Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00294021
Status:
COMPLETED
Last Update Posted:
2012-09-26
First Post:
2006-02-17
Brief Title:
Long-term Impact of Pneumococcal Conjugate Vaccine on Carriage
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Long-term Impact of the Pneumococcal Conjugate Vaccine on Pneumococcal Nasopharyngeal Colonization and Immune Correlates for Disease Protection
Status:
COMPLETED
Status Verified Date:
2012-09
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:
Pneumococcus is a major cause of morbidity and mortality In 2000 a pneumococcal conjugate vaccine PCV was licensed for use in children and is now part of the routine childhood vaccine schedule PCV is known to reduce invasive disease and protect against nasopharyngeal NP acquisition of vaccine serotype pneumococci it also results in an increased risk of nonvaccine serotype carriage This study proposes to assess the longterm impact of vaccine on NP carriage in a setting where there is intense antibody pressure on the ecology of the pneumococcus A cross sectional study of pneumococcal NP colonization among American Indian children will be combined with surveillance for invasive disease in the same population The purpose is to determine the impact of community wide PCV use on NP colonization and the relationship with invasive disease This longterm safety issue needs to be assessed to fully evaluate the impact of vaccine on NP ecology and invasive disease
Detailed Description:
There are four specific aims for this study 1 to determine the overall and serotype specific prevalence and incidence of pneumococcal carriage among children and adults at high risk for carriage and disease in the era of routine pneumococcal conjugate vaccine PCV use compared with those measures in the same population prior to use of PCV vaccine 2 to characterize the intrafamilial NP transmission of clones among those living with children less than 8 years of age 3 to determine the immune correlates of protection from serotype specific pneumococcal carriage among individuals immunized and not immunized with PCV and 4 to determine the relative invasiveness of serotypes of pneumococcus during an era of widespread PCV use and compare this to the relative invasiveness of serotypes prior to routine use of PCV
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