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Follow-Up Study of Thai Children From Dengue-003 and Evaluation of a Booster Dose of Dengue Vaccine

This study has been completed.

Sponsors and Collaborators: U.S. Army Office of the Surgeon General
GlaxoSmithKline
Information provided by: Walter Reed Army Institute of Research (WRAIR)
ClinicalTrials.gov Identifier: NCT00318916
  Purpose

The purpose of this study is to assess the immunogenicity of a booster dose of tetravalent live attenuated dengue vaccine administered approximately one year following the second dose.


Condition Intervention Phase
Dengue
Biological: Live attenuated tetravalent dengue (DEN) vaccine
Biological: Formulation 17
Phase I
Phase II

MedlinePlus related topics:   Dengue   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Phase I/II, Open, Five-Year, Clinical Follow-Up Study of Thai Children Who Participated in Dengue-003 (" Phase I/II Trial of a Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naive Children ") With Evaluation of a Booster Dose Given One Year After Primary Dengue Vaccination Series

Further study details as provided by Walter Reed Army Institute of Research (WRAIR):

Primary Outcome Measures:
  • Neutralizing antibodies (seropositivity rates and GMTs) to each dengue virus serotype, 30 days after the dengue vaccine booster dose

Secondary Outcome Measures:
  • Safety
  • Occurrence of solicited adverse events (AE) within 21 days follow-up after the dengue vaccine dose; Occurrence of unsolicited non-serious AEs within 31 days (days 0-30) after the dengue vaccine dose;
  • Occurrence of serious adverse events (SAEs) within 31 days (days 0-30) after the dengue vaccine dose;
  • Occurrence of alert values for safety laboratory determinations within 31 days after the dengue vaccine dose;
  • Occurrence of dengue (suspected or confirmed) that prompted evaluation by a physician after the conclusion of Dengue-003 to the one year follow-up visit, and during Dengue-005, (with clinical outcome);
  • Occurrence of hospitalized dengue for five years following the two-dose primary vaccination series;
  • Immunogenicity
  • Flavivirus immunity before administration of the dengue vaccine dose, assessed as the ratio of DEN IgM:IgG by isotype capture EIA in serum collected at the time of vaccination and 30 days after the dengue vaccine booster dose;
  • Tetravalent N antibody, 30 days after the dengue vaccine booster dose;
  • Tetravalent N antibody, assessed the day of dengue vaccine booster dose administration;
  • Neutralizing antibodies (seropositivity rates and GMT) to each dengue virus serotype, before the dengue vaccine booster dose at Visit 1;
  • Presence of dengue viremia 10 days after the dengue vaccine dose;
  • Tetravalent N antibody and neutralizing antibodies (seropositivity rates and GMT) to each dengue virus serotype one year after the booster dose.

Estimated Enrollment:   7
Study Start Date:   February 2005
Estimated Study Completion Date:   March 2006

Detailed Description:

Follow-up of Dengue-003 Study (in Dengue-003; 7 Thai children received two doses of dengue vaccine six months apart followed by two doses of JE vaccine. In this study the same children will receive a booster dose approximately one year after the primary vaccination series. A one year safety follow-up after the primary vaccination series and a 4 year safety follow-up after the booster dose (one visit each year for 4 years) will be conducted. Blood samples will be collected before the booster dose and one month and again one year after the booster.

  Eligibility
Ages Eligible for Study:   7 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Subjects who received two doses of dengue vaccine in the Dengue-003 study.
  • Subjects whose parents sign an informed consent form for participation.

Exclusion Criteria:

  • None
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00318916

Locations
Thailand
Department of Pediatrics, Pharamongkutklao Hospital    
      Bangkok, Thailand, 10400

Sponsors and Collaborators
U.S. Army Office of the Surgeon General
GlaxoSmithKline

Investigators
Principal Investigator:     Mammen P. Mammen, Jr., MD     U.S. Army Medical Component Armed Forces Research Institute of Medical Sciences (USAMC-AFRIMS)    
  More Information


Study ID Numbers:   WRAIR 1159, HSRRB Log No A-13227
First Received:   April 25, 2006
Last Updated:   May 22, 2006
ClinicalTrials.gov Identifier:   NCT00318916
Health Authority:   United States: Food and Drug Administration;   United States: USAMMDA;   Belgium: GSK

Keywords provided by Walter Reed Army Institute of Research (WRAIR):
Dengue  
Attenuated vaccine  

Study placed in the following topic categories:
Virus Diseases
Fever
Antibodies
Hemorrhagic Fevers, Viral
Dengue
Hemorrhagic fever
Viral hemorrhagic fever
Dengue fever
Arbovirus Infections
Dengue Hemorrhagic Fever

Additional relevant MeSH terms:
RNA Virus Infections
Flaviviridae Infections
Flavivirus Infections

ClinicalTrials.gov processed this record on October 06, 2008




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