Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease
To monitor the occurrence of invasive Hib disease over time and to determine product-specific rates of invasive Hib disease within the monitored population.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||Surveillance for Rates of Hib Disease Among Persons 0 Through 59 Months of Age Receiving Pentacel® or Other Hib Vaccines|
- The rate of invasive Hib disease among persons within the population monitored by the Active Bacterial Core surveillance program. [ Time Frame: Entire study period ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Participants has received at least one dose of an Hib vaccine
0.5 mL, Intramuscular
The purpose of the study is to conduct surveillance for Hib disease.
Prospective active population-based surveillance for invasive Hib disease, conducted by the Center for Disease Control and Prevention (CDC) Active Bacterial Core (ABCs) program within geographic regions currently representing 12% of the US population, will provide Hib case-occurrence (numerator) data.
The ABCs program and the National Center for Health Statistics will provide annual estimates of the number of persons under surveillance, by age group, within the ABCs catchment area.
Ongoing telephone sample surveys, conducted by M/A/R/C, a national sampling organization, will provide brand-specific vaccine exposure data by age group within the ABCs program catchment area at appropriate pre-specified intervals (denominator data).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855855
Show 59 Study Locations
|Study Director:||Medical Director||Sanofi Pasteur Inc.|