Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-25 @ 4:31 PM
Study NCT ID:
NCT01988857
Status:
COMPLETED
Last Update Posted:
2018-08-02
First Post:
2013-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Healthy Vietnamese Children
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Safety and Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix™) in Healthy Vietnamese Children
Status:
COMPLETED
Status Verified Date:
2018-06
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 will evaluate the safety and reactogenicity of GSK Biologicals' combined reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™ when given as a single injection to 6-10 year old children. Data that are available globally on the age group from four to six years of age will be used to bridge the age gap in this study and aid in the registration of the vaccine for children from the age of four years.
Detailed Description:
A phase III, single-group, open-label study of GSK Biologicals' vaccine BoostrixTM administered as a booster vaccine dose in healthy Vietnamese children aged 6-10 years. A single booster dose of BoostrixTM will be administered at Visit 1 (Day 0) and subjects will be observed until Visit 2 (Day 30). Safety will be assessed in terms of solicited adverse events (during 4 days post vaccination), unsolicited adverse events (during 31 days post vaccination) and serious adverse event (during the trial period).
This protocol summary was updated following an administrative change of adding the EudraCT number to this study.
This protocol summary was updated following an administrative change of adding the EudraCT number to this study.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|---|
| 2013-003859-37 | EUDRACT_NUMBER | None | View |