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

Sponsor:	U.S. Army Office of the Surgeon General
Collaborator:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Dengue

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	WRAIR 1159, HSRRB Log No A-13227
Study First Received:	April 25, 2006
Last Updated:	May 22, 2006
ClinicalTrials.gov Identifier:	NCT00318916 History of Changes
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

Additional relevant MeSH terms:

Virus Diseases
Hemorrhagic Fevers, Viral
RNA Virus Infections
Flaviviridae Infections

Flavivirus Infections
Dengue
Arbovirus Infections

ClinicalTrials.gov processed this record on November 30, 2009