Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Subjects in Singapore
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|ClinicalTrials.gov Identifier: NCT00880893|
Recruitment Status : Completed
First Posted : April 14, 2009
Last Update Posted : August 19, 2015
- To evaluate safety after each CYD Dengue vaccination.
- To evaluate the immune response to each CYD Dengue serotype after each vaccination in a subset of subjects.
|Condition or disease||Intervention/treatment||Phase|
|Dengue Fever Dengue Hemorrhagic Fever Dengue Virus Dengue Diseases||Biological: CYD Dengue vaccine Biological: NaCl + influenza virus or hepatitis A vaccine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1198 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Immunogenicity and Large-Scale Safety of Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Singapore|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||June 2015|
Experimental: CYD Dengue Vaccine Group
Participants will receive Sanofi Pasteur's CYD Dengue Vaccine at Day 0, Months 6 and 12, respectively.
Biological: CYD Dengue vaccine
0.5 mL, Subcutaneous on Day 0, Months 6 and 12
Other Name: Sanofi Pasteur's CYD Dengue Vaccine
Sham Comparator: Control Group
Participants will receive a NaCl (placebo) vaccine followed by either 2 Hepatitis A or 2 Influenza vaccines at Months 6 and 12, respectively.
Biological: NaCl + influenza virus or hepatitis A vaccine
0.5 mL, Subcutaneous (Intramuscular - Hepatitis A)
- To provide information concerning the safety of Sanofi Pasteur's CYD Dengue Vaccine. [ Time Frame: 28 days post-vaccination and entire study duration ]
- To provide information concerning the immunogenicity of Sanofi Pasteur's CYD Dengue Vaccine [ Time Frame: 28 following each vaccination ]
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): NCT00880893
|Singapore, Singapore, 119074|
|Singapore, Singapore, 169608|
|Singapore, Singapore, 229899|
|Singapore, Singapore, 308433|
|Singapore, Singapore, 529889|
|Study Director:||Medical Director||Sanofi Pasteur Inc.|