Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT01708720
Status:
COMPLETED
Last Update Posted:
2014-02-21
First Post:
2012-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of a New Inactivated Polio Vaccine in Healthy Adults
Sponsor:
Pauline Verdijk
Organization:
Study Overview
Official Title:
Safety and Immunogenicity of Sabin-IPV and Adjuvanted Sabin-IPV in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2014-02
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 trial is to determine whether the new inactivated polio vaccine that is based on attenuated poliovirus strains is safe and to evaluate the immune response in healthy adults.
Detailed Description:
The goal of this study is to assess the safety and immunogenicity of Sabin-IPV and adjuvanted Sabin-IPV produced with the production process set up for technology transfer by the National Institute for Public Health and the Environment (RIVM, formerly the Netherlands Vaccine Institute (NVI).
* The primary objective is to evaluate safety (local and systemic reactions) of intramuscular injection with Sabin-IPV and adjuvanted Sabin-IPV in healthy adults (first in human).
* The secondary objective is to evaluate immunogenicity of Sabin-IPV and adjuvanted Sabin-IPV in healthy immunized adults.
* The primary objective is to evaluate safety (local and systemic reactions) of intramuscular injection with Sabin-IPV and adjuvanted Sabin-IPV in healthy adults (first in human).
* The secondary objective is to evaluate immunogenicity of Sabin-IPV and adjuvanted Sabin-IPV in healthy immunized adults.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2010-024581-22 | EUDRACT_NUMBER | None | View |