Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-01-01 @ 1:57 AM
Study NCT ID:
NCT01577732
Status:
COMPLETED
Last Update Posted:
2020-01-21
First Post:
2012-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety of GSK Biologicals' Infanrix-IPV+HibTM Vaccine in Healthy Vietnamese Toddlers
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Safety and Reactogenicity of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix-IPV+HibTM) in Healthy Vietnamese Toddlers
Status:
COMPLETED
Status Verified Date:
2020-01
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:
This study aims to evaluate the safety and reactogenicity of a booster dose of Infanrix-IPV+Hib™ when administered to healthy Vietnamese toddlers at 12 to 24 months of age who were vaccinated previously against diphtheria, tetanus, and pertussis diseases within their first six months of lives.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013-002538-18 | EUDRACT_NUMBER | None | View |