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Safety and Immunogenicity of Formulations of Dengue Vaccines in Healthy Flavivirus-Naïve Adults

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ClinicalTrials.gov Identifier: NCT00740155
Recruitment Status : Completed
First Posted : August 22, 2008
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE May 7, 2008
First Posted Date  ICMJE August 22, 2008
Last Update Posted Date March 3, 2015
Study Start Date  ICMJE August 2008
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2008)
Safety: To provide information concerning the safety of ChimeriVax™ Dengue Vaccine [ Time Frame: 12 months post-vaccination ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00740155 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity of Formulations of Dengue Vaccines in Healthy Flavivirus-Naïve Adults
Official Title  ICMJE Safety and Immunogenicity of Bivalent and Tetravalent Formulations of Dengue Vaccine Candidates in Healthy Flavivirus-Naïve Adults Aged 18 to 45 Years
Brief Summary

This is part of an ongoing effort to develop a satisfactory dengue vaccine:

Primary objective:

To describe the safety after each vaccination with bivalent and tetravalent formulations of dengue vaccine candidates.

To describe the immune response after each vaccination of dengue vaccine.

Detailed Description Subjects will be randomized to five groups to receive assigned vaccines and followed up for 12 months.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Dengue Virus
  • Dengue Fever
  • Dengue Hemorrhagic Fever
  • Dengue Diseases
Intervention  ICMJE
  • Biological: Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero)
    0.5 mL, Subcutaneous (SC) (CYD-1,3 Day 0; CYD-2,4 Day 105)
  • Biological: Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero)
    0.5 mL, Subcutaneous (SC) (CYD-1,3 + CYD-2,4 on Day 0 and Day 105)
  • Biological: Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero)
    0.5 mL, Subcutaneous (SC) (Day 0 and Day 105)
  • Biological: Tetravalent CYD-1,2,3,4 Dengue (Vero)
    0.5 mL, Subcutaneous (SC) (Day 0 and Day 105)
  • Biological: JE-VAX®: Japanese encephalitis virus vaccine inactivated + Tetravalent CYD-1,2,3,4 Dengue (Vero)
    0.5 mL, Subcutaneous (SC) (JE-VAX® Day 0 + Tetravalent CYD-1,2,3,4 on Day 105)
    Other Name: JE-VAX®
Study Arms  ICMJE
  • Experimental: Group 1
    Intervention: Biological: Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero)
  • Experimental: Group 2
    Intervention: Biological: Bivalent CYD-1,3 Dengue (Vero) + Bivalent CYD-2,4 Dengue (Vero)
  • Experimental: Group 3
    Intervention: Biological: Tetravalent blending VDV-2/CYD-1,3,4 Dengue (Vero)
  • Experimental: Group 4
    Intervention: Biological: Tetravalent CYD-1,2,3,4 Dengue (Vero)
  • Active Comparator: Group 5
    Intervention: Biological: JE-VAX®: Japanese encephalitis virus vaccine inactivated + Tetravalent CYD-1,2,3,4 Dengue (Vero)
Publications * Dayan GH, Galán-Herrera JF, Forrat R, Zambrano B, Bouckenooghe A, Harenberg A, Guy B, Lang J. Assessment of bivalent and tetravalent dengue vaccine formulations in flavivirus-naïve adults in Mexico. Hum Vaccin Immunother. 2014;10(10):2853-63. doi: 10.4161/21645515.2014.972131.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2010)
154
Original Estimated Enrollment  ICMJE
 (submitted: August 21, 2008)
150
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria :

  • Healthy as determined by medical history, clinical examination, and biological safety parameters
  • Aged 18 to 45 years on the day of inclusion.
  • Informed consent form signed.
  • Able to attend all scheduled visits and to comply with all trial procedures
  • For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination and at least 4 weeks after the last vaccination.

Exclusion Criteria :

  • History of thymic diseases or thymectomy.
  • For a woman of child-bearing potential, known or suspected pregnancy or positive pregnancy test
  • Breast-feeding
  • Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures.
  • Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
  • Human Immunodeficiency Virus (HIV), Hepatitis B (HBs Ag) or Hepatitis C (HC) seropositivity in blood sample taken at screening.
  • Laboratory abnormalities considered clinically significant upon the Investigator's judgment or above the intensity thresholds (defined in the protocol) in blood sample taken at screening.
  • Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Previous residence in or travel of more than 2 weeks to areas with high dengue infection endemicity.
  • Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances (i.e. egg, egg products, proteins of rodent or neural origin, gelatin, and thimerosal.
  • History of urticaria after hymenoptera envenomation.
  • History of flavivirus infection as reported by the subject.
  • Previous vaccination against flavivirus diseases (including Japanese encephalitis, tick-borne encephalitis, and yellow fever).
  • Planned travel during the present trial period to areas with high dengue infection endemicity.
  • Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term (at least 2 weeks within the previous 3 months) systemic corticosteroid therapy (at a dose of a t least 10 mg).
  • Chronic illness at a stage that could interfere with trial conduct or completion.
  • Blood or blood-derived products received in the past 3 months.
  • Any vaccination in the 4 weeks preceding the first trial vaccination.
  • Vaccination planned in the 4 weeks following any trial vaccination.
  • Flavivirus vaccination planned during the present trial period.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00740155
Other Study ID Numbers  ICMJE CYD11
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP