)

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 IM vaccination
  • Severe diseases with or without fever, convulsions or neurological abnormalities without treatment or in progression.
Both
9 Years to 16 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Colombia,   Honduras,   Mexico,   Puerto Rico
 
NCT00993447
CYD13, UTN: U1111-1111-5511
Yes
Sanofi
Sanofi
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc.
Sanofi
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP