Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444457
Status:
COMPLETED
Last Update Posted:
2012-10-15
First Post:
2007-03-05
Brief Title:
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
A Phase 3 Randomized Active-Controlled Double-blind Trial Evaluating the Safety Tolerability and Immunogenicity of Three Lots of 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United States
Status:
COMPLETED
Status Verified Date:
2012-10
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:
The purpose of this study will be to evaluate safety tolerability and immunogenicity of three lots of 13-valent pneumococcal vaccine given to healthy infants Lots will be studied for consistency of the immune response as well as for non-inferiority and safety as compared to 7-valent Pneumococcal Conjugate Vaccine
Detailed Description:
None
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