Ignite Creation Date:
2024-05-06 @ 7:37 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02561871
Status:
COMPLETED
Last Update Posted:
2016-11-01
First Post:
2015-08-21
Brief Title:
A Study to Evaluate the Safety Tolerability and Immunogenicity of Ad26RSVFA2 Followed by Ad35RSVFA2 in Healthy Adult Volunteers
Sponsor:
Crucell Holland BV
Organization:
Crucell Holland BV
Study Overview
Official Title:
Phase 1 First in Human Study to Evaluate the Safety Tolerability and Immunogenicity of Ad26RSVFA2 Followed by Ad35RSVFA2 in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2016-10
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:
The purpose of this study is to assess the safety and tolerability of intramuscular prime-boost regimens of Ad26RSVFA2 given either once or twice followed by Ad35RSVFA2 human adenovirus-vectored vaccine candidate in healthy participants
Detailed Description:
This is a single-center randomized study vaccine assigned to participants by chance placebo-controlled study an inactive substance a pretend treatment with no vaccine in it that is compared in a clinical trial with a vaccine to test if the vaccine has a real effect double-blind neither the researchers nor the participants know what treatment the participant is receiving Phase 1 study in healthy participants The study comprises a 4-week screening period vaccination for each participant on Days 1 85 and 169 a 28-day follow-up period performed after each vaccination and a final visit at Day 337 Approximately 32 Participants will be randomized in parallel in a 332 ratio to 3 treatment groups Group 123 to receive either Ad26RSVFA2 or Ad35RSVFA2 or placebo The study duration will be approximately 52 weeks Blood samples for immunogenicity will be collected Participants safety will be evaluated throughout the study
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 |
|---|---|---|---|
| VAC18192RSV1003 | OTHER | Crucell Holland BV | None |