Status:
COMPLETED
Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US
Lead Sponsor:
Sanofi
Conditions:
Dengue Fever
Dengue Hemorrhagic Fever
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
Brief Summary
This study used 3 different formulations of tetravalent CYD dengue vaccine. The primary objective of the study was to evaluate the neutralizing antibody response after 2 doses of two different formul...
Detailed Description
All participants provided blood samples for immunogenicity assessments, while vaccine viremia was assessed in a subset of participants in each group. Safety was assessed in all participants as follow...
Eligibility Criteria
Inclusion
- Healthy, as determined by medical history, clinical examination, and biological safety parameters.
- Aged 18 to 45 years on the day of inclusion.
- Provision of informed consent signed by the participant or another legally acceptable representative.
- 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 until at least 4 weeks after the last study vaccination.
- Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion
- Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
- For a woman of child-bearing potential, known or suspected pregnancy or positive serum/urine pregnancy test.
- Breast-feeding woman.
- 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 present trial period.
- 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 (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 10 mg). Topical steroids were allowed.
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine 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 or past alcohol abuse or drug addiction that may interfere with the participant'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.
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
- Planned receipt of any vaccine in the 4 weeks following each of the trial vaccinations.
- Human Immunodeficiency Virus (HIV), hepatitis B surface antigen, or hepatitis C virus seropositivity in blood sample taken at Screening.
- Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
- Clinically significant laboratory test abnormalities (as determined by the investigator) in blood sample taken at Screening.
- Previous residence in, travel or planned travel of more than 2 weeks during the study period to areas with high dengue infection endemicity.
- Reported history of flavivirus infection as reported by the participant.
- Previous vaccination against flavivirus diseases (including Japanese encephalitis, tick-borne encephalitis, and yellow fever).
- Flavivirus vaccination planned during the trial period.
Key Trial Info
Start Date :
April 17 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00617344
Start Date
April 17 2008
End Date
February 1 2010
Last Update
June 11 2019
Active Locations (5)
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1
Investigational Site 004
Hoover, Alabama, United States, 35126
2
Investigational Site 002
San Diego, California, United States, 92103
3
Investigational Site 005
Vallejo, California, United States, 94589
4
Investigational Site 001
New Orleans, Louisiana, United States, 70119