Safety and Immunogenicity of the Dengue Virus Vaccine TV005 (TetraVax-DV TV005) in Healthy Adults, Adolescents, and Children in Dhaka, Bangladesh

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02678455

Recruitment Status : Completed

First Posted : February 9, 2016

Last Update Posted : August 6, 2020

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborators:

University of Vermont

Johns Hopkins Bloomberg School of Public Health

Information provided by (Responsible Party):

National Institute of Allergy and Infectious Diseases (NIAID)

Results Submitted - Not Posted on ClinicalTrials.gov

Results information has been submitted to ClinicalTrials.gov by the sponsor or investigator, but is not yet publicly available (or "posted") on ClinicalTrials.gov. The submitted information may not be available if it is pending Quality Control (QC) Review by the National Library of Medicine (NLM) or if issues identified during QC review are being addressed or corrected by the sponsor or investigator. NLM's limited QC review assesses for apparent errors, deficiencies, or inconsistencies. NLM staff do not verify the scientific validity or relevance of the submitted information.

Recruitment Status :	Completed
Actual Primary Completion Date :	August 10, 2017
Actual Study Completion Date :	February 5, 2020

Submission Cycle	Results Submitted to ClinicalTrials.gov	Results Returned after Quality Control Review
1	February 20, 2024	March 20, 2024

Publications:

Podder G, Breiman RF, Azim T, Thu HM, Velathanthiri N, Mai le Q, Lowry K, Aaskov JG. Origin of dengue type 3 viruses associated with the dengue outbreak in Dhaka, Bangladesh, in 2000 and 2001. Am J Trop Med Hyg. 2006 Feb;74(2):263-5.

Kirkpatrick BD, Durbin AP, Pierce KK, Carmolli MP, Tibery CM, Grier PL, Hynes N, Diehl SA, Elwood D, Jarvis AP, Sabundayo BP, Lyon CE, Larsson CJ, Jo M, Lovchik JM, Luke CJ, Walsh MC, Fraser EA, Subbarao K, Whitehead SS. Robust and Balanced Immune Responses to All 4 Dengue Virus Serotypes Following Administration of a Single Dose of a Live Attenuated Tetravalent Dengue Vaccine to Healthy, Flavivirus-Naive Adults. J Infect Dis. 2015 Sep 1;212(5):702-10. doi: 10.1093/infdis/jiv082. Epub 2015 Mar 22.

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