Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease

Sanofi

Status

Completed

Conditions

Diphtheria

Polio

Haemophilus Infections

Pertussis

Tetanus

Treatments

Biological: DTaP-IPV/Hib

Study type

Observational

Funder types

Industry

Identifiers

NCT00855855

M5A15

Details and patient eligibility

About

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

Full description

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).

Enrollment

20,830 patients

Sex

All

Ages

Under 59 months old

Volunteers

Accepts Healthy Volunteers

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

Not applicable.