Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-02-27 @ 1:09 AM
Study NCT ID:
NCT02111135
Status:
COMPLETED
Last Update Posted:
2015-07-20
First Post:
2014-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) in Infants Early in Life
Sponsor:
Vaxtrials S.A.
Organization:
Study Overview
Official Title:
Phase II, Observer-blind, Randomized Study on the Safety, Reactogenicity, Immunogenicity and Impact on Intestinal Shedding of a Single Dose of Monovalent High-dose Inactivated Poliovirus Type 2 Vaccine (m-IPV2 HD) or a Single Dose of Standard Trivalent Inactivated Poliovirus Vaccine (t-IPV) When Given Concomitantly With the Third Dose of Bivalent Oral Poliovirus Vaccine (b-OPV) to Infants Early in Life
Status:
COMPLETED
Status Verified Date:
2015-07
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:
IPV005
Brief Summary:
Phase II, observer-blind, randomized study on the safety, reactogenicity, immunogenicity and impact on intestinal shedding of a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD) or a single dose of standard trivalent inactivated poliovirus vaccine (t-IPV) when given concomitantly with the third dose of bivalent oral poliovirus vaccine (b-OPV) to infants early in life
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: