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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT01843621
First received: April 22, 2013
Last updated: April 26, 2013
Last verified: April 2013

April 22, 2013
April 26, 2013
February 2005
February 2005   (final data collection date for primary outcome measure)
Neutralizing antibodies as measured by plaque reduction neutralization test (seropositivity rates and geometric mean titers [GMTs] to each dengue virus serotype, 30 days after the DEN vaccine booster dose [ Time Frame: 30 days after the DEN vaccine booster dose ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01843621 on ClinicalTrials.gov Archive Site
  • Occurrence of solicited adverse events (AEs) within 21 days follow-up after the DEN vaccine dose [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
  • Occurrence of unsolicited non-serious AEs within 31 days (Day 0-30) after the DEN vaccine dose [ Time Frame: 31 days ] [ Designated as safety issue: Yes ]
  • Occurence of serious adverse events (SAE) within 31 days (Day 0-30) after the DEN dose [ Time Frame: 31 days ] [ Designated as safety issue: Yes ]
  • Occurence of abnormal findings at dengue physical examination after each vaccine dose [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Biochemistry and hematology parameters at Visit 1 (Day 0, year 1 post dose 2), Visit 3 (Day 10), Visit 5 (Month 1) and Visit 6 (Year 2) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To assess the immunogenicity of a booster dose of dengue vaccine administered approximately one year following the second dose [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Tetravalent neutralizing antibody, 30 days after the DEN vaccine booster dose [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Neutralizing antibodies to each dengue virus serotype, before the DEN vaccine booster dose at Visit 1 (Day 0, Year 1 post Dose 2 [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Presence of dengue viremia 10 days after the dengue vaccine dose [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
  • Tetravalent neutralizing antibody and neutralizing antibodies to each dengue virus serotype one and two years after the booster dose [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Neutralizing antibody titers to Japanese encephalitis virus at visit 1 (Day, 0 ,Year 1 post Dose 2), visit 5 (Month 1) and visit 6 ( Year 2) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Flavivirus infection in terms of dengue immunoglobulin M and immunoglobulin G per subject (ATP cohort for immunogenicity) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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?
Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Dengue
  • Biological: F 17
    Other Name: Live attenuated tetravalent dengue (DEN) vaccine
  • Biological: Japanese encephalitis virus
  • Experimental: Post-Transfection F17
    Live attenuated tetravalent dengue (DEN) vaccine
    Intervention: Biological: F 17
  • Experimental: JE
    Japanese encephalitis virus
    Intervention: Biological: Japanese encephalitis virus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
February 2009
February 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who received two doses of DEN vaccine in the Dengue-003 study and whose parents signed an informed consent form were eligible for participation in the five year follow-up study

Exclusion Criteria:

  • None
Both
6 Years to 9 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01843621
A-13227, GSK 103795, WRAIR 1159
Yes
U.S. Army Medical Research and Materiel Command
U.S. Army Medical Research and Materiel Command
GlaxoSmithKline
Principal Investigator: Sriluck Simasathien, M.D. Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand
Principal Investigator: Robert Gibbons, M.D. Armed Forces Research Institute of Medical Sciences (AFRIMS), Bangkok, Thailand
U.S. Army Medical Research and Materiel Command
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP