NCT01843621

A Phase I/II Trial of a Tetravalent Live Attenuated DEN Vaccine in Flavivirus Antibody Naive Children

A Phase I/II, Open, Five-year, Clinical Follow-up Study of Thai Children Who Participated in Dengue-003 ("A Phase I/II Trial of a Tetravalent Live Attenuated DEN Vaccine in Flavivirus Antibody Naive Children") With Evaluation of a Booster Dose Given One Year After Primary DEN Vaccination Series

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 6 Years – 9 Years
• Healthy volunteers: Accepted

Summary

One year follow-up on immunogenicity and safety of a booster dose of DEN vaccine administered approx. 1 year following the second dose

Detailed description

The purpose of this study is to find out more about the two doses of dengue vaccine, over a five year period, that the children received in the Dengue-003 study and to study a third dose of dengue that will be given to the children * Do children still have dengue antibodies intended to provide protection against dengue infection one year after the two doses of vaccine given in study Dengue-003? * Were there any major medical problems that appeared as dengue-like symptoms during the one year after vaccinations? * Will a third dose of dengue help to further stimulate the part of the immune system intended to help protect against dengue infection? * Is a third dose as safe as the first two doses? * Are the local reactions to a third dose of the vaccine similar to what your child experienced after the first two doses?

Conditions

• Dengue

Interventions

Type	Name	Description
BIOLOGICAL	DEN vaccine F17	The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4).

Timeline

• Start date: 2005-02-01
• Primary completion: 2005-02-01
• Completion: 2009-02-01
• First posted: 2013-04-30
• Last updated: 2018-11-26
• Results posted: 2018-11-26

Locations

1 site across 1 country: Thailand