NCT00855855

Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20,830 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 59 Months
• Healthy volunteers: Accepted

Summary

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

Detailed 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).

Conditions

• Haemophilus Infections
• Diphtheria
• Tetanus
• Polio
• Pertussis

Interventions

Type	Name	Description
BIOLOGICAL	DTaP-IPV/Hib	0.5 mL, Intramuscular

Timeline

• Start date: 2009-02-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2009-03-04
• Last updated: 2022-04-25

Locations

59 sites across 1 country: United States