Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT00875524|
Recruitment Status : Completed
First Posted : April 3, 2009
Last Update Posted : January 12, 2015
This trial will evaluate the use of a tetravalent vaccine against dengue.
- To describe the immune response to dengue before and after each vaccination with tetravalent dengue vaccine in adults, adolescents, and children.
- To evaluate the safety of each vaccination with sanofi pasteur's tetravalent dengue vaccine in 4 age cohorts.
- To evaluate the persistence of antibodies against dengue during 5 years after the first vaccination with sanofi pasteur's tetravalent dengue vaccine in the four age cohorts.
|Condition or disease||Intervention/treatment||Phase|
|Dengue Virus Dengue Fever Dengue Hemorrhagic Fever Dengue Disease||Biological: Chimeric dengue serotypes (1, 2, 3, 4). Biological: Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Immunogenicity and Safety of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Viet Nam|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Dengue Group
Participants will receive ChimeriVax™ tetravalent dengue vaccine.
Biological: Chimeric dengue serotypes (1, 2, 3, 4).
0.5 mL, Subcutaneous
Other Name: ChimeriVax™
Sham Comparator: Control Group
Participants will receive Meningococcal Polysaccharide Vaccine A + C, a placebo (NaCl containing human serum albumin), and Typhoid Vi polysaccharide vaccine (Typhim Vi®) as first, second, and third vaccinations, respectively.
Biological: Meningococcal Polysaccharide A+C; NaCl; Typhoid Vi polysaccharide
Each at 0.5 mL, Subcutaneous, respectively
- Immunogenicity: To provide information concerning the immune response to ChimeriVax™ tetravalent dengue vaccine [ Time Frame: 28 days post-vaccination ]
- Safety: To provide information concerning the safety of ChimeriVax™ tetravalent dengue vaccine [ Time Frame: 28 days post-vaccination and entire study duration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00875524
|Long Xuyen City, An Giang Province, Vietnam|
|Study Director:||Medical Monitor||Sanofi Pasteur Inc|