Efficacy and Safety of Dengue Vaccine in Healthy Children
|ClinicalTrials.gov Identifier: NCT00842530|
Recruitment Status : Completed
First Posted : February 12, 2009
Last Update Posted : September 19, 2014
There is currently no vaccine against dengue and no specific drug treatment against the disease. This study is aimed at generating information on the protective effect of the vaccine.
Primary Objective To assess the efficacy of dengue vaccine after three injections in children.
To evaluate the reactogenicity of dengue vaccine after each injection in a subgroup of children.
|Condition or disease||Intervention/treatment||Phase|
|Dengue Virus Dengue Fever Dengue Hemorrhagic Fever Dengue Diseases||Biological: Chimeric tetravalent dengue (serotype 1, 2, 3, 4) Biological: Inactivated Rabies virus vaccine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4002 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy and Safety of Dengue Vaccine in Healthy Children Aged 4 to 11 Years in Thailand|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||February 2014|
|Experimental: Dengue Vaccine Group||
Biological: Chimeric tetravalent dengue (serotype 1, 2, 3, 4)
0.5 mL, Subcutaneous
Other Name: ChimeriVax™
|Sham Comparator: Control Vaccine Group||
Biological: Inactivated Rabies virus vaccine
0.5 mL, Subcutaneous
Other Name: Verorab®
- Immunogenicity: To provide information concerning the immunogenicity of Dengue Vaccine [ Time Frame: 28 days post-vaccination 3 ]
- Safety: To provide information concerning the safety after administration of 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): NCT00842530
|Muang District, Ratchaburi Province, Thailand|
|Study Director:||Medical Monitor||Sanofi Pasteur Inc.|