Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00384670
Status:
COMPLETED
Last Update Posted:
2014-02-24
First Post:
2006-10-04
Brief Title:
A Phase III Trial of a Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naïve Children
Sponsor:
US Army Medical Research and Development Command
Organization:
US Army Medical Research and Development Command
Study Overview
Official Title:
A Phase III Trial of a Tetravalent Live Attenuated Dengue Vaccine in Flavivirus Antibody Naïve Children
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the safety reactogenicity and immunogenicity of two doses of the dengue vaccine in Flavi-virus antibody-naive children between 6 and 9 years of age
Detailed Description:
This study was a Phase III open-label trial with one treatment group 7 healthy flavivirus naïve children between the ages of 6 and 7 years residing in Bangkok Thailand Seronegative status was determined by measuring neutralizing N antibody titers to dengue 1-4 and JE virus JE using hemagglutination inhibition HAI 1st and PRNT 2nd assays Titers 10 and 10 respectively were considered negative Enrolled children received two doses of tetravalent dengue vaccine at study months 0 and 6 and two doses of JE vaccine study benefit at study months 7 and 75 Enrolled children attended 20 study visits received 4 injections and 7 venipunctures one additional blood sample for screening In the acute period 1 month following vaccination safety was assessed using symptom diary cards and clinical and laboratory evaluations Viremia was measured 10 days post dengue vaccination Solicited and unsolicited adverse events were assessed for 30 days following each dengue vaccination Serious adverse events were assessed throughout the study period In the case of illness investigators would complete additional clinical and virologic evaluations Dengue vaccine immunogenicity was assessed 30 days following each dengue vaccination using the PRNT50 assay The According to Protocol ATP cohort was determined by evaluating the occurrence of intermittent natural dengue infection using ELISA IgMIgG titer ratios A long-term follow-up of dengue vaccine recipients is described in a separate protocol Dengue-005 protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GSK Dengue-003 | OTHER | GSK | None |
| HSRRBA-12189 | OTHER | None | None |