Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00366340
Status:
COMPLETED
Last Update Posted:
2012-08-08
First Post:
2006-08-17
Brief Title:
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in 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 of the Safety Tolerability and Immunologic Non-Inferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Germany
Status:
COMPLETED
Status Verified Date:
2012-06
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:
The purpose of this study is to assess the safety tolerability and immunogenicity of a 13-valent pneumococcal conjugate 13vPnC vaccine compared to 7-valent pneumococcal conjugate PrevenarPrevenar 7vPnC when given concomitantly with Infanrix hexa at 2 3 4 months infant series and at 11-12 months of age toddler dose in Germany
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