Efficacy and Safety of Dengue Vaccine in Healthy Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00842530
First received: February 11, 2009
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

There is currently no vaccine against dengue and no specific drug treatment against the disease. This study is aimed at generating information on the protective effect of the vaccine.

Primary Objective To assess the efficacy of dengue vaccine after three injections in children.

Secondary Objective:

To evaluate the reactogenicity of dengue vaccine after each injection in a subgroup of children.


Condition Intervention Phase
Dengue Virus
Dengue Fever
Dengue Hemorrhagic Fever
Dengue Diseases
Biological: Chimeric tetravalent dengue (serotype 1, 2, 3, 4)
Biological: Inactivated Rabies virus vaccine
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: Efficacy and Safety of Dengue Vaccine in Healthy Children Aged 4 to 11 Years in Thailand

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Immunogenicity: To provide information concerning the immunogenicity of Dengue Vaccine [ Time Frame: 28 days post-vaccination 3 ] [ Designated as safety issue: No ]
  • Safety: To provide information concerning the safety after administration of Dengue Vaccine [ Time Frame: 28 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]

Enrollment: 4002
Study Start Date: February 2009
Study Completion Date: February 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dengue Vaccine Group Biological: Chimeric tetravalent dengue (serotype 1, 2, 3, 4)
0.5 mL, Subcutaneous
Other Name: ChimeriVax™
Sham Comparator: Control Vaccine Group Biological: Inactivated Rabies virus vaccine
0.5 mL, Subcutaneous
Other Name: Verorab®

  Eligibility

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Aged 4 to 11 years on the day of inclusion.
  • Subject in good health, based on medical history and physical examination.
  • Provision of assent form signed by the subject (for subjects ≥ 7 years old) and informed consent form signed by the parent or another legally acceptable representative.
  • Subject and parent/ legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures.
  • Subject attending one of the schools involved in the trial and living in the Ratchaburi Province.
  • For a female subject of child-bearing potential (girls post-menarche), 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 :

  • Febrile illness (temperature ≥ 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.
  • For a female subject of child-bearing potential (girls post-menarche), known pregnancy or positive urine pregnancy test on the day of the first trial vaccination.
  • Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
  • 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, or long-term systemic corticosteroids therapy.
  • Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to 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.
  • Receipt of blood or blood-derived products in the past 3 months.
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
  • 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.e
  • Subject who plans to attend another school (outside the trial area) or move to another city in the coming 30 months.
  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: NCT00842530

Locations
Thailand
Muang District, Ratchaburi Province, Thailand
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00842530     History of Changes
Other Study ID Numbers: CYD23
Study First Received: February 11, 2009
Last Updated: April 1, 2014
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Sanofi:
Dengue virus
Dengue fever
Dengue hemorrhagic fever
Dengue diseases
Dengue vaccine

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

ClinicalTrials.gov processed this record on July 22, 2014