Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549530
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Open-label Multicenter Immunogenicity and Safety Study of MVA-BN Vaccine in Children From 2 Years to Less Than 12 Years of Age Compared to Adults for the Prevention of Smallpox Mpox and Related Orthopoxvirus Infections
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Open-label Multicenter Immunogenicity and Safety Study of MVA-BN Vaccine in Children From 2 Years to Less Than 12 Years of Age Compared to Adults for the Prevention of Smallpox Mpox and Related Orthopoxvirus Infections
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
All participants will receive 2 vaccinations of the same dose of Modified Vaccinia Ankara Virus MVA-BN vaccine 4 weeks apart standard regimen
Serum samples for assessment of immune response will be collected at baseline visit of first vaccination and at 2 weeks week 6 6 months week 30 and 1 year after the second last vaccination
Serum samples for assessment of immune response will be collected at baseline visit of first vaccination and at 2 weeks week 6 6 months week 30 and 1 year after the second last vaccination
Detailed Description:
Both treatment groups will start with enrollment after all study approvals are in place For the pediatric group enrollment will open for both age subgroups children 6 to 12 years of age and 2 to 6 years of age at the same time An independent data monitoring committee DMC then will review reactogenicity and adverse events AEs from both children and adults after at least 10 children in each age subgroup have received the first vaccination and have completed the visit 1 week later If the DMC assesses the safety data to be positive the pediatric age subgroups can be opened to full enrollment
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