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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: September 18, 2014
Last verified: September 2014
  Purpose

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.

Condition Intervention Phase
Dengue
Dengue Hemorrhagic Fever
Dengue Virus
Dengue Fever
Biological: CYD Dengue Vaccine
Biological: Tetanus Toxoid Reduced Diphtheria Toxoid Acellular Pertussis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Enrollment: 600
Study Start Date: October 2009
Study Completion Date: March 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CYD Dengue Vaccine Group
Sanofi pasteur's CYD Dengue vaccine group
Biological: CYD Dengue Vaccine
0.5 mL, Subcutaneous at Day 0, 6 and 12 months
Other Name: sanofi pasteur's CYD Dengue Vaccine
Sham Comparator: Control Vaccine Group 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

Detailed 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. SAEs will be collected throughout the study.

  Eligibility

Ages Eligible for Study:   9 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 IM vaccination
  • Severe diseases with or without fever, convulsions or neurological abnormalities without treatment or in progression.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993447

Locations
Colombia
Bucaramanga, Colombia
Honduras
Tegucigalpa, Honduras
Mexico
Cuernavaca, Mexico
Puerto Rico
San Juan, Puerto Rico
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00993447     History of Changes
Other Study ID Numbers: CYD13, UTN: U1111-1111-5511
Study First Received: October 9, 2009
Last Updated: September 18, 2014
Health Authority: United States: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Honduras: Secretaria de Salud, Subsecretaria de Riesgos Poblacionales
Mexico: Ministry of Health

Keywords provided by Sanofi:
Dengue
Dengue hemorrhagic fever
Dengue virus
Dengue fever
Sanofi pasteur's CYD Dengue vaccine

Additional relevant MeSH terms:
Dengue
Fever
Hemorrhagic Fevers, Viral
Severe Dengue
Arbovirus Infections
Body Temperature Changes
Flaviviridae Infections
Flavivirus Infections
RNA Virus Infections
Signs and Symptoms
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014