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

This study has been completed.

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by:

Walter Reed Army Institute of Research (WRAIR)

ClinicalTrials.gov Identifier:

NCT00318916

First received: April 25, 2006

Last updated: May 22, 2006

Last verified: April 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

April 25, 2006

Last Updated Date

May 22, 2006

Start Date ^ICMJE

February 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00318916 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Dengue

Intervention ^ICMJE

Biological: Live attenuated tetravalent dengue (DEN) vaccine
Biological: Formulation 17

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

7 Years to 10 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Thailand

Administrative Information

NCT Number ^ICMJE

NCT00318916

Other Study ID Numbers ^ICMJE

WRAIR 1159, HSRRB Log No A-13227

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

U.S. Army Office of the Surgeon General

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Principal Investigator:

Mammen P. Mammen, Jr., MD

U.S. Army Medical Component Armed Forces Research Institute of Medical Sciences (USAMC-AFRIMS)

Information Provided By

Walter Reed Army Institute of Research (WRAIR)

Verification Date

April 2006

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

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