Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00325156
Status:
COMPLETED
Last Update Posted:
2020-01-02
First Post:
2006-02-08
Brief Title:
Assess the Safety Reactogenicity of DTPa-IPVHib Vaccine Administered at 3 4 5 18 Mths of Age in Healthy Infants
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
An Open Multicentric Post-marketing Surveillance Study to Assess the Safety and Reactogenicity of GlaxoSmithKline Biologicals DTPa-IPVHib Vaccine Administered at 3 4 5 and 18 Months of Age in Healthy Infants
Status:
COMPLETED
Status Verified Date:
2019-12
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:
To assess the safety and reactogenicity of the DTPa-IPVHib vaccine as primary and booster vaccination The DTPa-IPVHib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals rotavirus vaccine or Placebo
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
Single group study Subjects in GSK Biologicals rotavirus study Rota-028 in Singapore will be enrolled in this study 3-4-5 month schedule with a booster dose at 18 months
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 |
|---|---|---|---|
| 2015-001512-35 | EUDRACT_NUMBER | None | None |