Safety and Immunogenicity of Formulations of Dengue Vaccines in Healthy Flavivirus-Naïve Adults
Safety and Immunogenicity of Bivalent and Tetravalent Formulations of Dengue Vaccine Candidates in Healthy Flavivirus-Naïve Adults Aged 18 to 45 Years
1 other identifier
interventional
154
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2008
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2008
CompletedStudy Start
First participant enrolled
August 1, 2008
CompletedFirst Posted
Study publicly available on registry
August 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedMarch 3, 2015
March 1, 2015
1.2 years
May 7, 2008
March 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety: To provide information concerning the safety of ChimeriVax™ Dengue Vaccine
12 months post-vaccination
Study Arms (5)
Group 1
EXPERIMENTALGroup 2
EXPERIMENTALGroup 3
EXPERIMENTALGroup 4
EXPERIMENTALGroup 5
ACTIVE COMPARATORInterventions
0.5 mL, Subcutaneous (SC) (CYD-1,3 Day 0; CYD-2,4 Day 105)
0.5 mL, Subcutaneous (SC) (Day 0 and Day 105)
0.5 mL, Subcutaneous (SC) (JE-VAX® Day 0 + Tetravalent CYD-1,2,3,4 on Day 105)
Eligibility Criteria
You may qualify if:
- Healthy as determined by medical history, clinical examination, and biological safety parameters
- 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.
You may not qualify if:
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Tlalpan, 14050, Mexico
Unknown Facility
Valle de Chalco, 56613, Mexico
Related Publications (1)
Dayan GH, Galan-Herrera JF, Forrat R, Zambrano B, Bouckenooghe A, Harenberg A, Guy B, Lang J. Assessment of bivalent and tetravalent dengue vaccine formulations in flavivirus-naive adults in Mexico. Hum Vaccin Immunother. 2014;10(10):2853-63. doi: 10.4161/21645515.2014.972131.
PMID: 25483647RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Sanofi Pasteur Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2008
First Posted
August 22, 2008
Study Start
August 1, 2008
Primary Completion
October 1, 2009
Study Completion
January 1, 2010
Last Updated
March 3, 2015
Record last verified: 2015-03