Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-30 @ 8:54 PM
Study NCT ID:
NCT01193335
Status:
COMPLETED
Last Update Posted:
2017-05-11
First Post:
2010-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
A Phase 4, Open-label Trial Describing The Safety, Tolerability, And Immunogenicity Of The 13 Valent Pneumococcal Conjugate Vaccine In Preterm Compared To Term Infants
Status:
COMPLETED
Status Verified Date:
2016-09
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 describe the safety, tolerability, and immunogenicity of a 2,3,4 and 12 month schedule of the 13-valent pneumococcal conjugate vaccine when given to preterm infants with concomitant vaccines, compared to infants born at term.There will be a follow-up phase to assess the persistence of the antibody response at 24 and 36 months of age.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: