Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579755
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
A Study of Dengue Tetravalent Vaccine TDV in Adults Age 45 to 60 and 60 to 79 Years
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Placebo-Controlled Older Adults Aged 60 to 79 Years and Open-Label Adults Aged 45 to 60 Years Multicenter Trial to Investigate the Safety and Immunogenicity of a Dengue Tetravalent Vaccine TDV Administered Subcutaneously to Adults and Older Adults With or Without Comorbidities in Endemic Areas for Dengue
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dengue fever is caused by an infection with the dengue virus Vaccination with Dengue Tetravalent Vaccine TDV can help prevent dengue fever Researchers have seen that dengue fever now also happens more often in elderly persons The main aim of this study is to learn more about the side effects of TDV in adult 45 - 60 years and elderly 60 - 79 years persons and about TDVs ability to create an immune response in adult and elderly persons Another aim is to learn about the side effects of TDV in adult and elderly persons in endemic countries who have one or more additional medical conditions called comorbidities such as diabetes mellitus hypertension or a chronic kidney condition
In this study participants will receive 2 vaccinations with TDV the second 3 months after the first
During the study participants will visit their study clinic 5 times
In this study participants will receive 2 vaccinations with TDV the second 3 months after the first
During the study participants will visit their study clinic 5 times
Detailed Description:
None
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