Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00875524
First received: April 2, 2009
Last updated: January 24, 2014
Last verified: January 2014
  Purpose

This trial will evaluate the use of a tetravalent vaccine against dengue.

Primary objectives:

  • To describe the immune response to dengue before and after each vaccination with tetravalent dengue vaccine in adults, adolescents, and children.
  • To evaluate the safety of each vaccination with sanofi pasteur's tetravalent dengue vaccine in 4 age cohorts.
  • To evaluate the persistence of antibodies against dengue during 5 years after the first vaccination with sanofi pasteur's tetravalent dengue vaccine in the four age cohorts.

Condition Intervention Phase
Dengue Virus
Dengue Fever
Dengue Hemorrhagic Fever
Dengue Disease
Biological: Chimeric dengue serotypes (1, 2, 3, 4).
Biological: Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Viet Nam

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Immunogenicity: To provide information concerning the immune response to ChimeriVax™ tetravalent dengue vaccine [ Time Frame: 28 days post-vaccination ] [ Designated as safety issue: No ]
  • Safety: To provide information concerning the safety of ChimeriVax™ tetravalent dengue vaccine [ Time Frame: 28 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: March 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dengue Group
Participants will receive ChimeriVax™ tetravalent dengue vaccine.
Biological: Chimeric dengue serotypes (1, 2, 3, 4).
0.5 mL, Subcutaneous
Other Name: ChimeriVax™
Sham Comparator: Control Group
Participants will receive Meningococcal Polysaccharide Vaccine A + C, a placebo (NaCl containing human serum albumin), and Typhoid Vi polysaccharide vaccine (Typhim Vi®) as first, second, and third vaccinations, respectively.
Biological: Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide
Each at 0.5 mL, Subcutaneous, respectively
Other Names:
  • Meningococcal Polysaccharide Vaccine A+C
  • NaCl
  • Typhim Vi®

  Eligibility

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

Inclusion Criteria :

  • Aged 2 to 45 years on the day of inclusion.
  • Provision of Informed Consent/Assent Form signed by the subject (and/or by the parent or another legally acceptable representative for subjects <18 years).
  • Subject (and parent/guardian for subjects <18 years) 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 the first vaccination, until at least 4 weeks after the last vaccination.
  • Subject in good health, based on medical history, physical examination and laboratory parameters.

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 serum pregnancy test at Screening.
  • For a female subject of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of the first injection.
  • Breast-feeding female subject.
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
  • Human immunodeficiency virus, hepatitis B, or hepatitis C seropositivity in the blood sample taken at screening.
  • Planned participation in another clinical trial during the first year of the study.
  • 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 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.
  • 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 past 3 months that might interfere with the assessment of immune response.
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
  • Laboratory abnormalities of at least moderate severity or clinically significant according to the Investigator in blood sample taken at screening.
  • 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 receipt of any vaccine in the 4 weeks following the first trial vaccination.
  • Familial atopy medical history (parents, brothers, or sisters).
  • Previous vaccination with meningococcal A+C or typhoid vaccines within 3 years prior to inclusion.
  • History of meningococcal or typhoid infections (confirmed either clinically, serologically or microbiologically).
  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: NCT00875524

Locations
Vietnam
Long Xuyen City, An Giang Province, Vietnam
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00875524     History of Changes
Other Study ID Numbers: CYD22
Study First Received: April 2, 2009
Last Updated: January 24, 2014
Health Authority: Vietnam: Ministry of Health

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 24, 2014