Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488800
Status:
COMPLETED
Last Update Posted:
2007-12-28
First Post:
2007-06-18
Brief Title:
Safety and Local Tolerability of Prevenar in Indian Children
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 Postmarketing Surveillance Study Evaluating the Safety and Local Tolerance of PREVENAR in Indian Children
Status:
COMPLETED
Status Verified Date:
2007-12
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:
This postmarketing surveillance study will evaluate the safety profile of Prevenar in Indian children
Prevenar is indicated for active immunization of infants and children from 6 weeks of age through 9 years of age against invasive disease including meningitis bacteraemic pneumonia bacteraemia sepsis caused by Streptococcus pneumoniae serotypes 4 6B 9V 14 18C 19F and 23F
Prevenar has been marketed in India since June 2006 The Board of Health in India has given restricted permission to import and market Prevenar The present study is a post-approval regulatory commitment to the Board of Health in India
This is an observational study and the protocol for the study has been approved by the Board of Health
Prevenar is indicated for active immunization of infants and children from 6 weeks of age through 9 years of age against invasive disease including meningitis bacteraemic pneumonia bacteraemia sepsis caused by Streptococcus pneumoniae serotypes 4 6B 9V 14 18C 19F and 23F
Prevenar has been marketed in India since June 2006 The Board of Health in India has given restricted permission to import and market Prevenar The present study is a post-approval regulatory commitment to the Board of Health in India
This is an observational study and the protocol for the study has been approved by the Board of Health
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