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
  Purpose

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.

Condition Intervention Phase
Dengue
Dengue Hemorrhagic Fever
Biological: Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus
Biological: NaCl 0.9%
Biological: Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed
Biological: Meningococcal A+C vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in South America

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Enrollment: 150
Study Start Date: August 2010
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dengue Vaccine Group
Participants will receive Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus vaccine
Biological: Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus
0.5 mL, Subcutaneous (SC)
Other Name: CYD Dengue Vaccine
Placebo Comparator: Control Group
Participants will receive a placebo, NaCl 0.9%.
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

Detailed Description:

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.

  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
  • 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.
  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: NCT01187433

Locations
Brazil
Vitória, Brazil, ES, 29040-091
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01187433     History of Changes
Other Study ID Numbers: CYD30, UTN: U1111-1111-6073
Study First Received: August 20, 2010
Last Updated: November 26, 2013
Health Authority: Brazil: Ministry of Health
United States: Food and Drug Administration

Keywords provided by Sanofi:
Dengue
Dengue hemorrhagic fever
CYD Dengue Vaccines

Additional relevant MeSH terms:
Dengue
Hemorrhagic Fevers, Viral
Severe Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on September 18, 2014