Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease



Status:Active, not recruiting
Conditions:Infectious Disease, Hematology
Therapuetic Areas:Hematology, Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:2/8/2018
Start Date:February 2009
End Date:July 18, 2018

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Surveillance for Rates of Hib Disease Among Persons 0 Through 59 Months of Age Receiving Pentacel® or Other Hib Vaccines

To monitor the occurrence of invasive Hib disease over time and to determine product-specific
rates of invasive Hib disease within the monitored population.

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).

Inclusion Criteria:

- Residence within the geographic scope of Active Bacterial Core surveillance (ABCs)
during the period of surveillance

- Aged 0 through 59 months (prior to 5th birthday) on the day of inclusion for Hib
disease surveillance and 2 through 23 months (prior to 2nd birthday) for Hib vaccine
brand usage survey.

- 2009-2014 calendar years inclusive.

- For the Hib vaccine usage survey, agreement to complete the required survey.

Exclusion Criteria:
We found this trial at
59
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