Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00788151
First received: November 7, 2008
Last updated: September 18, 2014
Last verified: September 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 dengue vaccine in two age cohorts of children previously vaccinated with yellow fever (YF) vaccine
  • To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of children.

Condition Intervention Phase
Dengue Virus
Dengue Fever
Dengue Hemorrhagic Fever
Dengue Diseases
Biological: Chimeric dengue serotype 1, 2, 3, and 4
Biological: Pneumococcal polysaccharide vaccine
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 Children Aged 2 to 11 Years Previously Vaccinated Against Yellow Fever in Peru

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Immunogenicity: To provide information concerning the immunogenicity of 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 ]

Enrollment: 300
Study Start Date: October 2008
Study Completion Date: December 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Chimeric dengue serotype 1, 2, 3, and 4
0.5 mL, SC
Other Name: ChimeriVax™
Sham Comparator: 2 Biological: Pneumococcal polysaccharide vaccine
0.5 mL, SC
Other Name: Pneumo23®

Detailed Description:

The control group will receive two doses of placebo and then one dose of Pneumo 23 vaccine for the third vaccination

  Eligibility

Ages Eligible for Study:   2 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Aged 2 to 11 years on the day of inclusion.
  • Subject in good health, based on medical history, physical examination and laboratory parameters.
  • Provision of Assent Form signed by the subject (for subjects ≥8 years old) and Informed Consent Form signed by the parents or another legally acceptable representative (and by an independent witness for illiterate parent[s]).
  • Subject and parents/legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures.
  • 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.
  • Documented receipt of yellow fever vaccine since at least one month before the first vaccination.

Exclusion Criteria :

  • Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
  • For a female subject of child-bearing potential (girls post-menarche), known pregnancy.
  • For a female subject of child-bearing potential (girls post-menarche), known pregnancy or positive pregnancy test 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 participation in another clinical trial during the trial.
  • 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 vaccines components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
  • Systemic hypersensitivity to YF vaccine or history of a life-threatening reaction to YF vaccine.
  • Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
  • Current or past alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures.
  • Receipt of any blood or blood-derived products in the past 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.
  • Human Immunodeficiency Virus, hepatitis B antigen, or hepatitis C seropositivity in blood sample taken at Screening.
  • Clinically significant laboratory abnormalities (as determined by the Investigator) in blood sample taken at Screening.
  • Known previous vaccination with pneumococcal polysaccharide vaccine.
  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: NCT00788151

Locations
Peru
Chulucanas Morropon, Piura, Peru
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Monitor Sanofi Pasteur Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00788151     History of Changes
Other Study ID Numbers: CYD24
Study First Received: November 7, 2008
Last Updated: September 18, 2014
Health Authority: Peru: General Directorate of Pharmaceuticals, Devices, and Drugs

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

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

ClinicalTrials.gov processed this record on October 22, 2014