Status:
COMPLETED
Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Dengue Virus
Dengue Fever
Eligibility:
All Genders
2-45 years
Phase:
PHASE2
Brief Summary
This trial evaluated the use of a tetravalent vaccine against dengue. Primary objectives: * To describe the humoral immune response to dengue before and after each vaccination with tetravalent dengu...
Detailed Description
Safety assessments included solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study pe...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Aged 2 to 45 years on the day of inclusion.
- Provision of Informed Consent/Assent Form signed by the participant (and/or by the parent or another legally acceptable representative for participants \<18 years).
- Participant (and parent/guardian for participants \<18 years) able to attend all scheduled visits and to comply with all trial procedures.
- For a female participant 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.
- Participant 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 participant of child-bearing potential, known pregnancy or positive serum pregnancy test at Screening.
- For a female participant of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of the first injection.
- Breast-feeding female participant.
- 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 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.
- Participant 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).
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00875524
Start Date
March 1 2009
End Date
December 1 2014
Last Update
April 5 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi Pasteur Investigational Site
Long Xuyen, An Giang, Vietnam