Surveillance Program to Determine Product Specific Rates of Invasive Hib Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00855855|
Recruitment Status : Active, not recruiting
First Posted : March 4, 2009
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment|
|Haemophilus Infections Diphtheria Tetanus Polio Pertussis||Biological: DTaP-IPV/Hib|
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).
|Study Type :||Observational|
|Estimated Enrollment :||510000 participants|
|Official Title:||Surveillance for Rates of Hib Disease Among Persons 0 Through 59 Months of Age Receiving Pentacel® or Other Hib Vaccines|
|Actual Study Start Date :||February 2009|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Participants has received at least one dose of an Hib vaccine
0.5 mL, Intramuscular
- The rate of invasive Hib disease among persons within the population monitored by the Active Bacterial Core surveillance program. [ Time Frame: Up to 6 years post vaccination ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855855
Show 59 Study Locations
|Study Director:||Medical Director||Sanofi Pasteur Inc.|