Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Subjects
|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|
|Primary Completion Date :||August 2014|
|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 ]
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|