Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158795
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2005-09-08
Brief Title:
Assess Safety Reactogenicity of GSK Biologicals Hib Vaccine Co-administered With or Without Chinese DTPw Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Assess the Safety Reactogenicity of GSK Biologicals Hib Vaccine Co-administered With Chinese Local DTPw Vaccine When Compared to Chinese Local DTPw Vaccine Administered Alone in Healthy Infants at 34 5 Mths of Age
Status:
COMPLETED
Status Verified Date:
2017-05
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 safety and reactogenicity of GSK Biologicals Haemophilus influenza type b vaccine co-administered with or without Chinese DTPw vaccine administered alone in healthy infants 3 4 and 5 months of age
Detailed Description:
All subjects will be randomized into two groups One group will receive DTPw vaccine co-administered with Hib and another group will receive DTPw vaccine alone A specific follow-up of solicited local and general symptoms after each vaccination A specific follow-up of unsolicited symptoms after each vaccination Recording of serious adverse events reported during the study period
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