Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Subjects in Singapore

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00880893
First received: April 13, 2009
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

Primary Objectives:

  • To evaluate safety after each CYD Dengue vaccination.
  • To evaluate the immune response to each CYD Dengue serotype after each vaccination in a subset of subjects.

Condition Intervention Phase
Dengue Fever
Dengue Hemorrhagic Fever
Dengue Virus
Dengue Diseases
Biological: CYD Dengue vaccine
Biological: NaCl + influenza virus or hepatitis A 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: Immunogenicity and Large-Scale Safety of Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Singapore

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]
  • To provide information concerning the immunogenicity of Sanofi Pasteur's CYD Dengue Vaccine [ Time Frame: 28 following each vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: April 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CYD Dengue Vaccine Group
Participants will receive Sanofi Pasteur's CYD Dengue Vaccine at Day 0, Months 6 and 12, respectively.
Biological: CYD Dengue vaccine
0.5 mL, Subcutaneous on Day 0, Months 6 and 12
Other Name: Sanofi Pasteur's CYD Dengue Vaccine
Sham Comparator: Control Group
Participants will receive a NaCl (placebo) vaccine followed by either 2 Hepatitis A or 2 Influenza vaccines at Months 6 and 12, respectively.
Biological: NaCl + influenza virus or hepatitis A vaccine
0.5 mL, Subcutaneous (Intramuscular - Hepatitis A)
Other Names:
  • NaCl 0.9%
  • Vaxigrip®
  • Havrix® pediatric formulation

Detailed Description:

This is a multicenter trial involving three vaccinations over a period of 1 year, and a 4-year follow-up following the last vaccination.

  Eligibility

Ages Eligible for Study:   2 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Aged from 2 to 45 years on the day of inclusion.
  • Subject in good health, based on medical history and physical examination.
  • Provision of informed consent form (and assent form for subjects aged 6 to 12 years) signed by the subject and by the parent(s) or another legally acceptable representative for subjects aged less than 21 years.
  • Subject and parent(s)/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
  • For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks before the first vaccination until 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 the first vaccination, according to Investigator judgment.
  • For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of inclusion.
  • Breast-feeding woman.
  • Known systemic hypersensitivity to any of the components of the trial vaccines (especially egg proteins or neomycin) or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
  • Personal or family history of thymic pathology or myasthenia.
  • Previous hepatitis A vaccination (for children only).
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the past 6 months, or long-term systemic corticosteroid therapy.
  • 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 that might interfere with the assessment of immune response.
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
  • Planned participation in another clinical trial during the 18 coming months.
  • 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 an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
  • Current or past alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures.
  • Subject who plans to move to another country within the 18 coming 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: NCT00880893

Locations
Singapore
Singapore, Singapore, 308433
Singapore, Singapore, 119074
Singapore, Singapore, 229899
Singapore, Singapore, 169608
Singapore, Singapore, 529889
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00880893     History of Changes
Other Study ID Numbers: CYD28
Study First Received: April 13, 2009
Last Updated: April 8, 2014
Health Authority: Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)

Keywords provided by Sanofi:
Dengue virus
Dengue fever
Dengue hemorrhagic fever
Dengue diseases
Sanofi Pasteur's CYD Dengue Vaccine

Additional relevant MeSH terms:
Dengue
Fever
Severe Dengue
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 August 27, 2014