NCT01843621

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2005

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 30, 2013

Completed
5.6 years until next milestone

Results Posted

Study results publicly available

November 26, 2018

Completed
Last Updated

November 26, 2018

Status Verified

May 1, 2018

Enrollment Period

Same day

First QC Date

April 22, 2013

Results QC Date

December 29, 2016

Last Update Submit

May 15, 2018

Conditions

Dengue

Keywords

Dengue, Vaccine, Thailand

Outcome Measures

Primary Outcomes (2)

  • Percentage of Subjects With Seropositivity Rates for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)

    Neutralizing antibodies as measured by plaque reduction neutralization test (seropositivity rates to each dengue virus serotype at Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 time points.

    Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3

  • Geometric Mean Titers (GMTs) on All Subjects for Antibodies to DEN-1 - DEN-4 (ATP Cohort for Immunogenicity)

    Neutralizing antibodies as measured by plaque reduction neutralization test (geometric mean titers \[GMTs\]) to each dengue virus serotype at Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3 time points.

    Prebooster Year 1, 30 Days Post Booster, Year 2, and Year 3

Secondary Outcomes (8)

  • Solicited Local Adverse Events (AEs) Within 21 Day Follow-up

    21 days

  • Unsolicited Adverse Events (AEs) Within 31 Days Post Vaccination

    31 days

  • Serious Adverse Events (SAE) Within 31 Days Post Vaccination

    31 days

  • Abnormal Findings Reported During Physical Exam 31-Days Post Vaccination

    31 days

  • Monovalent, Bivalent, Trivalent and Tetravalent Response for Neutralizing Antibodies 30 Days Post Booster

    Prebooster year 1, 30 Days Post Booster, Year 2, Year 3

  • +3 more secondary outcomes

Study Arms (1)

Total vaccinated

EXPERIMENTAL

The total vaccinated cohort included all enrolled subjects who received the DEN vaccine F17 for whom data were available. These subjects were Thai children previously enrolled and vaccinated in study Dengue-003

Biological: DEN vaccine F17

Interventions

DEN vaccine F17BIOLOGICAL

The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4).

Also known as: Live attenuated tetravalent dengue (DEN) vaccine
Total vaccinated

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics, Phramongkutklao Hospital

Phayathai, Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Dengue

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Results Point of Contact

Title
Sriluck Simasathien, MD
Organization
Dept of Pediatrics, Pharmongkutklao Hospital, Bankok, Thailand
ssriluck@yahoo.com
66-2-644-8971

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2013

First Posted

April 30, 2013

Study Start

February 1, 2005

Primary Completion

February 1, 2005

Study Completion

February 1, 2009

Last Updated

November 26, 2018

Results First Posted

November 26, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share

GSK

Locations

TH(1)