Clinical trial NCT01843621: A Phase I/II Trial of a Tetravalent Live Attenuated DEN Vaccine in Flavivirus Antibody Naive Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dengue
Keywords: Dengue, Vaccine, Thailand
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
Collaborators: name: GlaxoSmithKline
First posted: 2013-04-30
Enrollment: 7
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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?

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
timeFrame: Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3
measure: Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)
timeFrame: Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3
Secondary outcomes:
measure: Solicited Local Adverse Events (AEs) Within 21 Day Follow-up
timeFrame: 21 days
measure: Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination
timeFrame: 31 days
measure: Serious Adverse Events (SAE) Within 31 Days Post Vaccination
timeFrame: 31 days
measure: Abnormal Findings Reported During Physical Exam 31-Days Post Vaccination
timeFrame: 31 days
measure: Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster
timeFrame: Prebooster year 1, 30 Days Post Booster, Year 2, Year 3
measure: Presence of Dengue Viremia 10 Days After the Dengue Vaccine Dose
timeFrame: 10 days
measure: Flavivirus Infection in Terms of Dengue Immunoglobulin M and Immunoglobulin G Per Subject (ATP Cohort for Immunogenicity)
timeFrame: 1 year, 30 Days Post Booster, 2 years
measure: Subject Biochemistry and Hematology Parameters Monitored for Alert Levels
timeFrame: Year 1 (day 0); Year 1 (day 30); Year 2
Other outcomes:
Locations:
city: Phayathai
country: Thailand
facility: Department of Pediatrics, Phramongkutklao Hospital
state: Bangkok
Study officials:
affiliation: Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand
name: Sriluck Simasathien, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Armed Forces Research Institute of Medical Sciences (AFRIMS), Bangkok, Thailand
name: Robert Gibbons, M.D.
role: PRINCIPAL_INVESTIGATOR
References: