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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01187433
First received: August 20, 2010
Last updated: November 26, 2013
Last verified: November 2013

August 20, 2010
November 26, 2013
August 2010
October 2012   (final data collection date for primary outcome measure)
  • Information concerning the immunogenicity of CYD dengue vaccine after primary vaccination. [ Time Frame: 28 days post-vaccination ] [ Designated as safety issue: No ]
  • Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events and serious adverse events post-vaccination with CYD dengue vaccine. [ Time Frame: 0-14 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01187433 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South America
Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in South America

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Dengue
  • Dengue Hemorrhagic Fever
  • Biological: Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus
    0.5 mL, Subcutaneous (SC)
    Other Name: CYD Dengue Vaccine
  • Biological: NaCl 0.9%
    0.5 mL, Subcutaneous
  • Biological: Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed
    0.5 mL, Intramuscular
    Other Name: ADACEL®
  • Biological: Meningococcal A+C vaccine
    0.5 mL, Intramuscular
  • Experimental: Dengue Vaccine Group
    Participants will receive Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus vaccine
    Intervention: Biological: Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus
  • Placebo Comparator: Control Group
    Participants will receive a placebo, NaCl 0.9%.
    Interventions:
    • Biological: NaCl 0.9%
    • Biological: Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed
    • Biological: Meningococcal A+C vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
December 2012
October 2012   (final data collection date for primary outcome measure)

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.
Both
9 Years to 16 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01187433
CYD30, UTN: U1111-1111-6073
Yes
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc.
Sanofi
November 2013

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